New Delhi: Raising hopes that the first jabs could be administered in December, German pharmaceutical company BioNTech and its US partner Pfizer on Tuesday said that they have applied for conditional approval of their coronavirus vaccine with the European Medicines Agency. Also Read - 2.2 Lakh People Given COVID Vaccine So Far; 447 Adverse Events Reported: Health Ministry
Issuing a statement, both the companies said the submission, which occurred Monday, completes the rolling review process they initiated with the agency on October 6. Also Read - PM Modi Should Have Taken COVID Vaccine Shot Like Joe Biden: Congress Leader
The development comes a day after rival Moderna said it was asking US and European regulators to allow emergency use of its COVID-19 vaccine. Also Read - 13 People in Israel Suffer From Facial Paralysis After Taking Coronavirus Vaccine Shots | Details Here
BioNTech said that if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.
Notably, both the companies have already filed for emergency use authorization with the US Food and Drug Administration on November 20.
With no major safety concerns, both the companies reported final trial results on November 18 that showed their vaccine candidate was 95 percent effective in preventing COVID-19.
On the other hand, the UK regulators said they are screening the BioNTech/Pfizer vaccine. Europe’s medicines regulator further stated that it would decide by December 29 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 it had received formal applications from both vaccine makers seeking the green light for their experimental jabs.