Vaccine advisers to the US Centers for Disease Control and Prevention argued long and hard Thursday before recommending booster shots for some Americans age 18 and older who got Pfizer’s Covid-19 vaccine.
The CDC’s Advisory Committee on Immunization Practices voted easily to recommend booster doses of Pfizer’s vaccine to people 65 and older who had their first two Pfizer doses six months ago or longer.
They also voted easily to recommend boosters to people 50 and older with underlying medical conditions that might put them at higher risk of severe disease. However, the advisers were divided on the question of recommending such boosters to people under 50. In a separate question, they voted 9-6 to recommend boosters to people 18-49 who have underlying health conditions.
After long arguments, they voted against recommending boosters for people whose occupations put them at high risk of infection – rejecting the US Food and Drug Administration’s emergency use authorization decision that included such people, such as healthcare workers and other first responders.
CDC Director Dr. Rochelle Walensky will now need to issue her own decision on ACIP’s recommendations.
The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted against allowing booster Covid-19 vaccines for people whose jobs or situations put them at high risk of breakthrough infections.
ACIP voted 9-6 against the question: “A single Pfizer-BioNTech Covid-19 vaccine booster dose is recommended based on individual benefit and risk for persons aged 18-64 years who are in an occupational or institutional setting where the burden of Covid-19 infection and risk of transmission are high, at least six months after the primary series under the FDA’s Emergency Use Authorization.”
These might have included frontline workers, include healthcare workers, caregivers for frail or immunocompromised people, people in homeless shelters and people in correctional facilities, the CDC said.
ACIP members argued before voting.
“We may just as well say give it to everyone 18 and older,” said Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University.
“I feel very uncomfortable about this,” said Dr. Wilbur Chen, a professor of medicine at the University of Maryland School of Medicine. “The implementation part of this is going to be fraught with such complexity that the people with the best health literacy will get boosters.”
But ACIP chair Dr. Grace Lee, a Stanford University pediatrician, said her personal experience made her aware of the need to make boosters widely available.
“I have cared for children who have died of Covid,” she said. “Their family members wish that they had extra protection for their kids.”
That was short of the FDA’s emergency use authorization, which OK'd giving boosters to anyone 18 and older at high risk of severe disease from breakthrough infections. ACIP instead limited its recommendation to people over 50 with such conditions after members expressed doubts about recommending boosters too broadly.
So staff added a third question that would allow a younger group to access boosters. Members were less enthusiastic about this option but voted 9-6 to recommend it.
The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted 9 to 6 Thursday to allow younger adults to get a Covid-19 vaccine dose if they have underlying health conditions.
The vote was on this question: “A single Pfizer Covid-19 vaccine booster dose is recommended for persons based on individual benefit and risk who are aged 18-49 years with underlying medical conditions, at least 6 months after the primary series, under the FDA’s Emergency Use Authorization.”
Moments earlier, ACIP voted to recommend boosters to people 65 and older and to people 50 to 64 with underlying medical conditions. That was short of the FDA’s emergency use authorization, which OK’d giving boosters to anyone 18 and older at high risk of severe disease from breakthrough infections. ACIP instead limited its recommendation to people over 50 with such conditions after members expressed doubts about recommending boosters too broadly.
So staff added a third question that would allow a younger group to access boosters. Members were less enthusiastic about this option.
Now they are voting on recommending boosters for people who are at high risk of infection because of occupation.
Vaccine advisers to the US Centers for Disease Control and Prevention voted 13 to 2 Thursday to endorse giving booster doses of Pfizer’s Covid-19 vaccine to people with underlying medical conditions.
The CDC’s Advisory Committee on Immunization Practices voted on the question: “A single Pfizer/BioNtech covid 19 vaccine booster is recommended for persons aged 50-64 years with underlying medical conditions least six months after the primary series under the FDA’s Emergency Use Authorization.”
Moments earlier, ACIP voted to recommend boosters to people 65 and older. One more vote is coming.
Late on Wednesday, the US Food and Drug Administration authorized giving boosters to people 65 and older and those at higher risk of severe disease and death, as well as people such as health care workers at higher risk of breakthrough infections because of their work.
Vaccine advisers to the US Centers for Disease Control and Prevention endorsed giving booster doses of Pfizer’s Covid-19 vaccine to people 65 and older, as well as long-term care facility residents.
The CDC’s Advisory Committee on Immunization Practices voted unanimously on the question: “A single Pfizer/BioNtech covid 19 vaccine booster is recommended for persons aged 65 years or older and long term care facility residents, at least six months after the primary series under the FDA’s Emergency Use Authorization.”
They are now voting on a second question.
Late on Wednesday, the US Food and Drug Administration authorized giving boosters to people 65 and older and those at higher risk of severe disease and death, as well as people such as healthcare workers at higher risk of breakthrough infections because of their work.
