Pfizer (PFE)-BioNTech (BNTX) Plans to Request EU authorization for COVID-19 Vaccine

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The U.S. and German Biotech’s are aiming to obtain the clearance for their potential coronavirus vaccine. The EU authorization will allow Pfizer-BioNTech to supply their vaccine to European countries.


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Pfizer Inc. (PFE) and BioNTech SE (BNTX) are heading towards the final phases of the COVID-19 vaccine to make it available to the public. After successful clinical trials, the vaccine is ready to help the most vulnerable regions in its first drive. For that reason, Pfizer along with its German partner is looking for regulatory approval for their vaccine in the European Union. The target is to obtain clearance before the end of the year.

On Monday, the company forwarded a formal application for the vaccine to the EU regulatory authority. The review process began on October 6, 2020, as soon as the vaccine emerged showing a strong response against the coronavirus.

As per the reports, the study of approximately 44,000 people showed that the vaccine dose showed 95% effectiveness against symptomatic coronavirus cases. The cases recovered from virus showing no side effects at all.

Following the announcement of COVID-19 vaccine, Pfizer, Inc. (PFE) and BioNTech SE (BNTX) rose significantly in November. With the EU authorization update, the stock of both the biotech’s are trading upwards.

As of today, Pfizer stock is trading at its 52-week high of $40.16. While, BioNTech stock is trading also trading at a 52-week high range of $128.12. The bullish momentum is a sign of both the firms thriving with the COVID-19 vaccine. Investors should jump in because both the companies are going to make massive sales as the vaccine demand is at its peakfrom around the world. Buying the stock at lows will be more profitable for the long run.

The world regulators are ready to examine immunization data, and the governments are eager to put their hands on the drug for vaccinating their populations.

At a press conference, the CFO of BioNTechSierk Poetting commented that they will begin shipping the first doses ‘immediately’ right after the regulatory clearance.

Pfizer-BioNTech vaccine is more likely to obtain regulatory approval before its competitor Moderna Inc. Moreover, The U.S. FDA is also ready to meet on December 10 to discuss the vaccine approval.

Both the companies believe that they will obtain the clearance if the European Medicines Agency concludes that the Pfizer-BioNTech vaccine is more efficient in comparison to its risks. They will obtain a conditional clearance that will allow them to supply the vaccine across Europe by the end of the year.

Pfizer and BioNTech are approaching other countries for the regulatory submissions including Canada, Australia, and Japan. The U.S.-German partners have signed deals for delivering millions of vaccine doses which include 200 million doses to EU, with an option of 100 million additional doses.

With the regulatory approvals across different regions, it will bring a big fortune for both the companies.

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