The EU medicines regulator has approved the Pfizer/BioNTech Covid-19 vaccine for use, clearing the way to begin vaccinations across the 27-member bloc within days.
Emer Cooke, European Medicines Agency executive director, hailed the decision to authorise the shot as a “major step in the right direction” to tackling Covid-19 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’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.”
Ms Cooke added that the EMA believed the vaccine would be effective against the new coronavirus mutation that the UK has identified as a big source of transmission, triggering a spate of bans on travel from Britain by many countries in Europe and the rest of the world.
The European Commission has provisionally designated December 27, 28 and 29 as “EU vaccination days” to start the rollout of vaccinations for many of the bloc’s 446m inhabitants.
The EMA gave the positive decision on the vaccine, which had been widely expected, after bringing forward the approval meeting from December 29 to Monday. The European Commission has vowed to rapidly issue the final authorisations needed to allow the use of the vaccine across the bloc.