The latest COVID booster footage will be released before human testing is complete
The Food and Drug Administration is expected to approve new COVID-19 booster shots this week — before the vaccines are tested in 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 modifications that protect recipients from the latest version of the Omicron variant.
Rather than waiting for data from human testing, the agency will use data from studies in mice, as well as the real-world evidence of the safety of the currently available COVID vaccines and test results from previous iterations of boosters targeting older strains to provide the latest to evaluate boosters, said FDA Commissioner Dr. Robert Califf.
“Real evidence from the current mRNA COVID-19 vaccines administered to millions of people tells us that the vaccines are safe,” Califf said on Twitter. “As we know from past experience, load changes can be made without compromising safety.”
He added that modifying existing vaccines to protect against different strains of the virus does not require changing the ingredients and is standard FDA practice for influenza vaccines.
“The FDA has extensive experience reviewing strain changes in vaccines, as is the case 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 launch a booster campaign this fall.
However, some health experts are suspicious of the decision to release the recordings without completed human trials.
In June, two experts wrote an op-ed urging the FDA not to rush the rollout of the latest recordings.
“I’m uncomfortable that we’re moving forward based on mouse data — that we would be administering millions or tens of millions of doses to humans,” one of the authors, Paul Offit, told the Journal.
Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, believes the comparison between flu shots and COVID-19 shots is not well founded because of differences in mutations and levels of protection.
Nor will the FDA convene another meeting to collect input from advisors on vaccine approvals, as it has done in previous launches.
Califf said advisors had already voted “overwhelmingly” to include an Omicron component in COVID-19 boosters at a meeting in June.
“The agency is optimistic about the extensive discussion that took place in June,” he said.
The COVID-19 vaccines currently on the market 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.
According to several experts, the newer versions are only changed very slightly to protect against new variants. Testing previous versions of the two companies targeting previous strains has also proven successful and secure. Such a recording has already been approved in Great Britain
Moderna has already started human trials of the latest subvariant-targeted vaccine, and Pfizer is expected to start this month, but the results won’t be available before the vaccines are made available to the general public.
“If we waited for the results of clinical trials, thank you very much, we would get them in the spring. It takes time to conduct clinical trials,” William Schaffner, professor of medicine at Vanderbilt University Medical Center, told the Journal. “This is just an update of the previous vaccine that we used.”