Pfizer will apply for FDA emergency use authorization


Pfizer and BioNtech will apply for emergency use authorization from the Food and Drug Administration on Friday for their coronavirus vaccine.

If Pfizer’s application is approved by the FDA, the vaccine will likely be limited and rolled out in multiple stages, with health care workers, the elderly, and those with underlying health conditions being first vaccinated. Essential staff, teachers and people in homeless shelters, as well as people in prisons, presumably after children and young adults, will be next on the list.

The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine is tentatively scheduled in early December.

“A COVID-19 vaccine filed in the US represents an important milestone in our journey to reach the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, which gives us the ability to Gives confidence, ”Pfizer CEO Albert Borla said in a statement.

Friday’s announcement, two days after Pfizer, said that a final data analysis found that the Conovid vaccine with BioNTech was 95% effective in preventing Kovid-19, was safe and protects against serious illness.

The final analysis evaluated 170 confirmed kovid infections among more than 43,000 participants in the late-stage trial. The companies said 162 cases of Kovid were seen in the eight cases seen in the group versus the placebo group, who received its two-dose vaccine. The estimated vaccine efficacy was 95%, he said.

Pfizer is the first in the Kovid-19 vaccine race to apply for emergency use with the FDA. Its vaccines contain genetic material called messenger RNA, or mRNA, which scientists hope to stimulate the immune system to fight the virus. Vaccines require storage temperatures of minus 94 degrees Fahrenheit, potentially posing challenges for widespread distribution. By comparison, Modern’s vaccines should be stored at minus 4 degrees Fahrenheit.

On July 22, Pfizer announced that the US agreed to purchase 100 million doses of its vaccine for $ 1.95 billion. The agreement, part of the Trump administration’s vaccine program Operation Tana Speed, allows the US to receive an additional 500 million vaccine doses. Pfizer CEO Albert Borla said on 9 November that the company is on track to produce 50 million vaccine doses this year and up to 1.3 billion doses in 2021.

It has already begun rolling submissions with a number of regulatory agencies worldwide, including the European Medical Agency and the Medicine and Healthcare Products Regulatory Agency in the United Kingdom.

The country’s leading infectious disease specialist, Dr. Anthony Fauci has said the vaccine may be available to all Americans by April or July next year.



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