“If the data is submitted are robust enough to conclude on the quality, effectiveness of the vaccine, EMA will conclude its assessment at the latest,” the EU regulator said.
Berlin: Europe’s medicines regulator said on Tuesday it would decide by 29th December whether to grant emergency approval to a Covid-19 vaccine developed by Germany’s BioNTech and its US partner Pfizer, ahead of a rival treatment from Moderna.
The European Medicines Agency (EMA) confirmed that they had received formal applications from both vaccine makers seeking the green light for their experimental jobs.
“If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine,” the Amsterdam-based agency said that it could conclude its assessment of the BioNTech/ Pfizer shot in an extraordinary meeting on 29th December “at the latest”.
A separate meeting to assess the Moderna shot would take place on January 12 at the latest, it added.
Large-scale trial data released last month showed that both vaccines were safe and around 95 percent effective against Covid-19.
European Commission spokesperson ‘Stefan de Keersmaecker’ told reporters that once the EMA had given regulatory permission, formal authorisation from Brussels would follow “very quickly”, probably “in a matter of days”.
Although both vaccines are being assessed in an accelerated process known as a “rolling review”, the latest timeline suggests Europeans would be lucky to receive the first jabs before the year is over.
BioNTech/Pfizer and Moderna have also applied for emergency use authorisation in the United States, where Americans are expected to start getting vaccinated around mid-December.
UK regulators, no longer have to wait for the EMA’s okay, are also in the process of considering emergency approval for the BioNTech/Pfizer vaccine.