Anti-Covid vaccines: Europe awaiting the green light from EMA experts on Monday
The HQ of the European Medicines Agency in 2019 © Wikimedia Commons CC BY-SA 4.0 Ceescamel
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The European Medicines Agency (EMA) must decide this Monday, 8 days ahead of the schedule initially planned, on the Pfizer-BioNtech vaccine.
If it gives the green light for a marketing authorization then the vaccine could be available in the 27 Member States by Christmas.
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Experts from the European Medicines Agency and the Member States have been peeling, day and night, for 3 months, the thousands of data provided by Pfizer-BioNtech laboratories, explains our correspondent in Brussels,
Joana Hostein
.
These experts who seek to know if the vaccine meets all the requirements for quality, safety and efficacy defined in the pharmaceutical legislation of the European Union.
They should also have no interest of any kind with the laboratories and are divided into several teams to ensure that they arrive at the same conclusions.
Respect of the “
benefit-risk
”
balance
The “
benefit-risk
”
balance
must be respected, that is to say that the protection provided by the vaccine must be much greater than the potential side effects of the treatment.
Even though the vaccine has already been licensed in the UK and US, experts need to analyze all aspects and may also have additional questions to submit to one of the producing companies.
A process described as "
the safest and most controlled
", according to Emer Cook, the director of the agency.
However, it has been speeded up considerably in recent weeks, under pressure from European governments such as Germany.
If the agency gives the green light for a marketing authorization for the vaccine in the 27 Member States - authorization valid for one year and revocable at any time - formal approval rests with the European Commission.
She promised to deliver her verdict 2 days after the agency's recommendation.
The approval of the vaccine from the Moderna laboratory, the other ongoing procedure, should be completed by January 6, 2021.
►Also read: Covid-19: a vaccine at what price?
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