Pfizer and BioNTech make final vaccine submission to European regulator
Pfizer and its German partner BioNTech have made their final submission to the European Medicines Agency for approval of their potential Covid-19 vaccine.
The firms said the formal application for conditional marketing authorisation (CMA), submitted on Monday and confirmed on Tuesday, completed the rolling review process of the BNT162b2 vaccine candidate.
“If the EMA concludes that the benefits of the candidate outweigh its risks in protecting against Covid-19, it will recommend granting a CMA that could potentially enable use of BNT162b2 in Europe before the end of 2020,” the firms said.
Albert Bourla, chief executive of America’s Pfizer, called the application a “key milestone”, adding: “We stand ready to ship Covid-19 vaccine doses as soon as potential authorisations will allow us.”
A CMA allows medicines that fulfil unmet medical need to be authorised with less complete data than normally required. According to the EMA, this only happens if the benefit of a drug being made immediately available outweighs the inherent risks of reduced data.
The EMA said it would now assess the Pfizer-BioNTech CMA submission, and that it planned to conclude the process at an extraordinary meeting scheduled for 29 December “at the latest”.
Clinical trials have indicated an efficacy rate of 95% for the vaccine, and stock markets around the world have soared on hopes that the pandemic could soon be brought under control. The drug, which has yet to be peer-reviewed, is not currently approved for distribution anywhere in the world.
Rolling submissions have also been made to the US Food and Drug Administration, the UK Medicines and Healthcare Products Regulatory Agency and other relevant regulators in Australia, Canada and Japan. The first submission supplied to the EMA was non-clinical data on 6 October.