Pfizer’s COVID Vax For Kids Under 5 Now DELAYED; Here’s Why
U.S. health regulators have delayed the review of Pfizer’s COVID vaccine for children under the age of 5 due to the two-dose regimen not working all that well against the omicron variant of the illness, according to reports coming out of the Wall Street Journal on Friday.
Last week, the Food and Drug Administration stated that it will need more data on the vaccine, delaying the decision to uses the vaccine in kids who are 6 months old through 4 years of age, for at least two months.
“An early look at data showed the vaccine to be effective against the delta variant during testing while that was the dominant strain, but some vaccinated children developed COVID-19 after omicron emerged, the report said, citing people familiar with the FDA’s decision,” Newsmax stated in its report.
Here’s more from their piece:
However, since the overall COVID-19 cases were low, the small number of omicron cases made the vaccine appear less effective in an early statistical analysis, the report added.
The FDA did not respond to a Reuters request for comment.
Pfizer and BioNTech had submitted data on the first two doses of a planned three-dose regimen earlier this month at the request of the FDA. Pfizer did not disclose efficacy data.
The submission was surprising because in December, the companies said early trial results of the two low doses of the vaccine fell short of expectations, and the clinical trial was amended to test a three-dose version.