BioNtech-Pfizer file 'formal application' seeking EU approval for its COVID-19 vaccine

Pfizer Inc and BioNTech said on December 2 that they have applied to the European drugs regulator seeking a conditional authorisation of their COVID-19 vaccine candidate BNT162b2 that showed 95 per cent efficacy against the highly-infectious disease. The formal application submission to the EU came after similar steps taken in Britain and the United States as a step closer to launch their vaccine into global markets. BioNTech in a statement said that submission on Tuesday has completed the rolling review process initiated on October 6. 

This also comes after European Medicines Agency said on December 1 that it would meet on December 29 “at the latest” to consider emergency approval for a COVID-19 vaccine developed by German drugmaker BioNTech in collaboration with US’ Pfizer Inc. In a statement, the EU regulator reportedly said that if the data is submitted are “robust enough” to conclude on the quality and effectiveness of its doses. 

Read - Pfizer/BioNTech Seek Emergency Vaccine Use In US

“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have submitted on Monday, November 30, 2020, a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. This submission completes the rolling review process initiated on October 6, 2020, with nonclinical data and partial Chemistry, Manufacturing, and Controls (CMC) data, followed by emerging clinical data submitted by Pfizer and BioNTech,” the statement said.

Read - Pfizer, Moderna, Oxford, Sputnik V: As Covid Vaccines Publish Results, Here's What We Know

Read - Russia's Sputnik V Doses Will Be Priced 'much Lower' Than Pfizer And Moderna Vaccines

Pfizer-BioNTech apply for emergency use authorisation in US

American biotech firm Pfizer and its German partner BioNTech, on November 20, applied to seek approval to roll out their coronavirus vaccine early. In the aftermath of their Phase 3 trials, the companies announced that their vaccine candidate- BNT162b2 showed 95 per cent effectiveness against the deadly COVID-19 infection. However, it still requires approval from the US Food and Drug Administration (FDA) to begin mass production and distribution.

Commenting on the request for emergency use authorization, the FDA asserted that its vaccines committee would meet on December 10 to discuss the same. However, it was still unsure how long it would take the review committee to give a go-ahead to the vaccine.

Read - Pfizer-BioNTech Apply For Emergency Use Authorisation For Their COVID-19 Vaccine

Read - Pfizer CEO Says COVID-19 Vaccine In 'FDA Hands'