Ultimate Resource On Vaccine Boosters
Pfizer Says Booster Shots of Vaccine Restore Waning Immunity. Ultimate Resource On Vaccine Boosters
Pfizer Inc. said that data from the U.S. and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants.
The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots.
“Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier,” Pfizer said in its presentation, which was posted on the FDA website. The drug giant is partnering with Germany’s BioNTech SE to make the shots.
The decrease in effectiveness is “primarily due to waning of vaccine immune responses over time,” rather than the delta variant, Pfizer researchers said in the presentation.
Pfizer shares rose 0.4% as of 11:51 a.m. in New York. BioNTech’s American depositary receipts rose 3.2%. Shares of Moderna Inc., the other maker of a U.S.-cleared messenger RNA vaccine, rose 0.3%.
FDA Staff Report
According to a meeting agenda the FDA posted on its website, the Friday panel meeting will include presentations from the Centers for Disease Control and Prevention, FDA staff, researchers from Israel and the U.K., along with Pfizer.
Marion Gruber, one of two top vaccine officials who FDA recently said will step down later this year, is also scheduled to speak. Gruber was co-author of an article in The Lancet earlier this week arguing that booster shots weren’t yet necessary for most people. The departure of the two longtime agency staffers is a potential sign of friction over the Biden booster plan.
Officials from Israel will present data from that country on booster protection against infections and severe disease, according to the agenda, and a professor of medical statistics from the University of Bristol will present data on real-world vaccine effectiveness.
FDA staff also posted its report for the panel’s consideration Wednesday, summarizing much of the same data that Pfizer presented earlier. Like Pfizer, the staff found that a booster shot of the Pfizer vaccine was safe and raised antibody levels. Still, the staff said it hasn’t yet independently reviewed or verified the underlying data or conclusions of some relevant studies, such as the Israel study, which will be summarized in Friday’s meeting.
The staff’s 23-page briefing paper noted that the likely benefit of a booster shot would depend on how much the third shot reduces disease relative to the first two.
If the first two shots are still highly effective, then the efficacy of the booster shot “is likely to be more limited,” the staff said. Overall data in the U.S. indicate that the first two shots of the vaccine still protect against severe disease and death, the staff said.
The staff also noted that it is not currently clear whether there will be an increased risk of inflammation of the heart and heart lining after a booster shot, and that potential risks of a booster shot also must be considered. It didn’t offer a clear indication of which way the agency was leaning, which it often does before meetings.
While its vaccine continues to provide strong protection against hospitalizations and severe disease in the U.S., Pfizer said in its report, the data from Israel and elsewhere suggest that a reduction in efficacy against infection may be followed by reduced effectiveness against severe disease, especially among vulnerable elderly people.
Early unpublished data from an Israeli health maintenance organization suggest that a third booster dose is highly effective in areas where the delta variant is dominant, according to the Pfizer document. Giving a third dose to people more than 60 years old was associated with 86% effectiveness against testing positive for Covid starting at least a week after the booster, Pfizer said.
Pfizer also detailed immune response results from a final-stage trial of booster shots in over 300 people, showing that a third dose bolstered blood antibody levels. One month after the third dose, levels of the protective antibodies were more than triple what they had been a month after the second shot.
No new unexpected side effects were identified from safety data associated with boosters in the final-stage study, according to the Pfizer report. Consideration of a booster dose six months after a second dose of its shot is warranted, based on similarities between the outbreaks in Israel and the U.S., Pfizer said.
Understanding The Debate Over Covid Booster Shots
With the especially contagious delta variant threatening efforts to end the pandemic, a growing number of wealthy countries are planning to or considering administering booster shots of Covid-19 vaccines, at least to particularly vulnerable groups. U.S. regulators said Sept. 22 that people 65 and over and others at high risk of Covid complications can receive a third dose of the Pfizer Inc.-BioNTech SE vaccine.
Officials at the World Health Organization have characterized the wide rollout of boosters in wealthier countries as unethical as long as poorer countries still lack supplies to cover significant portions of their populations with initial doses.
1. What’s A Booster Shot?
The term traditionally has referred to an additional dose of a vaccine given some time after the initial course of inoculation to bolster protection that may have started to wane. While many vaccines produce long-lasting immunity, the U.S. Centers for Disease Control and Prevention recommends that adults receive boosters of the tetanus vaccine every decade, for example.
For Covid-19, a new disease, researchers are working out the optimal schedule and dosage for a wide variety of vaccines on the fly in the midst of an ongoing pandemic.
The term booster is being used loosely to refer to additional shots given for a variety of reasons to people who have already received the prescribed course of a Covid vaccine, meaning one dose of Johnson & Johnson’s formulation or two doses of any of the others.
With the messenger RNA vaccines, the first two shots were given relatively close together, either three or four weeks apart. If an additional dose is given six months or so after the first two, it may produce longer-lasting immunity, by training the immune system to realize that Covid is a long-term threat.
2. What Are The Reasons?
There’s a small group of people with weakened immune systems, such as transplant recipients, who are likely to need an additional shot sooner rather than later. The extra shot isn’t a traditional booster, as these people likely never get an adequate response to an initial course of Covid vaccine.
For the rest of the population, an additional shot (or shots) may prove to be helpful if immunity wanes over time or if new coronavirus variants emerge that evade vaccine protection. In the first scenario, giving another dose of the original vaccine may be sufficient. That’s mostly what is being considered for the immediate future. In the second scenario, shots customized against new variants may be needed.
3. What Other Countries Have Signed On To Extra Covid Shots?
Germany, France and the United Kingdom are among those that have started or decided to offer them to more vulnerable groups, such as the elderly, those over 50, or those who are immunocompromised. Offering them more broadly to people months after their last dose are Israel, Russia, Hungary and the United Arab Emirates. Some countries plan to give extra shots using a vaccine type that’s different from the one people got initially.
For example, Chile announced plans to offer booster shots from AstraZeneca Plc to people 55 and older who earlier received the vaccine from Sinovac Biotech Ltd. This mix-and-match strategy is called a heterologous boost, and there’s some evidence it can provide an advantage over an additional dose of the same formulation.
4. What’s Motivated The Move To Boosters?
The rise of the delta strain, combined with some preliminary data suggesting that Covid vaccine effectiveness may decline relatively quickly, has intensified the focus on booster shots. In Mesa County, Colorado, where delta took off earlier than in other parts of the state, a study by state health officials found that vaccines were 78% effective in a two-week period ending June 5, versus 89% in other counties.
And an observational study from Israel, one of the first countries to vaccinate most of its population, suggested that a third dose of the Pfizer-BioNTech shot dramatically boosted protection in people 60 and over, at least in the short term. According to the data published in the New England Journal of Medicine, confirmed infection rates were 11 times lower in the booster group compared to those who had only gotten the standard two doses starting 12 days after the third dose.
A separate analysis of data from the final-stage trial of the Pfizer-BioNTech vaccine showed that efficacy eased to about 84% at the end of a six-month period compared with 96% early on.
5. Is Everything Pointing Toward A Need For Boosters?
No. Moderna Inc. said on Aug. 5 that data from its final-stage trial showed its vaccine remained 93% effective through six months, just one percentage point less than the initial shorter term results. (Moderna does say it expects protection to wane over time, and it has applied for emergency clearance in the U.S. for a third shot.)
A U.K. study published in the New England Journal of Medicine in July found that the Pfizer-BioNTech vaccine was 88% protective against symptomatic cases of the delta variant, while AstraZeneca’s vaccine was 67% effective.
In September, a published analysis of data from 21 US hospitals in 18 states found that while the Pfizer-BioNTech vaccine declined in protection against hospitalization after about four months, protection from Moderna’s shot remained stable.
6. How Are Decisions About Boosters Made?
It’s a judgment call by public health officials, since there’s no scientific consensus for when booster shots become necessary. In the U.S., the Food and Drug Administration official in charge of vaccine regulation, Peter Marks, has said that the U.S. doesn’t have a “predetermined minimum” for how much efficacy must fade before it authorizes booster shots and will look at the totality of the evidence before making decisions.
7. What Are The Objections?
“It would be unconscionable to offer people already fully vaccinated another dose before protecting people who haven’t been vaccinated at all,” the global nonprofit Doctors Without Borders said in a July 22 statement.
Epidemiologists warn that allowing the coronavirus to continue to run rampant in some parts of the world increases the odds that more dangerous variants will arise.
Those new variants may make their way across the globe and prolong the pandemic. Drug companies with a financial interest in selling more doses have been some of the loudest voices talking up the need for boosters.
And Covid vaccines seem to be holding up well in achieving their key goals — preventing severe disease, hospitalization and death — even if they aren’t quite as effective at blocking milder cases of symptomatic infection with delta.
In the U.S., for example, as of Sept. 13, only about 15,800 patients with Covid vaccine breakthrough infections had been hospitalized or died, a tiny fraction of the total hospitalizations and deaths, according to the CDC.
8. Is It Possible To Expand The Vaccine Supply?
White House spokeswoman Jennifer Psaki has called the WHO’s position that rich countries should put boosters on hold until poor countries vaccinate more of their population a “false choice.” The U.S. can both donate vaccines abroad and provide boosters domestically if regulators recommend them, she said Aug. 4. But in reality, the Covid vaccine supply is limited, and wealthier countries have bought up a hugely disproportionate share of the available shots.
In September, Covax, the global program to immunize the world against Covid, cut its 2021 supply forecast by 25%, citing hurdles in production and other constraints. The 5.95 billion doses given as of Sept. 19 is only enough to fully vaccinate just under 38.7% of the world population, according to the Bloomberg Vaccine Tracker.
Countries and regions with the highest incomes are getting vaccinated more than 20 times faster than those with the lowest. At the current rate of giving shots, it will take six months to cover 75% of the world population, according to the tracker.
How Many Boosters Will We Need? Israel Says Too Soon To Know
Researchers from Israel told a panel of U.S. vaccine experts weighing a potential Covid-19 booster dose from Pfizer Inc. and BioNTech SE on Friday that it’s unclear how long the benefit of such a shot would last.
A big part of the case for booster shots is data from Israel showing that, in the short term, a third dose of the vaccine dramatically lowered infections and severe illness in the short term in people over age 60 and older.
However, it isn’t yet clear whether the enhanced protection boosters could provide would be short-lived, or if the benefit would be lasting.
When asked by members of a Food and Drug Administration advisory panel whether more shots would be needed to keep Covid-related illness away, the Israeli scientists said it was simply too soon to know.
“This is very early, we can’t really tell,” said Sharon Alroy-Preis from the Israel Ministry of Health. “It is not really clear where this is going.”
FDA Panel Recommends Pfizer’s COVID-19 Booster For 65 And Older, But Not For The General Public
Advisors also recommend booster for high-risk adults.
A group of advisors to the Food and Drug Administration on Friday reframed a proposed approval of BioNTech and Pfizer’s COVID-19 booster for the general population, and it instead recommended authorization of an additional dose of the vaccine to people at least 65 years old and those at high risk for severe disease.
The decision to recommend a booster for older adults and at-risk people came after the FDA’s Vaccines and Related Biological Products Advisory Committee voted against a broader FDA approval of the BioNTech and Pfizer booster for people who are at least 16 years old and vaccinated six months ago.
The FDA isn’t required to follow the advice of the committee but often does.
“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” Dr. Cody Meissner, director of pediatric infectious disease at Tufts Medical Center and a committee member, said during Friday’s meeting.
Pfizer’s shares and BioNTech’s American depositary receipts closed 1.3% and 3.6% lower on Friday and extended their losses into the after-hours session.
“I suspect that many of us are heading toward the suggestion that we can confine vaccination at this point,” said Dr. Eric Rubin, adjunct professor of the department of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.
Several committee members debated different ages to begin rolling out boosters, including 50, 60, and 65 years old.
