Companies seeking marketing approval of vaccines against variants of the SARS-CoV-2 virus will need to provide solid justification for the choice of variants they intend to include in their vaccines, based on a good understanding of the strains circulating at the time the variant is selected.
Regulators are discussing how new versions of existing COVID-19 vaccines can be rapidly approved, and the European Commission is close to completing a proposed legal and regulatory framework for doing...
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