Pfizer Files Emergency COVID-19 Vaccine Application With FDA

Pfizer Files Emergency COVID-19 Vaccine Application With FDA
November 23, 2020

 

Pfizer Inc (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) stated on Friday that it had applied to the US FDA (Food and Drug Administration) for emergency authorization use of its COVID-19 vaccine. Following the news, the stock closed at $36.70, up $0.51 or 1.41% from the prior close.

In case Pfizer’s application gets endorsed, the vaccine will probably face some limitations and be introduced in stages, with health-care staffs, elders, and people with various health issues receiving the first vaccinations. It will be followed by critical workers, tutors, and individuals in homeless care facilities and jails. In the third stage, children and young adults will receive the vaccination.

It may take a few weeks for the FDA to process the application. In this regard, a consultative committee meeting to evaluate the vaccine has been provisionally planned for early December. Some U.S. residents could receive their initial dose of the vaccine in about a month.

Pfizer CEO Dr. Albert Bourla said, “Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”

The news has come two days after Pfizer revealed that a conclusive data analysis identified its COVID-19 vaccine, developed in partnership with BioNTech, to be 95% effective in hampering COVID-19. Additionally, the vaccine has been proven to be safe while preventing critical illness.

The final study assessed 170 proven COVD-19 infections among the 43,000 volunteers who took part in the late-stage trial.  The companies stated that 162 COVID-19 infections were seen in the placebo group against eight cases recorded in the group that was subject to a two-dose COVID-19 vaccine. That confirmed the assessed vaccine efficacy of 95%.

Notably, the New York-based Pfizer is the first pharmaceutical company to submit an application for the emergency of the COVID-19 vaccine with the FDA. The company’s vaccine consists of genetic material called messenger RNA (mRNA), which triggers the immune system to battle the virus. The vaccine necessitates a storage temperature of -94° Fahrenheit. Therefore, it is likely to create some distribution issues. In comparison, Moderna’s vaccine necessitates a storage temperature of -4° Fahrenheit.

On July 22nd, Pfizer stated that the U.S. has decided to purchase 100 million doses of its vaccine for roughly $1.95 billion. The deal, one of the initiatives under the Trump administration’s vaccine program Operation Warp Speed, permits the U.S. to purchase an extra 500 million vaccine doses. Bourla stated that the company is on course to produce a maximum of 50 million vaccine doses in 2020 and up to 1.30 billion doses in 2021.

The company has already started filing the clinical research data with regulatory agencies worldwide, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency in the United Kingdom.

Dr. Anthony Fauci, the country’s top infectious disease professional, has stated that a vaccine could be made available to all U.S. residents by April or July.

Notably, investors and lawmakers believe that a secure and effective vaccine can only address the issues faced by the global economy.

The positive news on the COVID-19 vaccine is expected to keep the stock of Pfizer range-bound with a slight bullish bias.

The historical price chart indicates that the stock of Pfizer has bounced off the support at 35. The next resistance is anticipated only near 40. Additionally, the stochastics RSI indicator is in the bullish region. Therefore, we are expecting the stock to remain on an uptrend in the short-term.

pfe - technical analysis - 23rd November 2020

Disclaimer: Any financial trading analysis offered here is our opinion and is not intended as advice or direction for investors. We cannot guarantee the success of any trades made as a consequence of this article, and we encourage traders to incorporate a strong money management strategy to limit losses when they enter the markets. Please use this article as part of your own research before formulating strategies prior to trading.

Andrew Wright

Prior to founding tradersasset.com in 2014, Andrew worked as a proprietary trader, then as a market maker. As a market maker, he traded options in over 100 stocks, he then began trading currency pairs in 2013. Andrew still actively trades both, and prides himself on educating and informing traders on the benefits of both Binary Options and Forex.


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