The next step is to wait and see whether the FDA decides to approve or authorize the booster, as the nation heads toward President Joe Biden’s target date of Sept. 20 to begin rolling out extra doses to people who were vaccinated with the two-dose mRNA shots. If an FDA approval happens, the Centers for Disease Control and Prevention will also weigh in.
Moderna Inc. has also submitted an application for authorization of a booster dose. Johnson & Johnson has not filed for a booster at this time. Of the three available COVID-19 vaccines in the U.S., BioNTech and Pfizer’s is the furthest ahead in the regulatory process.
Why Some Physicians Have Concerns About COVID-19 Booster Shots
Unlike the initial authorizations of those vaccines, which were widely supported, there has been a lot more debate among scientists, researchers, and public-health experts about whether boosters are needed at all or at this time, or if they should only be made available to more vulnerable populations, like the elderly.
There are also lingering questions about the clinical data used to inform Pfizer’s application.
One of the main sticking points for scientists is that most of the COVID-19 hospitalizations and deaths in the U.S. are occurring among the unvaccinated. And even though the number of breakthrough cases among the vaccinated is increasing, it still means the vaccines are working.
Separately, many of the real-world learnings that the U.S. is relying on come from Israel, which has widely rolled out a third dose of Pfizer’s vaccine in recent months to ward off the surging delta variant there. (Israel and Pfizer have a data-sharing agreement, and Pfizer’s shot is the primary vaccine administered in Israel.)
“If we had not started booster doses at the end of July, we would have come to the capacity of Israel’s hospitalization capabilities,” Dr. Sharon Alroy Preis, the Israeli Ministry of Health’s director of public health services, said during the meeting.
But even with compelling data coming out of Israel, there are some very specific differences between Israel and the U.S., including the fact that Israel’s definition of severe disease is different than the one used in the U.S.
In Israel, officials count elevated respiratory rate or an oxygen level below 94% as severe disease, according to Sara Oliver, a CDC official who leads the COVID-19 vaccines work group. The U.S. classifies severe disease as occurring in those who have been hospitalized, care for in an intensive care unit, or dying.
Why the COVID-19 Booster Debate Is So Complicated
Giving someone a booster will increase their neutralizing antibody titers, an important metric for immunity. The drug makers behind all three vaccines have said this.
“T-cell responses are really not important when we look at infection,” Kathrin Jansen, Pfizer’s head of vaccine research and development, said. “It is clear that neutralizing antibodies are responsible to prevent the infection.”
But there are also concerns that a third dose puts people at risk for rare but serious side effects, like myocarditis, though Israeli officials said only one case of the heart condition had been reported in booster recipients.
“I have a serious concern about myocarditis and young people, if it’s related to the immune response,” Dr. James Hildreth, CEO of Meharry Medical College and a temporary voting member of the committee. “And the booster shots induce a very strong response in those in those individuals.”
Fauci Says More Data Likely To Support Broader U.S. Booster Plan
President Joe Biden’s chief medical adviser said booster shots for more of the U.S. population remain a possibility soon, as additional data on the still-widening outbreak come in.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, spoke two days after an advisory panel to the U.S. Food and Drug Administration rejected a national rollout of boosters for all ages, approving them only for people 65 and older and those who are medically vulnerable.
“The story is not over because more and more data is coming in and will be coming in,” Fauci said Sunday on ABC’s “This Week.”
Last month, Biden said a broad booster plan would begin on Monday. The panel’s narrower recommendation on Friday was seen as rebuke to a president whose policy was getting ahead of the science.
Fauci said he did not believe the panel “made a mistake.”
“The one thing people need to realize is data are coming in literally on a daily and weekly basis,” he said on CNN’s “State of the Union.” “They are going to continue to look at this literally in real-time.”
The FDA panel approved limited third shots for the vaccine by Pfizer Inc. and BioNTech SE. Fauci said on ABC he expected booster data from Moderna Inc. and Johnson & Johnson would likely be evaluated in “a couple of weeks.”
He said he expected vaccines for children younger than 12, who aren’t eligible yet, would be evaluated as early as October.
Requiring vaccines on airlines, a policy Fauci has said he personally supports, remains a possibility.
“Everything is on the table,” he said NBC’s “Meet the Press.” “We consider these things literally on a daily basis.”
CVS Makes Hiring Push (25,000 New Jobs) Amid Worker Shortage, Increased Covid-19 (Booster) Vaccine Demand
Pharmacy chain plans to add 25,000 people this week as stores struggle with long lines, frustrated customers.
CVS Health Corp., one of the biggest U.S. providers of Covid-19 tests and vaccines, is racing to hire thousands of workers as staffing shortages prompt stores to close drive-through lanes and at times turn away customers seeking shots.
The largest U.S. pharmacy chain by stores said it plans to add 25,000 employees this week in a single-day hiring spree to prepare for a potential surge in demand from booster shots and as more people seek Covid-19 tests and flu vaccines.
CVS employees and customers at some locations have described chaotic stores, hourslong lines and phones that go unanswered as the chain addresses a national labor shortage. Companies in sectors from retail to manufacturing are having a hard time filling jobs, leading to deteriorating service, production slowdowns and burnout among staff.
The worker shortfall at CVS, also hitting rival Walgreens Boots Alliance Inc., is being exacerbated by rising demand for Covid-19 tests as people begin to seek flu vaccines ahead of what health officials predict will be a severe influenza season.
“This is testing our role in the community,” said Neela Montgomery, who has been president of CVS’s pharmacy retail unit since November. “But provided we staff up the way we intend to, we’re going to make our way through this.”
Ms. Montgomery said CVS is administering more tests than it was at the height of the pandemic as Covid-19 cases rise and as more employers, schools and other entities require unvaccinated workers, students and customers to produce negative test results.
Demand for flu shots is already higher than usual, she said, and the company didn’t initially anticipate that the booster-shot rollout would converge with flu season. A U.S. Food and Drug Administration advisory panel on Friday endorsed booster shots of the Covid-19 vaccine for adults older than 65 years and those at high risk of severe disease.
CVS employees, in interviews and posts on social media, have described short-staffed pharmacies, customers lashing out during long waits and workers quitting out of stress.
Kate-Madonna Sieger, of Lakeville, Minn., said that when her 9-year-old son exhibited potential Covid-19 symptoms a few weeks ago, she visited three CVS pharmacies and each said there was no pharmacist on duty to administer a test. Ms. Sieger, 39, who is receiving treatment for breast cancer, also said she received an expired, but ultimately harmless, prescription last month from the CVS she regularly frequents.
“I called the pharmacist to ask him how this could have happened and he said, ‘We’re really short-staffed, and we’re really sorry,’” she said. “I have nothing against CVS but that’s concerning.”
A CVS spokesman said staffing issues aren’t systemic.
“We’re always going to have in pockets some staffing issues that may unfortunately cause some service issues,” Ms. Montgomery said. “But we are very focused on deploying district and regional teams to support those stores when they are understaffed. That is one of the advantages of having 10,000 stores.”
Walgreens, which has shortened store operating hours in some cases because of staffing shortages, on Friday announced cash awards to pharmacists and pharmacy technicians. A company spokeswoman said Walgreens overall had had, “minimal disruption.”
The company will pay $1,000 “certification awards” to be paid out over a six-month period to pharmacy technicians who are or become certified to administer flu and Covid-19 vaccines, along with bonuses of $1,250 for full-time pharmacists and $1,000 to part time pharmacists.
The U.S. has relied heavily on retail pharmacies for nationwide Covid-19 testing and vaccine distribution through a federal partnership with nearly two dozen retail pharmacy chains, including Walmart Inc., Kroger Co. and Rite Aid Corp., as well as CVS and Walgreens.
The participating companies have administered roughly one-third of the more than 300 million doses administered since vaccines became available at the end of 2020, according to the U.S. Centers for Disease Control and Prevention. CVS and Walgreens, with some 19,000 U.S. locations between them, have delivered the bulk of those shots. CVS said it has given 34 million doses to date.
The CDC said in a statement that the agency is working closely with pharmacies to ensure they are prepared to administer booster and flu shots this fall. It said unlike at the height of the pandemic, supply isn’t a problem, and providers are well-versed in storing and administering shots.
CVS, more than other chains, has expanded the size and scope of its pharmacy business in recent years. The chain has begun offering medical services from diagnostics to mental-health counseling in stores. It also has taken on more business as regional and grocery chains go out of business.
CVS has taken steps to attract more workers. The chain in August said it would raise its minimum hourly wage to $15, with increases starting this summer and fully implemented by July.
The company also said it would eliminate the grade-point-average requirement for university recruitment this year. It has done away with the high-school diploma or General Education Development requirement for most entry-level roles.
Walgreens also has announced plans to raise starting pay to $15 an hour, beginning in October and fully implemented by November 2022.
Ms. Montgomery, CVS’s pharmacy chief, said the company encourages retail employees to enroll in its pharmacy technician training program in an effort to expand the pool of workers.
The hiring event, planned for Friday, aims to fill 19,000 open positions while adding another 6,000 jobs at roughly 10,000 locations nationwide.
Pharmacy technicians will comprise 14,000 of the new hires, with the remaining jobs going to pharmacists, nurses and retail workers. CVS’s pharmacy operations, which include distribution centers, operational roles and clinics as well as store and pharmacy workers, employ 200,000.
Job seekers can start the application process via text or on the company’s website, try out for the job virtually and potentially get hired immediately, the company said. CVS isn’t accepting in-person applications.
Pharmacy technician wages start at $16 an hour. Pharmacy techs make $17.50 an hour on average in the U.S., with higher pay going to those who work in hospitals, according to the U.S. Bureau of Labor Statistics. A pharmacy tech working at a retail setting makes $16.55 an hour on average while the same job in a hospital averages $19.80 an hour.
Doctors Left To Decide Who Gets Extra Covid-19 Vaccines Amid Booster Debate
Physicians are making decisions about whose existing conditions qualify them to receive fresh doses.
Jennifer Boral badly wants a Covid-19 vaccine booster shot.
An asthmatic with a history of getting colds that develop into serious lung infections, the 41-year-old unemployed real-estate agent in Briarcliff Manor, N.Y., is terrified that getting Covid-19 might land her in the hospital or worse.
Though her doctor believes she is at high risk and wrote a note to help her get vaccinated early in the rollout of shots in February, Ms. Boral isn’t technically eligible for a booster yet. Currently, only patients with seriously compromised immune systems are cleared for the extra shots, such as people who have recently received an organ transplant, blood-cancer patients and those taking immunosuppressant drugs.
“I would go out and get one immediately if I could,” Ms. Boral said. “I don’t understand why our country is dragging its feet.”
The Biden administration’s plan to make boosters available to more people in the U.S. is in flux. A Food and Drug Administration advisory panel on Friday endorsed booster shots of the vaccine from Pfizer Inc. and BioNTech SE for adults 65 and older and those at high risk of severe disease.
Some officials and researchers support additional vaccines for most people to bolster immunity against the virus. Others say boosters might only be necessary for now among certain groups like older and immunocompromised people.
The uncertainty is frustrating patients as physicians and pharmacists draw different conclusions about whether people in their care qualify for Covid-19 booster shots.
Some doctors say current guidelines exclude high-risk patients who might benefit from a booster, such as cancer survivors who recently completed a chemotherapy treatment or patients with a history of respiratory problems, like Ms. Boral.
“There’s a lot of gray area around how to define someone as moderately or severely immunocompromised,” said David Cohn, an oncologist and chief medical officer at the James Cancer Hospital in Columbus, Ohio. “You kind of have to set a bar somewhere.”
Some hospitals, including James Cancer, have begun contacting cancer patients and other people with compromised immune systems to schedule booster shot appointments.
“Our goal is to make it as easy as possible” to get a booster, Dr. Cohn said.
Other doctors and some public-health officials have said patients shouldn’t seek booster shots until authorities can administer as many vaccines as possible to those who have declined to get vaccinated and to residents of developing nations where vaccine supplies remain limited.
