WASHIGNTON – The pharmaceutical company Pfizer and its German partner BioNTech announced that they will request an emergency authorization from the Food and Drug Administration (FDA) for your vaccine COVID-19.
Would be available in December
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 Pfizer’s vaccine, of which on Wednesday announced that it is 95% effective from 28 days after the first dose.
Pfizer said 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.
Who will get it first?
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 has been scheduled for early December.
“The presentation in the US represents a critical 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 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 of age was greater than 94% ”.
43,000 people on trial
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 enrolled participants and that no serious safety concerns were observed.
The only major side effects have been fatigue (3.8%) and headache (2%).
Pfizer is the first in the COVID vaccine race to apply for emergency use with the FDA.
Their 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 of vaccines globally in 2020 and up to 1.3 billion doses by the end of 2021.
The United States reached 11,698,661 confirmed cases of the coronavirus and 252,419 deaths from COVID-19 on Thursday, 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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