The EU’s Committee for Medicinal Products for Human Use is holding an exceptional meeting on December 21 to conclude its assessment of the BioNTech and Pfizer BNT162b2 vaccine.
And once the Committee recommends a marketing authorisation, the vaccine will be available in all Member States within days.
This is what a press release said on Wednesday, adding that the exceptional meeting followed receipt on Tuesday evening of additional data requested by the Committee from the company. And that the meeting planned for December 29 will be maintained if needed.
“A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines,” it also said.
“It will be valid in all EU Member States at the same time enabling all Member States to benefit from the joint work done at EU level and allowing them to start rolling out their vaccination campaigns at the same time,” it added.
European health authorities and experts, the press release stressed, are working towards the first marketing authorisation of a COVID-19 vaccine with all the safeguards, controls and obligations imposed, including:
- full prescribing information and package leaflet with detailed instructions for safe use;
- a robust risk-management and safety monitoring plan;
- manufacturing controls including batch controls for vaccines and conditions for storage;
- an investigation plan for use in children;
- legally binding post-approval obligations (i.e., conditions) and a clear legal framework for evaluation of emerging efficacy and safety data.