World Health Organization Director-General Tedros Adhanom Ghebreyesus said this month that the body lacks sufficient data to recommend booster shots for healthy patients. He asked wealthy nations on Wednesday to hold off on administering boosters until the end of the year.
“Starting with boosters, especially giving it to healthy populations, is really not right,” Dr. Tedros said.
Booster shots have been available to immunocompromised people in the U.S. since mid-August, when the FDA authorized a third shot for patients over age 18 who had received a second dose at least 28 days earlier.
Studies suggest that the vaccines’ effectiveness has held up well against the highly contagious Delta variant of the SARS-CoV-2 virus, which became the dominant strain in the U.S. over the summer, but that protection wanes over time.
Some physicians are administering boosters only to patients who qualify under the Centers for Disease Control and Prevention’s criteria, while others are giving boosters to other patients they determine to be at high risk. Some refer patients to pharmacies and other vaccination sites that might be strictly adhering to federal guidance for confirming a patient’s booster eligibility.
Pharmacy chains like CVS Health Corp. and Walgreens Boots Alliance Inc. said they are offering booster shots to people who sign a form stating that they qualify for the shot because they are immunocompromised, based on the CDC’s criteria.
The agency’s list of qualifying patients includes those with advanced or untreated HIV infection, patients undergoing active cancer treatment and recent stem-cell-transplant recipients. Both chains said they aren’t requiring patients to show documentation of their immunocompromised status.
Some doctors have said boosters should be given only when they are most effective, after immunity has waned, and in the most efficient dosages possible—both points that current data hasn’t defined well yet.
Most people should hold off on getting boosters until the data is more conclusive, said Megan Ranney, a professor of emergency medicine at the Alpert School of Medicine at Brown University.
“Most likely we are going to all need boosters at some point, because that’s just how vaccines work. Immunity wanes. Viral mutations happen. But the question to me is at what point,” Dr. Ranney said.
Lucy McBride, an internist in Washington, D.C., said she is generally following CDC and FDA guidelines on booster shots but that some patients’ situations don’t easily fit the government’s recommendations.
She cited examples of people who live with severely immunocompromised family members, or older people who work in areas of high community transmission—two situations where she said she would advise administering boosters.
“Because the messaging has been so confusing and because the data is still evolving, we’re basically asking patients and pharmacies to make their own decisions,” said Dr. McBride. “At the end of the day, it comes down to the person in front of me, and because the CDC can’t possibly speak to every American, they have to draw these somewhat arbitrary lines in the sand.”
Some patients, especially older Americans, are getting impatient. Richard Graus, a 78-year-old retired geologist from Front Royal, Va., said he has been wearing a mask indoors and monitoring the news to find out when he can get a third shot. The FDA panel’s recommendation Friday means he is likely to get access to a booster soon.
“I’m of an age where the immunity that I have is probably not as good as it was when I was younger,” Mr. Graus said. “I’m not desperate for it at this point, and I can wait another month if that’s what it takes, but I don’t want to have to be overly cautious for the rest of my life.”
J&J Says Covid-19 Vaccine Booster Two Months After First Shot Increases Protection
Trial participants in the U.S. who received a second dose eight weeks after the first had 94% protection against the illness.
Johnson & Johnson said a booster dose of its Covid-19 vaccine administered two months after the first shot increased protection against symptomatic illness in trial participants, as federal regulators evaluate data for the country’s strategy for rolling out boosters.
Data released Tuesday from a late-stage clinical trial showed that study participants in 10 countries including the U.S. who received a second dose of the company’s vaccine two months after the first had 75% protection against symptomatic Covid-19. Participants in the U.S. had 94% protection against the illness. J&J didn’t explain the reason for the difference in efficacy rates.
A double dose of the vaccine provided participants with 100% protection against severe or critical Covid-19 at least two weeks after the second shot, J&J said.
The company earlier this year said a large clinical trial showed that a single dose of its vaccine was 66% effective at protecting people from moderate to severe Covid-19.
“We now have generated evidence that a booster shot further increases protection against Covid-19 and is expected to extend the duration of protection significantly,” said Paul Stoffels, chief scientific officer at J&J. The company said it has shared available data with the Food and Drug Administration.
The late-stage study tested a two-dose regimen of the vaccine in about 32,000 people aged 18 and over in the U.S., Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain and the U.K., J&J said. The company said about half of participants received the placebo but didn’t say how many participants were in the U.S.
J&J said Tuesday that an extra shot given two months after the first boosted antibody levels four to six times higher than observed after the single shot. It said a booster administered six months after the first shot initially increased antibody levels ninefold and continued to climb to 12-fold higher four weeks after the second shot. J&J released some of the six-month boosting data in August.
Neither that data nor the results released Tuesday have been peer reviewed or published in a scientific journal.
“The data are supportive of giving a second shot of the J&J vaccine, anywhere from two months onwards,” said Dan Barouch, an immunologist at Beth Israel Deaconess Medical Center in Boston who helped develop J&J’s vaccine. “The longer you wait, the better the boost will likely be.”
He said some countries might choose to offer boosters, while others might stick with a single shot. “Different people or different countries might actually make different choices based on what their desires or needs are,” Dr. Barouch said.
J&J also highlighted data it said showed its single-shot vaccine offered durable protection even as the Delta variant spreads.
In a study of about 390,000 people in the U.S. who received the J&J vaccine compared with 1.52 million similar unvaccinated people from March to late July 2021, the single-dose vaccine was 79% effective against infections and 81% effective against hospitalizations related to Covid-19.
The Biden administration is hoping to begin at least part of its boosting strategy this week. It is waiting for the FDA to authorize additional doses of the vaccine from Pfizer Inc. and BioNTech SE for people who are 65 years old and over or at high risk of developing severe Covid-19. A Centers for Disease Control and Prevention advisory panel is set to discuss the Pfizer boosting strategy on Wednesday and Thursday.
Plans to offer boosters more widely were scaled back as federal health officials and medical experts remain divided over the need for boosters and regulators have asked for more time to review data from J&J and Moderna Inc.
Mauritius To Become Second African Nation To Offer Booster Shots
“The campaign will start with people who had their second dose four months ago,” Health Minister Kailesh Jagutpal told reporters in Port Louis, the capital, on Tuesday.
Nations from Israel to the U.S. have either started administering booster shots or plan to as the contagious delta variant threatens efforts to end the pandemic. Mauritius will become the second country in Africa after the Seychelles to do so as new surges could threaten plans for the island nation to attract tourists.
Health officials, including the World Health Organization Director for Africa Matshidiso Moeti, have called the rollout of Covid-19 booster shots by a growing number of nations a “mockery of vaccine equity,” with less than 4% of the continent fully vaccinated against the virus.
Mauritius is yet to decide on which booster to give those who were inoculated with AstraZeneca Plc’s Covishield and Covaxin vaccines at the beginning of the vaccination campaign in January, he said.
The tourism-dependent economy has begun to see a decline in cases after a surge in recent months. Asymptomatic cases have fallen to 64 from 272 on Sept. 1., according to Health Ministry data.
Mauritius is set to reopen its borders to fully vaccinated tourists with a negative PCR test on arrival from Oct. 1.
Of about 1.3 million people in Mauritius, 67% of the population have received a first dose and 62% have completed the course, according to Jagutpal.
J&J Says Its Booster Shot Works, But Its Vaccine Remains Effective Without A Second Dose
Johnson & Johnson said early Tuesday that a booster dose given two months after the first shot of its one-and-done Covid-19 vaccine offered 75% protection against moderate to severe Covid-19 globally, and 94% protection in the U.S.
The company also said, however, that its vaccine remains effective without a booster. It suggested that delivering more first doses remained more important than offering boosters.
Johnson & Johnson said Wednesday that a second dose of its Covid-19 vaccine was found in a study to generate a strong immune response, justifying a booster shot.
The Centers for Disease Control and Prevention has said it expects single-dose J&J vaccine recipients would need boosters but has held off on making recommendations as it awaits more data. Wednesday’s findings are expected to inform the U.S. booster strategy set to begin in September, when the U.S. plans to begin offering boosters to people who received messenger-RNA vaccines. Later it is likely to expand the program to include J&J’s viral-vector vaccine.
J&J said researchers found antibody levels increased ninefold among people who received a second dose of its vaccine, compared with one month after they received a first dose. The company didn’t specify exactly when or how many subjects received the second dose, though information posted about the clinical trial in an online government database indicates it was administered six months after the first shot.
J&J said that it will submit data from two studies to a preprint server, meaning that the data haven’t been peer-reviewed or published in a scientific journal.
The company said researchers observed significant increases in antibody responses in participants between ages 18 and 55 and in those 65 and older who received a lower booster dose.
J&J also said a booster is needed after eight months based on interim data it reported in the New England Journal of Medicine in July, which showed strong antibody responses through eight months after immunization with the J&J one-dose shot.
“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson Covid-19 vaccine, boosting eight months or longer after the primary single-dose vaccination,” Dr. Mathai Mammen, global head of R&D at Janssen Pharmaceutical Cos. of Johnson & Johnson, said Wednesday.
Federal regulators are likely to approve Covid-19 booster shots for vaccinated adults starting at least six months after the previous dose, a person familiar with the plans said. The Biden administration has said it plans to distribute boosters more widely beginning Sept. 20.
Currently boosters are only authorized for immunocompromised people who received two-dose messenger-RNA vaccines. The Food and Drug Administration must authorize extra doses before they can be offered more broadly as recommended by the Biden administration to those 18 and older who received two-dose messenger-RNA vaccines, and it is expected to do so before Sept. 20, when health authorities said messenger-RNA boosters would become available.
The CDC’s expert advisory panel on vaccines will meet next week to discuss the Biden administration’s plans for booster shots.
The J&J vaccine is authorized for emergency use in people 18 and older. Only Pfizer Inc. and partner BioNTech SE’s vaccine is fully approved by the FDA for those 16 and older. Moderna’s two-shot messenger-RNA vaccine has emergency authorization for people 18 and over.
Nearly 14 million people in the U.S. have received a single-dose J&J vaccine, according to CDC data.
“The single-dose vaccine is still highly protective, and we know that—that is not diminished, but now we also know that a second dose given at six months boosts immune responses substantially,” said Dr. Dan Barouch, who contributed to the development of the J&J vaccine but wasn’t directly involved in the booster information shared Wednesday.
He was part of the New England Journal of Medicine study showing the vaccine’s protections held for eight months.
Use of the J&J shot dropped after U.S. health authorities in April temporarily paused rollout of the shots to investigate reports of a rare blood-clotting condition.
The company added a warning to its label in July saying its vaccine is linked to a very small incidence of cases of a rare neurological disorder seen with other vaccines or viral infections, called Guillain-Barré syndrome.
Early studies have mostly shown that J&J’s vaccine holds up well against the Delta variant. A recent study from South Africa including nearly 480,000 healthcare workers found that the J&J vaccine has an efficacy of up to 71% against hospitalization resulting from the Delta variant, 67% against hospitalization from the Beta strain and up to 96% against death overall, though another study suggested a single dose elicited a relatively weak antibody response against Delta.
J&J is also studying the efficacy of two doses of its vaccine, in an effort separate from the results released Wednesday. That data will analyze two shots given closer together, rather than the six-month interval of a booster dose.
FDA Clears Covid-19 Booster Shots From Pfizer For High-Risk People
Third dose of the vaccine was authorized for people who are 65 or older or at high risk of severe Covid-19, including from their jobs.
U.S. health authorities cleared Covid-19 vaccine booster shots for people 65 and older and certain other adults at high risk of severe illness, a bid to help curb the pandemic and the dangerous Delta variant.
The Food and Drug Administration on Wednesday said it permitted a third dose of the shot from Pfizer Inc. and BioNTech for people who got two doses of the Pfizer-BioNTech messenger RNA vaccine and are 65 years and older or are at risk of severe disease and death, including because of their jobs or where they live.
