Biden’s Booster Shot Push Raises Concerns Among Health Experts

(Bloomberg) -- The White House’s plan to begin offering booster shots next month to almost all vaccinated U.S. adults is raising concerns among health experts that the administration is rushing ahead without enough data and regulatory oversight. 

On Wednesday as expected, officials from the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, along with the U.S. Surgeon General and White House Covid-19 adviser Anthony Fauci, announced the booster plan. But it came without the FDA and CDC publicly saying they had fully vetted giving a third shot to the 100 million fully-vaccinated Americans by year’s end.

Messenger RNA vaccines made by Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE will be used in the booster push, according to the announcement. Johnson & Johnson’s is still under review because it came into use later. These vaccines were cleared under an emergency use authorization (EUA) that would have to be amended to allow the booster program to go forward. 

“Endorsing boosters before FDA changes the EUA or grants full approval is actually endorsing something that is not currently permissible under the law,” said Holly Fernandez Lynch, a University of Pennsylvania bioethicist. “Any use beyond the specific terms of the EUA would be unauthorized.” 

It would be very strange for the Biden administration to be the one calling the shots on boosters, according to Dorit Reiss, a professor who studies vaccine policy at the University of California Hastings College of the Law.

“This is not something that’s generally done by the administration or by political actors,” Reiss said. “If they are going to circumvent the process, then I’m very concerned.”

The Biden administration’s move subtly echoes former P

resident Donald Trump’s voluble efforts to push the FDA to quickly approve vaccines before the November election. However, the current White House hasn’t engaged in publicly attacking the regulator like the former president did.

Push Back

In a White House briefing on Wednesday, Surgeon General Vivek Murthy pushed back on the notion that the administration was front-running regulators, saying it would follow the normal protocols. The early announcement was made to be transparent with the public and ensure that states and localities have enough time to plan, he said.

Health officials are making progress on discussing booster shots. The CDC’s Advisory Committee on Immunization Practices, which includes medical and public health experts, will meet on Aug. 24. The FDA is also working with the CDC and the National Institutes of Health to consider when boosters might be given, according to a FDA spokeswoman.

ACIP members have been discussing the topic for months, and the data are adequate for the Biden administration to make this recommendation, according to Camille Kotton, an ACIP member and clinical director of transplant and immunocompromised host infectious diseases at Massachusetts General Hospital in Boston.

Lynn Bahta, also an ACIP member, said the announcement includes the necessary steps to involve the FDA and ACIP in reviewing the data, which is important for transparency of the process.

Delta Variant

“We are still in a pandemic, and there is much broader involvement of top decision-makers,” Bahta said. “The good news is that it gives states and the general public a heads up that allows for planning.”

Stephen Hahn, who served under President Trump as FDA last commissioner, said that data on the vaccine boosters should decide who should get one, and that it’s possible that may not be immediately available for all populations.

“It’s OK to admit that there might be gaps in information, but we’re trying to fill those,” Hahn said. “People get it when a doctor says, ‘There’s a gap in information, but this is the best information we can give you.’”

The push for booster shots comes as new waves of Covid cases fueled by the delta variant have caused a surge in hospitalizations and fatalities across the country. More transmissible than other viral mutations, delta has shown itself to be adept at evading the protection afforded by vaccines. New data published by the CDC Wednesday showed that vaccine effectiveness against infection and the delta variant is decreasing over time. 

While the Biden administration could be right to offer boosters widely, there isn’t enough convincing data to suggest that everyone needs one, according Michael Osterholm, a University of Minnesota epidemiologist and former Biden adviser. The concern of waning immunity is associated with the elderly and immunocompromised, he said.

“This isn’t about yes or no,” Osterholm said. “It’s about whether we need this for everyone.”

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