Health Officials Advise Biden to Scale Back Covid-19 Booster Shots Plan For Now


WASHINGTON — Top federal well being officers have informed the White House to cut back a plan to supply coronavirus booster pictures to most people this month, saying that regulators want extra time to accumulate and evaluate all the required knowledge, in accordance to folks accustomed to the dialogue.

Dr. Janet Woodcock, the performing commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention, warned the White House on Thursday that their businesses might have the option to decide within the coming weeks whether or not to advocate boosters just for recipients of the Pfizer-BioNTech vaccine — and presumably simply a few of them to begin.

The two well being leaders made their argument in a gathering with Jeffrey D. Zients, the White House pandemic coordinator. Several individuals who heard concerning the session stated it was unclear how Mr. Zients responded. But he has insisted for months that the White House will all the time comply with the recommendation of presidency scientists, wherever it leads.

Asked concerning the assembly, a White House spokesman stated on Friday, “We always said we would follow the science, and this is all part of a process that is now underway,” including that the administration was awaiting a “full review and approval” of booster pictures by the F.D.A. in addition to a suggestion from the C.D.C.

“When that approval and recommendation are made,” the spokesman, Chris Meagher, stated, “we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus.”

Less than three weeks in the past, Mr. Biden stated that contingent on F.D.A. approval, the federal government planned to start offering boosters the week of Sept. 20 to adults who had received their second shot of the Pfizer-BioNTech or Moderna vaccine at least eight months ago. That would include many health care workers and nursing home residents, as well as some people older than 65, who were generally the first to be vaccinated. Administration officials have said that recipients of the single-dose Johnson & Johnson vaccine would probably be offered an additional shot soon as well.

Mr. Biden cast the strategy as another tool that the nation needed to battle the highly contagious Delta variant, which has driven up infection rates, swamped hospitals with Covid-19 patients and led to an average of more than 1,500 deaths a day for the past week, according to a New York Times database. “The plan is for every adult to get a booster shot eight months after you got your second shot,” he said on Aug. 18, adding: “It will make you safer, and for longer. And it will help us end the pandemic faster.”

But the announcement of a late September target date for starting the booster campaign set off alarm bells inside the F.D.A. — apparently playing a role in decisions by two of its top vaccine regulators, announced this week, to leave the agency this fall.

Both Dr. Woodcock and Dr. Walensky helped draft the plan and publicly endorsed it. Some public health experts have said that by doing so, they increased pressure on scientists weighing the evidence for boosters in their respective agencies to go along with the administration’s strategy.

“Now those agencies are in a box,” said Dr. Steven Joffe, a professor of medical ethics and health policy at the University of Pennsylvania. “We want doctors and scientists and the public to trust in the recommendations and decisions that are made, to be able to point to the F.D.A. and C.D.C. doing their due diligence.”

Privately, Dr. Woodcock had argued that 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, they said, new hurdles appeared.

Among the reasons for delaying is that regulators need more time to decide the proper dosage for a possible third Moderna shot. The company’s application asking the F.D.A. to authorize a booster shot contains insufficient data, one federal official familiar with the process said. Other data expected from Johnson & Johnson has not been delivered.

Nor has the raw data that the F.D.A. has been seeking from Israel, which is already giving boosters to everyone 12 and older. Israeli officials say their data shows that the potency of Pfizer’s vaccine wanes over time against severe disease and hospitalization, but that a third shot significantly bolsters protection. The F.D.A. wants to see the underlying data, to make sure it backs up summaries that the Israeli government has provided.

Narrowing the booster plan could confuse the public and create a perception that federal vaccine policy is in some degree of disarray. But some public health experts will most likely welcome it.

They have been arguing strenuously that the administration lacks the data to justify a broad rollout of extra shots and should instead concentrate on vaccinating the roughly 25 percent of Americans who are eligible for shots but remain unprotected. And some have said that senior Biden officials, including the leaders of health agencies, wrongly cornered regulators by announcing a strategy before they could conduct a full review.

Regulators are only beginning to review critical data that will help them determine if and how boosters should be given. Pfizer completed its booster application to the F.D.A. last week, and Moderna said on Friday that it had just completed its own.

The two vaccine regulators who announced that they would be leaving the agency this fall — Dr. Marion Gruber, who directs the agency’s vaccines office, and her deputy, Dr. Philip Krause — have told people there was not nearly enough data to justify offering extra shots to the general population starting in just weeks. Dr. Gruber is set to depart in October, and Dr. Krause in November.

More friction may lie ahead. On Sept. 17, the F.D.A.’s outside advisory committee is scheduled to publicly review Pfizer’s data supporting a booster shot. Even though Pfizer has asked the F.D.A. to approve booster doses for people 16 and up, the agency could decide to restrict who gets a booster. The C.D.C. and its outside advisory panel would also have to weigh in.

One key member of the F.D.A.’s advisory panel, Dr. Paul A. Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, argues 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 had appeared to expect that the F.D.A. and the C.D.C. would rubber-stamp its booster timeline. “Bypassing and marginalizing those agencies led veterans who you need in this pandemic to leave the F.D.A.” he said, referring to the departures of Dr. Gruber and Dr. Krause.

Various studies have shown that the potency of the Pfizer-BioNTech and Moderna vaccines ebbs against infection over time, but suggest that the vaccines continue to offer robust protection against severe illness and hospitalization.



Source link Nytimes.com

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