The people should receive a booster at least six months after they had taken a second dose, the FDA said.
The authorization is a major step toward making the extra doses available after some people who had been vaccinated but were eager for added protection tried to get the extra shot but were turned away. Among those eligible: healthcare workers, teachers and grocery-store employees as well as prison inmates and those in homeless shelters.
Yet the authorization doesn’t go as far as the Biden administration initially envisioned. The administration initially planned to make boosters available beginning this week to all adults, but the FDA dialed back its go-ahead after agency staff and advisers said that evidence so far didn’t support broad use.
The development caps weeks of public debate—over whether booster shots are necessary, when they should be given and who should receive them—that has split federal health officials and outside health experts.
Some federal health officials have said booster shots are important for helping the vaccinated sustain protection against the Delta variant that has swept across the U.S.
Boosters will help the U.S. stay ahead of the pandemic, federal health officials have said.
Yet other health experts and researchers, including some within the federal government, have said there isn’t conclusive data supporting wide use, pointing to research showing the vaccines continue to work at preventing severe disease and death.
FDA Acting Commissioner Janet Woodcock indicated that the agency was interested in expanding access to booster doses, if more data emerged supporting broader use.
“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of Covid-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Dr. Woodcock said.
In clearing boosters, the U.S. joins Israel, Germany, the U.K. and other wealthier countries administering additional doses.
However, the World Health Organization has urged the nations to forgo boosters for now and instead share the shots with low-income countries who haven’t been able to access vaccines.
The additional doses should be available in the U.S. in the coming days, authorities said, but will also depend on a vote—by a panel of experts advising the Centers for Disease Control and Prevention meeting Wednesday and Thursday—on who should receive the shots.
The CDC usually follows the recommendation of the panel. Vaccination sites don’t have to follow the agency’s guidance, but many pharmacies and doctors do in practice.
“We have been preparing for weeks to administer booster shots to eligible Americans and are ready to do so following CDC’s final recommendation later this week,” White House press secretary Jen Psaki said.
There are about 22 million people 65 and over who have received two doses of the Pfizer vaccine, according to the CDC.
The vaccines are expected to be available at about 80,000 locations around the U.S., including retail pharmacies such as CVS Health Corp. and Walgreens Boots Alliance Inc., as well as mass vaccination sites and doctors’ offices.
The Biden administration and Pfizer have said that there should be enough supply for the boosters, which will be available to no cost to people in the U.S.
The Pfizer-BioNTech Covid-19 shot was the first to be authorized by regulators and the only one so far to be fully approved. Moderna Inc. has filed with regulators for full approval of its shot, and J&J has said it plans to file this year.
Research has shown that Covid-19 vaccines such as Pfizer-BioNTech’s remain highly protective against severe disease and death even without boosters.
Citing the vaccines’ effectiveness, federal health officials in July dismissed talk of boosters, saying they weren’t needed.
The spread of Delta and infections in a small number of people who were fully vaccinated prompted some people with weak immune systems and others to seek extra doses.
The shifting pandemic also prompted federal health officials to reassess the need for boosters.
Studies from Pfizer and elsewhere showed diminishing levels of antibody protection against infections.
“We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated. Today’s FDA action is an important step in helping the most vulnerable among us remain protected from Covid-19,” Pfizer Chief Executive Albert Bourla said.
Federal health officials have also cited data out of Israel that found that rates of infection and severe illness were substantially lower among study subjects aged 60 years and older who had been vaccinated at least five months earlier and then received a booster dose of the Pfizer vaccine.
In August, the FDA authorized a third dose of Covid-19 shots from Pfizer-BioNTech and Moderna for certain people who are immunocompromised 12 years and older.
The latest green light came after FDA’s own staff concluded recently that the vaccines cleared for use in the U.S., including Pfizer’s, continue to afford protection against severe Covid-19 and death without additional doses.
The FDA authorization was in line with a recommendation last week by an outside advisory panel that recommended boosters for only those 65 and older and adults at high risk for severe disease.
The panel had also indicated it would support boosters for people at high risk of exposure at work, such as healthcare workers or teachers, but didn’t formally vote on it.
The panel, however, rejected a request by Pfizer to clear the doses for people over 16 years old after a daylong meeting that included dueling presentations about booster doses.
The authorization applies to boosters of the vaccine from Pfizer-BioNTech only.
Plans to offer extra doses of vaccines by Moderna and Johnson & Johnson are delayed because the FDA needs more time to collect and analyze data about them.
Moderna has asked the FDA to greenlight a smaller dose of its vaccine for administration as a booster, while J&J has shared data with regulators but hasn’t yet filed for authorization of its own shot.
Pfizer Clearance Sets Stage For Broader Booster Push In U.S.
People over age 65 and adults at high risk of severe Covid-19 who have previously taken the Pfizer Inc.-BioNTech SE vaccine can receive a booster dose, the Food and Drug Administration said, opening a new and more controversial phase of the U.S. immunization campaign.
The emergency-use authorization also allows boosters for people 18 and older whose occupational exposure to the SARS-CoV-2 virus puts them at elevated risk of serious complications. Booster doses can be given any time at least six months after a person received their second Pfizer shot, the FDA said in a statement.
The decision applies only to the Pfizer-BioNTech shot, the agency said. Booster shots for recipients of the Moderna Inc. and Johnson & Johnson vaccines haven’t yet been cleared.
Pfizer shares rose 1.6% at 9:40 a.m. on Thursday in New York, and BioNTech gained 2.1%.
Acting FDA Commissioner Janet Woodcock said the authorization would allow people such as teachers and day-care staff, as well as health-care and grocery workers, to get the third shot.
On Thursday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet to make its own recommendations about who should receive the additional dose.
The panel is likely to discuss guidance for physicians on how to administer the third doses, and to further explore questions about the broader aims of the vaccination campaign in the U.S., including whether the ultimate goal is to prevent coronavirus infections or to curb severe disease.
The emergency clearance for the Pfizer shot is in line with a recommendation last week from FDA advisers but narrower than the full approval that the drug giant and its German partner had sought.
It also means the Biden administration will have to move more slowly on its planned wider rollout of boosters. Third doses were previously authorized for certain people with compromised immune systems.
“We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated,” Pfizer Chief Executive Officer Albert Bourla said in a statement. “Today’s FDA action is an important step in helping the most vulnerable among us remain protected from Covid-19.”
The authorization leaves the door open for the FDA to consider broader use of boosters, including in younger adults, as more data on their safety and efficacy become available. And it assures that many of the older Americans who were first in line for the initial shots will be among the earliest to get additional protection.
A surge in virus infections caused by the delta variant has coincided with fears that vaccine potency will fade as the weather turns colder.
Scientists have been divided on the need for boosters. Real-world studies suggested that the efficacy of the Pfizer vaccine diminished somewhat this summer, especially in preventing mild breakthrough cases, though it is hard to distinguish waning immunity from the effects of the highly infectious delta variant.
But other data have suggested that the shot provides lasting protection against severe disease leading to hospitalization and death, and some researchers have said that boosters for most people could be put off for some time.
The FDA said it authorized the booster in part because of an analysis from Pfizer showing that people who got the vaccine earlier in a clinical trial showed “a modest decrease in the efficacy” in July and August, compared with those who had received the vaccines later.
In addition, the agency considered real-world data on the vaccine’s efficacy from the U.K., U.S. and Israel.
Safety of the booster doses was studied in over 300 people, most of them ages 18 to 55. The most common side effects were pain and swelling at the injection site, fatigue, headache and muscle pain. Swollen lymph nodes in the armpit were more common after the booster dose than the first two doses, the agency said.
The ACIP panel, made up of outside vaccine experts, also met Wednesday for a general review of vaccine efficacy over time and booster-shot science.
Some members raised the question of whether people who had received a Moderna or J&J vaccine for their primary immunization should receive the Pfizer booster, or whether they should wait to match with a supplemental dose of the shot they first received. No consensus was reached at the meeting.
FDA vaccine official Doran Fink told the panel that the agency is “working as rapidly as possible” to review Moderna’s booster submission.
Since the FDA said Aug. 13 that people with weakened immune systems can receive a third shot, more than two million Americans have gotten one, according to CDC data. It isn’t clear how many of those people were immunocompromised or what shot they had initially received.
The clearance for now leaves booster shots off the table for younger recipients of the Pfizer shot, which was approved for ages 16 and up earlier this year and can be given to adolescents from 12 to 15 under an emergency authorization.
There has been concern among some scientists, including members of the FDA’s vaccine advisory panel, about the risk of heart-related side effects from the vaccine, particularly in younger males.
Use of a third shot to protect vulnerable people was backed by recent evidence from other countries. An Israeli study in the New England Journal of Medicine showed a third dose of the Pfizer vaccine can dramatically cut rates of Covid-related illness in people 60 and older.
Additionally, a Pfizer study suggested that the efficacy of its first two shots waned in a matter of months, and that booster doses are an effective way to combat the spread of the virus and new variants.
Some critics have said that booster shots should wait until immunizations are more widespread globally. World Health Organization Director-General Tedros Adhanom Ghebreyesus has argued that uneven vaccine distribution will be the world’s biggest obstacle to ending the pandemic and recovering.
Prior to last week’s meeting of the FDA vaccine advisory panel, top scientists and two FDA officials questioned the scientific support for a third shot, saying in a review published in The Lancet that available doses would be better used to immunize the unvaccinated.
CDC Chief Backs Pfizer Boosters For At-Risk Workers In Break With Panel
Director Rochelle Walensky signs off on a series of recommendations for third Covid-19 shots.
Pfizer Inc. booster doses will be available to millions of Americans after Centers for Disease Control and Prevention Director Rochelle Walensky backed the shots for seniors, many adults with underlying health conditions and workers at high risk of Covid-19 exposure.
President Biden said Friday the majority of Americans who are fully vaccinated with Pfizer and partner BioNTech SE’s vaccine will be eligible for boosters, a total of 60 million people and 20 million Americans currently. He said the administration is looking to expand the rules to include more people.
“If you’re fully vaccinated, you’re highly protected from severe illness…we’re doing everything we can to keep it that way, which is where the booster comes in,” he said.
The eligible—people who were fully vaccinated with the Pfizer-BioNTech shot—would get an extra dose at least six months after their second dose.
Dr. Walensky overruled a CDC advisory panel to make frontline workers like nurses, teachers and grocery-store employees eligible for shots, an unusual move capping several weeks of sometimes confusing and contradicting messaging on the U.S. booster policy.
The CDC director normally follows the advisory panel’s lead.
Eric Topol, director of the Scripps Research Translational Institute in La Jolla, Calif., expressed concern the wavering could undermine public confidence in vaccines.
“None of this looks good. It looks like there’s confusion at the top, and it just flows through to the public,” he said.
Dr. Walensky also backed the panel’s decision to recommend boosters to people 65 years and older as well as adults 50 to 64 years with underlying medical conditions. She said the shots should be made available to 18- to 49-year-olds with underlying medical conditions.
Vaccination sites don’t have to follow the CDC’s guidance, but many pharmacies and doctors do in practice.
Many people will qualify for the booster because the CDC’s list of underlying medical conditions is wide-ranging. They include cancer, chronic lung and kidney disease and heart disease, as well as diabetes, obesity, pregnancy and smoking.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
She said the U.S. vaccination campaign remains focused on inoculating as many people as possible with primary doses and that the CDC would review information on the Moderna Inc. and Johnson & Johnson vaccine boosters as soon as possible.
The decision to go against the recommendation of the Advisory Committee on Immunization Practices marks the latest shift in federal planning for giving boosters.
Food and Drug Administration staff and advisers refused to endorse the Biden administration’s original plan for making boosters widely available beginning this week, saying data so far didn’t support broad use.
The FDA cleared boosters of the Pfizer vaccine for people 65 and older and certain other adults at high risk of severe illness, including because of their jobs or where they live.
Some health experts inside and outside the federal government have expressed concern that the back-and-forth over who should get the extra doses will confuse people and potentially deter some who would benefit from the additional dose.
The White House has said it wanted to make plans for boosters to make for a smooth rollout, but it always planned to leave the details of authorization to regulators acting on scientific evidence.
Those who qualify for boosters will have to attest to their eligibility but won’t have to provide additional documentation, CDC officials said.
The ACIP is a 15-member panel including pediatricians, infectious-disease doctors and other medical experts.
After the FDA greenlights vaccines, the ACIP advises the CDC on who should receive them, when and under what circumstances. Usually it meets three times a year, though the panel has met many more times during the pandemic.
The CDC advisory panel was worried about supporting a broad recommendation for people such as healthcare workers or others exposed because of their jobs. The panel feared it would essentially allow anyone who wanted a booster to get one without enough safety data to back that up.
“It seems uncharacteristically openly ended for the lack of data of need in any of these groups,” said Sarah Long, a professor of pediatrics at Drexel University College of Medicine.
The Biden administration also said Friday that federal contractors and subcontractors must be vaccinated against Covid-19 by Dec. 8.
The deadline was included in new guidelines issued by The Safer Federal Worker Task Force, a coalition of federal entities that includes the White House’s Covid-19 response team and the Office of Management and Budget.
The guidelines offer exemptions to the vaccination requirement “in limited circumstances where an employee is legally entitled to an accommodation.”
The rules follow an executive order issued this month by Mr. Biden mandating federal workers and contractors be vaccinated against Covid-19. The directive stepped up the requirements for these workers after Mr. Biden earlier said federal workers and contractors who work on-site must be vaccinated or face regular testing and other measures.
The task force had already said federal workers must be fully vaccinated by Nov. 22.
Mr. Biden has said updated vaccine rules covering federal workers and contractors and healthcare settings, along with a forthcoming emergency temporary standard from the Labor Department that will apply vaccine and testing requirements at private employers with 100 or more employees, will affect about 100 million Americans, equivalent to two-thirds of all workers.
Behind Covid-19 Booster Authorization Were Disagreements on Evidence, Broad Access
Extra Pfizer doses are rolling out to certain adults after disputes inside the U.S. government and with its scientific advisers.
The Biden administration publicly touted its plan to roll out Covid-19 boosters to almost all the fully vaccinated during the week of Sept. 20, saying data from Israel supported the approach.
Yet behind the scenes, federal regulators tasked with clearing boosters and recommending who should get them were locked in a pitched battle over whether the data supported the plan, according to people familiar with the matter.
Some regulators argued that only certain vulnerable groups such as seniors needed an additional shot and that the decision-making timeline was too rushed, the people said.
The dissenters also bristled at the Biden administration’s declaration, in August, that boosters would be widely available if authorized by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention, arguing it put pressure on the agencies to follow the announced course, the people said.
Most recently, late Thursday, CDC Director Rochelle Walensky took the unusual step of overruling agency advisers and recommended nurses, teachers and other workers at high risk of exposure should get an additional shot, as well as a swath of Americans who are seniors or have underlying medical conditions that the advisers backed.
The disagreements have complicated the rollout of the boosters, a linchpin of the Biden administration’s response to surging Covid-19 cases due to the contagious Delta variant.
As pharmacies gear up to deliver the extra shots, however, some administration officials said they are concerned the public disputes will confuse people who expected from the administration’s announcement there would be broad access to the shots, according to two people familiar with the planning.
The disputes may also deter some people from getting boosters that promise to rein in Delta’s spread, the people said.
“This has not been done according to the rules. It started in Washington with the president’s announcement,” while such matters usually work their way up from the FDA to CDC, said Dr. William Schaffner, a nonvoting member of the CDC’s vaccine advisory panel and chairman of the department of preventive medicine at Vanderbilt University School of Medicine. “This has been confusing all along.”
The backlash surprised some in the Biden administration who say that data for a wider rollout was convincing and that the plan’s announcement was necessary for keeping the public informed and properly preparing for a potential launch of booster shots, a considerable undertaking.
“A lot of people were saying, ‘We’re making a decision,’ ” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases who was involved in the administration’s deliberations. “We weren’t. We were making a plan.” He said that at the end of the day nothing would happen if regulators didn’t sign off.
The Biden administration booster plan played a role in the decisions by two top career scientists at the FDA to announce they were leaving the agency, according to people familiar with the resignations.
Some experts advising the FDA and CDC also pushed back against broad use of boosters. In overruling the CDC’s advisers, Dr. Walensky believed the clinical data supporting use by the front-line workers was compelling and the benefits outweighed the risks, according to a person familiar with the decision.
White House press secretary Jen Psaki has said the administration decided to pursue boosters, without political interference, to be prepared to give out the shots if the scientific evidence supported their use.
“I’ve made clear all along, the decision of which booster shot to give, when to start the shot and who will get them is left to the scientists and the doctors. That’s what happened here,” President Biden said on Friday.
Boosters are used to bolster the immune defenses of people who have been vaccinated against certain infectious diseases such as Tetanus, measles and hepatitis A and B. The vaccine-induced molecular defenses can wane over time, prompting need for an additional shot to increase a person’s virus-fighting readiness.
Federal health officials have long said boosters could be necessary and an additional shot may offer long-term protection. The introduction of Covid-19 vaccines was so fast that researchers didn’t have time to gather evidence on how long they would last or the ideal number of doses.
From early on, it was unclear when or how a move to boosters might be advisable.
When Pfizer Inc. and partner BioNTech SE said in July they planned to seek authorization from the FDA for an additional dose, the agency and Centers for Disease Control and Prevention issued a statement saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”
Then Delta swept across the U.S. The strain increased infections and overwhelmed hospitals just as governments were easing restrictions and people were dropping precautions. The U.S. averaged more than 100,000 new cases a day in mid-August, up from more than 10,000 cases a day in the first week of June.
New data also was coming from Israel, including results that showed infection was lower in the elderly who were given a booster. Data on rhesus macaques who had gotten a booster showed they had far higher levels of neutralizing antibodies titers.
Especially alarming to federal health officials, they said, were reports of so-called breakthrough infections among those who had been fully vaccinated. Vaccines were protecting most recipients from severe disease, but a small percentage of the cases landed people in the hospital or could spread the virus, the officials said.
U.S. Surgeon General Vivek Murthy and Dr. Fauci said they became convinced about the urgent need for boosters.
“We were seeing diminution with CDC data, and we knew Israeli was confirming,” Dr. Fauci said. “What would the general public have said if we hadn’t said anything? There would be a major backlash.”
In mid-August, they assembled the top medical members of the White House Covid-19 team for a virtual call reassessing the need for boosters. The call started about 7 p.m., with a discussion of the surge in cases driven by the contagious Delta strain and data from Israel and other sources. Among those dialing in were CDC’s Dr. Walensky, FDA Acting Commissioner Janet Woodcock and Dr. David Kessler, the chief science officer of the White House Covid-19 response team.
“The protection against moderate infection, we were worried it would break down,” Dr. Murthy said. “You can’t flip a switch, you need to do planning with states, it’s a whole operation. This was always contingent on FDA review.”
The group agreed on the need to act fast, people familiar with the discussion said, because some elderly and healthcare workers had received vaccinations in December and January. Some studies indicated vaccine efficacy fell somewhat after six months. More breakthrough infections were already cropping up.
The eight participants agreed to sign a statement saying boosters would likely be needed. The call for boosters was among several announcements issued by the Biden administration, on Aug. 18, aimed at curbing Delta’s spread.
While there was consensus among the officials that boosters were necessary, FDA staff clashed inside the agency over how quickly the agency could authorize the shots and who should get them, according to people familiar with the agency’s deliberations.
“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” Marion Gruber and Phillip Krause, the career FDA scientists who announced in late August they will leave the agency, wrote in the Lancet medical journal. The scientists didn’t respond to requests for comment.
Early this month, Dr. Woodcock and Dr. Walensky asked the White House to push back the timetable for a booster campaign. The leaders also said they would tackle Pfizer’s booster first, then take more time to review extra doses of Moderna Inc. and Johnson & Johnson vaccines.
The FDA’s outside advisers, in a meeting last week, said they didn’t find evidence supporting broad use.
“The studies that have been published in the United States so far have shown that the vaccines that we use do exactly” what they were supposed to: protect against severe disease, said Dr. Paul Offit, an infectious-disease specialist who is on the FDA’s vaccine advisory committee.
The FDA on Wednesday authorized additional doses but to select groups, including seniors and people at high risk of severe Covid-19. It also cleared them for people in occupations with high risk of exposure like healthcare workers, teachers and grocery-store staff.
The CDC’s advisers, who make up the Advisory Committee on Immunization Practices, on Thursday endorsed shots for seniors and many adults with underlying medical conditions like asthma and diabetes, but recommended against giving the shots to the front-line workers.
Late that night, Dr. Walensky overruled the committee’s stance on front-line workers and endorsed boosters for that group. The closeness of the panel’s vote on giving the shots to the workers was a factor, along with her view that the data supported offering boosters to the workers, the person familiar with the decision said.
“It was a decision about providing rather than withholding access,” Dr. Walensky told reporters Friday.
Under the decision, some 60 million people in the U.S. are or will be eligible for a Pfizer-BioNTech booster depending on when they pass the six-month mark after their second dose, according to the White House.
The numbers approach the Biden administration’s original goal for the booster plan, a White House official said, though the figures aren’t close to the more than 182 million people in the U.S. who are fully vaccinated.
The administration could have avoided public disagreements and resulting confusion if it had waited for stronger evidence on booster use before making the August announcement, said Walid Gellad, a drug-policy researcher at the University of Pittsburgh School of Medicine.
“Everyone is seeing the debate play out in public partly because the administration was too quick to say, ’This is what’s going to happen,’ ” he said.
The debate is still playing out inside the FDA, according to people familiar with its deliberations. Some agency staff support expanding the Pfizer-BioNTech booster authorization further. Additional safety data could come in the next few weeks, a person familiar with the matter said.
Pharmacies Prepare For Broader Covid-19 Booster Distribution
CVS, Walgreens say people will self-identify as meeting qualifications for third shots.
Pharmacies and other Covid-19 vaccine providers prepared for a new surge in demand after federal officials widened booster eligibility to most people who say their health or job puts them at heightened risk of infection.
The Centers for Disease Control and Prevention endorsed offering booster shots to people ages 18 and older who have underlying medical conditions or work jobs that might put them at heightened risk of exposure to the virus.
President Biden on Friday mentioned obesity and diabetes as well as work in healthcare, teaching and supermarkets as examples of situations in which people would qualify for a booster.
“We’re also looking to the time when we’re going to be able to expand the booster shots, basically across the board,” Mr. Biden said.
A CDC presentation released on Thursday said higher-risk workers included people who interacted within 6 feet of other people. CDC spokeswoman Kristen Nordlund said people would self-identify as qualifying for a booster under the new guidelines.
CVS Health Corp. and Walgreens Boots Alliance Inc., the largest U.S. pharmacy chains by stores, said they would rely on vaccine-seekers to accurately report their eligibility. People will also need to provide their cards verifying previous vaccination, the companies said.
Ashley Cohagen, a 30-year-old ICU nurse from Detroit who is working on a temporary contract at a hospital in Oakland, Calif., said she plans to seek a third Pfizer Inc. shot from her hospital as soon as possible.
“With the Delta variant and waning vaccine protection, you start to feel that anxiety again,” Ms. Cohagen said. “Nurses have been putting ourselves and our families at risk every day for a long time now.”
Retail pharmacies are the biggest administrators of Covid-19 shots in the U.S. through a federal partnership and in conjunction with local health agencies and employers.
