This article talks about the reasons why Dr. Paul Offit voted against the approval of the booster shots designed for the Omicron variant.
Dr. Paul Offit is a member of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which advises the FDA on whether new vaccines should be approved.
VRBPAC met on June 28 to decide if an Omicron-based booster is necessary. According to Dr. Offit, the data that Moderna and Pfizer presented were “not compelling,”
First, their data showed a 1.75-fold increase in neutralizing antibodies against the Omicron. While that may sound good, the vaccine makers did not provide any clinical evidence to show that they prevent severe COVID-19.
Dr. Offit referenced that in December 2020, Moderna had double the amount of neutralizing antibodies elicited compared to Pfizer, but that did not translate into preventing COVID-19 hospitalization and deaths.
The second issue is that Omicron is gone. It has mutated into BA.4 and BA.5, causing most of the infection. However, “Pfizer and Moderna did not show any neutralizing antibodies to the BA.4 and BA.5, which is the obvious thing to do.”
Note: The study about Pfizer’s BNT162b2 vaccine detected antibodies to BA.2 and involved only 24 people.
Third, there is no evidence based on animal studies that Omicron-boosters elicit neutralizing antibodies. To support this, Dr. Offit quoted the work by Gagne et al. that I discussed in How to prepare for the inevitable COVID-19 reinfection.
Unusual circumstances
A few days before the meeting, instead of getting the usual 400 pages of information about the vaccines, the VRBPAC members received only 22 pages, including half a page of the Pfizer data and another half from Moderna.
The other odd thing was that representatives from the WHO and the FDA were there and presented their opinion. Both representatives think the Omicron booster vaccines were a “good idea.” All of these are “unusual,” according to Dr. Sachs.
He was surprised that 19 of the 21 members of VRBPAC approved the boosters because he did not see any benefits outweighing the risks.
The next day, the Health and Human Services ordered 103 million doses of the COVID-19 shots for fall 2022.
Dr. Offit felt they were “being led here with a critical lack of information.”
The next shot shows ZDoggMD open-mouthed with disbelief.
Watch the video from 3:40 to 9:02.
Dr. Santiano’s comments
As of today, there are no safety data about the Omicron-booster shots. Additionally, coronaviruses always mutate because they are made from RNA. Even if Pfizer and Moderna make a BA.4 and BA. 5-based boosters, nobody knows what will be the dominant variant this coming fall.
Truth heals. Lies kill. Don’t Get Sick!
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