Moderna : CDC Panel Recommends Giving First Covid-19 Vaccines to Health Workers, Nursing Homes -- 4th Update

By Peter Loftus, Jared S. Hopkins and Betsy McKay

A federal vaccine advisory panel recommended that health-care workers and residents of long-term care facilities be the first to receive any Covid-19 vaccine doses from the limited supply that will be available initially.

The panel, which advises the Centers for Disease Control and Prevention, voted 13-1 on Tuesday in favor of giving the first vaccines to about 21 million health-care workers and three million residents of long-term care facilities.

Health experts have long expected that the panel would recommend health-care workers get first dibs, but some federal health officials have been advocating including those most medically vulnerable to Covid-19.

Federal officials have said they expect there will be about 40 million doses available in December. The initial vaccines available are given in two doses three or four weeks apart, so there may be enough for 20 million people to be vaccinated in the early weeks. Supplies are expected to increase during 2021.

U.S. health regulators are expected to decide in the coming weeks whether to authorize the emergency use of two Covid-19 vaccines, one from Pfizer Inc. and BioNTech SE and another from Moderna Inc. The companies have been manufacturing doses, but it could take several months to make enough to vaccinate the broader population.

The CDC usually follows the recommendation of its advisory panel, and if they are accepted by the agency's director and Secretary of Health and Human Services Alex Azar, they will become official CDC policy. A CDC spokeswoman said CDC Director Robert Redfield will likely make the decision on Wednesday.

Mr. Azar, who has supported early vaccination of nursing-home residents, has said state governors may make final decisions about whom to vaccinate first with the doses that the federal government allocates to them based on their adult populations.

States wouldn't have to follow the CDC recommendations, but state and local authorities are expected to rely on them as guideposts for deciding who gets the vaccine first. States have until Friday to indicate to the federal government where they want their initial doses sent.

The CDC panel, an outside group of medical experts known as the Advisory Committee on Immunization Practices, held an emergency meeting Tuesday to consider how to prioritize which groups are most in need of receiving the initial doses.

"We see a growing number of health-care providers that have become infected and some of which, unfortunately, have passed away," said committee chairman José Romero. "We see individuals living in long-term care facilities are at exceptional risk for mortality and morbidity due to the virus and disease."

Other high-risk populations, including essential workers such as teachers and police, adults with underlying health conditions and people ages 65 and over who aren't in communal settings, are expected to be next in line, although the panel didn't set recommendations for them yet.

Votes on the order of priority for them would probably come later, after U.S. regulators authorize each vaccine and more clinical trial data becomes available.

A special National Academy of Medicine committee recommended health-care workers be in the very first phase of vaccination, followed by older adults in crowded settings such as nursing homes. Adding residents of long-term care facilities represents a compromise with some federal health officials advocating for those most vulnerable to Covid-19, according to people familiar with the discussions.

Still, the expected limited supply means there may not be enough even for all health-care workers and long-term care residents in the early days of vaccination. So facilities will need to further prioritize who among their staff and residents should get shots in the early days.

CDC staffers who briefed the advisory panel Tuesday said skilled nursing sites should be given priority among long-term care facilities because they house the most medically vulnerable residents. Among health-care workers, those in direct contact with sick patients and infectious materials should get priority over others, said Dr. Sara Oliver, a CDC officer who is working with the committee.

Hospitals and other health facilities also must consider the vaccines' side effects when scheduling immunizations. In studies, people receiving Pfizer's and Moderna's vaccines experienced symptoms like fever and headache, which were more intense after the second doses. CDC officials said health facilities should avoid vaccinating all of their workers at once, and instead stagger them in case workers have to miss work for a day or two if they experience side effects.

Both the Pfizer and Moderna vaccines were shown to be more than 94% effective and generally safe in late-stage testing and could be authorized within weeks. Pfizer's will be discussed next week during a public meeting by an outside panel of experts advising the Food and Drug Administration, with Moderna's discussed at a second meeting the week after.

The committee typically votes on recommendations for the use of vaccines only after they have been cleared by regulators. It was originally going to vote on Covid-19 vaccine prioritization in September, but the committee delayed action until it could learn more about the particular shots.

Supplies are expected to be limited initially. Pfizer and BioNTech have said they could provide the U.S. with about 25 million doses, potentially enough for 12.5 million people, and Moderna has said it could make 20 million doses by the end of December. Weekly shipments of five million to 10 million doses are expected upon authorization, federal officials said Tuesday.

Government officials have expressed differing views on which of the two populations in the top group -- health-care workers and people in long-term care facilities -- should be given priority for the limited supplies likely to be available in December.

Older people are at greatest risk of death. Long-term care facilities are linked to 6% of all Covid-19 cases, but 40% of deaths, according to the Kaiser Family Foundation. Covid-19 had claimed the lives of more than 100,000 nursing-home residents and staff as of the last week of November, the foundation said.

Health-care workers have fared better, but public-health experts argue they should be first in line because exposure to Covid-19 and illness reduce the number of staff who can care for the sick during a surge like the current one. Health-care workers can be exposed both at the hospital or in the community, and some hospitals have recently reported staffing shortages.

While most ACIP members supported the inclusion of long-term care residents in the first wave of vaccinations, one member, Dr. Helen Keipp Talbot, dissented. Explaining her vote against the recommendations, the Vanderbilt University Medical Center infectious-disease specialist said she was concerned about whether the vaccine is safe and effective among frail, elderly people. She also said there are limitations to systems that monitor safety of vaccines among long-term care residents.

Dr. Richard Zimmerman, a professor of family medicine and clinical epidemiology at the University of Pittsburgh, called the decision to include nursing-home residents premature because it isn't known yet how well the most vulnerable respond to the vaccine. Those data have yet to be made public, said Dr. Zimmerman, a former ACIP member.

"We need to look at medical benefit," he said. "Because we think it works well with seniors, we hope that it works great in long-term care facilities. It's a hope but it's not a known fact."

The U.K., which is soon expected to approve the Pfizer and BioNTech vaccine, plans to provide vaccines to residents and staff in nursing homes first, followed by health workers and people over 80.

A U.S. government modeling study found that vaccinating nursing-home health-care workers would reduce infections and deaths more than vaccinating nursing-home residents.

As of Nov. 30, 243,826 cases of Covid-19 were reported among just over two million health-care workers, or about 12% of the measured population, according to CDC data. The agency has mortality data on 180,989 of the health-care workers with Covid-19. Of them, 858 died.

Write to Peter Loftus at [e-mail], Jared S. Hopkins at [e-mail] and Betsy McKay at [e-mail]

(END) Dow Jones Newswires

12-01-20 2023ET