The CDC said it expects the rollout of boosters to proceed more smoothly than the first months vaccines were made available, when demand outstripped supply and people experienced long waits to book appointments. CVS and Walgreens are both asking customers to make appointments before showing up.
But some public-health experts expect demand to test pharmacies’ capacity to quickly administer booster shots, especially in the approaching winter months when respiratory illnesses tend to spread.
“They’re going to have to get up to capacity again, which may not happen overnight,” said Jason Gallagher, a professor of pharmacy and infectious diseases at Temple University. “The public is much more eager for boosters than public-health professionals are. People have gotten the message that this is coming.”
While vaccines are plentiful in the U.S., retail pharmacies are struggling with labor shortages that have led both CVS and Walgreens in some cases to close stores early, shut down drive-throughs or turn away people seeking vaccines. CVS on Friday embarked on a single-day hiring spree, intending to add 25,000 workers in anticipation of additional demand from booster shots.
CVS and Walgreens have said they plan to increase their minimum hourly wage and Walgreens is offering bonuses to pharmacists and to workers who become certified as pharmacy technicians capable of giving shots.
CVS and Walgreens have said testing and vaccination programs are a profitable part of their pandemic-era business models. Both companies have said their ability to meet revenue and profit targets this year hinges in part on strong demand for vaccines and boosters.
Walgreens is offering $5 in loyalty-card rewards to people who get boosters in its stores and encouraging recipients to get a flu shot along with the Covid-19 booster.
Diverging from the advice of its advisory panel, which recommended against opening booster eligibility to high-risk workers, allowed the CDC to get boosters to more people more quickly, said Jody Lanard, a physician and former pandemic-communications adviser to the World Health Organization.
“The CDC is moving as close to what the Biden administration has said it wants, that boosters should be available to everybody, as they can without parroting his exact words,” Ms. Lanard said.
Liars May Get Covid Boosters Before Those In Need
U.S. experts had a difficult series of decisions to make about boosters based on limited data. But it’s hard to say their final advice is clear, evidence-based or in the best interests of public health.
Now that the top U.S. health regulators have delivered their verdict on Covid-19 booster shots, who exactly is in line to get one in the coming weeks? Sadly, too many of the wrong people and too few of the right ones, adding more messiness to a rollout process that’s been far from smooth.
The Biden Administration already jumped the gun on boosters last month, calling for third shots for all adults ahead of evaluation from the Food and Drug Administration and Centers for Disease Control and Prevention, and before agencies could review data on any shot except the one made by Pfizer Inc. and BioNTech SE.
Both agencies weighed in this week, with external advisers raising doubts about the need for universal boosters when protection against severe disease is largely holding up.
The result, however, was an authorization so broad — it effectively could encompass everyone older than 18 at higher risk because of their job or a health issue — that any adult that got Pfizer’s vaccine can likely get a third shot six months after their second if they’re willing to lie. At the same time, millions of Americans 65 and older can’t get another shot if they received a different vaccine.
Officials and experts had a difficult series of decisions to make based on limited data. But it’s hard to say that the end result is clear, evidence-based, or the best result for public health.
Pfizer initially requested booster approval for those 16 and older. But the FDA instead followed the advice of its panel of external experts and authorized Pfizer boosters only for adults 65 and older and those at high risk from their jobs or other health problems. However, it left eligibility requirements vague.
This week, the CDC’s Advisory Committee on Immunization Practices, which sets national vaccine policy, met to provide further guidelines. The group fully recommended boosters for the 65-and-older set and those between 50 and 64 who are at higher risk of severe Covid.
At-risk adults aged 18 to 49 got a more limited recommendation calling for individual risk-benefit assessment for third doses because there’s less evidence of need in the group. But in practice, that may not make a difference because people can self-report a condition to get a shot.
The panel did vote against third shots for those in high-risk workplaces amid concern it would open the door to boosting too broadly, but CDC Director Rochelle Walensky overruled them. That’s arguably the right move for health workers, where preventing infection can keep them on the job in overwhelmed hospitals. But eligibility extends well beyond that group.
Another troublesome aspect: The agencies were willing to accept weak evidence and potential negative consequences, including still unknown safety risks and the possibility of diverting supply from first vaccinations elsewhere in the world, in order to allow broad boosters of the Pfizer-BioNTech vaccine.
But they were unwilling to do the same for people at genuinely higher risk who received a vaccine from Moderna Inc. or Johnson & Johnson, which means a 25-year-old with asthma who received a Pfizer-BioNTech shot may be eligible for a booster ahead of an elderly person with extensive comorbidities who received Moderna’s vaccine, which uses the same mRNA technology.
It’s true that there’s limited evidence about mixing vaccines, which is why the FDA is holding back. But it’s not as if there’s nothing to go on. The U.K. has produced enough data that it’s comfortable with extensive mixing in its booster program, and there’s no clear evidence of elevated risk.
The FDA even set a precedent for flexibility in August by allowing immunocompromised people to mix mRNA vaccines. To their credit, the CDC’s external panelists pushed back on this dichotomy and argued for shots in high-risk people regardless of the initial regimen, but weren’t given the option to recommend it.
It makes sense that the U.S. authorization process should have some malleability to it in a pandemic. It’s just being applied inconsistently and without the right priorities. And that’s leaving some vulnerable people at real risk.
Covid-19 Booster Shots Are Here, and So Is The Angst Over Who Gets One
The CDC’s backing extra shots for some people, but not all, has left many with more questions than answers.
For doctors, the queries are coming fast and furious: Am I eligible for a booster? After six months or eight months? What if I got Moderna or Johnson & Johnson ?
Americans have reached the booster angst stage of the pandemic—and the Centers for Disease Control and Prevention’s announcement on Friday backing extra shots for some people, but not all, has left many with more questions than answers.
In August, with the Delta variant surging and breakthrough infections rising, the Biden administration indicated boosters would be widely available in the U.S. starting this month. After heavy debate among scientists, the CDC ultimately endorsed boosters for a narrower group. Yet its guidance left plenty of room for interpretation about who qualifies, doctors say.
“The patient portal is being overrun with emails from patients,” says Mark Fierstein, a primary care physician at NYU Langone Ambulatory Care Lake Success in New York. “There’s a lot of questions. The confusion is because every day someone comes out and says something a little different.”
“The booster conversation has people’s heads spinning,” says Laura Morris, a family physician in Fulton, Mo. She says some patients have been asking about boosters all summer, including whether they’re really necessary. Several asked about them Friday; she gave two patients, both in their 70s, the extra shots.
The CDC said Pfizer vaccine recipients who are 65 and over, as well as people ages 50 to 64 with certain underlying medical conditions, should get boosters.
It also laid out other groups of people who may get boosters, based on their risk levels and potential benefits, prompting a host of new questions and decision-making. For recipients of the Moderna and J&J vaccines, the FDA and CDC have said that they need more time to review data.
Lucy Ballentine, a 33-year-old in Washington, D.C., is pregnant. Pregnancy and her age likely put her in the category of people who the CDC said “may” receive a booster, but the agency didn’t explicitly say they “should” receive a booster. Ms. Ballentine says she’s interested in getting a booster shot but has questions for her midwife. She wants to know whether she should get one before she gives birth, or wait until after.
If her midwife says she should get it while pregnant, Ms. Ballentine says, “I want to pass on as many antibodies as possible.”
The biggest gray area now is for people ages 18 to 49, doctors say. “That is definitely the group that probably needs to have the most counseling and probably we need to take a closer look at what their individual risk is,” says Dr. Morris.
In that group, doctors say it’s important to look at occupation, where people live and work, who they are commonly exposed to, and their health. Dr. Morris says she has a healthy patient in that age bracket who cares for her mother who is severely immunocompromised. She wanted a booster earlier this week but Dr. Morris told her to hold off; now, she says she’d recommend that the patient get one.
Cameron Wolfe, associate professor of medicine in the division of infectious diseases at Duke University health system, says the guidelines give doctors a lot of flexibility for 18- to 49-year-olds. “We’re going to use this in a fairly permissive fashion. If someone is interested and tolerated the first two doses and it’s been six months, I think this is open,” he says.
Some of the questions to consider, he says: “What sort of work do you do? Who’s at home with you who might be at higher risk? Can you afford a couple of weeks off if you get sick? How did you tolerate the first two doses? Have you had Covid before?”
Many people who don’t obviously qualify now are anxious to know when they will. Lauren Lipowicz, a 41-year-old real-estate agent in Lower Merion, Pa., is eager for a booster and will ask her doctor when she might be eligible.
“I want it now,” she says, adding that she won’t get one until she qualifies. “I don’t have an underlying condition and I don’t believe I qualify for having a high-risk job, but if they tell me I can, then I will be the first in line,” she says. She got Covid in August 2020, and got vaccinated this year. “I don’t want to ever have to go through that again,” she says of the virus.
Erica Aikey, a 20-year-old Boston University student who received her second Pfizer shot in June, wants to know when, or if, boosters will be available for people her age. She is eager for an extra dose of protection, she says. “I’m in in-person classes, in a big city,” she says. “I’d like to put myself in a healthier position.”
Some people are seeking out boosters regardless of their status. Pharmacies and vaccine clinics don’t always scrutinize booster-seekers and some doctors have more permissive views on boosters.
Lucy McBride, a Washington, D.C., primary-care physician, says despite her counseling that the mRNA vaccines from Pfizer and Moderna are working very well in preventing severe Covid-19 in most people, some of her patients have decided to get a booster anyway.
“People are sensing the ambiguity and the abundance of vaccine and just deciding on their own to go get it,” says Dr. McBride.
Covid Q&A: Picking The Best Booster Shot
My husband and I received two doses of the Pfizer vaccine last winter. Should we get a Pfizer or a Moderna booster? News reports earlier this year described stronger protection from mixed vaccines.
First up, let’s get the fine print out of the way: There’s still ample debate over who exactly should get booster shots, and when. Washington is in the midst of an inter-agency war over this question as we speak.
On Friday the director of the Centers for Disease Control and Prevention overruled a recommendation by an agency advisory panel that didn’t support booster shots for front-line workers.
Many scientists still think that we haven’t yet seen sufficient evidence to call for booster shots at all, outside of those with weakened immune systems. This is a great question, and one likely to be on the minds of many as more people become eligible for booster shots. At present, U.S. health officials only recommend booster shots for older adults and those with immune deficiencies.
That said, it seems likely that eventually boosters will be in the cards for most Americans and this question is likely to be top of mind for many people. So back to Karen’s question.
”There are no downsides to vaccine mixing and maybe even a benefit,” said David Topham, an immunologist at the University of Rochester Medical Center.
We’ve talked about mixing shots before in this newsletter, and indeed some research suggests it may be extra effective. The gist is that different types of vaccines boost the immune system in different ways, so multiple vaccines provide broader coverage. It’s not an uncommon practice in the world of immunology.
Research suggests it may be an effective strategy with different types of Covid vaccines. A study of nearly 700 people in Spain, for example, showed that people who got a second dose of Pfizer’s vaccine after a first dose of AstraZeneca saw their neutralizing antibodies climb sevenfold—a much more robust immune response than in those who just had two Astra doses.
But the key is mixing different types of vaccines. Pfizer and Moderna use a new technology called messenger RNA that triggers healthy cells to produce viral proteins that stimulate an immune response.
The AstraZenca vaccine uses a chimpanzee adenovirus to help the immune system identify and battle Covid. Two different mRNA vaccines are unlikely to produce the same dramatic effect that was observed in the AstraZenca-Pfizer trial.
That said, a boost is a boost, no matter which shot you’re getting.
“I suggest they get whichever vaccine is available to them,” Topham said. “The response to a third dose, distanced in time, is very strong and highly cross reactive, even against the delta variant.”
FDA Leans Toward Authorizing Moderna Booster At A Half Dose
The U.S. Food and Drug Administration is leaning toward authorizing half-dose booster shots of the Moderna Inc. coronavirus vaccine, satisfied that it’s effective in shoring up protection, people familiar with the matter said.
The authorization would set the stage to further widen the U.S. booster campaign after earlier authorization of the Pfizer Inc.-BioNTech SE shot. About 170 million fully vaccinated people in the U.S. received the Moderna or Pfizer shots, or 92% of the total inoculated so far.
The people spoke on the condition of anonymity, before a potential announcement. It’s not clear when an announcement will come.
Shares of Moderna rose as much as 3.6% in morning trading in New York Wednesday. The stock had fallen in the past three sessions.
Any authorization would also introduce different dosage levels for boosters. Moderna’s initial inoculations contained 100-microgram doses, and the company’s submission to regulators amounted to a push to authorize a half-dose booster.
Pfizer’s shot, for comparison, has 30-microgram initial doses and a 30-microgram booster. Boosters are so far being given with, or planned for, the same vaccine that a person received initially, though studies are ongoing about whether to mix vaccines.
Proceeding with a 50-microgram dose could reduce the risk of side effects from a booster, and would also allow Moderna to produce more doses globally in the near-term. That would ease supply constraints and potentially blunt criticisms of rich countries beginning sprawling booster campaigns before many nations have given widespread first shots.
Moderna declined to comment on Tuesday night. The White House and the FDA declined to comment.
The U.S. is rolling out boosters to head off what President Joe Biden’s health advisers warn are a pair of concerning trends: Hints that vaccine efficacy wanes over months, and that the two-dose regimens are weaker generally against the delta variant than against other iterations of the virus.
The U.S. has dealt with a summer and fall wave of new cases, hospitalizations and deaths, driven by spread among unvaccinated people but increasing the exposure risk for the vaccinated.
The booster campaign was widely expanded late last week when Centers for Disease Control and Prevention Director Rochelle Walensky overruled an advisory panel to broaden eligibility for Pfizer’s booster shots. The World Health Organization has called for a moratorium on boosters this year, a request the U.S. has disregarded.
As of now, only people who received Pfizer shots are eligible for a booster in the U.S. “We will continue to evaluate data as it becomes available in real time and with urgency, and update our recommendations to make sure that all of those at risk have the protection they need,” Walensky said Tuesday.
The U.S. has donated about 160 million shots abroad, and the vast majority were surplus domestic supply from Moderna. Biden has also announced deals for a total of 1 billion Pfizer shots bought specifically for donation. Those began shipping in August and will be delivered by September of 2022.
The FDA had been seeking information about the effectiveness of a full third dose of the Moderna vaccine, but is now ready to move forward and consider the half-dose booster Moderna has proposed, the people said.
Biden, who got his Pfizer booster on Monday, has said this remains a pandemic of the unvaccinated.
Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, has said he believes Pfizer and Moderna will eventually be considered three-dose vaccines.
As the vaccination campaign widens, sites that administer them will have to juggle different versions. In addition to Moderna potentially adding a half-dose booster, Pfizer is seeking authorization of a vaccine for children ages 5 to 11, with a 10-microgram dose — one-third the strength given to those 12 and up.
Fauci has indicated that there’ll be progress soon on booster shots for Moderna as well as Johnson & Johnson’s one-dose vaccine. “I believe it will be weeks and not months,” he told NBC’s “Meet the Press” earlier this month.
World Can Have Covid Boosters and Its First Doses, Too
There is a way to bolster existing immunity and speed up the next phase of vaccination at the same time.
As the U.S. and other developed countries start rolling out Covid-19 vaccine booster shots, many are expressing concern that this will slow down the global vaccination campaign — prolonging the pandemic and causing significant harm along the way.
But there is a way to deliver boosters and speed up the next phase of vaccination at the same time. It’s the difference between pushing and pulling.
At present, vaccines are mostly purchased through what are called “pull” contracts. Manufacturers determine total production capacity, and countries simply buy — or “pull” — out of the resulting supply. That means if wealthier countries who tend to get their contracts fulfilled more promptly start rolling out boosters, then other, mostly poorer, countries have to wait longer for their first doses.
In most markets, that sort of zero-sumness is only a short-term problem. If enough buyers want to “pull” at once, then there is a strong incentive to expand capacity in order to create new supply. But a key part of the economic equation is missing for vaccines: increasing demand isn’t driving up prices enough to make investing in new capacity worthwhile for producers.
Covid-19 vaccine contract prices are usually far below market rates for good reason. Price increases would exacerbate already widespread inequality in access to vaccines, mostly along income lines. Besides, the sooner we get vaccines to everyone, the sooner we arrest the development of new variants and hopefully bring a sustained end to the pandemic. That’s the very definition of a public good.
But this means we need to think about vaccine production and purchasing differently from other goods. Instead of buying vaccines through “pull” contracts, we should be using what are called “push” contracts: orders that represent explicit commitments to purchase additional vaccine doses and to install additional production capacity to make some or all of those doses. 1
This strategy wouldn’t fix the problem overnight, with early booster orders cutting into existing supply. But if capacity is expanded enough through the contractual shift I’m suggesting, then total production should be able to increase sufficiently for other countries to catch up — and eventually even overtake their current vaccination pace.
For a stylized example of how this works, let’s imagine that U.S. booster demand takes up three months’ supply of a given vaccine that would otherwise go to three smaller countries. Under the status quo, those countries just get pushed back in line by three months, and all the countries scheduled to receive vaccines after them do, as well — as illustrated in the figure below.
Now let’s imagine that the U.S. instead bought vaccines through a “push” contract with enough capacity investment to cover the full supply it had requisitioned for boosters, but the new capacity will take three months to come online. In that case, the first three countries still get pushed back in line, but they catch up right after the new capacity becomes available. And by one month after that, total production is higher than it would’ve been before, so other countries effectively move up in line.
Of course, it’s unlikely that countries would write “push” contracts that offset booster production 1-for-1 like in the example I just described. But still the same principle applies: because “push” contracts increase production throughput, they’ll eventually result in countries getting vaccines sooner than they would have otherwise.
To be sure, expanding production capacity will take more than a contractual overhaul. And the U.S. and other countries still have to do everything possible to counteract the impact of boosters on global vaccine supply in the interim. Expert medical ethicists Govind Persad, William Fiske Parker, and Ezekiel J. Emanuel recently proposed a series of strategies for this, including giving boosters at smaller dosages, and “mixing and matching” across vaccines to maximize antibody production.
All the layers of the supply chain will need to be shored up, as well. Vaccines require a range of scarce ingredients and components — everything from bioreactor bags to horseshoe crab blood — and producing vaccines at our current unforeseen scale has put strain on those inputs. 2
So far, more than 6 billion vaccine doses have been administered, an amazing feat in less than a year. But it’s still not enough to stop a pandemic that threatens to ravage the countries at the end of the vaccine line and spur more harmful variants. To fully address the pandemic, we have to change the way we think about buying the vaccines that are helping us beat it.
Behind Israel’s Swift Rollout of Covid-19 Vaccine Boosters
By getting early access to Pfizer’s vaccine, Israeli scientists had more and earlier data than their counterparts elsewhere—and were willing to act on it.
In late July, dozens of Israeli scientists and government health officials were locked in a marathon video call where they examined new data indicating that the effectiveness of the Covid vaccine developed by Pfizer Inc. and BioNTech SE was waning.
Infections from the new Delta variant were increasing, and growing numbers of people were falling seriously ill, even those who had had both shots of the vaccine. Lives were potentially on the line.
Within days of the midnight vote that decided to distribute a third shot, the first of millions of booster shots were administered, months before the U.S. or any other country would take the same step.
“It was a really tough discussion,” said epidemiologist Gili Regev-Yochay, who presented key research on the effectiveness of booster shots. “[But] it was a decision that was reached essentially with one voice.”
Throughout the global effort against Covid-19, Israel’s public health experts have been consistently ahead of their counterparts elsewhere in the world. By securing an early supply deal with Pfizer for its vaccine, sweetened in part by a promise to share data from Israel’s extensive network of health maintenance organizations, they have had an edge in understanding how the vaccine behaves in the real world.
They were also willing to act quickly when they saw that data, among other things suggesting to extend the vaccine to younger teenagers and to adopt a Covid passport system to persuade holdouts to get their shots if they wish to visit cinemas, restaurants or other entertainment sites.
At times the country has moved faster than some other nations might prefer. The World Health Organization, among others, has been critical of vaccinating younger teenagers or providing third booster doses at a time when billions of people in poorer countries haven’t yet had their first shots.
But where Israel goes, others often follow. President Biden received a booster shot at the White House on Monday, days after the U.S. Food and Drug Administration cleared it for people aged 65 and older and adults in high-risk groups, a recommendation backed by the Centers for Disease Control and Prevention.
The U.K, which was also quick to roll out vaccines, started this month to offer booster shots to over-50s and vulnerable people, while the European Union regulator will decide whether to endorse a third shot early next month.
Those involved in the decision-making process in Israel credit a culture of debate and a willingness to improvise, instilled in part by long careers in the military common among senior health professionals, and tested during national security crises.
Arnon Afek, a doctor and member of the advisory group, served as a senior officer in the medical corps and later as Health Ministry director-general before becoming director of the Sheba Hospital in Tel Aviv. When the pandemic first struck, he said he turned part of his hospital’s parking garage into a coronavirus ward.
“We are always living on the verge of an emergency,” Dr. Afek said. “It might be from the Gaza strip or Covid or cyberwars against our enemies. We know how to rely on ourselves and know how to deal with emergency situations.”
Since members of the advisory panel all work pro bono, neither politicians nor government officials can stop them speaking their minds when they meet with Israel’s cabinet.
“Nobody has any leverage on me when I sit in that room,” said Ran Balicer, head of the primary experts advisory committee on Covid-19, who said he does most of his advisory work at night after his busy day job as a senior official at Israel’s largest health care organization Clalit.
Israel’s leaders have largely listened to the scientists, the advisers say, despite a protracted period of political turmoil that saw Prime Minister Naftali Bennett dislodge long time leader Benjamin Netanyahu.
One of the few times when the government has diverged from the advice it was given was when Mr. Netanyahu wavered last year on creating a tiered system of lockdowns like a traffic light: red, green and amber. Israel later had to impose another nationwide lockdown.
The medical professionals who voted to approve boosters shots—perhaps the most contentious issue they have faced—were swayed by two studies.
One was a Health Ministry analysis of Israeli data that showed those vaccinated in January through March were far more likely to get sick than those inoculated later.
The second study to swing the late-night debate behind a shot for over 60s was presented by Dr. Regev-Yochay and her team at Sheba Hospital. It pointed to the sharp rise in infections coming not only from the virulence of the Delta variant, but also from the waning prevalence of antibodies in people who had been vaccinated.
Her research showed that resistance to the virus had been falling in test subjects for months. They also knew from booster shots given to immunocompromised patients at Sheba that a third dose could successfully increase antibodies. The rest of the panel agreed to proceed.
Pfizer said at the same time that its own research also showed that antibody levels were waning over time.
The decision quickly paid off. When the booster shot campaign began, the majority of Delta infections were detected among patients who had already been vaccinated and had assumed they were safe from the virus. Infection levels per capita were among the highest in the world and it appeared the country was headed toward another economically debilitating lockdown.
Since then, more than three million of Israel’s nine million inhabitants have gotten a booster shot, including a majority of those in at-risk groups. Most infections are now among those who are unvaccinated, and talk of a fourth lockdown has been replaced with discussions about learning to live with the virus.
There is a small minority of Israelis who think the country is moving too quickly and resent being at the forefront of how to deal with Covid. Eldad Yaniv, a prominent political activist and critic of Mr. Netanyahu, has now taken Mr. Bennett’s government to task for moving more quickly than the U.S. Food and Drug Administration in approving boosters.
“An experiment is taking place in Israel,” he wrote in a Facebook post on Sept. 12, arguing Israel’s deal with Pfizer for vaccines is propelling it to push ahead of other countries in approving third shots for the new mRNA vaccines.
Israeli officials say their deal with Pfizer is not exclusive, nor obliges them to expand their vaccination campaign quicker than other countries.
Most of Israel’s doctors and epidemiologists remain undeterred, turning their firsthand view of the vaccines’ effects into research that much of the world has turned to. Dr. Balicer was the lead writer on a landmark paper published in the peer-reviewed New England Journal of Medicine in February, showing that Pfizer was effective in real-world conditions.
He later led another paper in the same journal that demonstrated that the risks of getting ill from Covid-19 outweigh potential risks from receiving the vaccine.
While the FDA was deliberating whether to approve boosters last week, an Israeli Health Ministry-backed and peer-reviewed paper in the NEJM said the adjusted rate ratio of confirmed cases for Israelis over 60 at least 12 days after receiving a booster shot was lower by a factor of 11 compared with those who had had only two shots.
The authors said they found the rate of severe illness among those over 60 who got the booster shot was lower by a factor of around 20 times, compared with those who hadn’t received the boosters.
Already, the country’s scientific community is again moving out in front of counterparts elsewhere by discussing the possibility of recommending further booster shots in the months and years to come.
“There will be a fourth, fifth, sixth or even seventh shot as long as Covid-19 continues to strike the world…we’ll continue to see variants rising up,” said Dr. Afek.
Americans Are Getting Covid-19 Boosters—No Questions Asked
People say they are securing third vaccines by attesting that they meet the latest requirements.
Doctors and pharmacies are rapidly signing up patients for Covid-19 booster shots, many without requiring proof of eligibility under standards that federal officials set last week.
The Food and Drug Administration and Centers for Disease Control and Prevention have authorized a third shot of the vaccine made by Pfizer Inc. and BioNTech SE for a wide swath of the U.S. population. Anyone over age 65 is eligible for a booster shot, as is anyone over 18 with a pre-existing condition predisposing the person toward a severe case of Covid-19.
Also eligible are those with a job or living situation that poses a higher risk of contracting Covid-19. Boosters for all patients must be given at least six months after an initial Pfizer vaccine course.
Patients who received initial doses of the vaccines made by Moderna Inc. and Johnson & Johnson aren’t eligible yet. Approval of a booster regimen for those patients is expected in the coming months. The FDA did amend its emergency-use authorization in August, however, to allow a third Moderna dose for immunocompromised people.
Debbie Hirsch, a 67-year-old retired special-education teacher who received the Moderna vaccine initially, wasn’t going to wait; she made an appointment on Monday at her local CVS Health Corp. pharmacy in Poughkeepsie, N.Y. A nurse there gave her a third Moderna shot, no questions asked, she said.
Ms. Hirsch, whose husband is recovering from heart surgery, said she checked a box on the CVS website attesting that she was immunocompromised, even though she doesn’t qualify. FDA guidelines for patients receiving a third Moderna jab include patients who take medication to suppress their immune systems and cancer patients currently undergoing treatment.
“I felt I fell under that category where you’re above 65, and your immunity starts to wane, even though I’m not undergoing chemotherapy or anything like that,” Ms. Hirsch said.
CVS spokesman Michael DeAngelis said the chain is administering third Moderna doses only to eligible immunocompromised people but said it is following CDC guidance to allow patients to self-attest to their eligibility without requiring documents of proof.
West Virginia Gov. Jim Justice said Monday that all adult residents of the state who have been vaccinated for at least six months should seek a booster. “If you’re 18 or above, you will qualify in some way,” Gov. Justice said. “I would really highly encourage you to run to the fire again and get that booster shot.”
A spokesman for the governor said he was encouraging all eligible West Virginians to seek a booster, adding that the CDC’s guidance, “interpreted broadly, allows all healthcare workers, retail workers and anyone who works indoors around other people to qualify.”
White House Covid-19 coordinator Jeff Zients said at a media briefing Tuesday that more than 400,000 people received a Covid-19 vaccine booster at U.S. pharmacies last weekend. Nearly 1 million people have scheduled appointments to get their booster shots, Mr. Zients said.
Valencia Jennings is 27 years old and works in the human-resources department of a hospital in Memphis, Tenn. She says she has no underlying medical conditions but got her first doses of the Pfizer vaccine earlier than most people, in December 2020, because she is technically a healthcare worker.
“I interact with a lot of people on a daily basis, and I don’t know anyone’s vaccination status,” she said. She received her Pfizer booster on Monday from a clinic in the hospital.
Other patients said that pharmacies weren’t asking for confirmation of eligibility beyond their online scheduling tools. Lauch Hines, a retirement adviser from Campobello, S.C., got his Pfizer booster on Monday after calling around to local pharmacies.
“They just said, ‘Come on down and bring your vaccine card,’” said Mr. Hines, who is 75.
Michele Cozadd, a former supply-chain information technologist from Columbus, Ohio, who lives on disability because of a brain aneurysm three years ago, said she got her booster this week without any questions from her pharmacist.
“Even on the scheduling app it didn’t ask me if I had a pre-existing condition or a high risk factor,” said Ms. Cozadd, 46.
People who feel that they are at high risk of serious Covid-19 will do whatever they can to get a booster shot, including skirting eligibility requirements, said Neil Sehgal, a professor of health policy at the University of Maryland.
“Some of the demand we’re seeing for boosters is the shadow of policies we’ve had before that failed to mitigate the spread of Covid,” Mr. Sehgal said. “Thousands of people are still dying each day. We’re not out of the woods yet.”
Here’s Why COVID-19 Booster Shots Are Good For Business
The Biden administration’s decision to make COVID-19 booster shots available to millions of vaccinated adults may speak more to the economics of the pandemic than the science.
For the last two months, scientists and federal officials have debated whether COVID-19 boosters are needed — right now, or at all — and, if so, who should get them.
The outcome came last week when the U.S. authorized an extra dose of BioNTech SE and Pfizer Inc.’s COVID-19 vaccine for people who are at least 65 years old, adults who have underlying medical conditions, and people who are at increased risk of exposure because of their jobs.
Much of the debate centered on one key issue. If preventing severe disease is the nation’s “top priority,” and clinical data demonstrate that all three of the COVID-19 vaccines available in the U.S. continue to largely protect people against hospitalization and death, why give out extra shots?
‘The real problem is the unvaccinated. That is where all the infections are coming from. What is much easier is telling a bunch of people who already believe in a vaccine to get [a] booster.’
— Christina Marsh Dalton, Wake Forest University
“If the scientists are concerned that this is being rushed, and the science is not behind it, I could see that policy makers could be scrambling for anything that would guarantee a normal path forward,” said Christina Marsh Dalton, an associate professor of economics at Wake Forest University. “The real problem is the unvaccinated. That is where all the infections are coming from. What is much easier is telling a bunch of people who already believe in a vaccine to get [a] booster.”
If the administration’s priorities take into account the economy, it stands to reason that shoring up immunity among the vaccinated would make sense as we head further into the school year, more employees return to the office, and families prepare to gather for the winter holidays.
“There’s a big economic case to be made for boosters,” Andy Slavitt, a former adviser to the White House’s COVID-19 response team, said in an interview. “President Biden stated this. If you bring the pandemic to an end more quickly, you open up the economy more quickly.”
Slavitt recently said that giving out boosters to people 65 and older makes sense if the sole goal is to keep people from becoming critically ill. But if the aim is something more along the lines of returning to normal, that’s a differently positioned goal post.
“Are we trying to reduce spread?” he tweeted on Sept. 18. “Symptoms? Keep schools open? Get the economy & jobs back? What about the impact on global equity?”
The Economics Of Boosting
We know that the vaccines developed by BioNTech and Pfizer, Moderna Inc., and Johnson & Johnson do a great job at keeping most people out of the hospital and from dying.
But vaccinated people can still infected and get sick, and they can still spread the virus, even though those so-called breakthrough cases are rarely severe and those individuals usually have smaller viral loads.
“It is an assumption that it’s okay to get infected and to get mild-to-moderate disease as long as you don’t wind up in the hospital and die,” Dr. Anthony Fauci, Biden’s chief medical officer, said Tuesday at The Atlantic Festival. “I have to be open and honest: I reject that. I think we should be preventing people from getting sick from COVID even if they don’t wind up in the hospital.”
If boosting can prevent breakthrough infections, however, that could reduce sick days and quarantine time, and it could help make up for lost productivity at work and school.
‘President Biden stated this. If you bring the pandemic to an end more quickly, you open up the economy more quickly.’
— Andy Slavitt
Many well-educated, white-collar workers have been able to do their jobs from home over the last year and a half and therefore aren’t at risk of exposed to the virus at a workplace on a daily basis. But workers in the service industry, for example, where working remotely typically isn’t an option, have had a much more difficult time. “The rest of the economy is not doing fine,” Dalton said.
Businesses “want the pandemic to end and they want to take steps to do it,” Slavitt said. “Otherwise, you’d have it dragging on and on and on under this slow burn and risking further disruption with further waves. And that’s not good for our health. It’s not good for our economy.”
Slavitt estimates that the U.S. could be losing 15 million working hours each week because people are sick or quarantining at home, he said. The European Central Bank’s Christine Lagarde said earlier this month that boosters would be an “add-on” to resolving the pandemic.
And Federal Reserve Gov. Lael Brainard, citing government survey data, said Monday that the number of people who are “not working due to either being sick with COVID or caring for someone sick with COVID more than doubled between late July and early September.”
“A lot of policy makers understand that a healthy population is really important for economic growth,” Neeraj Sood, vice dean for research for the USC Price School of Public Policy, told MarketWatch. “If you’re not healthy, you’re unable to work. And so that would make a big difference in terms of how productive people are.”
Sood, whose work focuses on economic epidemiology, said that surges of coronavirus cases often lead to restricted economic activity.
“Consumer confidence goes down. Businesses don’t like uncertainty,” he said. “So if boosters could prevent surges, then there would be an argument for it. But I don’t know if the evidence is strong enough to suggest that boosters prevent surges.”
The Limitation To COVID-19 Boosters
Infectious-disease and vaccine experts have been saying for months that there isn’t enough clinical data to make the case for widely boosting the population. (To be clear, boosters are available to a much smaller group of people than had been included in President Joe Biden’s initial recommendation back in August that all adults who had received the mRNA vaccines get an extra dose.)
These experts also say that the focus should remain on the more challenging task of persuading the unvaccinated to get a shot.
Federal health officials have acknowledged that distinction.
“Boosters are important, but the most important thing we need to do is get more people vaccinated,” Biden, who is 78, said Monday as he got his booster shot.
But economists still say there are potential downsides to rolling out a booster program at this time. This could include giving another reason for concern to the unvaccinated, some of whom are worried about the speed of the authorization process, corporate pharmaceutical interests, or whether the advent of boosters signals that the vaccines don’t work.
The mRNA vaccines carry a small risk of rare adverse events, such as myocarditis among men who are younger than 30. And the vaccinated could take up appointment slots, making it harder for the unvaccinated to schedule or show up for a shot.
‘We will not boost our way out of this pandemic.’
— Rochelle Walensky, CDC
“This means that it’s open season for boosters, and we expect vaccination centers, clinics, and pharmacies to be swamped with vaccination appointments for ‘the worried well’ in addition to the truly eligible subjects at increased risk,” SVB Leerink analyst Geoffrey Porges told investors.
The biggest concern for economists is whether the booster program slows down the campaign to get people vaccinated at a time when 25% of people who are eligible for a vaccine have not gotten a single shot and so many people in other countries lack vaccine access.
“Economists talk a lot about the idea of opportunity costs,” Marsh Dalton said. “Once we throw money at boosters, it’s not going toward the unvaccinated.”
This is another point that federal health officials have acknowledged, even as they encourage people who are eligible to get a booster shot.
“We will not boost our way out of this pandemic,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Friday. “Infections among the unvaccinated continue to fuel this pandemic rise.”