October 4, 2023

WASHINGTON – Top federal health officials have advised the White House to scale back its plan to offer coronavirus booster vaccinations to the public this month.

Dr. Janet Woodcock, Acting Commissioner for the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention, warned the White House Thursday that her authorities may be able to make a decision in the future weeks whether boosters will only be available to recipients of the Pfizer BioNTech Vaccine should be recommended – and possibly just a few of them to start with.

The two health leaders argued in a meeting with Jeffrey D. Zients, the White House pandemic coordinator. Several people who heard from the meeting said it was unclear how Mr. Zients reacted. But he has insisted for months that the White House always follow the advice of government scientists wherever it leads.

When asked about the meeting, a White House spokesman said on Friday: “We always said we were following science and this is all part of a process that is now underway,” adding that the government is on a Wait for “full review and approval”. of booster vaccinations by the FDA and a recommendation from the CDC

“With this approval and recommendation in place,” said spokesman Chris Meagher, “we will be ready to implement the plan developed by the best doctors in our nation to stay one step ahead of this virus.”

Less than three weeks ago, Biden said that, pending FDA approval, the government planned to give boosters to adults who received their second vaccination of the Pfizer BioNTech or Moderna vaccine at least eight months ago by the week of September 20 to offer. This includes many health care workers and nursing home residents, as well as some people over 65 who are usually the first to be vaccinated. Government officials said recipients of Johnson & Johnson’s single-dose vaccine would likely be offered an additional vaccination soon as well.

Mr Biden described the strategy as just one more tool the nation needed to tackle the highly contagious Delta variant, which has been driving infection rates high, flooding hospitals with Covid-19 patients and historically averaging over 1,500 It has resulted in deaths per day week, according to a New York Times database. “The plan is for every adult to have a booster vaccination eight months after the second vaccination,” he said on Aug. 18, adding, “It will make you safer and longer. And it will help us end the pandemic faster. “

But the announcement of a target date in late September for the start of the booster campaign set alarm bells ringing at the FDA – apparently it played a role in the decisions of two of its top vaccine regulators that announced this week that they would be leaving the agency this fall .

Both Dr. Woodcock and Dr. Walensky helped draft the plan and publicly endorsed it. Some public health experts said they were putting pressure on the scientists who are weighing the evidence for boosters in their respective agencies to follow the government’s strategy.

“Now these agencies are in a box,” said Dr. Steven Joffe, professor of medical ethics and health policy at the University of Pennsylvania. “We want doctors and scientists and the public to trust the recommendations and decisions that are made to indicate that the FDA and CDC are doing their due diligence.”

Dr. Woodcock had privately argued that it was risky to set a fixed date for the introduction of a booster before regulators had a chance to thoroughly review the dates, some of which had yet to be submitted by vaccine manufacturers, and decide whether to Vaccinations are safe and necessary, according to several people familiar with the discussions.


9/3/2021, 8:30 p.m. ET

And since the White House announced the booster plan in mid-August, new hurdles have emerged, it said.

One of the reasons for the delay is because it takes regulators more time to decide the right dosage for a possible third Moderna shot. The company’s application asking the FDA to approve a booster vaccination contains insufficient data, said a federal official familiar with the procedure. Other data expected by Johnson & Johnson was not provided.

Not even the raw data that the FDA has requested from Israel, which already gives boosters to everyone aged 12 and over. Israeli officials say their data shows that the Pfizer vaccine’s effectiveness wears off over time against serious illness and hospitalization, but that a third shot increases protection significantly. The FDA wants to see the underlying data to make sure it supports the summaries provided by the Israeli government.

Narrowing the booster plan could confuse the public and create the impression that government vaccine policy is to some extent disorganized. But some public health experts will most likely welcome it.

They argued vigorously that the government lacks the data to justify widespread adoption of additional vaccinations and should instead focus on vaccinating about 25 percent of Americans who are eligible for vaccination but remain unprotected. And some have said that senior Biden officials, including heads of health officials, have mistakenly cornered regulators by announcing a strategy before they could conduct a full review.

Understand US vaccination and mask requirements

    • Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. Both California and New York City have introduced vaccination mandates for educational staff. A survey published in August found that many American parents of school-age children are against mandatory vaccines for students, but are more supportive of masking requirements for students, teachers and staff who do not have a vaccination.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13th. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, without the option of weekly testing. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Regulators are only just beginning to review critical data that will help them determine if and how boosters should be administered. Pfizer finalized its booster application with the FDA last week, and Moderna said Friday that it had just finalized its own.

The two vaccine regulators who have announced they will be leaving the agency this fall – Dr. Marion Gruber, who heads the agency’s vaccine office, and her deputy, Dr. Philip Krause – told people there isn’t nearly enough data to warrant additional offers shots to the general population starting in a few weeks. Dr. Gruber will be leaving in October, Dr. Krause in November.

More friction may be imminent. On September 17, the FDA’s external advisory committee is due to publicly review Pfizer’s data supporting a booster vaccination. Although Pfizer has asked the FDA to approve booster doses for people aged 16 and over, the agency may decide who can get a booster vaccination restricted. The CDC and its external advisory body would also have to weigh up.

A key member of the FDA advisory board, Dr. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, argues that booster vaccinations are premature. “There is no compelling reason to get a third dose now,” he said in an interview on Thursday.

He said the government apparently expected the FDA and CDC to approve their booster schedule. “The circumvention and marginalization of these agencies resulted in veterans who need you in this pandemic leaving the FDA,” he said, referring to the departures of Dr. Gruber and Dr. Frill.

Various studies have shown that the Pfizer-BioNTech and Moderna vaccines decrease in effectiveness against infection over time, but suggest that the vaccines continue to provide robust protection against serious illness and hospitalization.

But dr. Vivek Murthy, the surgeon general, said in an interview Thursday that some studies suggest a decrease in protection from serious illnesses over time. “Our feeling was that if we waited several more months, the protection against hospitalizations and deaths would break down,” he said.

In an interview posted on WebMD.com Thursday, Dr. Woodcock shared this view, saying that the trend towards breakthrough infections has at some point led health officials to believe that “we will experience hospitalizations and more serious illnesses in fully vaccinated people”. . When that happens, she said, “let’s be ready with the booster plan”.

Some Americans are getting a booster vaccination even before FDA approval: More than a million fully vaccinated people have received an extra dose since mid-August. The agency approved vaccines for some people with compromised immune systems on August 12; It is not known how many of the people who received extra doses belong to this group.

Kitty Bennett contributed to the research.