The US Food and Drug Administration says SARS-CoV-2 vaccine developers won't have to conduct large trials of new vaccines or vaccine boosters aimed at new viral variants, Bloomberg reports.
A number of new SARS-CoV-2 variants have been identified, some of which have raised concerns. For example, B.1.1.7, which was first identified in the UK, appears to be more readily transmitted. At the same time, vaccines appear to have a weaker response against B.1.351, which was first uncovered in South Africa. This has suggested that vaccine makers may have to update their vaccines or develop boosters.
According to CNBC, the FDA will allow updated vaccines or boosters against variants, clearing them as an amendment to the developers' initial Emergency Use Authorization, based on immunogenicity studies. It notes that this approach is what is used for the yearly flu vaccines.
The agency further issued new guidance for test developers, recommending that they design their tests to be robust to the effect of viral variants and note any variant-based limitations, as GenomeWeb has reported.
"By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts," Janet Woodcock, acting FDA commissioner, says in a statement.