Lagging Data May Push Back Biden’s Booster Shot Timeline: Report

Two federal health officials warned the Biden administration on Thursday that the COVID-19 booster plan the White House outlined earlier this summer might not be possible because of insufficient data, The New York Times reported Friday morning. 

The officials, CDC Director Dr. Rochelle Walensky and FDA acting commissioner Dr. Janet Woodcock, made the comments in a meeting with White House pandemic coordinator Jeffrey Zients. From The New York Times: 

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 bolsters protection significantly. The F.D.A. wants to see the underlying data, to make sure it backs up summaries that the Israeli government has provided.

Only last month, President Joe Biden said his administration was preparing to begin booster shots beginning the week of September 20, contingent on FDA approval. 

“The plan is for every adult to get a booster shot eight months after you got your second shot,” Biden said on August 18, notes The New York Times. The president added, “It will make you safer, and for longer. And it will help us end the pandemic faster.”

The move by the two health officials will likely slow down the Biden administration’s rollout for vaccine boosters, a push that some experts already believed was premature of the administration to announce. 

“In the heat of the moment and when we’re all dealing with a real public health emergency, it becomes almost doubly important that we continually reassess and have the normal processes in place,” Jesse Goodman, a former chief FDA scientist, told Stat News back in August.  “And I do worry that we not put the cart before the horse.”

“How did you pick the week of September 20?” former FDA vaccine head Norman Baylor remarked to the medical news website at the time.  “Since this meeting hasn’t occurred and you don’t know what they’re going to say — this is an independent body — suppose they say: ‘We don’t think so.’ Then what are you going to do with that?”

In a statement to The Washington Post, White House spokesperson Chris Meagher said the administration was intent on following the science.

“We always said we would follow the science and this is all part of a process that is now underway,” said Meagher. “We are awaiting a full review and approval by the FDA and a recommendation by the [CDC’s Advisory Committee on Immunization Practices]. When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus.”

The booster plan has also been controversial among some federal regulators, who believe that, by setting a date for the COVID-19 booster plan rollout before the data was fully reviewed, the Biden administration was interfering in the vaccine’s regulatory process. 

Two top FDA officials also recently announced they would be stepping down. Although the reason for their departures has not been clear, POLITICO reports, citing a former FDA official, they may have been motivated by anger about the administration’s decision to weigh in on boosters too soon. 

Frustration at the FDA reportedly prompted Woodcock to issue a memo to staff on Tuesday.

“The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges,” said the memo, reports POLITICO. 

According to The New York Times, Walensky and Woodcock told the White House on Thursday that there may only be enough data to recommend booster shots for specific recipients of the Pfizer-BioNTech vaccine. Weeks ago, however, the Biden administration was publicly saying they hoped to start boosters for adults who had received the Pfizer vaccine and the Moderna vaccine. 

The White House, in response to the report, told The New York Times that they were waiting for booster shots to receive “full review and approval” and were going to “follow the science.” They also said they would, upon FDA approval, “implement the plan our nation’s top doctors developed so that we are staying ahead of this virus.”

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