Back in June, the FDA’s panel of independent vaccine experts met to consider switching the country to a new booster that targets Omicron, given how quickly that variant is dominating new infections. At the time, the two largest COVID-19 vaccine makers, Pfizer-BioNTech and Moderna—which both make mRNA-based vaccines—had developed shots against an earlier Omicron variant, BA.1. The panel decided that if health authorities were going to change the booster shot to target Omicron, the next one should protect against the BA.4 and BA.5 subvariants, which would continue to account for almost all cases in the winter season.
They asked the vaccine manufacturers to develop a new vaccine, one that combined the original vaccine and also targeted Omicron BA.4 and BA.5. At the end of August,
both companies submitted data on their new, bivalent vaccines to the FDA for emergency use authorization.
Given the short time they had to develop the shot, however,
the data only included information on the safety and efficacy of the booster in animals.
Human studies are planned and will be ongoing even if the FDA and CDC decide to authorize the shots and the government starts distributing them.
Obviously, human studies are planned. Real world human test subjects in real time- Same as has occurred and is occurring and will occur again.
The FDA has also decided to review the animal study data without consulting its advisory committee again.( AGAIN. Let that sink in)
“That has vaccine experts divided. Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons.He notes that t
he data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming”
Underwhelming? Surely the impetus to make profit was over whelming!
“While conducting human studies does take more time, Offit say
s even a small trial involving about 100 people to measure their antibody levels after getting a BA.4/5 booster would be helpful”
Helpful, but not reassuring or conclusive or indicative of long term issues
“The public might feel it’s a panacea that signals the end of the pandemic, but without any data showing how well the booster will protect people from not only getting sick, there might be unrealistic expectations about what the boost can do. “I get a little nervous, frankly, when I hear this [booster] is going to be miraculous,” Offit says.”
Wash, rinse, repeat
“While the data on this vaccine does come from animals, using that data to decide whether or not to authorize the booster is a matter of “hedging bets.”
“If the shots are released and people get boosted, health officials will be carefully monitoring data from those vaccinees to ensure that
the assumptions they made about the safety and efficacy of the booster hold.”
“Carefully monitored” that’s laughable