New Booster Rollout With No Human Testing!

Sept. 1, 2022

New Booster Rollout With No Human Testing With Meryl Nass, M.D., Toby Rogers, Ph.D. and Brian Hooker, Ph.D.

Instead of waiting for data from testing in humans, the agency will use data from trials in mice — as well as the real-world evidence of the safety of currently available COVID vaccines and test results from earlier iterations of boosters targeting older strains — to evaluate the newest boosters, FDA Commissioner Dr. Robert Califf said.

"Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe," Califf said on Twitter. "As we know from prior experience, strain changes can be made without affecting safety."

Both Moderna and Pfizer-BioNTech have submitted new COVID vaccine boosters to the agency for approval and the FDA hopes to roll out a booster campaign this fall.

However, some health experts are wary of the decision to release the shots without completed human trials.

In June, two experts penned an op-ed demanding that the FDA not rush through the rollout of the newest shots.

Dr. Paul Offit vaccines covid children HPV

"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," one of the authors, Paul Offit, told the Journal.

Offit, an FDA adviser and director of the Vaccine Education Center at Children's Hospital of Philadelphia, believes the comparison between flu shots and COVID-19 shots is not well grounded due to the differences in mutations and protection levels.

Pfizer and Moderna both said current data proves the newest shots are safe and effective, according to the Journal.

Effective at what? What are the COVID vaccine side effects? Short and long term?