FDA Weighing Approval of New COVID-19 Booster Shots Based Only On “Mouse Data” – Human Trials Still Incomplete; Advisor “Uncomfortable”

WASHINGTON, D.C. – Despite the fact that testing among human subjects has not yet been completed – and thus its ultimate degree of safety not yet being completely known as a result – the Food and Drug Administration (FDA) is nonetheless considering approving Pfizer-BioNTech’s COVID-19 new booster shots for public this week, leading to intense concerns among both the public and medical professionals.

The updated booster vaccine developed by Pfizer-BioNTech is designed to be more effective against COVID-19 variants – such as BA.4/BA.5 versions of Omicron – than the original vaccine. This was reportedly achieved by combining the mRNA of the SARS-CoV-2 spike protein found in the initial vaccine with mRNA spike protein for the Omicron BA.4/BA.5 variant.

Human trials of the new booster were only started in August, according to Pfizer-BioNTech representatives, who stated the vaccine will be possibly approved by the FDA and distributed to U.S. residents before the trials are completed by way of an emergency use authorization, provided the FDA grants it.

The new vaccine is currently slated for use by those who are age 12 and older, and can be distributed “immediately,” according to Pfizer Chairman and CEO Albert Bourla.

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” he said. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.”

The most recent data provided by the CDC reveals that the BA.5 variant is responsible for 88.7 percent of all new cases between August 21 and August 27. The BA.4 variant included an additional 3.6 percent of new cases.

Moderna has also petitioned the FDA to approve an emergency use authorization request for their updated vaccine, which if granted could be available in September.

FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, Paul Offit, said that approving widespread use of the new booster could put countless people at risk, given that the most complete data Pfizer-BioNTech has is currently based on rodent experimentation only.

“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,” he said.

The completion of human-based studies is not required for FDA emergency use approval to be granted; however, experts worry that the fact that human trials are not yet complete will cause those who are hesitant or fearful of taking the jab to avoid doing so, especially in light of reported side-effects from previous versions of COVID-19 vaccines.