FDA – Vaccines and Related Biological Products Advisory Committee :: EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU

Milestones :: Perspectives :: Research

 

Week of 7 December 2020

 

10 December 2020 – Thursday – 0900-1800/New York
FDA – Vaccines and Related Biological Products Advisory Committee
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The online web conference meeting will be available at the following:
https://youtu.be/owveMJBTc2IExternal Link Disclaimer
https://twitter.com/US_FDAExternal Link Disclaimer (Supported in Chrome browser)
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d.

 

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11 December 2020 – Thursday – 1300-1630/CET
EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
:: Agenda – EMA public stakeholder meeting on COVID-19 (PDF/310.91 KB) (new)
:: Documents
:: Live broadcast
EMA is organising this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties.
It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.
Please note that some issues of high public interest, such as patient access to COVID-19 vaccines and national vaccination campaigns, lie outside EMA’s remit and will not be covered at this event.

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
Last updated: 16/11/2020
MA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.)…The rolling review will continue until enough evidence is available to support a formal marketing authorisation application