- State public health programs should prioritize early supplies of COVID-19 vaccines for healthcare workers and nursing home residents, a federal advisory committee voted on Tuesday. The 13-1 recommendation should help guide officials through the early phase of a mass immunization program, when only enough doses will be available for a small fraction of the U.S. population.
- The vote comes as the Food and Drug Administration begins its review of emergency use applications for partners Pfizer and BioNTech, and from Moderna. Both groups recently reported study results showing their experimental shots to be about 95% effective. Authorizations are expected for both before the end of the year.
- State and local public health officials have already begun walkthroughs of the distribution of Pfizer and BioNTech's vaccine, which requires special handling because doses must be stored at minus 70 degrees Celsius. The first flights transporting mass shipments of vaccine doses to distribution sites began last week.
Hundreds of millions of U.S. residents will want a COVID-19 vaccine as soon as it is available, likely within weeks. But constrained supplies will likely mean only 20 million people or so will be able to receive a shot by the end of 2020, assuming the FDA clears both Pfizer and BioNTech's as well as Moderna's.
Facing tough decisions on who to put first in line, state and regional public health officials look to the Centers for Disease Control and Prevention, and its expert consultants on the Advisory Committee for Immunization Practices, to set priorities.
ACIP has spent several months debating the priority list, working through a range of issues. Experts have weighed different groups' risk of coronavirus exposure or disease, whether to prioritize keeping essential parts of the economy functioning, and questions of healthy equity. Tuesday's vote is the first decision on who should get initial coronavirus vaccine doses.
Healthcare workers have emerged as a high priority for several reasons and appeared likely to be first in line even by ACIP's discussions this summer. Doctors, nurses and other healthcare professionals are frequently exposed to SARS-CoV-2, and their absence due to symptoms or exposure can place heavy stress on the places they work.
A relatively higher proportion of health workers are from racial or ethnic communities that have experienced a heavier burden from COVID-19, too.
Beyond healthcare workers, the discussion has been more complex. Among the possible priority groups considered were essential workers like police officers, firefighters and teachers; people aged 65 and older; and people with medical conditions like diabetes and heart disease, which put them at higher risk of severe infection and death.
ACIP decided that next on the list should be residents in long-term care facilities — about 3 million people — because of the number of outbreaks, hospitalizations and deaths that have occurred in those places. Nearly 332,000 COVID-19 cases had been confirmed in nursing home residents as of Nov. 15 and nearly 70,000 deaths. Nearly 5,500 residents in assisted living facilities have died.
The strong vote of support to place long-term care residents in the first group contrasts with some questions about the safety and effectiveness of vaccines in these people, who weren't included in the large trials Pfizer and Moderna are using to support their applications.
ACIP member Henry Bernstein, a pediatrics professor at Zucker School of Medicine at Hofstra, said he'd been concerned about safety in nursing home residents, but noted the two vaccines led to fewer side effects in older patients enrolled in mid-stage trials.
However, Helen Keipp Talbot, an associate infectious diseases professor at Vanderbilt University, said that fewer adverse events indicates these vaccines are likely stimulating a less active immune response, which could mean their effectiveness is more limited in nursing home residents.
"We've entered this realm of 'we hope this works and we hope it's safe,'" she said.
A further operational issue will be turnover among nursing home residents. The pharmacy partners that agreed with HHS to supply nursing homes have planned three visits to those homes which signed on to a federal program. Yet CDC modeling shows that over time nursing home vaccination coverage with a two-dose regimen would shrink to less than 40% after a few months due to discharges.
Some residents, for instance, might be discharged after only a single dose, complicating public health programs' efforts to supply a booster shot.
An advisory panel for the FDA is scheduled to meet on Dec. 10 to review Pfizer and BioNTech's vaccine, and on Dec. 17 for Moderna's.