Divisions are emerging among top U.S. officials over when the country’s first Covid-19 vaccine will be authorized — and who should be at the front of the line to get vaccinated.
Robert Redfield, the director of the Centers for Disease Prevention and Control, and others have suggested vaccination of Americans could begin by the end of next week. In their scenario, the Food and Drug Administration will authorize emergency use of a vaccine developed by Pfizer and BioNTech almost immediately after a Dec. 10 meeting of an advisory committee, which is expected to recommend authorization.
But the head of the FDA center responsible for any such authorization said in a presentation to patient groups last week that it may take several days or even “a few weeks” after the advisory committee meeting before his office gives the vaccine a green light.
“You may have heard in the media that it will be a few days. It’s possible that it could be within days, but our goal is to make sure it is certainly within a few weeks,” said Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research. The remarks by Marks, who did not respond to a request for comment from STAT, were first reported by CNN.
Separately, STAT has learned that senior leaders in the Trump administration’s coronavirus response are pressing for adults 65 years old and older to be given first access to the vaccine. That approach contradicts the position of a committee that advises the Centers for Disease Control and Prevention on vaccine policy; the Advisory Committee on Immunization Practices has signaled for months that it will recommend health care providers be at the front of the vaccination line.
The conflicting views risk sending mixed signals to public health authorities at the state level who are racing to try to finalize plans for deploying limited doses of vaccines within, as the administration insists, 24 hours of the vaccines being cleared for use by the FDA. “It’s going to be messy,” said a senior government official, who spoke on condition of anonymity.
The Advisory Committee on Immunization Practices is meeting in an emergency session Tuesday to vote on a recommendation that would enshrine its position on health care providers — and add residents of long-term care facilities to “Phase 1a” of the vaccination priority schedule. Though some members of the committee have expressed concerns about putting long-term care residents in the first group, none has voiced an objection to giving first access to health workers.
José Romero, the committee’s chairman, said all of the analyses the committee has conducted indicate that vaccinating these two groups first provides the best “bang for our buck” when vaccine supplies are limited — as they will be for the first month or two of the vaccine rollout. The U.S. expects to have enough vaccine from Pfizer and Moderna — whose vaccine is expected to be authorized for use a week or so after the Pfizer product — to vaccinate 20 million Americans in December and another 25 million in January.
There are an estimated 21 million people working in health care in the country and roughly 3 million people living in long-term care. As of last week, nearly 230,000 health workers have contracted Covid-19 and 822 have died. The toll among long-term care residents is very high — they make up about 6% of the country’s Covid cases and 39% of deaths, according to CDC data.
“We will protect [health workers], allow them to continue to provide care in an environment where cases are surging and there appears to be no control over the spread,” Romero, secretary of the Arkansas Department of Health, told STAT. “And … the second group, that group of individuals that live in long-term care facilities that have high morbidity and mortality, we can decrease that number significantly when compared to the other groups.”
Earlier this fall, an expert panel established by the National Academy of Medicine also recommended that high-risk health care workers — who are now struggling to cope with a massive increase in cases — should be given access to Covid vaccines first.
The fact that the ACIP is voting on a recommendation at all now is a reversal for the committee, which had previously said it would wait until specific vaccines had been authorized by the FDA before making recommendations on their use.
Operation Warp Speed, the government’s initiative to fast-track development and delivery of vaccines, pressed the group to hold a vote earlier, a source told STAT, so that states — which have the ultimate say on who gets doses — could better determine where to have the first deliveries sent. States have been given until Friday to signal where they want those deliveries to be deployed.
At the same time, HHS Secretary Alex Azar and White House coronavirus task force coordinator Deborah Birx are pushing to have seniors precede health workers in the vaccine rollout schedule, because of the high death rate among older and elderly adults, according to the senior government official.
In an interview with Fox News recently, Redfield also appeared to signal a priority scheme that differs from ACIP’s expected schedule, saying nursing home residents would be first, followed by “some combination of health care providers and individuals at high risk for a poor outcome.”
More than 100 million Americans have health conditions that put them at risk of developing severe disease if they contract Covid-19, the CDC estimates.
STAT asked the White House and HHS for comment on Azar’s and Birx’s positions on vaccine priorities. A White House spokesman deferred to HHS.
“Secretary Azar has insisted that science and data drive the process for vaccines and therapeutic development, and will do so for vaccine allocation and distribution,” an HHS spokesman said. “This means the doctors will make their recommendations, and ultimately the governors will make a determination of what works best for their communities based on input they receive and the circumstances on the ground.”
Including long-term care residents in the first phase of vaccination may satisfy the desire to vaccinate the most vulnerable early in the rollout.
The challenging characteristics of the Pfizer vaccine — it must be stored at -94 Fahrenheit — may also impede any effort to push people 65 and older closer to the front of the line. Most seniors get their health care from primary care physicians, who would not have the ultracold freezers needed to store the Pfizer vaccine. In the case of long-term care facilities, however, Operation Warp Speed has signed contracts with major pharmacy chains to run the vaccination efforts in those locations.
It’s not yet clear how the ACIP will vote on including long-term care residents in the first phase of vaccination. During a discussion at a meeting last week, several members supported the idea. But others raised concerns about the fact there aren’t yet data to indicate how well the first vaccines work in elderly people who are frail.
“I recognize that they have suffered some of the greatest burden. But … we have no efficacy data in this population because it hasn’t been studied,” said Robert Atmar, an infectious diseases professor at Baylor College of Medicine. “We know from flu vaccine studies that this population tends to have less efficacy of flu vaccine compared to other persons.”
Romero said Tuesday’s vote is a critical one for the ACIP.
“In my tenure of now almost seven years on the ACIP, this is the most serious vote that we have ever taken,” Romero said. “They’re all serious, but this one is very, very significant. And we have given a lot of time and thought to this.”
Once the committee votes, the recommendation will go to Redfield, the CDC director. In the history of this committee, the CDC director has only once overruled a recommendation from the ACIP, related to a program to vaccinate health workers against anthrax after the 2001 anthrax attacks.
https://www.statnews.com/2020/11/30/divisions-emerge-among-u-s-officials-over-when-first-covid-19-vaccine-doses-will-be-available-and-for-whom/
