The pharmaceutical company Pfizer and its German partner BioNTech 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 mid to end of December for risk groups, the company said in a statement.
The submission of the application to the FDA is based on the results of the phase 3 clinical trial of the Pfizer vaccine, which on Wednesday announced that it is 95% effective as of 28 days after the first dose.
Pfizer 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.
It is expected that FDA screening process takes a few weeks and an advisory committee meeting to review the vaccine has been scheduled for early December.
“Launch in USA represents a major milestone on 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 its latest phase three evaluation confirmed that the efficacy of its vaccine “was consistent across age, gender, race, and ethnicity,” and highlighted that “The efficacy observed in adults over 65 years was greater than 94%”.
In total, about 43,000 people participated in that 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 registered participants and that no serious security issues were observed.
The only major side effects have been fatigue (3.8%) and headache (2%).
Pfizer is the first in the vaccine race against coronavirus in requesting emergency use with the FDA.
Your vaccine uses messenger RNA or mRNA technology, which scientists hope will elicit a better response so that the immune system fights 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 acquiring an additional 500 million doses.
The company expects to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses by the end of 2021, according to Pfizer.
The United States reached this Thursday 11,698,661 confirmed cases of the coronavirus and the 252,419 deaths from covid-19, according to 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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