Pfizer and BioNTech applied for conditional marketing authorization (CMA) from the European Medicines Agency (EMA).
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:
“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need. We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us.”
The Race to Roll Out the Vaccine
With COVID-19 bringing the world to a standstill, the race to roll out the first coronavirus vaccine is understandably heated. Pfizer and BioNTech are the leaders, but yet another American company, Moderna, is hot on their heels.
Moderna stated on Monday that it was applying for emergency clearance from the US Food and Drug Authority for its coronavirus vaccine. This was after new data confirmed the company’s vaccine is more than 94% effective.
Immediately following the announcement, the company saw its shares shoot up 16.8%. Moderna’s shares were up a further 11.5% in pre-market action today, trading at $170.36. Now the stock is trading at $156.92.
While the three companies race to get the regulator’s approval, one researcher now claims that this may not be their biggest challenge. According to Sam Fazeli, distributing the vaccine and getting people to ‘take the jab’ may pose a bigger challenge.
Fazeli, who is the head of EMEA Research at Bloomberg Intelligence stated today:
“I think distribution, and the usual challenge of getting people through the door to take the jab is going to be their biggest challenge in my view.”
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