(WASHINGTON) — The Food and Drug Administration on Wednesday released new data from Pfizer’s submitted application to approve booster doses of its Covid-19 vaccine. In it, Pfizer demonstrates what it sees as proof that third shot will be both safe and necessary for most Americans to take, arguing that immunity wanes over time — regardless of any new variant of concern.
It comes two days ahead of a critical juncture in the COVID-19 vaccine booster approval process: Friday, the Food and Drug Administration’s independent advisory committee (VRBPAC) is set to convene to review and discuss the latest data on potential booster doses of the Pfizer vaccine. The committee will be asked to vote on whether a booster dose is safe enough for widespread use — and whether it’s necessary and effective at improving protection levels.
In mid-August, the FDA authorized boosters of Moderna and Pfizer for the roughly 7 million immunocompromised Americans who didn’t get an optimal immune response to their initial vaccine doses.
Pfizer/BioNTech, which partnered to develop the nation’s first fully approved vaccine, has said it has early data suggesting a booster dose anywhere from six to 12 months after the second dose will help maintain a high level of protection; Pfizer asked the FDA to approve booster doses of its vaccine in late August by submitting an application and data. On Wednesday morning, the FDA made that data public.
While the independent members of the VRBPAC’s votes are not binding, the agency takes its recommendations under serious advisement in deciding whether to grant vaccines new authorization or approval. If and when a recommendation does come to green light booster shots, several additional steps must follow before it’s time for more Americans to role up their sleeves a third time.
First, the FDA would need to formally amend its current vaccine approval for Pfizer; then the Centers for Disease Control and Prevention’s advisory committee (ACIP) will weigh to whom, and when, expanded booster shots should begin. Then, the CDC director must formally sign off on whether to recommend the vaccine to the public, including who it will be recommended for and at what time period. It’s expected to be authorized for anyone eight months after their second dose. Authorization for Moderna and Johnson & Johnson may not be far behind.
The new data — and proximate committee vote — also come days before the Sept. 20 date set by the White House as the target to begin deploying booster shots for a wider pool of Americans.
The question of whether America’s immunity is waning has become an urgent question in recent months with the rise of the delta variant and large pockets of the country still unvaccinated.
FDA acting Commissioner Janet Woodcock and CDC Director Rochelle Walensky — both White House appointees — endorsed President Joe Biden’s Sept. 20 plan.
However, it has been getting some pushback, with health experts criticizing the Sept. 20 boosters-for-all timeline as premature and prior to any ruling from their advisory groups.
Two top FDA officials who are leaving the agency later this year publicly waded into the booster debate on Monday, splitting from the agency and arguing in a scientific journal that it was too soon to give booster shots to the general public since the vaccines still offer strong protection against serious disease.
One of them is scheduled to attend Friday’s VRBPAC discussion.
“The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination,” the officials wrote, backed by other worldwide organizations.
For their part, the Biden administration has emphasized that science will lead and federal regulators will have the final say — and that their call to push out booster shots is motivated by wanting to “stay ahead” of the virus.
“You don’t want to find yourself behind playing catch up,” Dr. Anthony Fauci said when announcing the plan. “Better stay ahead of it than chasing after it.”
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