Home > Analysis > Pfizer and BioNTech File for EUA with FDA for Their COVID-19 Vaccine

Pfizer and BioNTech File for EUA with FDA for Their COVID-19 Vaccine

Pfizer is on track to deliver up to 50 million doses in 2020 and about 1.3 billion doses in 2021.

The duo of Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) has applied for an Emergency Use Authorization (EUA) with the United States Food and Drug Administration (FDA) for its COVID-19 vaccine candidate dubbed BNT162b2. According to a report by ABC News, the filing for the EUA comes following the final report from the two firms’ ongoing late-stage COVID-19 vaccine trials.

The latest results from the trial which has about 43,000 participants showed that the vaccine is 95% effective in preventing COVID-19. This new trial analysis is based on a total of 170 COVID-19 cases amongst the participants. The companies said that of this number, 162 of the COVID-19 cases came from the group of participants administered placebo as against 8 for those with the vaccine shots. This implies an efficacy rate of 95%.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Dr. Albert Bourla, chairman and CEO of Pfizer, said in a statement Friday. “Filing in the US 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.”

As widely reported, the FDA will be setting up an Advisory Committee to look into the EUA application, a process that can take weeks as the meeting scheduled to review the vaccine will take place early in December.

The EUA news has sent the shares of both Pfizer and BioNTech up in the pre-market. Pfizer is up by 1.58% while BioNTech is up by 5.24% at the time of writing.

Distribution Plans for Pfizer and BioNTech Vaccine

Should the Emergency Use Authorization application of Pfizer and BioNTech be approved, the duo has perfected plans to roll out the vaccine following the launch of its COVID-19 delivery trial in four US states earlier in the week. This trial was necessitated by virtue of the ultra-low storage temperature of the vaccine which is around minus 94 degrees Fahrenheit.

The vaccine will likely be made available to health care workers first as well as the elderly and citizens with underlying conditions. Dr. Anthony Fauci, the United States leading infectious disease expert says that every US citizen will probably get a shot of the vaccine by April or July 2021 according to CNBC.

The United States government under President Donald Trump has committed about $1.95 billion dollars for 100 million doses of the vaccine through its Operation Warp Speed, with an option to get an additional 500 million doses of the vaccines. This projected number is more than enough for the entire United States population. Pfizer is on track to deliver up to 50 million doses in 2020 and about 1.3 billion doses in 2021.

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Benjamin Godfrey is a blockchain enthusiast and journalists who relish writing about the real life applications of blockchain technology and innovations to drive general acceptance and worldwide integration of the emerging technology. His desires to educate people about cryptocurrencies inspires his contributions to renowned blockchain based media and sites. Benjamin Godfrey is a lover of sports and agriculture.

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