The Food and Drug Administration is expected to approve new COVID-19 booster shots this week — before the vaccines are tested on humans, according to a new report from the Wall Street Journal.
The new boosters are similar to the COVID vaccines currently available in the US, with minor tweaks that protect recipients from the latest version of the Omicron variant.
Rather than waiting for data from human trials, the agency will use data from mouse trials — as well as real-world evidence of the safety of currently available COVID vaccines and test results from previous iterations of boosters targeting older strains to help reduce the risk of infection. latest boosters to be evaluated, said FDA Commissioner Dr. Robert Califf.
“Real world evidence of current mRNA COVID-19 vaccines, which have been administered to millions of individuals, shows us that the vaccines are safe,” Califf said on Twitter. “As we know from past experience, voltage changes can be made without compromising safety.”
He added that modifying existing vaccines to include protection against different viral strains does not require ingredient changes and is a common practice the FDA does with flu vaccines.
“FDA has extensive experience assessing strain changes in vaccines, as is done with the annual flu vaccine,” Califf said.
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 wrote an op-ed demanding the FDA not rush through the rollout of the latest shots.
“I feel uneasy 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 advisor and director of the Vaccine Education Center at the Children’s Hospital in Philadelphia, believes the comparison between flu shots and COVID-19 injections is not well-founded because of the differences in mutations and levels of protection.
The FDA will not convene a new meeting to gather consultant input on vaccine approval, as it has done in previous rollouts.
Califf said advisors already voted “overwhelmingly” at a meeting in June to include an ommicron component in COVID-19 boosters.
“The agency is confident in the extensive discussion held in June,” he said.
COVID-19 vaccines on the market now are not as effective against newer virus strains, including the latest Omicron subvariant BA.5.
Pfizer and Moderna both said current data proves the latest shots are safe and effective, according to the Journal.
The newer versions are only slightly modified to protect against new variants, according to several experts. Testing the earlier versions of the two companies targeting earlier strains has also proved successful and safe. One such recording has already been approved in the UK
Moderna has already begun human trials of its latest vaccine against subvariants, and Pfizer is expected to begin theirs this month, but the results will not be available until the vaccines are disclosed to the general public.
“If we were to wait for the results of clinical trials, thank you very much, we would get them in the spring. It takes time to do clinical trials,” William Schaffner, a professor of medicine at Vanderbilt University Medical Center, told the Journal. “This is just an update of the previous vaccine we used.”
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