Marks defends push toward COVID vaccine boosters

Regulatory NewsRegulatory News
| 13 September 2021 | By Michael Mezher 

Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), defended the agency's moves toward authorizing third doses of COVID-19 vaccines amid their limited global supply.
Speaking at RAPS Convergence 2021 on Monday, Marks said he is "fully confident" that those who tune into the agency's upcoming advisory committee meeting to discuss Pfizer and BioNTech's supplemental biologics license application (sBLA) for a third dose of their vaccine will be persuaded by the evidence in support of boosters.
"I am fully confident that when people come to the advisory committee meeting and tune in on September 17th and they witness the Israelis presenting their data and they witness other data being presented, that there will be a good rationale for why boosters might be necessary," Marks said.
His remarks came the same day two top CBER officials who announced their retirement from the agency last month, together with other international experts, published a viewpoint refuting the need for widespread COVID-19 booster shots in The Lancet. In the viewpoint, the authors suggest that boosters may be more impactful if they are developed to match currently circulating variants and that providing initial vaccinations to more people globally will do more to help end the pandemic.
However, Marks stressed that the evidence available from the US and Israel does indicate that the efficacy of the current vaccine regimens is waning.
"Evidence from the United States and Israel seems to show that immunity to the current vaccine may wane. Actually, 'may' is too weak a word. It is waning, particularly in the setting of the delta variant," Marks said.
Marks pointed out that viewing the third doses as "boosters" may be the wrong way to think of them, citing vaccines for other diseases that require three doses for a full course.
"Boosters may turn out to be very important, because they may not actually be boosters, they may be the final dose in a primary series that helps protect us with immunity against COVID-19 that is more durable," he said.
Marks also responded to a question about The Lancet viewpoint: "First of all, that Lancet paper was a [World Health Organization] WHO product of a working group on which Phil Krause was the lead author and Marion Gruber signed on. They signed on in their individual capacity as private citizens of these United States … there was a disclaimer that they did not represent the opinions of the United States government."
The CBER director explained that "as a United States government employee it is my obligation to ensure that the health of the United States population is best cared for and not to make global political decisions. So, if it turns out that a third dose is appropriate for everyone in the world to help prevent COVID-19 from coming around in cycles, we should be doing that, and if we happen to get to it before others realize that that's the right thing to do, that's just the way it is."
Marks said he has "tremendous respect for both Drs. Gruber and Krause," and stressed that he has not been pressured to make any specific decisions on the vaccines or boosters.


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