WASHINGTON — Federal health officials have told the White House to scale back a plan to offer coronavirus booster shots to the general public this month, saying regulators need more time to collect and review all the necessary data, according to people familiar with the discussion .
dr. Janet Woodcock, the Acting Commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, chief of the Centers for Disease Control and Prevention, warned the White House on Thursday that in the coming weeks, their agencies should recommend whether boosters should be recommended only to recipients of the Pfizer-BioNTech vaccine — and possibly just a few to get started. .
The two health leaders made their argument during a meeting with Jeffrey D. Ziess, the White House pandemic coordinator. Several people who heard about the session said it was unclear how Mr. Ziens reacted. But he’s been insisting for months that the White House will always follow the advice of government scientists, wherever it leads.
Asked about the meeting, a White House spokesperson said Friday: “We’ve always said we’d follow the science, and this is all part of a process that’s now underway,” adding that the administration was waiting for a “full review and approval”. of booster shots by the FDA and a recommendation from the CDC
“When that approval and recommendation is made,” said spokesperson Chris Meagher, “we will be ready to implement the plan our country’s best doctors have developed so that we stay ahead of this virus.”
Less than three weeks ago, Mr. Biden said that, subject to FDA approval, the government was planning to offer boosters the week of Sept. 20 to adults who had their second injection of the Pfizer-BioNTech drug at least eight months ago. or received Moderna vaccine. . That includes many health professionals and nursing home residents, as well as some people over the age of 65, who were generally the first to be vaccinated. Administration officials have said recipients of the single-dose Johnson & Johnson vaccine will likely also receive an additional shot soon.
Biden pitched the strategy as another tool the nation needed to combat the highly contagious Delta strain, which has pushed infection rates, flooded hospitals with Covid-19 patients and resulted in an average of more than 1,500 deaths per year. day in the past week, according to a NewsMadura database. “The plan is for every adult to get a booster shot eight months after you get your second shot,” he said on Aug. 18, adding, “It will make you safer and taller. And it will help us get through the pandemic faster.” to end.”
But the announcement of a target date of late September for the booster campaign to start raised alarm bells within the FDA — which apparently played a role in the decisions of two of its key vaccine regulators, announced this week, to leave the agency this fall. .
Both Dr. Woodcock as Dr. Walensky helped draft the plan and publicly endorsed it. Some public health experts have said that by doing so they have increased the pressure on scientists who have weighed the evidence for boosters in their respective agencies to go along with the government’s strategy.
“Now those instances are in a box,” says Dr. Steven Joffe, professor of medical ethics and health policy at the University of Pennsylvania. “We want physicians and scientists and the public to rely on the recommendations and decisions being made to point out that the FDA and CDC are doing their due diligence.”
Privately, Dr. Woodcock argued it was risky to set a firm date for a booster rollout before regulators had a chance to thoroughly review the data, some of which had yet to be submitted by the vaccine manufacturers, and decide whether shots were safe and necessary, according to several people familiar with the discussions.
And since the White House announced the booster plan in mid-August, new hurdles have emerged.
One reason for the delay is that regulators need more time to determine the correct dosage for a possible third Moderna shot. The company’s application asking the FDA to approve a booster injection lacks sufficient data, said a federal official familiar with the process. Other information expected from Johnson & Johnson has not been provided.
Nor has the raw data the FDA sought from Israel, which already gives boosters to anyone 12 years and older. Israeli officials say their data shows that the potency of Pfizer’s vaccine decreases over time against serious illness and hospitalization, but a third injection significantly improves protection. The FDA wants to see the underlying data to make sure it supports the summaries provided by the Israeli government.
Restricting the booster plan could confuse the public and create the impression that federal vaccine policy is disordered to some extent. But some public health experts will most likely welcome it.
They have argued strongly that the government does not have the data to justify a broad introduction of additional injections and should instead focus on vaccinating the roughly 25 percent of Americans who are eligible for injections but unprotected. stay. And some have said senior Biden officials, including health agency leaders, wrongly cornered regulators by announcing a strategy before they could conduct a full review.
