American pharmaceuticals giant Pfizer Inc (NYSE: PFE) and German biotech firm BioNTech SE (NASDAQ: BNTX) have submitted applications for their coronavirus vaccine in Europe. The two believe they will receive the nod to roll out the vaccine in Europe before the end of 2020.
In a press release, Pfizer and BioNTech revealed they had applied for conditional marketing authorization (CMA) in Europe from the European Medicines Agency (EMA).
A CMA is granted to firms whose medicines “address unmet medical needs of patients,” the European regulator states on its website. To receive a CMA, a company must prove that “the benefit of immediate availability outweighs the risk of less comprehensive data.”
As the two companies indicated, receiving the CMA will allow them to roll out their BNT162b2 vaccine before the end of 2020.
Pfizer stock price recorded a slight 2.92% rise in the pre-market following the news to trade at $39.30. Now it is at $39.72 (+3.68%). The New York-based giant is up 14.6% for the month. BioNTech, on the other hand, remained largely unmoved by the announcement. Now the stock is at $119.41.
The two companies have in recent days revealed that clinical data demonstrated a vaccine efficacy rate of 95%. Efficacy was also consistent across gender, age, race and ethnicity. For people aged of 65 and above, the efficacy rate stood at 94%. This is significant since this age group is the most vulnerable to coronavirus.
Dr. Albert Bourla, the Pfizer chairman and CEO remarked: