Pfizer will request an emergency authorization for its covid vaccine in the United States today

A volunteer in the United States receives the vaccine developed by Pfizer and BioNTech.AP

The pharmaceutical company Pfizer and its German partner BioNTech have announced that they will request an emergency authorization from the United States Food and Drug Administration (FDA) this Friday for their vaccine against covid-19.

This is the first coronavirus vaccine that seeks authorization from the United States regulatory body and that could be available in mid or late December for risk groups, according to the company in a statement.

The submission of the application to the FDA is based on the results of the phase 3 clinical trial of the vaccine.

On Wednesday Pfizer announced that it is 95% effective as of 28 days after the first dose.

Pfizer has reported in a statement that if the application is approved, its vaccine could begin to be distributed in December in phases, starting with high-risk groups, including health workers, the elderly and people with health problems.

Essential workers, teachers, and the homeless, as well as those living in shelters and prisons, would likely be next, followed by children and young adults.

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

“The presentation in the United States represents a fundamental milestone in our journey to deliver a Covid-19 vaccine to the world, and we now have a more complete picture of the efficacy and safety profile of our vaccine, which gives us confidence in its potential, ”said Pfizer President and CEO Albert Bourla in a statement.

The announcement comes two days after Pfizer reported that in its latest phase three evaluation, the efficacy of its vaccine "was consistent across age, gender, race and ethnicity," and that "observed efficacy in adults over 65 years it was higher than 94% ”.

In total, about 43,000 people participated in this trial worldwide, of which just over 41,000 received a second dose on November 13.

According to Pfizer, the data shows that the vaccine was well tolerated in all populations of its enrolled participants and that no serious safety concerns were observed.

The only major side effects have been fatigue (3.8%) and headache (2%).

The vaccine uses messenger RNA or mRNA technology, which scientists hope will elicit a better response for the immune system to fight the virus.

Pfizer announced on July 22 that the United States agreed to purchase 100 million doses of its vaccine for a total of $ 1.95 billion and the possibility of purchasing an additional 500 million doses.

The company expects to produce up to 50 million doses worldwide in 2020 and up to 1.3 billion doses by the end of 2021. The United States this Thursday reached 11,698,661 confirmed cases of the coronavirus and 252,419 deaths from covid-19, according to with the independent count from Johns Hopkins University.

The balance represents an absolute record of new infections, with 200,146 more in one day and also the highest number of deaths in 24 hours (2,239) since the beginning of May, in the middle of the explosion of the pandemic.

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