The United States Medicines Agency (FDA) was warned: the pharmaceutical company Pfizer and its German partner BioNTech have requested this Friday an emergency authorization for their vaccine against covid-19, becoming the first manufacturers to do so in the United States or Europe. The vaccine could be available in mid to late December for risk groups, the company said in a statement.
The announcement had been expected for several days, after the publication of the results of the phase 3 clinical trial of the vaccine that has been underway since July with 44,000 volunteers in several countries and according to which the vaccine to prevent covid-19 would have no side effects. serious. 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 Donald Trump government has planned to vaccinate 20 million people belonging to these risk groups, and then between 25 and 30 million people per month. The speed of this process is unprecedented in the history of vaccines. On average, it has taken eight years to develop the vaccines licensed in the last decade in the United States.
In March, BioNTech proposed to Pfizer to use its new messenger RNA technology, as the world was going through its first lockdown. The first volunteer received the vaccine on April 23 in Germany, in the first phase of trials. Phase 3, and last, began on July 27. Half of the volunteers have received a placebo and the other half the experimental vaccine, without knowing who received what. The volunteers continued their lives normally, taking the same precautions as the general population and progressively – with the explosion of the pandemic in the United States in the fall – the number of covid-19 cases among the placebo group has grown but not among the group of the vaccinated. Of 170 registered cases among the participants, 162 received placebo and 8 the vaccine, according to statements from the manufacturers. Statistics indicate that a vaccinated person has 95% less risk of contracting the disease than an unvaccinated one.
A vaccine for the world
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 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, ”Pfizer Chairman and CEO Albert Bourla said in a statement.
The announcement comes two days after Pfizer reported that in its last phase 3 evaluation, the efficacy of its vaccine “was consistent based on age, gender, race and ethnicity,” and that “observed efficacy in adults over 65 years it was higher than 94% ”. 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 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 reached 11,698,661 confirmed cases of the coronavirus on Thursday 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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