EMA Committee Recommends Conditional Approval Of Pfizer-BioNTech Vaccine In Europe

Pfizer Inc. PFE-BioNTech SE's – ADR BNTX coronavirus vaccine candidate – BNT162b2 – is inching closer to getting conditional approval in European Union, after similar approvals in the U.S., U.K., Bahrain Saudi Arabia, Canada, Mexico and Switzerland.

What Happened: Following a rigorous evaluation of BNT162b2, which is to go by the trade name Comirnaty in Europe, the European Medicines Agency's Committee For Medicinal Products For Human Use concluded by consensus that sufficiently robust data on the safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorization.

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The EMA has recommended to the European Commission to grant conditional marketing authorization, which paves the way for first ever marketing authorization for a vaccine against SARS-CoV-2 in the European Union.

"This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens," the EMA statement read.

Why It's Important: The COVID-19 pandemic is still unsettled despite ravaging the global economy for about a year now.

Potential approval of the vaccine candidate in Europe should bode well for elimination of the pandemic and the returning to normalcy.

Pfizer shares were slipping 1.88% to $36.97, while BioNTech was advancing 2.49% to $106.84 at publication time.