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BNT162b2 - a Covid-19 Vaccine of Pfizer and BioNTech

What is Pfizer's COVID-19 vaccine, known as BNT162b2?

German company BioNTech and its US partner Pfizer announced on Monday that early results from ongoing Phase III trials showed that their vaccine, known as BNT162b2, was 90% effective in preventing COVID-19 infections.

The first 94 confirmed cases of Covid-19 among the more than 43,000 volunteers who got either two doses of the vaccine or a placebo. It found that fewer than 10% of infections were in participants who had been given the vaccine. More than 90% of the cases were in people who had been given a placebo.

This is a significant milestone in the fight against a virus that has infected more than 50 million people around the globe, resulting in over 1.2 million deaths.

Experts said they wanted to see the full trial data, but the preliminary results looked encouraging.

"This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general," said Peter Horby, professor of emerging infectious diseases at the University of Oxford Reuters cited.

Number of doses: 1.3 billion doses of Covid-19 vaccine in 2021

Vaccine already in production: Over 43,500 people took part in the trial which has been ongoing since late July. The two companies said they would apply for authorization with the US Food and Drug Administration in the coming week.

Pfizer has previously said it hopes to produce as many as 50 million doses by the end of this year (assuming approval from the FDA) and as many as 1.3 billion in 2021.

Tinglong Dai, an associate professor of Operations Management & Business Analytics at Johns Hopkins, said the U.S. will likely initially roll out the vaccines to adults.

"Given that the U.S. has a total of 250 million adults. If 75% of the adult population takes two doses each, we will need about 375 million doses," Tinglong Dai said to Foxnews.

EU waiting for more data before approval: German Health Minister Jens Spahn said the European Union will wait to approve the vaccine until late-stage safety data is collected to ensure the broadest possible acceptance for the vaccine.

Pfizer CEO and Chairman Dr. Albert Bourla, stated: “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis."
What is BNT162b2   a Covid-19 Vaccine of Pfizer and BioNTech with 90% effective?
What does “90% effective” mean for Pfizer’s Covid-19 vaccine?

Cost of Pfizer's COVID-19 vaccine

$39. In July, Pfizer said it would charge the U.S. $19.50 per dose (the vaccine requires two doses, three weeks apart).

At least $2 billion. Pfizer agreed to provide the U.S. -- via Operation Warp Speed -- up to 100 million doses for $1.95 billion. The agreement added the U.S. has the option to buy an additional 500 million doses.

Pfizer's vaccine was not developed as part of Operation Warp Speed, the US government's coronavirus vaccine effort, according to CNN. The federal government has invested $1.95 billion in Pfizer's vaccine to help it manufacture a billion doses or more by next year, but it is not helping to test it and Pfizer has said it will distribute the vaccine itself.

When Pfizer's COVID-19 vaccine will be approved by the FDA?

Still unknown at this point when the vaccine will be approved by the FDA. However, most experts believe "the second half of 2021" is when the vaccine will get into the hands of most Americans, CNN, Foxnews reported.

If the US Food and Drug Administration (FDA) permits it, Pfizer will go back and analyze its results for Covid-19 cases that occurred two weeks after the second dose to see if there’s a difference in immune response over time.

Pfizer expects to seek U.S. emergency use authorization for people aged 16 to 85. To do so, it will need two months of follow-up safety data to assure no side effects crop up. That is expected to be available in the third week of November.

U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process the data before a potential approval.

The World Health Organization called the results very positive, but warned there was a funding gap of $4.5 billion that could slow access to tests, medicines and vaccines in low- and middle-income countries.

There are other challenges as well that could affect less affluent countries. The Pfizer vaccine must be shipped and stored at an extremely cold temperature, which requires necessary infrastructure.

Biden and Trump welcome vaccine

US President Donald Trump, celebrated the news and the boost to the stock market as "SUCH GREAT NEWS," in a post on Twitter.

US President-elect Joe Biden welcomed the promising results from the vaccine trials, but warned that widespread vaccination was still months away. He also urged the US public to continue wearing masks and social distancing.

"Today’s news is great news, but it doesn't change that fact," Biden said in a statement. "Today's announcement promises the chance to change that next year, but the tasks before us now remain the same."

Stock Market Surge

The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of theme park and travel companies battered by the pandemic soared. Movie chain operator AMC Entertainment Holdings was up 60%.

Shares in companies that have thrived during lockdowns, such as Netflix Inc and conferencing platform Zoom Video tumbled.

Pfizer shares jumped more than 8% to their highest since July last year, while BioNTech's stock hit a record high.

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