STEP SKIPPER: Latest COVID Booster Approved Before Human Testing Complete, Report Shows

According to a report in The Wall Street Journal, some FDA members are sounding the alarm on the latest COVID-19 booster; they are “uncomfortable” with the lack of human data on the new shot.

“I’m uncomfortable that we would move forward—that we would give millions or tens of millions of doses to people—based on mouse data,” Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told the Wall Street Journal in a report published on Sunday.

From The Daily Wire:

The updated Pfizer and BioNTech vaccine contains mRNA of the original SARS-CoV-2 spike protein found in the current vaccine together with mRNA spike protein for the Omicron BA.4/BA.5 variant. Pfizer and BioNTech said it is starting a human study of the booster shot this month, though it would not be completed until after its potential approval and distribution to Americans.

Pfizer and BioNTech have requested that the FDA grant an emergency use authorization for its COVID vaccine adapted to the BA.4/BA.5 versions of the Omicron variant. The emergency request would allow the booster’s approval without the traditional studies required for such a vaccine.

The new booster dose is intended for individuals 12 years of age and older and would be available to ship immediately, according to a news release from the company.

Red more over at The Daily Wire: