On Wednesday, the Food and Drug Administration released new details about a meeting of its vaccine advisory committee planned for early December, a meeting that could result in Emergency Use Authorization of Pfizer’s vaccine, which the company submitted for approval last week.
The committee, which is made up of independent vaccine experts from outside the FDA, will meet virtually on Dec. 10 from 9 a.m. to 6 p.m. EST. It will be open to the public and streamed live online.
Based on the committee’s review of the data and their recommendations, the FDA commissioner could issue an EUA following the meeting. Once approved, millions of doses of Pfizer’s vaccine could go out within 24 hours, as Spectrum News previously reported.
General Gustave Perna, who oversees vaccine distribution, said he expects the first doses to be distributed as soon as Dec. 12, depending on when the FDA issues its approval. Operation Warp Speed — the effort to quickly develop and distribute a vaccine — is working with each U.S. state, territory and a handful of large metropolitan areas.
“The governors and the states will figure out the plan, and we are ready to execute in collaboration with their plan as we've been working on for six months, doing numerous tabletop exercises and now extending it into actual rehearsals of how to move the product,” Gen. Perna said on a call with reporters last week.
Both Pfizer, the only company to apply for an EUA so far, and Moderna have said their vaccines are about 95 percent effective. Moderna could apply for approval within the coming days, and a third vaccine candidate from AstraZeneca and Oxford also reported promising results this week.
Officials working on Operation Warp Speed said they expect to vaccinate as many as 20 million people by the end of December, but that timeline depends on the FDA. Health and Human Services Secretary Alex Azar told Spectrum News that most health care workers should be able to get vaccinated by the end of January, with the majority of Americans having access by summer of 2021.
In recent days, both Sec. Azar and Dr. Anthony Fauci of the National Institutes of Health said they are confident the vaccine will be safe.
“While we have a tremendous sense of urgency, no corners are getting cut,” Secretary Azar told Spectrum News. “I’ll have so much confidence in this vaccine program and the FDA’s determinations that, as soon as they’ll let me, I’ll get a vaccine on TV.”
Dr. Fauci told Spectrum News he “would not hesitate” to get vaccinated or recommend it to his family.
Still, questions remain about whether the vaccines will completely prevent the spread of the virus, especially if only a fraction of the U.S. population receives one. On Friday, the FDA will start accepting public comments ahead of its Dec. 10 meeting.
On Wednesday, HHS officials gave president-elect Joe Biden’s team their first official briefing on Operation Warp Speed, as first reported by POLITICO.
Admiral Erica Schwartz, who oversees the transition for the agency, led the meeting, which focused on vaccines and distribution plans. President-elect Biden has previously said a delay in sharing information could cost lives, but his team did not get briefings from HHS until just this week.
On Tuesday, Sec. Azar told reporters the agency began sharing plans with Biden’s team after the presidential transition officially began Monday night.
“Transition planning and execution will be professional, cooperative and collaborative in the best spirit of looking out the health and well-being of the American people,” he said.