09-27-2022, 12:23 PM
Quote:A top vaccine expert is saying that healthy young people should not receive the latest COVID-19 booster shot, because “there’s not clear evidence of benefit.”
Paul Offit is the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania, a member of National Institutes of Health working group on vaccines and a member of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. Previously, Offit was a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. He is also one of the few vaccine experts voicing caution on the new COVID boosters.
On Aug. 31, the FDA granted emergency use authorizations of COVID-19 boosters from Moderna and Pfizer-BioNTech. The bivalent version of the previous vaccines are for use as a single booster dose at least two months following primary or booster vaccination. Moderna’s mRNA booster shots are approved by the FDA for individuals 18 years of age or older, and the Pfizer-BioNTech version is authorized for those 12 or older.
During an appearance on CNN earlier this month, Offit said that those over 65, the immuno-compromised and anyone with serious chronic health ailments could benefit from the boosters; however, he expressed concern that government health agencies would try to push for everyone to get the booster.
“What I fear is that they’re going to say everybody should get it when in fact, the healthy young person really is unlikely to benefit from the booster dose, and so I hope they targeted more specifically, to those really who are most likely to benefit from this additional dose,” he said during the CNN interview.
The host, who seemed confused that Offit was not recommending it for everybody, asked, “Why not get it? Right? If it does give you even if it’s a smaller benefit, is there any reason not to get the booster?”
Offit replied, “I think that when you’re asking people to get a vaccine, I think there has to be clear evidence of benefit, and we’re not going to have clinical studies before this launches.”
Moderna has begun human trials on the booster shots, and Pfizer is expected to begin theirs this month. Those trials will likely not be completed until spring, experts say.
“But you’d like to have at least human data people you know, getting this vaccine, you see a clear and dramatic increase in neutralizing antibodies, and then at least you have a correlate of protection against BA.4 and BA.5,” he continued.
“You’re asking people to get a new product for which there’s no data,” Offit also told CNN. “Mice data are not adequate to launch a 100-plus-billion-dose effort.”
The FDA authorized the booster shot despite the fact that it has not yet been tested on humans. Pfizer’s preliminary findings were based on tests on eight mice. The EUA authorization was based on those tests, data from current COVID-19 vaccines and earlier boosters.
“Because if you don’t have that, if there’s not clear evidence of benefit, then it’s not fair I think to ask people to take a risk no matter how small,” Offit declared. “The benefit should be clear.”
Offit wrote an op-ed in the Wall Street Journal on Sept. 21, titled: “CDC Oversells the ‘Bivalent’ Covid Shot.”
“The Centers for Disease Control and Prevention recommends that everyone over 12 receive a ‘bivalent’ COVID-19 vaccine as a booster dose,” he wrote. “But only a select group are likely to benefit, and the evidence to date doesn’t support the view that a bivalent vaccine containing omicron or its subvariants is better than the monovalent vaccine. The CDC risks eroding the public’s trust by overselling the new shot.”
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