It comes a few days before the FDA advisory committee discusses the booster injections.
The Food and Drug Administration on Wednesday released new data from Pfizer’s request to approve booster doses of its Covid-19 vaccine. In it, Pfizer demonstrates what it sees as proof that the third shot will be both safe and necessary for most Americans, arguing that immunity wanes over time – regardless of any new variant of concern.
It comes two days before a critical moment in the COVID-19 vaccine recall approval process: On Friday, the Food and Drug Administration’s Independent Advisory Board (VRBPAC) is due to meet to review and discuss the latest dose data potential boosters of Pfizer vaccine. The committee will be asked to vote on whether a booster dose is safe enough for widespread use – and whether it is necessary and effective to improve levels of protection.
In mid-August, the FDA cleared recalls of Moderna and Pfizer for the approximately 7 million immunocompromised Americans who did not achieve an optimal immune response to their initial doses of the vaccine.
Pfizer / BioNTech, which has partnered to develop the country’s first fully approved vaccine, said it has preliminary data suggesting that a booster dose between six and 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 this data public.
First, the FDA should formally change its current vaccine approval for Pfizer; Next, the Centers for Disease Control and Prevention (ACIP) advisory committee will assess who and when the expanded booster injections should start. Next, the CDC director must formally approve whether to recommend the vaccine to the public, including who it will be recommended for and when. It should be cleared for anyone eight months after their second dose. Clearance for Moderna and Johnson & Johnson may not be far behind.
The new data – and the committee’s immediate vote – also comes days before the September 20 date set by the White House as a target to begin rolling out booster shots to more Americans.
The question of whether U.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.
Acting FDA Commissioner Janet Woodcock and CDC Director Rochelle Walensky, both appointed to the White House, have endorsed President Joe Biden’s September 20 plan.
However, it has suffered some setback, with health experts criticizing the September 20 all recall schedule as premature and prior to any decision by their advisory groups.
Two senior FDA officials who will be leaving the agency later this year publicly launched into the recall debate on Monday, parting ways with the agency and arguing in a scientific journal that it was too early to give injections of reminder to the general public since vaccines still offer strong protection against serious diseases.
One of them is expected to attend the VRBPAC discussion on Friday.
“The message that a booster may soon be needed, if not supported by solid data and analysis, could undermine confidence in vaccines and undermine messages about the value of primary immunization,” the officials wrote, supported by other global organizations.
For its part, the Biden administration has stressed that science will rule and federal regulators will have the final say – and that their call for the booster shots to come out is driven by a desire to “stay ahead” of the virus.
“You don’t want to find yourself behind catching up,” Dr Anthony Fauci said when announcing the plan. “Better to stay in front of him than to run after him.”