FDA stays mum on issue of spring boosters for Covid

AAre you six months away from your Covid-19 bivalent booster and wondering when you can get another shot?

If you live in the UK or Canada, you already have your answer. The Canadian and British governments, acting on the recommendations of expert committees, plan to offer spring booster shots to those most at risk of becoming seriously ill from Covid.

But in the United States, there has been radio silence from the Food and Drug Administration on the issue of spring recalls, creating frustration among a small group of determined people who wish they didn’t have to wait until fall to get another dose of Covid. vaccine.

“I will tell you that patients message me every day about this,” Camille Kotton, clinical director of transplant and immunocompromised host infectious diseases at Massachusetts General Hospital, told STAT.

Jamie Loehr, a family physician in Ithaca, NY, has patients who received the updated recall last fall now asking him to give them non-compliant clearance slips for a second bivalent shot.

“There are people who actively want regular updates on this,” Loehr said during a discussion of the future of Covid vaccination at the late February meeting of the Advisory Committee on Immunization Practices. , a group of experts that advises the Centers for Disease Control and Prevention on vaccination policy. Both Loehr and Kotton are members of ACIP.

Despite the lack of guidance from the FDA, there is evidence that the agency was considering the issue even last fall. In an interview with STAT in October, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, acknowledged that he’s concerned that one booster a year isn’t enough for the elderly and immunocompromised.

“I would lie to you if [I said] it doesn’t keep me awake at night worrying that there’s some chance we’ll have to roll out another booster – at least for some of the population, maybe older folks – before September, next October,” Marks said at the time. .

The FDA declined a request to interview Marks for this article. In an email, the agency dodged most questions from STAT, saying only on the issue of spring boosters that “We continue to closely monitor emerging data in the United States and around the world, and we We will base any decision on additional updated boosters on this data.”

Evidence to date suggests that Covid vaccines provide strong protection against serious illness, hospitalization and death. But their ability to ward off infection is short-lived.

With this in mind, the UK’s Joint Committee on Vaccination and Immunization and Canada’s National Advisory Committee on Immunization have both issued recommendations that people at high risk should be offered the option of being vaccinated against Covid this spring.

In the UK, where 82.5% of people aged 75 and over received a dual booster last autumn, the recommendation is that people aged 75 and over, or who live in a nursing home for people elderly, or who are 5 years and older and immunocompromised should be offered a spring booster, provided that six months have passed since their last injection.

“To protect the most vulnerable in the population from the serious problems of Covid-19, the JCVI believes that providing a spring booster dose for these individuals is a proportionate response in 2023,” the group said. in a press release.

In announcing the recommendation, the UK Health Security Agency’s head of vaccination pointed to a recent rise in severe cases among older people. “Covid-19 is still circulating widely, and we have recently seen an increase in the number of older people being hospitalized,” said Mary Ramsey.

NACI, Canada’s vaccine advisory group, recently voted to recommend that people be allowed to receive a spring booster if they are age 80 or older, are adult residents of long-term care facilities, have 18 years and older and are moderately or severely immunocompromised. , or are between the ages of 65 and 79, especially if they have no known history of previous Covid infection.

The UK’s recommendation is that people identified as high risk “should” receive another booster. The Canadian expert panel issued a softer recommendation, saying the high-risk people it highlighted “could” receive an additional dose this spring, an approach that, in public health parlance, is called a “permissive” recommendation.

This latter approach is one that some people would like to see adopted in this country. Loehr, the family doctor, said at the February ACIP meeting that he thinks there should be annual Covid reminders, but people who are immunocompromised or aged 65 and over should be given the option to obtain a second booster six months later, in consultation with a health care centre. supplier.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, would go further, saying people aged 50 and over in the United States should be given the option of getting a second booster. He noted that in the second half of 2022, 97.3% of people who died from Covid in this country were aged 50 and over.

“It’s a pretty targeted group that you can reach out to,” Osterholm said.

He acknowledged what is obvious to anyone who has followed the adoption of bivalent booster in the United States: doctors’ offices and pharmacies would not be faced with a tsunami of people looking for a spring booster, if the one was allowed. Only 16.3% of those eligible for the updated vaccine received one; even among the most at-risk population, people aged 65 and over, less than half of eligible people – 41.6% – have been vaccinated.

“We live in a world right now where those who want extra booster doses really want them. And those who don’t want them don’t want them at all. And what we’re trying to do is put on this needle,” Osterholm said.

“I think given the data we’ve seen on the decline in immunity over time, that if someone wanted to be vaccinated every six months and they were in a high-risk group by age or by underlying medical condition, then I think that should be allowed. I do not believe for a moment that this will be a generalized practice.

At the ACIP’s February meeting, members were told that the Covid Vaccine Task Force, a subset of its membership, had debated whether to recommend spring boosters. But the group concluded they did not have enough evidence to say another shot was needed at this time.

“The data was not yet conclusive to identify a need for frequent vaccinations and there was concern that it might not be possible to implement a vaccination program for all adults aged 65 and over twice a year,” said said CDC vaccine expert Sara Oliver. , said at the meeting.

Oliver also noted, however, that the Covid task force has recognized that the elderly and immunocompromised are likely to remain more vulnerable to developing serious illness if they contract Covid, and there is likely to be a need for more flexibility. to deal with their situations in the future. .

“I really like this idea of ​​flexibility. And if the FDA decides there can be increased flexibility around the recommendations, I think that will be helpful,” MGH’s Kotton said during the discussion.

But this flexibility does not currently exist. Bivalent Covid vaccines have not yet been licensed; they are given under FDA Emergency Use Authorization. EUA rules are strict. Products covered by the EUAs may only be used in accordance with the FDA decision.

Once a vaccine is fully licensed, ACIP has the discretion to recommend a use that differs from the FDA license. For example, although the FDA appears poised to authorize new respiratory syncytial virus vaccines for people age 60 and older, ACIP’s RSV working group reported in February that cost-benefit analyzes did not favor the use of vaccines among people aged 60 to 64 years.

In the absence of FDA clearance for a spring booster, ACIP is unable to recommend one.

Although there are strong supporters of spring booster shots, not everyone is convinced that they are necessary.

“With a downward trend in hospitalizations and deaths, there is no movement toward a spring recall,” said Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland School of Medicine, in an email.

Neuzil noted that there are other tools for people at high risk who contract Covid – antiviral drugs. “These are underused for influenza…and we don’t want them to be underused for Covid-19,” she said. “They are an important tool, especially for the elderly and immunocompromised, and people should be encouraged to contact their health care providers early in their illness.”

In the interview with STAT, Kotton noted that things have improved dramatically for immunocompromised people — her patient base — since the pandemic began. And that’s even though the monoclonal antibody product Evusheld, which had been used to help these patients avoid Covid infection, is no longer used because the evolution of the virus that causes Covid has rendered it ineffective.

“I mean, overall, we’re seeing much lower overall rates of serious, life-threatening illness in immunocompromised and older people compared to before,” she said. “For people who are fully vaccinated, including with a bivalent vaccine, and who have easy access to treatments such as remdesivir, Paxlovid and other additional treatments, we are now seeing much better results overall compared to what we were, say, a year or so ago.”

Kotton seemed unsure of the value of allowing a spring recall.

“We don’t just want to give doses because people are nervous, do we? We want to make sure that there is a good reason based on data why we would want to administer additional doses of vaccine,” she said. “So we’re basically waiting — we’re waiting to hear more from the CDC and the FDA.”

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