5 reasons why the COVID-19 vaccine needs clinical trials before approval
I couldn’t help but notice that the mainstream media is upset that going forward the fall COVID 19 booster might require randomized trials measuring clinical endpoints, rather than allowing Peter Marks to pick a variant target (based on an analogy to him buying milk) and then generate antibodies against the target. Helen Branswell from Stat, however, says that trials are not feasible. Is this true? Here are 5 reasons why COVID-19 shots should require trials.
Helen’s argument that COVID-19 shots can’t be tested because the timespan the virus is transmitted is within a short season is false. The virus spreads year round. This is a basic fact, and in contrast with the actual seasonal respiratory viruses.
Contrast that with Flu and RSV
It is standard practice for vaccines to undergo clinical testing, showing improvement in clinical endpoints, prior to approval. This standard practice was even adhered to in 2020 with the initial vaccine studies. Although we can debate the methodological rigor of the trials, they were done. It was later abandoned in the setting of subsequent boosters— leading to the resignation of Gruber and Krause at FDA— but there is no logical basis to abandon it now, as the risk of bad COVID outcomes has fallen.
The American people have shown they are unwilling to get an unproven annual booster. Rates of booster uptake remain abysmal. This graph would be EVEN WORSE if you include babies over 6 months olds. The surest way to get a lower percentage in 2025 is to further waive the basic requirements of trials.
Other nations do not give COVID shots annually to all babies over 6 months old. This is not the practice across Europe. It is hard to fully capture just how absurd such a policy is. Taking the lowest risk individuals in a society and exposing them to an absolutely unproven, injected novel medical product. Under Joe Biden, America was a demented outlier.
As vaccines undergo strain modification, they are entirely new products. Their efficacy and safety may be untethered from prior products. Without trials, it is only a matter of time before the FDA approves a vaccine that causes some bad outcome like vaccine-induced narcolepsy If this happens, you can kiss faith in vaccines goodbye. You will see vaccine hesitancy like you have never seen before. The FDA must have a strong commitment to safety and efficacy to preserve vaccine’s remaining reputation.
Folks who think COVID-19 vaccines should continue to roll out without randomized trials are anti-vaccine, anti-science, and pro-corporate.
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This is overdue. Rubber stamping annual covid boosters has no scientific, medical, or public rationale. No one know if this approach is "safe and effective." Time to find out.
Amen! I simply do not understand why there even is a Covid booster still being pushed when there are no longer bad outcomes for any populations, especially for the pediatric population who are at lowest risk. I can see NO other explanation than greed and corruption, especially with you being able to point out why randomized trials are indeed doable, and how differently other countries treat covid now. Thank you, Vinay!