The new boosters are similar to the COVID vaccines currently available in the US with minor modifications that protect recipients against 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 the actual safety data of available COVID vaccines and test results from previous iterations of boosters targeting older strains — to evaluate the newer boosters , said FDA Commissioner Dr. Robert Califf. “Real-world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of people, shows us that the vaccines are safe,” Khalif said on Twitter. “As we know from past experience, strain changes can be made without affecting safety.” He added that modifying existing vaccines to include protection against different viral strains does not require a change in the ingredient and is a common FDA practice with flu vaccines. Newer vaccines aim to protect against the latest sub-variants of COVID-19.REUTERS “FDA has extensive experience reviewing strain changes in vaccines, such as the annual flu shot,” 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 wary of the decision to release the shots without comprehensive human trials. In June, two experts wrote an op-ed urging the FDA not to rush to present the latest shots. “I feel uncomfortable that we would go ahead — that we would give millions or tens of millions of doses to people — based on the mouse data,” said Paul Offit, one of the authors in the Journal. Offit, an FDA consultant and director of the Center for Vaccine Education at the Children’s Hospital of Philadelphia, believes the comparison between flu vaccines and COVID-19 vaccines is not well-founded because of differences in mutations and levels of protection. The FDA will not convene another meeting to gather input from consultants on vaccine approvals, as it has done in previous versions. Califf said councilors already “overwhelmingly” voted to include an omicron ingredient in the COVID-19 boosters at a meeting held in June. “The agency feels confident about the extensive discussion that took place in June,” he said. The COVID-19 vaccines now on the market are not as effective against newer strains of the virus, including the newer Omicron BA.5 subvariant. Pfizer and Moderna both said current data show the latest shots are safe and effective, according to the Journal. Newer versions change little only to protect against new variants, according to several experts. Also, tests on the two companies’ previous releases targeting former executives have proven successful and safe. Such a download is already approved in the UK Moderna has already started human trials of its newest subvariant-targeting vaccine, and Pfizer is expected to start its own this month, but results won’t be available before 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. “This is just an update of the previous vaccine we used.”
