On Tuesday, the Advisory Committee on Immunization Practices (ACIP), which is a panel of outside experts that advises CDC on vaccines, made its first recommendations on which Americans should get the first available doses of an authorized coronavirus vaccine. However, there are still many steps in the distribution process that could determine how the vaccines, when available, are allocated.
Who should be first to get a coronavirus vaccine, according to ACIP
ACIP members on Tuesday voted 13-1 to approve a recommendation calling for health care workers and residents and staff of long-term care facilities to be the first Americans to access a vaccine against the novel coronavirus once a vaccine candidate is authorized for use in the United States by FDA.
Those two groups of Americans, which together represent nearly 24 million people, are at high risk for contracting the novel coronavirus, Politico reports. According to Politico, CDC data presented during Tuesday's meeting showed that at least 243,000 health care workers have contracted the virus and 858 have died from Covid-19, the disease caused by the new coronavirus. In addition, CMS data shows that, as of the week ending Nov. 15, up to 500,000 residents and staff in skilled-nursing facilities had been infected with the virus and nearly 70,000 had died from Covid-19.
Helen "Keipp" Talbot, an associate professor of medicine at Vanderbilt University and a member of ACIP, was the only panelist who voted against the recommendation. Talbot said she opposed the recommendation because she believes there isn't yet sufficient data to support the use of a coronavirus vaccine in long-term care residents.
"I have spent my career studying vaccines in older adults. We have traditionally tried a vaccine in a young, healthy population and then hoped it worked in our frail, older adults. And so we enter this realm of 'We hope it works and we hope it's safe.' And that concerns me on many levels," said Talbot. She added, however, that she has "no reservations for health care workers taking this vaccine."
ACIP Chair José Romero said he initially shared Talbot's concerns, especially because federal health officials have said they expect to have up to 40 million vaccine doses available by the end of this year—which will be enough to vaccinate only 20 million Americans, because the leading vaccine candidates require individuals to receive two doses. However, Romero said he changed his mind once he noticed the coronavirus's significant impact on residents of long-term care facilities.
Many groups representing health care providers and long-term care facilities applauded the ACIP's recommendations.
Susan Bailey, president of the American Medical Association, in a statement said, "By first vaccinating our frontline health care personnel and residents of long-term care facilities against Covid-19, we will help ensure patients continue to receive vital care during the pandemic and safeguard those who are most at risk for severe illness."
Mark Parkinson, president of and CEO of the American Health Care Association and National Center for Assisted Living, in a statement said a coronavirus vaccine "will literally be a lifesaver for thousands of [long-term care] residents and expedite the reopening of our facilities to family members and loved ones."
What happens next—and why ACIP's recommendation isn't set in stone
Presenters at Tuesday's meeting said ACIP will refine and finalize its recommendations for vaccine distribution once FDA authorizes a coronavirus vaccine and more robust data from late-stage clinical trials on vaccine candidates becomes available. Those recommendations likely will include further guidance on how to prioritize vaccine access for other groups, as well, including pregnant women, essential workers, and others.
Then, CDC Director Robert Redfield will review the recommendations and ultimately decide whether to approve them. If Redfield approves the recommendation, CDC will use the recommendation to issue guidance on who should get priority access to the vaccine. That guidance will be intended to help states determine their vaccination distribution plans, though states are not required to follow the guidance.
However, according to STAT News, the initial recommendation that ACIP approved on Tuesday could influence states' decisions on who they should prioritize for vaccination in their early distribution plans. That's because states must submit their first orders for coronavirus vaccines to the federal government by this Friday, STAT News reports.
According to STAT News, FDA is expected to issue an emergency use authorization (EUA) for Pfizer's coronavirus vaccine candidate within days after an FDA advisory committee meets to review the experimental vaccine and its EUA application, which is currently scheduled for Dec. 10. That same panel is also scheduled to meet on Dec. 17 to review and consider issuing an EUA for Moderna's coronavirus vaccine candidate.
In addition, the Trump administration has invited government officials and executives from vaccine manufacturers and drug distributors to participate in a "Covid-19 Vaccine Summit" early next week. According to officials familiar with the event's plans, the summit is intended to serve as an opportunity for the White House to pressure FDA to quickly authorize a coronavirus vaccine candidate, STAT News reports.
White House spokesperson Brian Morgenstern said President Trump "looks forward to convening leaders from the federal government, state governments, private sector, military, and scientific community for a comprehensive discussion with the American people as the administration prepares to deliver this historic, life-saving vaccine to every zip code in the United States within 24 hours of an FDA approval" (Branswell, STAT News, 12/1; Lim, Politico, 12/1; Sun/Stanley-Becker, Washington Post, 12/1; Facher, STAT News, 12/1; Owens, "Vitals," Axios, 12/2; Higgins-Dunn, CNBC, 11/16).