Understanding Vaccine and Mask Mandates in the US
- Vaccine Rules. On August 23, the Food and Drug Administration gave full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, paving the way for an increase in mandates in both the public and private sectors. Private companies are increasingly mandating vaccines for employees. Such mandates are permitted by law and have been confirmed in court proceedings.
- Mask Rules. The Centers for Disease Control and Prevention recommended in July that all Americans, regardless of vaccination status, wear masks in indoor public places in areas with outbreaks, a reversal of the guidance it offered in May. Find out where CDC guidelines apply and where states have their own masking policies. The battle over masks has become controversial in some states, with some local leaders defying state bans.
- College and universities. More than 400 colleges and universities are demanding that students be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- schools. Both California and New York City have introduced vaccine mandates for educators. A survey published in August found that many U.S. parents of school-aged children are opposed to mandatory vaccines for students, but were more in favor of mask mandates for students, teachers and staff who have not received their injections.
- Hospitals and Medical Centers. Many hospitals and major health systems require workers to receive a Covid-19 vaccine, citing the increasing caseload fueled by the Delta variant and persistently low vaccination coverage in their communities, even within their workforce.
- New York City. Evidence of vaccination is required from employees and customers for indoor meals, gyms, performances and other indoor situations, although enforcement will not begin until September 13. Teachers and other education workers in the city’s vast school system must have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital employees should also receive a vaccine or be tested weekly. Similar rules apply to employees in New York State.
- At the federal level. The Pentagon announced it would aim to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “by mid-September.” President Biden announced that all civilian federal employees would be required to be vaccinated against the coronavirus or undergo regular testing, social distancing, mask requirements and restrictions on most travel.
Regulators are only beginning to review critical data that will help them determine whether and how boosters should be given. Pfizer completed its booster filing with the FDA and Moderna last week said on Friday that it had just completed its own.
The two vaccine regulators who announced they would be leaving the agency this fall — Dr. Marion Gruber, who heads the agency’s vaccine office, and her deputy, Dr. Philip Krause – have told people there was not nearly enough data to begin offering additional shots to the general population in just weeks. dr. Gruber will be leaving in October, and Dr. Krause in November.
There could be more friction ahead. On September 17, the FDA’s external advisory committee will publicly review Pfizer’s data supporting a booster injection. Although Pfizer has asked the FDA to approve booster doses for people ages 16 and older, the agency could decide to limit who gets a booster. The CDC and its external advisory panel should also weigh in.
A key member of the FDA’s advisory panel, Dr. Paul A. Offit, the director of the Vaccine Education Center at the Children’s Hospital in Philadelphia, argues that boosters are premature. “There is no compelling reason to get a third dose now,” he said in an interview on Thursday.
He said the administration seemed to expect the FDA and CDC to stamp their booster timeline. “Bypassing and marginalizing those agencies has resulted in veterans you need in this pandemic leaving the FDA,” he said, referring to Dr. Gruber and Dr. Krause.
Several studies have shown that the potency of the Pfizer-BioNTech and Moderna vaccines decreases over time against infection, but suggest that the vaccines continue to provide robust protection against severe illness and hospitalization.
But dr. Surgeon general Vivek Murthy said in an interview on Thursday that a few studies have suggested that protection against serious diseases diminishes over time. “We felt that if we waited a few more months, we would see protections against hospitalizations and deaths diminish,” he said.
In an interview published Thursday on WebMD.com, Dr. Woodcock expressed that opinion, saying the trend of breakthrough infections had at one point led health officials to believe that “we will see hospitalizations and more serious illnesses” among fully vaccinated people. When that happens, she said “we want to be done” with the booster plan.
Some Americans are already getting booster shots 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 weakened immune systems on Aug. 12; it is not known how many of the people who received extra doses are in that group.
Kitty Bennett research contributed.