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US FDA may act fast on COVID-19 vaccines post-panel; Warp Speed chief mulls exit

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Moncef Slaoui, chief scientific adviser for Operation Warp Speed
Source: Milken Institute

The U.S. Food and Drug Administration's decision on whether to allow emergency use of Pfizer Inc.'s and BioNTech SE's experimental COVID-19 vaccine could come within hours after the agency's outside advisers meet to review the product, according to a top scientific adviser at the White House.

The FDA's Vaccines and Related Biological Products Advisory Committee is set to meet Dec. 10 to examine the application Pfizer and BioNTech submitted late last week to the agency seeking emergency use authorization, or EUA — a regulatory mechanism created by Congress in 2004 to permit preapproval marketing of medical products during public health crises, such as COVID-19.

Moncef Slaoui, Operation Warp Speed's chief scientific adviser and a former GlaxoSmithKline PLC executive, said Nov. 22 on CNN's "State of the Union" the Pfizer-BioNTech vaccine could potentially be shipped as soon as Dec. 11 or 12 — within 24 hours after gaining an EUA, if it is granted shortly after the FDA meeting.

On ABC's "This Week," Slaoui disclosed that the FDA's advisory committee has set aside Dec. 17 to review Moderna Inc.'s application for an EUA, which the company has not yet submitted. Slaoui said he anticipates Moderna to file for an EUA by the end of November.

Neither the FDA nor Moderna responded to requests for comment about Slaoui's remarks.

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The Warp Speed top adviser also said he anticipated the U.S. Centers for Disease Control and Prevention to "almost immediately" ask its Advisory Committee on Immunization Practices, or ACIP, to recommend guidelines on which populations should be prioritized to get the vaccines once those products gain EUA status.

The ACIP has met virtually a number of times in recent months to discuss what it should consider in making its recommendations and is convening online again Nov. 23.

The National Academies of Science, Engineering and Medicine has already made recommendations on which groups should get the vaccines first — putting healthcare workers and first responders, along with older Americans in congregate settings, at the top of the list.

Health and Human Services Secretary Alex Azar told reporters last week that he was hoping the ACIP could time its deliberations to coincide with the FDA's review of the COVID-19 vaccine applications so that a decision from the CDC panel could come immediately after regulators clear the products.

Distribution, allocation, administration

While the ACIP will make recommendations, the final decision on how the vaccines will be allocated will be up to the states, Slaoui said on NBC's "Meet the Press."

"The vaccine doses will be distributed on a proportionate basis to the population. And, frankly, I don't see that the federal government will intervene on a state decision," he said, adding he anticipated states to act "responsibly" and base their decisions on the ACIP's recommendations.

U.S. Army Gen. Gustave Perna, Warp Speed's chief operating officer, told reporters Nov. 19 that Pfizer will be distributing its COVID-19 vaccine on its own using FedEx Corp. and United Parcel Service Inc., while the federal government will supply and ship ancillary kits — needles, syringes, alcohol wipes and the diluent required for the vaccine.

The government's contractor McKesson Corp. will ship Moderna's vaccine and the ancillary kits through FedEx and UPS.

Americans will be able to get COVID-19 shots free of charge at most U.S. pharmacies, such as CVS Health Corp. and Walgreens Boots Alliance Inc., and a number of supermarkets and small drugstores under a federal government deal when the vaccines are cleared for the U.S. market. CVS and Walgreens will also be administering the vaccines to older Americans living in long-term care facilities.

CVS Health CEO Larry Merlo told CBS' "Face the Nation" on Nov. 22 that his company was staffing up with additional pharmacists and pharmacy technicians to administer the shots.

Last week, philanthropist Bill Gates criticized the Trump administration's vaccination strategy as "dysfunctional."

Transition team meetings

President Donald Trump has blocked HHS officials and members of his Coronavirus Task Force, including National Institute of Allergy and Infectious Diseases Director Anthony Fauci, from communicating with Biden's transition team and COVID-19 scientific advisers.

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Operation Warp Speed is a public-private initiative to advance the development of COVID-19 vaccines, drugs and tests.
Source: U.S. Department of Defense

On ABC Nov. 22, Ronald Klain, President-elect Joe Biden's chief of staff, said that while he respects a number of people involved in the vaccination effort, "the fact of the matter is the Trump administration has a history of failure in dealing with the COVID crisis."

Biden's team needs access to the vaccine distribution plan to ensure it can meet any gaps when he enters the White House on Jan. 20, Klain said.

Merlo said CVS has had discussions with Biden's team. Biden said he would also meet with drug and vaccine manufacturers.

On both ABC and CNN, Slaoui said it would be a better situation if the transition could run smoothly but acknowledged he has had no contact with Biden or his advisers.

Slaoui noted he is not a federal employee and therefore can speak with Biden, though the Warp Speed adviser said he was told by the Trump administration he could not discuss anything the White House has deemed confidential.

Slaoui's future

Slaoui said his goal with Warp Speed was to stay only until two vaccines and two therapies were authorized for the U.S. market.

Both Eli Lilly and Co. and Regeneron Pharmaceuticals Inc. have received EUAs for their COVID-19 antibody drugs. If Pfizer and Moderna receive EUAs in December, Slaoui said he expects to either exit the program at that point or only stay on part time, though it is not clear if Biden or his HHS secretary — a candidate who may be named as early as this week — will keep him.

"I need to go back to my private life and business," Slaoui said on CNN.