The companies said they would submit their two-shot coronavirus vaccine to the U.S. Food and Drug Administration for an Emergency Use Authorization, or EUA. If approved the vaccine could be administered to high-risk individuals in the U.S. by “the middle to end of December,” according to their joint news release.
“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,” Pfizer Chief Executive Albert Bourla said in the release.
Bourla said earlier this year the company could have trial results by October but maintained that the company is “moving at the speed of science” instead of following a timeline laid out by politicians.
Pfizer Stock: Seeking Approval Abroad
Pfizer and BioNTech are also looking at regulatory approval abroad and said Friday that they started rolling out regulatory submissions in Australia, Canada, Europe, Japan and the U.K. The companies plan to produce up to 50 million vaccine doses by the end of the year and 1.3 billion doses by the end of 2021.
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Dec. 8-10, a source told CNN earlier this week. Pfizer and BioNTech said they were ready to start distributing the vaccine candidate “within hours after authorization.”
But further steps are needed before the vaccine can be administered. The CDC’s Advisory Committee on Immunization Practices will also have to review the data and develop recommendations on its use and which groups should be vaccinated first, CNN reported.
Meanwhile, President Donald Trump on Friday accused Pfizer of intentionally delaying its positive test results until after the presidential election. Trump had pushed to lower drug prices. Trump made the statement in his first press conference since losing the presidential race.
BioNTech, Pfizer Rise But So Do Covid-19 Cases
Pfizer shares rose 1.4% to close at 36.70 on the stock market today. Pfizer stock is down more than 7% from its latest buy point, signaling a failed breakout, according to MarketSmith analysis. BioNTech shares surged 9.6% to finish at 104.07. The biotech is in buy range after breaking out of a cup-with-handle base with a 97.39 buy point.
The last several months have been a mad sprint for biotechs and pharmaceutical companies to find a vaccine for the deadly coronavirus, which has killed more than 1.3 million people globally since emerging out of China last year. Vaccines usually take years if not a full decade to develop.
Pfizer and BioNTech’s vaccine was proved to be 95% effective in final-phase testing. The results came after Moderna (MRNA) announced its Covid-19 vaccine was 94.5% effective earlier this week. Moderna is analyzing safety data to seek its own emergency authorization from the FDA. AstraZeneca (AZN) and the University of Oxford released positive preliminary results from their coronavirus vaccine tests on Thursday.
But Covid-19 cases are also on the rise as the U.S. heads into the Thanksgiving holiday. The Centers for Disease Control recommended travelers stay home for the holiday as daily cases soar past 185,000. States began reimplementing restrictions on schools and businesses to help curb the spread of the virus.
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