BRUSSELS (Reuters) – The European Union could give final approval for the Pfizer-BioNTech COVID-19 vaccine as early as Dec. 23, a senior Commission official said on Wednesday, only two days after a possible green light from the bloc’s regulator.
Under EU rules, the European Medicines Agency (EMA) recommends the approval of new medicines and vaccines, but the final decision to allow them onto the market is made by the EU executive Commission after consultation with EU governments.
The EMA said on Tuesday it could issue a recommendation on the Pfizer-BioNTech vaccine on Dec. 21..
“If this is the case, the European Commission is ready to provide the formal authorisation placing it in the market in supersonic, fast procedures,” Commission vice-president Margaritis Schinas told EU lawmakers.
“We can do it in two days,” he said, meaning final approval could come as early as Dec. 23.
This further shortens the approval timetable after the EMA brought forward by more than a week its possible decision, originally planned for Dec. 29. The Commission said last week it could approve vaccines within three days of approval by the EMA.
Britain and the United States are among countries which have already approved the Pfizer/BioNTech vaccine.
The EMA usually takes at least seven months to issue a recommendation on vaccines after it receives full data from manufacturers, while the Commission can take as long as two months to authorise a vaccine after EMA approval.
If the EMA approves the vaccine on Monday, it will have taken just 20 days to assess the shot since it received data from large-clinical trials from Pfizer on Dec. 1.
The approval would be a conditional authorisation, meaning the vaccine would continue to be strictly monitored for efficacy and possible side-effects.
Available data show that in the short term the vaccine is highly effective against the new coronavirus and causes only mild side-effects. But long-term data are not yet available.
(Reporting by Francesco Guarascio @fraguarascio. Editing by Mark Potter)
