The US pharmaceutical company Pfizer Inc (NYSE: PFE) and its collaborator BioNTech SE (Nasdaq: BNTX) stated that they have submitted an application to the European Medicines Agency (EMA) for contingent marketing approval of their COVID-19 vaccine. Following the news, Pfizer closed Tuesday’s trading at $39.41, up $1.10 or 2.87% from the prior close. However, BioNTech lost $10.23 or 8.23% to close at $114.01.
According to BioNTech, in case authorization is granted by EMA quickly, vaccinations could begin sometime this month.
As per EMA’s website, authorization is issued to drugs “that address unmet medical needs of patients on the basis of less comprehensive data than normally required.”
Regarding the process of issuing a conditional license, EMA’s website states: “In the interest of public health, applicants may be granted a conditional marketing authorization for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.” However, the requester should have the ability to submit detailed clinical data in the weeks ahead.
Pfizer Chairman and CEO Dr. Albert Bourla said, “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.”
Regarding delivery of the vaccine, Albert Bourla said: “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 news has come roughly two weeks after the New York-based Pfizer and Mainz, Germany-based BioNTech revealed that conclusive data assessment from the late-stage trial of their COVID-19 vaccine candidate demonstrated 95% efficacy in shielding from coronavirus infection.
Twenty-eight days after the first dose, the vaccine, referred to as BNT162b2, has proven to be highly efficient against the coronavirus, as per the claims made by Pfizer and BioNTech in mid-November. Furthermore, Pfizer and its partner have pointed out that the vaccine’s efficacy is uniform across all age groups, ethnicities, and races. Furthermore, senior citizens who are prone to the threat of extreme illness from COVID-19 recorded vaccine efficacy of over 94%.
On November 20th, Pfizer and BioNTech submitted an application to the US FDA for emergency use authorization. The FDA’s scrutiny process is anticipated to get completed in a few days, and an advisory committee meeting to evaluate the vaccine is expected in early December.
In addition to the applications submitted with the EMA, the FDA and UK Medicines and Healthcare Products Regulatory Agency, BioNTech and Pfizer “have initiated rolling submissions across the globe, including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world.”
Competing drug manufacturer Moderna stated that it would seek emergency approval from the FDA and the EMA for its COVID-19 vaccine after the latest clinical data affirmed that it was harmless and over 94% effective in inhibiting coronavirus infection.
The EMA stated that if its subject experts receive enough info from Pfizer and Moderna about their potential vaccines, it would finish its assessment by December 29th and January 12th, respectively.
The news of Pfizer applying for COVID-19 vaccine approval in Europe is expected to keep the stock bullish in the near-term.
The historical price chart indicates that the stock has broken above the ascending triangle. Additionally, the stock is trading above its 50-day moving average, while the stochastics RSI is in the bullish zone. Therefore, we are anticipating the stock to rally in the short-term.
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