FDA Reportedly Will Approve New COVID-19 Boosters Without Human Testing

Approval for the new COVID-19 booster shots is expected from the Food and Drug Administration this week, but there’s a catch. The shots developed to fight the latest Omicron variant are being released months before human trials are completed.

The Wall Street Journal said FDA approval is just days away for the “bivalent” boosters. These target both the BA.4 and BA.5 coronavirus strains as well as provide additional immunity for the original COVID-19 virus.


The Journal said that approval is coming without something that is considered normal procedure — trials done “showing whether the shots were safe and worked in humans.”

The FDA will instead look at testing on mice, results from vaccines already in use, and earlier versions of the COVID boosters. Those vaccines have proven to be not nearly as effective against newer coronavirus variants as they were in earlier rollouts.

These newest versions are similar to those already in use, just with minor variations. These were made to protect the boosted from the latest Omicron variants.

FDA Commissioner Dr. Robert Califf said the agency relies on “real world” evidence from boosters administered to millions to prove the vaccines are safe. He tweeted that “strain changes can be made without affecting safety.”

He added that it is already common practice to modify successful vaccines to provide protection against new viral strains. It does not require a change of ingredients, and the FDA commonly approves the variations in flu vaccines.

In June, however, a pair of experts wrote an op-ed expressing their discomfort at giving “millions or tens of millions of doses to people — based on mouse data.” FDA advisor Paul Offit told the Journal that the comparison between flu shots and COVID-19 shots “is not well grounded.”

Offit said the FDA will not even convene another meeting for input from advisers as done with earlier rollouts. Instead, it intends on taking the data from mouse trials and previous iterations of the vaccine boosters and giving approval, likely as early as the end of this week.

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