The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
The European Medicines Agency (EMA) has requested that developers determine if their COVID-19 vaccines protect against new virus mutations that have been identified in the United Kingdom, South Africa, and Brazil. On Feb. 10, 2021, the agency announced that it is developing guidance to assist manufacturers in making changes to existing COVID-19 vaccines in order to treat these variants in the coronavirus.
A reflection paper will describe the data and studies needed to support changes to existing vaccines to treat mutations to SARS-CoV-2 in the European Union. The paper will address options for introducing a new strain into an existing approved vaccine; the minimal regulatory requirements for quality, safety, and efficacy; and bridging studies required to provide reassurance of a vaccine’s efficacy against a new strain.