After Britain became the first western country to endorse a COVID-19 shot on Wednesday, 2 December, European Union has criticised the rapid approval of Pfizer and BioNTech’s COVID-19 vaccine, saying its own procedure was more thorough.
The decision was made under an ultra-fast emergency approval process, which allowed the British drugs regulator to temporarily authorise the vaccine only ten days after it began examining data from large-scale trials.
The European medicines agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.
The agency said it would decide by December 29, whether to provisionally authorise the vaccine from U.S. drugmaker Pfizer and its German partner BioNTech.
A spokesman for the European commission said the EMA’s procedure was the most effective regulatory mechanism to grant all EU citizens access to a safe and effective vaccine as it was based on more evidence.
The EMA started a rolling review of preliminary data from Pfizer trials on October 6, an emergency procedure aimed at speeding up possible approval which usually takes at least seven months.