The Food and Drug Administration (FDA) has authorized the latest COVID-19 “updated booster” shots, developed for the Omicron variant, without running trials on humans
In lieu of human trials, the vaccines will rely on testing on mice and will be approved for public use months before human trials are complete. The new Omicron shots were approved by the FDA on Wednesday, reports Fox.
“Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination,” it said in a statement.
The new shots, which the FDA is referring to as “updated boosters,” contain “two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”
Despite not having been tested on humans, the vaccination will be pushed by the government on all Americans.
Aside from testing on mice, the FDA will also rely on data from current COVID-19 vaccines, and earlier iterations of boosters.
In June, two health experts wrote an op-ed urging the FDA not to release the booster shots without proper research.
The article was written by John P. Moore – a virologist and professor of microbiology and immunology at Weill Cornell Medicine – and Paul A. Offit – a pediatrician, professor of pediatrics, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, and a member of the Vaccines and Related Biological Products Advisory Committee.
Offit told the Wall Street Journal, “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.”