A CDC analysis showed it was much more beneficial to give a booster dose to people 65 and older than to people in younger age groups.
After CDC Director Dr. Rochelle Walensky signs off on the ACIP recommendations, booster shots may be given immediately.
Additional types of Covid-19 vaccines may be available at some point in the future, National Institutes of Health Director Dr. Francis Collins said on Thursday.
“There are two vaccines that depend upon a purified protein subunit, basically purifying that spike protein, and adding to it an adjuvant to kind of get the immune system to kick in, and one of those is Sanofi GSK, and one of those is Novavax,” he said in a discussion hosted by Bloomberg Philanthropies.
“Neither of those have yet come forward to the FDA but I, the Novavax Phase 3 trial is really good, the Sanofi GSK trial’s going on right now so it would not be surprising, if, in the next few months those also became available. Let's see what it looks like as far as safety and efficacy. More is better.”
Collins said there’s also interest in a vaccine that’s easier to handle, store, and administer.
“You want something that is not going to be challenging in terms of its cold chain demand, something that requires ultra-low temperatures is not going to be easy to administer in a lot of parts of the world. There is effort also ongoing, although it’s some distance away, to develop vaccines that could be given by basically a nasal spray, instead of requiring a needle and obviously, that makes it even easier, but you got to be sure it's going to work.”
While vaccines in children aged 5 to 11 may become available by the end of October, vaccination schedules mean children in this age group won’t be fully vaccinated until December, National Institutes of Health Director Dr. Francis Collins said Thursday.
In a discussion hosted by Bloomberg Philanthropies, Collins said data from Pfizer on its vaccine in this age group is “supposedly coming to FDA in the next week or so.”
“FDA has announced that they're going to do 24/7, going through it, and do everything they can to make a decision about approval maybe as soon as Halloween,” Collins said. “Keep in mind, of course, that doesn't mean those kids go and get a shot and then there's no risk. You’ve got to go through two shots, three weeks apart, and then another two weeks after that. So if you got immunized on Halloween and you're, you know, nine years old, it's still going to be December by the time you have that full protection.”
Collins said this time frame means that other Covid-19 mitigation measures will still be important for preventing spread in schools through the fall.
“Realistically, in schools for the fall semester, we're going to have to depend on other means of mitigation. Which means the best thing you can do for those kids is actually be sure they're hanging out with other people who are immunized,” he said, naming parents, older siblings, and teachers.
Data available so far indicates an additional dose of a Covid-19 vaccine can substantially reduce infection, National Institutes of Health Director Dr. Francis Collins said Thursday.
“Without dipping my hand too much, I will say the data looks really impressive, that the boosters do in fact provide substantial reduction in infection, like a tenfold reduction just within 12 days after that booster – and also a reduction in severe illness, which is the thing we're most concerned about,” Collins said in a conversation hosted by Bloomberg Philanthropies.
Currently, the US Centers for Disease Control and Prevention’s Advisory Committee for Immunization Practices is meeting to consider the recommendation of an additional dose of Pfizer’s Covid-19 vaccine in certain groups.
“Obviously, CDC now, with FDA having come out and said this is recommendation from them, to begin to offer boosters to everybody over 65 if they're six months or more away from their original immunization, and for younger groups, 18 to 64, if they had risk of medical complications because they had some previous medical comorbidity, those were also on the FDA list. And then also people at higher risk because of occupational or institutional exposure, thinking about healthcare providers, thinking about teachers in schools,” he said.
“Now we'll see whether CDC agrees with that. People may say this is a very strange and contorting process, but it’s our process, and what it does make possible is for everybody who’s interested to see the data and hear the debate in the public meeting and then understand how we came to the conclusion. I think that's a really good thing.”
The US Food and Drug Administration understands that people who got Moderna or Johnson & Johnson vaccines want to know if and when they can get booster doses, too, a top FDA official said Thursday.
The CDC’s Advisory Committee on Immunization Practices is considering how to recommend use of boosters after the FDA extended emergency use authorization to Pfizer for a third dose six months after certain people are fully immunized, including those over 65.
The EUA only covered Pfizer’s vaccine, with boosters going to those who got their first two doses of Pfizer/BioNtech vaccine at least six months ago. The FDA has not decided on Moderna’s application for booster authorization, and Johnson & Johnson has not yet applied.
Dr. Peter Marks, who heads the FDA’s vaccine branch, jumped into ACIP’s discussion Thursday.
“I think we understand at FDA the relative urgency here of trying to have a solution for anyone who’s been vaccinated with any of the authorized or approved vaccines,” said Marks, who heads the FDA’s Center for Biologics Evaluation and Research (CBER).
But he said there is no precise timeline yet.
“I can tell you that we will proceed with all due urgency to try to get there as rapidly as possible working with the various vaccine sponsors,” Marks said.