First COVID-19 vaccine goes to FDA today for emergency authorization


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Pfizer headquarters are in Manhattan, New York City, United States on November 19, 2020.
Zoom in / Pfizer headquarters are in Manhattan, New York City, United States on November 19, 2020.

Today, the US Food and Drug Administration will receive the first submission of a candidate vaccine to combat the pandemic Coronavirus.

The pharmaceutical giant Pfizer and the German biotech company BioNTech Announced early this morning They are submitting a formal application for an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for companies MRNA vaccine, BNT162b2.

The introduction comes on the heels of the famous news on Wednesday only that the companies have finished testing the third phase and found the vaccine 95% effective in preventing symptoms of COVID-19The disease caused by the coronavirus, SARS-CoV-2.

Although the full data on the trial had not been published, the companies announced through a press release that the vaccine appeared to be consistently effective across racial and ethnic backgrounds and was 94 percent effective in people over the age of 65 – the age group most at risk of developing serious illness. The experimental data also indicated that the vaccine was protective against severe disease as well as mild cases.

The trial reached its end point when 170 cases occurred out of 43,661 participants, who were recorded at one of 150 trial sites in the United States, Germany, Turkey, South Africa, Brazil and Argentina. Of the 170 cases, there were 162 cases in the placebo group and only eight cases in the group that received the experimental two-dose vaccine. Of all the cases, 10 were severe, nine of them were in the placebo group.

Urgency

In addition to the impressive effectiveness numbers, the companies will also provide the U.S. Food and Drug Administration with detailed safety reports on 8,000 randomly selected adult participants and data on about 38,000 adult participants who were passively monitored for two months after the second dose of the vaccine. In addition, the companies have safety data on 100 children between the ages of 12 and 15. The companies did not report any severe reactions to the vaccine, with the most troublesome side effects including severe headache and fatigue.

It is unclear how long it will take for the FDA to review the EUA application. However, the FDA has repeatedly said that it is committed to taking swift action to address the dire health crisis, which is getting worse by the day.

In announcing the registration, Pfizer Chairman and CEO Dr. Albert Burla said:

Our work to deliver a safe and effective vaccine has not been more urgent than ever, as we continue to see an alarming rise in the number of COVID-19 cases globally. The registration in the United States marks a milestone in our journey to introduce the COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety of our vaccine, giving us confidence in its potential.

The companies said they are also preparing to present them to other regulatory agencies around the world, including the filing rolling out with the European Medicines Agency.

They stated in the announcement that Pfizer and BioNTech “will be ready to distribute the candidate vaccine within hours after permission.”

The couple has the capacity to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021. Deal with the United States government To deliver 100 million doses – enough to vaccinate 50 million people – with an option for the United States to purchase an additional 500 million.


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