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The disregard for children’s safety in vaccine trials is becoming apparent.
A month since the FDA advised against use of the Pfizer-BioNTech COVID-19 booster shot for most demographics — with additional authorization requested for high-risk Americans and those over the age of 65 — the FDA committee is now giving unanimous approval (17-0) for administration of the booster treatment on children, ages 5-11.
The FDA’s decision to put kids first in approval for boosters has adhered to pressure from President Joe Biden to get authorization done before the end of September 2021. With a month since his deadline in the books, the committee is reworking its evaluations and now setting up kids as lab mice to test boosters.
In weeks, children will receive the booster, with established full vaccination. Concurrently, the CDC’s open-ended research on potential side effects or harmful responses for recipients of the booster shot still leaves plenty of questions regarding its safety.
The CDC’s data on the lasting effect of the Pfizer-BioNTech booster shows a steep drop off after 120 days. Within that timeframe, the booster has shown an efficacy rate of 91 percent drop down to 77 percent.
During the Delta variant’s surge during the summer, a study out of Israel evidenced that people with natural immunity were six times less likely to catch a breakthrough case compared to vaccinated citizens.
According to editor-in-chief of the New England Journal of Medicine Dr. Eric Rubin, the booster shot’s authorized use for children has run into pressure to be expeditiously approved, without much consideration for potential heart problems previously observed.
“This is a much tougher one, I think, than we had expected coming into it,” Dr. Rubin commented. “The data shows that the vaccine works and it’s pretty safe … we’re worried about a side effect that we can’t measure yet.”
At the start of October, several Nordic countries restricted the use of COVID therapeutics after they led to cases of heart inflammation among younger males.
“It just seems to me that in some ways, we’re vaccinating children to protect the adults, and it should be the other way around,” mentioned President and CEO of Meharry Medical College, Dr. James Hildreth. “I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children … that seems a bit much for me.”
Follow along on Twitter: @AlejandroAveela