HHS Says It's Working With Biden, Touts AstraZeneca Vaccine

By Kevin Stawicki
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Law360 (November 24, 2020, 5:30 PM EST) -- After appearing to hedge last week on the potential of a Joe Biden transition, the head of the U.S. Department of Health and Human Services said Tuesday that he's working with the president-elect's team and that the agency has high hopes for one of AstraZeneca's coronavirus vaccine candidates.

HHS Secretary Alex Azar said during a press briefing that in the wake of the General Services Administration's formal recognition Monday of Biden as the president-elect, the HHS' top official has also contacted the transition team.

"Rear Admiral [Erica] Schwartz, who has been leading our transition efforts, was last night in communication with the Biden transition team," Azar said. "We are immediately getting them all of the preprepared transition briefing materials. We will ensure coordinated briefings with them to ensure they're getting whatever information that they feel they need that's consistent with statute and past practice."

Last week, Azar fended off questions about how vaccine distribution will be affected by a transition of power to Biden, saying that the agency would ensure cooperation "in the event of a transition" as the Trump campaign's legal challenges to election results are pending in various courts.

Tuesday's briefing also reiterated the success of public-private partnerships backed by the Trump administration's vaccine program, Operation Warp Speed, particularly AstraZeneca's announcement that one of its coronavirus vaccine candidates achieved 90% effectiveness.

While the average efficacy of AstraZeneca's two dosing regimens hit only 70% — below the rates recently reported for Pfizer's and Moderna's vaccine candidates — Dr. Moncef Slaoui, the program's chief science adviser said, that the results are nonetheless promising.

"These have been very interesting and encouraging data," Slaoui said. "The fact that one part of the trial has demonstrated 90% efficacy further reinforces the observations with Pfizer and Moderna vaccines that this virus can be very, very strongly protected against."

"That's very important for everybody to understand, and hopefully will help the majority of the U.S. population to stay with an open mind in terms of accepting to be vaccinated," he added.

AstraZeneca's announcement came days after the independent Data and Safety Monitoring Board said on Nov. 16 that Moderna's COVID-19 vaccine candidate is 94.5% effective. Pfizer said days later that its vaccine candidate is 95% effective.

The FDA is scheduled to meet with the Vaccines and Related Biological Products Advisory Committee on Dec. 10 to consider a request by Pfizer and its German partner BioNTech for emergency approval. If granted, the government said it will be able to distribute the vaccine across the country within 24 hours.

Moderna recently announced that it has entered a supply agreement with the U.K. to begin distribution in March — pending the vaccine's approval — adding that it's ramping up production so it can deliver roughly 500 million doses per year and possibly up to 1 billion doses per year starting in 2021.

Also on Tuesday, Operation Warp Speed's chief operating officer Gen. Gustave Perna detailed how HHS, the U.S. Department of Defense and its private partners are continuing to ramp up distribution rehearsals for sending out 40 million doses of COVID-19 vaccines to 20 million of the "most vulnerable Americans" by December, if the FDA provides emergency use authorization.

"Each and every week we get stronger," he said. "We're one week closer to distributing the vaccine. We're one week closer to refining to the exactness that we need to have to do this."

--Additional reporting by Lauren Berg. Editing by Adam LoBelia.

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