FDA remains 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 UK governments, based on recommendations from expert committees, plan to offer spring boosters for people most at risk of becoming seriously ill. be due to covid.

But in the United States, there has been radio silence from the Food and Drug Administration on the issue of spring boosters, sparking frustration among a small but determined group of people eager not to wait until the fall to get another dose of Covid. vaccine.

“I’ll tell you, patients message me about this every day,” Camille Kotton, clinical director for transplantation and immunocompromised host infectious diseases at Massachusetts General Hospital, told STAT in an interview.

Jamie Loehr, a family medicine doctor in Ithaca, NY, is now having patients who received the updated booster shot last fall ask him to provide off-label consent forms for a second bivalent jab.

“There are people who want regular updates on this,” Loehr said during a discussion about 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 policies. . Loehr and Kotton are both members of ACIP.

Despite the FDA’s lack of guidance, there is evidence that the agency was even considering the issue last fall. In an October interview with STAT, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, admitted that he was concerned that one booster per year wouldn’t be enough for older adults and those with weakened immune systems.

“I’d be lying to you if [I said] it doesn’t keep me awake at night because I’m concerned that there’s a certain chance that we’ll have to deploy another booster before September, October, at least for some of the population, maybe older individuals,” Marks said at the time .

The FDA declined a request to interview Marks for this article. In an email, the agency sidestepped most of STAT’s questions, saying only about the issue of spring boosters: “We continue to closely monitor emerging data in the United States and globally, and we will review any decision on additional updated boosters on those base data.”

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

With that in mind, the UK’s Joint Commission on Vaccination and Immunization and Canada’s National Advisory Committee on Immunization have both made recommendations that individuals at high risk should be given the opportunity to receive a Covid booster shot this spring.

In the UK, where as many as 82.5% of people aged 75 and over received a bivalent booster last autumn, the recommendation is that people aged 75 and over, or who live in a care home for the elderly, or who are 5 years and older are older and immunocompromised should be offered a spring booster as long as it has been six months since their last injection.

“To protect the most vulnerable in the population from being seriously unwell by Covid-19, JCVI believes that providing a spring booster dose for these people is a proportionate response in 2023,” the group said in a statement.

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

NACI, the Canadian vaccination advisory group, recently voted to recommend that people should get a spring booster if they are 80 years old or older, are adult residents of long-term care facilities, are 18 years old and older, and are moderately or severely immunocompromised. or are between the ages of 65 and 79, especially if they have no history of previous Covid infection.

The British recommendation is that those identified as high risk should “get” another booster. The Canadian expert panel made a softer recommendation, saying the high-risk people it highlighted “could” get an extra dose this spring, an approach that has been called an “indulgent” recommendation in public health parlance.

The last approach is one that some people would like to see in this country. Loehr, the GP, told the ACIP meeting in February that he believes there should be annual Covid boosters, but people who are immunocompromised or aged 65 and over should have the option to have a second one six months later. booster, in consultation with a health care provider. provider.

Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, goes further, saying people age 50 and older in the US should be given the opportunity to get a second booster. He noted that in the second half of 2022, 97.3% of people who died from Covid in this country were 50 and older.

“That’s a pretty focused group you can turn to,” Osterholm said.

He acknowledged what is obvious to anyone who has followed the uptake of the bivalent booster in the US: Doctor’s offices and pharmacies would not face a tsunami of people seeking a spring booster, if allowed to do so. Only 16.3% of people eligible for the updated jab have received one; even among the highest-risk population, people aged 65 and older, less than half of those eligible – 41.6% – have received the shot.

“We currently live in a world where those who want extra booster doses really want it. And those who don’t want them don’t want them at all. And what we’re trying to do is thread that needle,” Osterholm said.

“I think given the data we’ve seen on declining immunity over time, if someone wants to get vaccinated every six months and if they fall into a high-risk group based on age or underlying health condition, I think that would should be allowed. I don’t for one moment believe it will be a widespread practice.”

At the ACIP’s February meeting, members were told that the Covid vaccine working group, a sub-group of its members, had been debating whether to recommend spring boosters. But the group concluded it didn’t have enough evidence to say another injection is needed at this point.

“The data were not yet conclusive to establish the need for frequent vaccines and there was concern that it might not be feasible to conduct a vaccination program in all adults age 65 and older twice a year,” says Sara Oliver, a vaccine expert at the CDC. , said at the meeting.

However, Oliver also noted that the Covid working group recognized that older adults and people with weakened immune systems are likely to remain more vulnerable to developing serious illness if they contract Covid, and that there is likely a need for more flexibility to deal with it in the future. handle their situations. .

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

But that flexibility is not there at the moment. The bivalent Covid vaccines are not yet licensed; they are given under FDA Emergency Use Authorization. The rules surrounding EUAs are strict. Products covered by EUAs may only be used in the manner specified by the FDA.

Once a vaccine is fully approved, the ACIP has leeway to recommend uses that deviate from the FDA’s authorization. For example, while the FDA appears poised to license new respiratory syncytial virus vaccines for people ages 60 and older, ACIP’s RSV Working Group indicated in February that cost-benefit analyzes would support the use of the vaccines in people ages 60 to 64. year not favored.

Without FDA approval for a spring actuator, ACIP cannot recommend one.

While there are staunch proponents of springtime booster shots, not everyone is convinced they are necessary.

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

Neuzil noted that there are other tools for high-risk people contracting Covid: antivirals. “These are underused for flu… and we don’t want them to be underused for Covid-19,” she said. “They are an important resource, particularly for the elderly and the immunocompromised, and people should be encouraged to contact their healthcare providers early in their illness.”

In the interview with STAT, Kotton noted that things have improved significantly for immunocompromised people — her patient base — since earlier in the pandemic. And that while the monoclonal antibody product Evusheld, which had been used to help such patients prevent Covid infection, is no longer used because the evolution of the virus that causes Covid has rendered it ineffective.

“I do want to say, the big picture, we’re generally seeing much lower rates of serious, life-threatening disease in the immunocompromised and the elderly compared to before,” she said. “For people who are fully vaccinated, including with a bivalent vaccine, and with easy access to treatments such as remdesivir, Paxlovid and other complementary treatments, we are now generally seeing much better outcomes compared to where we were, say, a year or two were. earlier.”

Kotton seemed unsure of the value of approving a spring actuator.

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

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