Biden administration eyeing booster shot recommendation within weeks – POLITICO

Some of those health officials, including top Food and Drug Administration vaccine regulator Peter Marks, have advocated expanding those who would be eligible for an additional booster shot by the first week of April, arguing that the vaccination campaign needs to start well ahead of the next surge, the people with knowledge of the matter said.

Though cases in the U.S. are still dropping, the Biden administration has closely monitored recent Covid spikes in several European countries — where BA.2 is spreading — noting that prior surges there have preceded surges here. The subvariant, which is a more infectious version of Omicron, accounts for roughly 35 percent of all U.S. Covid cases so far, Centers for Disease Control and Prevention data shows, though it is already the majority strain in the New England region.

Administration health officials have also reviewed recent data showing the vaccines’ effectiveness beginning to wane.The White House declined to comment.

While there is broad agreement that a fourth shot eventually will be warranted, other officials are wary of preempting an April 6 meeting of the FDA’s vaccine advisory committee.

At that meeting, the agency’s outside advisers are slated to discuss frameworks for who should get booster shots and when. The FDA traditionally consults the committee members before making major vaccine decisions, and risks angering those influential health experts if the agency presses ahead without their input.

Some health officials also remain uncertain whether older Americans need a booster just yet. There is no definitive sign that the European case surge will lead to a rise in U.S. infections. And recent data reviewed by the administration shows that while the vaccines’ ability to guard against infection is eroding significantly within a few months, those vaccines still remain largely protective against the risk of serious illness and death. Top health officials are waiting on more definitive data from the CDC and Israel to determine the effectiveness of a fourth shot on different groups and populations, according to one of the people with knowledge of the matter.

“The somewhat encouraging news is that despite the increase in cases, they are not seeing an increase in [intensive care unit] admissions,” Anthony Fauci, President Joe Biden’s chief medical adviser, said of the feedback that U.S. officials are getting from their European counterparts. “Although they’re seeing an increase in hospitalizations, they think it is contributed somewhat by a lack of distinguishing people who are admitted with Covid versus for Covid.”

Top Biden officials have repeatedly emphasized that their primary goal for managing the pandemic is to keep people out of the hospital — not prevent infections. But there is still no consensus within the administration on how far the vaccines’ effectiveness against hospitalization needs to drop before another booster is warranted.

Further complicating the debate are fears among health officials over vaccine equity — specifically, that authorizing a second booster only for those over 65 would open up eligibility for a demographic that skews more heavily white, even though Black Americans and Latinos have been disproportionately affected by Covid.

The internal deliberations come days after Pfizer and its partner, BioNTech, officially sought authorization for a second booster shot for people over 65. Moderna also filed a similar application, though it asked the FDA to clear its booster for all adults. On Wednesday, the company said it would file an emergency use authorization request for vaccine distribution to children under the age of 6.

Those companies made their case by relying heavily on data from Israel indicating the additional shot could shore up people’s defenses against Covid. Pfizer CEO Albert Bourla has pushed repeatedly in public for the administration to recommend an additional shot, calling it a “necessary” move.

“The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths,” he said last Sunday on “Face the Nation.” “It’s not that good against infections, but doesn’t last very long.”

Since then, the FDA and CDC have been in close contact about the companies’ booster shot applications, said one person with knowledge of the matter. The White House, meanwhile, has conveyed that whatever decision the health department makes, it needs to be communicated clearly and definitively to the public.

An FDA spokesperson declined to comment on the internal discussions, but said the agency “will review the requests as expeditiously as possible using our thorough and science-based approach.”

The Biden administration is eager to avoid a repeat of last year’s messy debate over the first round of boosters, which was dominated by clashes inside and outside the government over whether another shot was necessary for the broader population — especially as other countries struggled to secure first doses.

The CDC ultimately recommended the booster for certain demographics deemed high risk, including those over 65 and other adults at risk of Covid exposure in the workplace. But that compromise fueled confusion and criticism of the administration’s messaging. Though the CDC opened up eligibility to all adults months later, many health officials blame the episode for suppressing enthusiasm for the boosters.

Roughly two-thirds of people over 65 have received a booster, according to CDC data. But fewer than half of all adults have gotten the additional shot.

This time around, officials have stressed the need to get buy-in from all the various health agencies on any plan for a second booster before going public, one person with knowledge of the matter said.

Internal discussions have played out as well against the backdrop of a standoff over Covid response funding in Congress, where lawmakers have yet to approve billions of dollars that the administration says are needed to purchase more vaccines, treatments and tests.

The administration has enough vaccines on hand to provide second boosters to all Americans over 65, officials said. But there isn’t enough supply to cover the entire adult population, prompting warnings that the nation could be left shorthanded later this year.

The government needs to begin negotiating new supply deals with Pfizer and Moderna at the beginning of April to ensure doses are delivered by the fall, one official said — a process that cannot begin until Congress passes more funding.

Sarah Owermohle contributed to this report.

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