Dr. Paul Offit, a member of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), expressed doubts over the COVID-19 bivalent booster. The regulator reportedly approved the updated version of the vaccines against SARS-CoV-2 without conducting human clinical trials.
"When you're asking people to get a vaccine, I think there has to be clear evidence of benefit," he said during an interview. "Because if you don't have that, then it's not fair to ask people to take a risk, no matter how small."
"A healthy young person is unlikely to benefit from the extra dose," Offit remarked, pertaining to the boosters that specifically target the B11529 omicron strain and its BA4 and BA5 sub-variants.
He reiterated his opposition to the bivalent booster in a Sept 21 op-ed for the Wall Street Journal, writing that he voted against authorizing the updated vaccine during a VRBPAC meeting.
According to Offit, the more contagious omicron rendered even the fully vaccinated at risk of mild illness. In turn, the Centers for Disease Control and Prevention (CDC) found that a third and fourth COVID-19 vaccine dose reduced hospitalizations.
"But not everyone benefited. Those who did fell into three groups: the elderly, people with serious health problems and people who were immunocompromised," he pointed out. "It would be wise to focus on those at risk rather than the young and healthy."
"How does it compare with the old monovalent one? We don't know for sure, because the FDA authorized the new shot without clinical trials," Offit remarked. (Related: We FINALLY found a vaccine that Paul Offit doesn't endorse: the "bivalent booster" for covid.)
The CDC issued a recommendation on Sept. 1 for the reformulated bivalent boosters from Pfizer and Moderna. It recommended the Pfizer booster dose for Americans aged 12 and up, while the Moderna booster was recommended for those aged 18 and older. The public health agency advised people to get the updated boosters at least two months after their last vaccination.
Offit explained in his op-ed that "the new bivalent vaccine contains mRNA from the ancestral strain and BA4 and BA5, the sub-variants that account for virtually all currently circulating SARS-CoV-2 [infections]."
Members of the CDC's Advisory Committee on Immunization Practices (ACIP) also expressed doubts about recommending a vaccine that did not undergo human clinical trials. ACIP member Dr. Oliver Brooks remarked during a committee meeting: "I really do struggle with a vaccine that has no clinical data that has been reported for humans."
Dr. Melinda Wharton, associate director for vaccine policy and clinical partnerships at the CDC's National Center for Immunization and Respiratory Diseases, downplayed concerns by Brooks and other ACIP members. She compared the bivalent COVID-19 shots to influenza vaccines, which are updated annually without any human data.
Despite acknowledging that "there will be some bumps in the road" as officials transition to the updated shots, Wharton reiterated the importance of the new bivalent vaccines that – according to her own words – "will provide more protection."
CDC Director Dr. Rochelle Walensky also defended the bivalent boosters, saying that they were "formulated to better protect against the most recently circulating COVID-19 variant" and can "help restore protection" against the pathogen.
Watch Stew Peters and Dr. Jane Ruby discuss the FDA's approval of the untested bivalent COVID-19 vaccines.
This video is from the High Hopes channel on Brighteon.com.