Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

 

European Medicines Agency
News: EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
Last updated: 03/02/2021
EMA’s human medicines committee (CHMP) has started a rolling review of NVX-CoV2373, a COVID19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID19.
The company is currently conducting trials in people to assess its safety, immunogenicity (how well it triggers a response against the virus) and its effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.
The rolling review will continue until enough evidence is available for a formal marketing authorisation application

 

 

News: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU (updated)
Last updated: 29/01/2021
Update: COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 29 January 2021.