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Senators press Woodcock on COVID vaccines, boosters

Posted 20 July 2021 | By Michael Mezher 

Senators press Woodcock on COVID vaccines, boosters

Senators on both sides of the aisle pressed Janet Woodcock, acting commissioner of the US Food and Drug Administration (FDA), and other officials during a hearing on Tuesday. The senators asked for specifics on the timing of COVID-19 vaccine booster shots and when the vaccines currently authorized for emergency use might obtain full approval.
More than a year into the COVID-19 pandemic, the full Senate Health, Education, Labor and Pensions committee met to explore the nation’s path forward through the pandemic amid rising case counts driven by the more contagious Delta variant and persistent regional pockets where vaccination rates remain stubbornly low.
Chief among the concerns raised by committee members were how the federal agencies represented at the hearing were tracking the Delta variant and determining whether, or when, boosters of the vaccines currently in use will be necessary to counter waning immunity among the vaccinated population.
In a warm welcome to Woodcock, Ranking Member Richard Burr (R-NC), praised her leadership and said he hopes to see her at another hearing again soon, “preferably a confirmation hearing.” Despite being six months into his term, President Joe Biden has yet to nominate a permanent FDA Commissioner. Under the Federal Vacancies Reform Act, officials are normally limited to serving up to 210 days in an acting capacity without a permanent replacement being nominated. That timeline can be further extended, however, depending on when the vacancy was filled and in the case that a nomination is withdrawn or rejected.
“The FDA should build on the great success that we’ve had, staying the more nimble and creative agency it’s become during the COVID-19 response. This is especially important as the agency works to make final its user fee agreements and transmit them to Congress for our approval next year,” Burr said.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky also appeared before the Senate committee. When pressed on the need for COVID-19 vaccine booster shots by Sen. Mitt Romney (R-UT) in light of other countries, including Israel, beginning to offer boosters to some individuals Walensky said that US agencies are still gathering data and have had conversations with health officials in Israel on the matter.
“The agencies represented here are all monitoring this extremely carefully; as you’ve heard, 99.5% of all people being hospitalized now are unvaccinated. At the moment, the people getting sick are the people who haven’t been vaccinated,” Woodcock added, noting that the vaccines currently in use in the US would require an emergency use authorization (EUA) amendment to enable the administration of booster doses.
Pressed further, Woodcock said that FDA is expecting data from Pfizer to make the case for a booster shot of its mRNA vaccine developed in partnership with BioNTech and that FDA would review that data when they are made available, but would not comment on whether a submission had been made.
Responding to questions from Sen. Bill Cassidy (R-LA), Woodcock pushed back against the immediate need for boosters without further data. “The agencies involved are monitoring this very carefully and we’re sharing all the data,” Woodcock said, noting that the goal is to identify “when does immunity wane to the point that you need to give a booster.”
“What is being followed is the waning of humoral immunities … It’s waning, it isn’t vanished and that is clear because everybody who is getting hospitalized is unvaccinated and they’re being exposed to the Delta variant, and so the vaccination is holding right now in the US,” she said.
Sen. Thomas Tuberville (R-AL) asked Woodcock when COVID-19 vaccines might be fully approved, noting that some vaccine hesitancy may be based on the vaccines’ EUA status. Woodcock acknowledged Pfizer’s submission of a full biologics license application (BLA) for their vaccine, which the company said has been accepted for priority review last week, but would not comment on a potential timeline for that decision.
On the subject of barriers to donating vaccines internationally, Woodcock said that FDA has taken steps to assist foreign regulators to approve COVID-19 vaccines locally. “We have collaborations with regulators around the world, through the [International Coalition of Medicines Regulatory Authorities] … as well as other ways, so we are actively reaching out to foreign regulatory authorities to give them information about what we’ve done to review vaccines and what we know about them.”
Toward the end of the hearing, Woodcock also addressed the controversial accelerated approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab). Asked about the approval and questioned about the drug’s efficacy and cost by Sen. John Hickenlooper (D-CO), Woodcock argued that FDA is doing what Congress instructed by using the accelerated approval pathway to authorize a treatment for a life-threatening disease.
“A lot of the confusion--and some of the controversy—is simply what you said. This is an accelerated approval, that means it was approved on a surrogate endpoint that we believe it is reasonably likely to predict clinical benefit,” Woodcock responded.
“Congress has urged us to use the accelerated approval pathway for life-threatening diseases that don’t have any effective therapy, Alzheimer’s is one,” Woodcock added. “I think part of the issue was it was brought to an advisory committee proposed for traditional approval, not on a surrogate endpoint. The advisory committee more or less conclusively shot that down, and so the agency went back and looked at all the data on the surrogate endpoint.”
Burr, who had praised Woodcock earlier, said “the decision that FDA made relative to surrogate endpoints is exactly that forward-leaning approach that we envisioned when we created that expedited pathway, and I applaud the decision.”


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