The Food and Drug Administration (FDA) is looking to authorize a new Covid -19 booster shot soon. The booster shots will be released to the public even before trials on humans are completed, according to a new report.
The Wall Street Journal reported. The new booster shot will be “bivalent” which means it can target the original Covid-19 strain and the Omicron BA.5 subvariant. The booster if approved will be available to Americans despite not having been tested on humans.
The FDA is relying on testing done on mice, and data drawn from boosters given to people in earlier dispersals FDA commissioner Robert Califf issued a statement on Twitter laying the ground work for how the government will continue to use emergency use authorization to push through the booster.
FDA will rely on the totality of the available evidence in making a decision, including; Clinical trial data from other bivalent mRNA Covid-19 boosters RWE from current Covid-19 vaccines administered to millions of people non clinical data for the bivalent BA 4/5 vaccines, bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients.”
He went on to reassure people that in his words “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.”
In June two health experts wrote an op-ed on statnews dot com urging the FDA to not 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.”
Some have to wonder why the rush? Since CDC data shows that less than 50% of Americans received the first booster shot and only 33% of Americans over the age of 50 got the second dose, indicating Americans may not be that interested in drive thru boosters.
The Wall Street Journal noted, “The Food and Drug Administration is expected to authorize the new covid 19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans”