First vaccinations expected to start across 27-member bloc within days
The Pfizer/BioNTech vaccine has become the first Covid-19 shot to win approval from the EU medicines regulator, clearing the way for vaccinations to begin across the 27-member bloc within days.
Emer Cooke, European Medicines Agency executive director, hailed the decision to authorise the vaccine as a “major step in the right direction” and “an indication that 2021 can be brighter than 2020”.
The approval comes after several EU countries had questioned the time the European regulator was taking to authorise a vaccine that had already been approved for use in the UK and US. The EMA says its approval is a more comprehensive authorisation that is the “most appropriate regulatory mechanism” to underpin mass vaccination campaigns.
“The EMA’s scientific assessment is based on the strength of the scientific evidence on the vaccine’s safety, quality and efficacy — and nothing else,” Ms Cooke told reporters on Monday. “The evidence convincingly shows that benefits are greater than the risks of this Covid-19 vaccine.”