Pfizer submits the application to the FDA for permission to use the emergency vaccine of COVID-19 in November

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Pfizer submits the application to the FDA for permission to use the emergency vaccine of COVID-19 in November

22.10.2020 News

Shares of the largest US pharmaceutical company Pfizer, down to 3.14% since the beginning of the year, rose to 3.83% on Friday on good news about its vaccine against the COVID-19.

Currently, the mTNA candidate vaccine of BNT162b1, developed by Pfizer in the partnership with the German company BioNTech, the mechanism of the action of which is based on the ribonucleic acid (RNA), is undergoing the large-scale testing for 30,000 voluntary participants.

The companies have not yet completed the final testing and have not yet received the approval to manufacture and to sell its vaccine, however, in July, their vaccine received the “accelerated” status from the FDA, which gives the chance for the accelerated transition to these stages.

On Friday, Pfizer’s management has denied the US President Donald Trump’s promises that its vaccine against COVID-19 will be ready by the election day, on November 3.

Pfizer`s CEO, Albert Bourla, explained that based on the current research schedule, the company assumes that it will be ready to submit the data on the safety of the vaccine “in the third week of November.”

“FDA permission for the emergency use in the US potential vaccine COVID-19 FDA requires that the companies provide safety data for two months for half of the participants in the trial after the last dose of the vaccine, “said Bourla. “Safety is and will remain our number one priority, and we will continue to monitor and report on the safety for all the test participants for two years.”

In July, Pfizer and BioNTech signed the agreements with the US Department of Health and Human Services and the US Department of Defense on the supply of 100 million doses of vaccine from COVID-19 in the amount of $ 1.9 billion.

And the last month, the companies have reached the agreement with the European Union to supply up to 300 million doses of the vaccine and said they could have up to 1.3 billion doses ready by the end of 2021, when it will eventually be approved by the health officials.

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