The Food and Drug Administration is expected to approve new COVID-19 booster shots this week – before vaccines are tested on humans, according to a new report from the the wall street journal.
The new boosters are similar to COVID vaccines currently available in the United States with minor changes that protect recipients of the latest version of the Omicron variant.
Instead of waiting for data from human tests, the agency will use data from mouse trials – as well as real evidence of the safety of currently available COVID vaccines and test results from previous iterations of boosters targeting older strains to evaluate newer boosters, said FDA Commissioner Dr. Robert Califf.
“Real-world evidence from current COVID-19 mRNA vaccines, which have been given to millions of individuals, shows us that the vaccines are safe,” Califf said on Twitter. “As we know from experience, strain changes can be made without affecting safety.”
He added that modifying existing vaccines to include protection against different virus strains does not require an ingredient change and is standard FDA practice with influenza vaccines.
“The FDA has extensive experience reviewing strain changes in vaccines, such as the annual flu vaccine,” Califf said.
Moderna and Pfizer-BioNTech have submitted new COVID vaccine recalls to the agency for approval, and the FDA hopes to launch a recall campaign this fall.
However, some health experts are wary of the decision to release the vaccines without completed human trials.
In June, two experts write an editorial demanding that the FDA not rush into rolling out new vaccines.
“I’m uncomfortable that we’re going ahead — whether we’re giving people millions or tens of millions of doses — based on the mouse data,” said one of the authors, Paul Offit, in the Journal.
Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, says the comparison between influenza vaccines and COVID-19 vaccines is not well-founded because of differences in mutations and levels. protection.
Nor will the FDA convene another meeting to gather adviser input on vaccine approvals, as has been the case in previous rollouts.
Califf said the already “overwhelming” advisers voted to include an omicron component in COVID-19 boosters at a meeting in June.
“The agency is confident in the thorough discussion that took place in June,” he said.
COVID-19 vaccines currently on the market are not as effective against newer strains of the virus, including Omicron’s brand new BA.5 subvariant.
Both Pfizer and Moderna have said current data proves the new vaccines are safe and effective, according to the Journal.
New versions are only very slightly modified to protect against new variants, according to several experts. Additionally, tests on earlier versions from both companies targeting earlier strains have proven to be effective and safe. Such a shot has already been approved in the UK
Moderna has already started human trials on the latest vaccine targeting the subvariants and Pfizer is expected to begin theirs this month, but results won’t be available until the vaccines are made available to the general public. .
“If we were waiting for the results of the clinical trials, thank you very much, we would have them in the spring. It takes time to do clinical trials,” William Schaffner, professor of medicine at Vanderbilt University Medical Center, told the Journal. “It’s just an update of the previous vaccine we used.”