A senior official said the European Union may approve the Pfizer vaccine on December 23, two days after the executive group “green light”.
Under European Union (EU) regulations, the European Pharmaceutical Authority (EMA) recommends the approval of new drugs and vaccines. The final decision is taken by the EU Executive Committee, after consulting the governments of the member countries.
The EMA said on December 15 they could make a recommendation for the Pfizer-BioNTech vaccine on December 21.
“If that is the case, the European Commission is ready to officially issue the official license to bring vaccines to the market through an expedited procedure,” said Margaritis Chinas, the Commission’s Vice President, to EU lawmakers.
“We can do it in two days,” he said, meaning that final approval could be made as early as December 23.
This further shortens the approval timetable, after the EMA moves feasible decisions a week earlier, which is slated for December 29. The commission said last week it could approve the vaccine within three days of the EMA’s approval.
The EMA typically takes at least seven months to make a vaccine recommendation after getting enough data from the manufacturers, while the Commission can take up to two months to license the vaccine after the EMA approves it.
If the EMA approves the vaccine on December 20, it will only take 20 days to evaluate the vaccine since data on Pfizer’s large clinical trials is received.
The approval is conditional, which means vaccines continue to be strictly monitored for efficacy and possible side effects.
The short-term data available show that the vaccine is highly effective against CoV in the short term and causes only mild side effects. But more long-term data are not available.
The Pfizer-BioNTech vaccine was the world’s first Covid-19 vaccine to complete the trial, and is 95% effective. Currently, four countries have approved this vaccine and started to put it in mass vaccination, namely the UK, Bahrain, Canada and the US.
Chile (According to the Reuters)