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Pfizer may be within days of filing for an emergency use authorization for its Covid-19 vaccine, having collected the safety data necessary to submit an application to the Food and Drug Administration, CEO Albert Bourla said Tuesday.

“We are very close to submitting for an emergency use authorization,” Bourla said during the STAT Summit, which this year is a virtual event. Bourla sidestepped the question of whether Pfizer’s filing would be made this week.

“Let us not create expectations,” he said in conversation with STAT’s Matthew Herper. “We will announce it as soon as we are doing it.”

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The FDA required manufacturers to follow at least half of the people who received vaccine in their Phase 3 clinical trials for two months, to ensure there is at least that amount of safety data before a vaccine is considered for use.

Pfizer, which is producing a messenger RNA, or mRNA, vaccine, was the first to announce preliminary results from its Phase 3 trial. It is expected it will be the first Covid-19 vaccine cleared for use in the United States. If all goes according to plan, vaccinations could begin sometime in December. It’s expected the company will be able to supply the U.S. with enough vaccine in 2020 to vaccinate 20 million people.

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The Pfizer vaccine was shown to be strongly protective in a preliminary analysis of Phase 3 data, with efficacy of over 90%. The trial was designed to show if the vaccine protected against symptomatic Covid infection. Pfizer’s announcement was followed this week by word from Moderna that its vaccine — also an mRNA vaccine — had been shown to be highly protective.

Bourla said he was relieved to see that another vaccine was also successful and hoped there are many more, because the global need for Covid vaccines exceeds the production capacity of any single company.

Asked how the company was able to move so swiftly — no vaccine has ever been produced this fast — Bourla said Pfizer had to make “zillions” of decisions in the process, and was blessed in making the right calls. “To get this done the stars needed to be aligned and stay aligned,” he said.

He denied allegations that the company played politics in the timing of the announcement that the vaccine worked. President Trump has alleged the news was held until after the Nov. 3 election to deny him a vaccine “win.”

“It happened just at the speed of science,” Bourla said, recalling that he told Pfizer scientists in March that there would likely be a fall surge in cases and a vaccine would be needed to save lives.

“I did not have any political or any artificial timelines in my mind when I said I’m expecting it by the end of October. I said it because we had a very high probability that we would have results by the end of October,” he said.

Pfizer intends to offer vaccine to people who were randomly assigned to get a placebo injection in their Phase 3 trial; Bourla said the company has a “moral obligation” to the people who stepped forward to volunteer for the trial.

The FDA has been discouraging vaccine manufacturers from doing that preemptively, arguing that the trials should stay blinded — neither the participants nor the scientists who monitor them know who got vaccine and who got placebo — for as long as is practical to generate as much data out of the trials as possible. Bourla said Pfizer is in discussions with the FDA over when the vaccination of placebo arm participants can take place.

The Pfizer CEO was also asked about the mRNA technology, long thought to be highly promising but only now being put to the test. While companies have been working on mRNA vaccines for a number of pathogens for several years, these will be the first licensed vaccines made this way, if they are approved.

Bourla predicted the technology will be used for multiple viral vaccines and other uses as well, such as cancer therapies.

“I think we have a very glorious demonstration that the technology works,” he said. “I think this technology is cutting edge and we’re just seeing the beginning of what it can offer humanity.”

  • I can hook you up. I can get you in touch with my local underground black market vaccine dealer LOL ! That’s not how vaccine distribution works man , no one can ” get you in touch with someone to help you get one ” LOL . ONCE YOUR LOCAL HEALTH DEPARTMENT gets the doses they will distribute accordingly ( those age groups at risk and underlying conditions) then you go in and stand in line to get it .

  • I’m so encouraged by the article I just read. I’m sure you guys are also encouraged by what your research has shown with this cutting edge technology! I am very interested in volunteering for a COVID vaccine because I have a compromised immune system and a couple of other challenges when it comes to surviving a battle with COVID-19! I’m not in terrible health but just have enough that I need the vaccine like numerous other Americans! Please get me in touch with someone that can help me get a VACCINE!!!!!!!

  • Question? They reported of mental health issues of people that had the virus, I’m not a doctor/scientist, but with a rush making vaccines and no placebo cross testing and only been tested on relativity few people in a short time , do you believe this is really at all safe to take? I mean God knows what could happen to you by next year if let’s say you took the vaccine today??

  • I just want to say thank you. For your, and the rest of the medical world’s, unfaltering dedication to defeating this virus. Thank you. So very much.

  • “The speed of science” LMAO, ya, Im sure. Too bad literally everyone with 1lb of brain matter foresaw EXACTLY what you were going to do .

  • Way too many hoops to jump through, this is not a vaccine to replace the old mumps vaccine, this is a vaccine for the Wuhan virus that is killing people, they have known it’s safety for months now, lets skip the rest of the hoops, i want a vaccine so i can go back to the gym .

    • Ridiculous cavalier attitude!Skeptical of All the #s,the hype,the process.How is it that therapies and vaccines for more deadly diseases took more than months or a year or still are not developed.Too many shortcuts,the science is bad and unproven,dangerous even due to unforseen interactions and longterm consequences.Trying a vaccine on a handful of people does not Begin to be representative of the diverse human population.Researchers are just beginning to get indepth understanding of the differences in peoples immune responses and other dactors affecting health.Not only is this a new,not properly tested peer-reviewed study and vaccine,it is a novel approach which changes DNA.I think the CEO,his family,friends,and all the U.S. Health Dept. Staff should get it first.After a year wexan see who died from What unforseen problem-maybe heartattack,a weird infection,systemic inflammation,stroke???

    • Agree. The science is neither bad or unproven. If you consider 10’s of thousands of people in these trials are just a handful, then I’m amazed. It seems that for the FDA to want to continue to not offer the vaccine to the placebo group to collect more vaccine data while those volunteers face this deadly disease borders on criminal. The risk of the vaccine appears minimal compared to the consequences of contracting the disease. At the very least let the people who are willing to take whatever risk the vaccine poses receive it with informed consent.

  • Good morning , it’s really good news, I hope next month will be everything ok, but I have a suggestion for researchers/scientists they must keep continue doing research on coronavirus origin we must need know who made this virus because it’s not natural virus, it’s very bad for the world and they may can make again this type of virus , world should be in safe hand. 🙏🏻Thanks everyone for saving lives.

  • Good Evening: I have a question, will we be getting the Covid 19 Vaccines like within the next couple of weeks. Yeah we are all so ready to take the Vaccines and get out of Covid Prison and get back to our normal lives.

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