EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
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.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
