(Reuters) – Vaccine developers may need to modify their vaccines to provide protection against any potential new variants of the coronavirus in the United States should they fail to elicit immune response in their current form, the U.S. health regulator said on Monday.
“At this time, available information suggests that the FDA-authorized vaccines remain effective in protecting the American public against currently circulating strains of SARS-CoV-2,” the U.S. Food and Drug Administration said in a statement.
The agency made the comments as part of a newly updated guidance bit.ly/3pEGUPH for companies making vaccines, tests and therapeutics for COVID-19. (bit.ly/3pEGUPH)
The emergence of new variants that are considered more infectious has prompted the U.S. government to step up efforts to track coronavirus mutations and keep vaccines and treatments effective against any new variants.
As part of its updated guidance, the FDA recommended that vaccine makers test any modified vaccines in both previously unvaccinated people and vaccinated people. The manufacturers should compare the immune response of a modified vaccine against both the new variant as well as the original virus.
The FDA also recommended monitoring test subjects’ safety for at least seven days, to support emergency use authorization for modified vaccines.
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