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
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
