FDA Lets Pfizer Test Experimental COVID-19 Vaccine on U.S. Children
Americans have been following COVID-19 vaccine trial developments for weeks, watching companies jockey for frontrunner status like contestants in a reality TV show. And though participants in some of the studies (by Moderna, Oxford, Johnson & Johnson and Pfizer) have surfaced with reactions serious enough to pause several of the trials, market analysts remain “bullish” about the near-term prospects for approval of these liability-free products by the U.S. Food and Drug Administration (FDA).
On Oct. 16, Pfizer’s CEO indicated the company would likely file for FDA Emergency Use Authorization for its experimental BNT162b2 vaccine in late November. That statement came three days after Pfizer announced that it had received FDA permission to administer the unproven vaccine to children as young as 12, becoming the first company in the U.S. to include young participants in Phase 3 trials. In the UK, Oxford and AstraZeneca gained approval to test their vaccine in children aged 5-12 back in May, a couple of months before two of their adult clinical trial participants developed transverse myelitis.
To date, Pfizer has administered two doses of vaccine to almost 35,000 adult participants in five countries. Unworried by the dramatic side effects reported by some of these adults — including high fever, pounding headaches, body aches, exhaustion and shivering intense enough to crack teeth — more than 90 parents have already expressed interest in volunteering their teenagers.
Are these parents (perhaps left unemployed by coronavirus restrictions) tempted by the financial incentives offered to clinical trial participants, reportedly anywhere from $1200 to $2000? Otherwise, their motivation for wanting to throw their children into the experimental fray is unclear; as the director of the Cincinnati Children’s Hospital stated, “most of the time, what a coronavirus causes is a cold” that does not even make children “sick enough to where a parent says they need to go to a doctor.”
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