The European Medicines Agency has recommended Pfizer – BioNTech’s Covid-19 vaccine for a conditional marketing authorisation in the EU, it announced on Monday.
“This is really a historic scientific achievement. Within less than a year, a vaccine will have been developed and authorised against a new disease,” EMA said.
The evaluation of the vaccine started in October in what is known as a rolling review, “a practice whereby data is reviewed on an iterative basis as it becomes available while development is still ongoing,” EMA explained, adding that “the companies then submitted a formal marketing authorisation application on the first of December.”
The recommendation for authorisation comes as the vaccine has already been approved for emergency use in the UK and the United States for several weeks now, but “ensuring vaccine safety has been our number one priority,” the organisation underlined. The vaccine has also been approved in Israel where large-scale vaccination started on Sunday.
Now that the vaccine is recommended for authorisation, the European Commission can start fast tracking its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States.
Provided Pfizer can deliver the vaccines across the EU at the same time, the first Belgians could receive their first dose of the vaccine on Sunday, as health minister Frank Vandenbroucke confirmed that Belgium is ready to start administering the vaccine.