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COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones
December 18, 2020
FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D….
December 19-20, 2020
Advisory Committee on Immunization Practices (ACIP) – CDC
Emergency Meetings following VRBPAC Meeting on 17 December 2020.
No official statement at time of publication.
EMA News: Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
CHMP, Last updated: 15/12/2020
EMA’s human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID19 mRNA vaccine.
The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.
Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible. The meeting planned for 29 December will be maintained if needed.
The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks.
Once the CHMP recommends a marketing authorisation, the European Commission will then fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days…
EMA News: Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
CHMP, Last updated: 17/12/2020
Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine. A continuous dialogue with the company has ensured that questions that arose during the evaluation were swiftly followed up and addressed by the company.
The rate of progress of the further evaluation will depend on the robustness of these data as well as availability of additional information from the company to respond to questions raised during the evaluation. The CHMP will conclude its assessment at the earliest possible timepoint, but only if the evidence shows convincingly that the benefits of the vaccine are greater than any potential risks.
Today, ahead of schedule, the company has submitted the last outstanding data package needed for the assessment of the application. This contains information that is specific to the manufacturing of the vaccine for the EU market.
Taking due account of the progress made, the Committee has scheduled an extraordinary meeting on 6 January 2021 to conclude its assessment, if possible. The meeting planned for 12 January 2021 will be maintained if needed. These two meetings will be virtual, as the EMA premises are closed for external visitors and staff are currently working remotely due to the pandemic…