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For the Pfizer and BioNTech coronavirus vaccine to be approved by the U.S. FDA, they will have to provide the regulatory body with at least two months of safety data.
Shares of Pfizer Inc (NYSE: PFE) jumped approximately 2.19% during Friday’s pre-market to trade around $37.36, they continued their growth as the market opened. Now they are up 3%. On the other hand, BioNTech SE ADR (NASDAQ: BNTX) stocks jumped approximately 4.14% to trade around $94.12 during Friday’s pre-market. As the market opened, BNTX shares are 3.74% up.
The tweak is attributed to a news announcement that Pfizer is seeking for an emergency use approval from the United States Food and Drug Administration to have their coronavirus vaccine used by late November. Pfizer (PFE) is in collaboration with the German BioNTech (BNTX) researchers to develop a coronavirus vaccine that can be used across all ages.
Notably, the company announced that it will incorporate young children in its coronavirus vaccine trial. For the Pfizer and BioNTech coronavirus vaccine to be approved by the U.S. FDA, they will have to provide the regulatory body with at least two months of safety data.
Pfizer’s Chief Executive Officer Albert Bourla noted in a letter posted on its website that the filing depended on several factors, including data on effects that may or may not be available by late October.
PFE, BNTX Stocks and U.S. Coronavirus Update
With the United States coronavirus numbers spiking by the day as the country approaches the presidential election, an approved emergency coronavirus vaccine is prudent to save thousands of lives.
However, the FDA is on the other hand skeptical of approving a vaccine that is not up to standard for mass use. Moreover, it would be better for people to recover slowly from the coronavirus than have adverse and irreversible effects of the drugs in future.
Pfizer and BioNTech remain confident with their coronavirus vaccine after rigorous clinical testings that have taken place in the United States and overseas. As of October 15, the United States had reported 8,168,998 coronavirus cases with 2,656,326 active cases, 5,290,510 already recovered and 222,162 fatalities.
Globally, the United States remains the leading country with the highest infection rate possibly due to its high testing capacity. There were 38,947,112 coronavirus confirmed cases globally with total confirmed deaths at 1,099,628.
Pfizer stocks were down 6.71% year to date and remained stagnant in the past few months. Having been critically analysed by 18 Wall Street analysts, Pfizer stocks received an average of Over rating.
Notably, the company had a market capitalization of around $203.1 billion with 5.56 billion outstanding shares. On the other hand, BioNTech stocks had rallied over 539% in the past one year, and were up 166.77% year to date through Thursday.
BioNTech had a market capitalization of approximately $21.53 billion with 238.17 million outstanding shares. Similarly, the company received an average of Over rating from approximately 11 Wall Street analysts.