Friday, 20 November 2020 – 14:46
The announcement had been expected for several days, after the publication of the results of the clinical trial with 95% efficacy
The alliance between the American pharmaceutical group Pfizer and the german company BioNTech has confirmed that it will present this Friday to the Food and Drug Administration (FDA) a authorization request for the marketing of its coronavirus vaccine, becoming the first manufacturers to do so in the United States.
The announcement had been expected for several days, after the publication of the results of the clinical trial in progress since July with 44,000 volunteers in various countries and according to which the vaccine would have a 95% efficiency to prevent Covid-19 no serious side effects. In addition, the head of BioNTech had advanced Thursday to AFP that the application will be submitted on Friday.
“The application in the United States represents a crucial step on our journey to offer a Covid-19 vaccine to the world and now we have a more complete picture both the efficacy and safety of our vaccine, which gives us confidence about its potential, “said Pfizer CEO Albert Bourla.
The vaccine is also being evaluated continuously for weeks by the European Union, Australia, Canada, Japan and the United Kingdom. “The companies will be ready to distribute the vaccine in the hours after it receives the authorization,” the companies said in their statement.
Green light for December
The FDA has not reported how long it will take to examine the data, but the US government is preparing for the green light to arrive in the first half of December. Europe could follow him as early as the second half of December, according to the president of the European Commission, Ursula von der Leyen.
The government of Donald Trump has planned to vaccinate 20 million people in December, and then to between 25 and 30 million people per month. The speed of this process is unmatched in the history of vaccines. It has taken eight years on average to develop the vaccines licensed in the last decade in the United States.
In March BioNTech proposed to Pfizer to use its indigenous messenger RNA technology, at a time when the world is experiencing its first lockdown. The first volunteer received the vaccine on April 23 in Germany, in the first phase of trials. Phase three, and last, started on July 27 and has recruited some 44,000 participants.
Half of the volunteers have received a placebo and the other half the experimental vaccine, without knowing which. Then they have 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 autumn) the number of Covid-19 cases among the placebo group has grown but not among the group vaccinated.
Of 170 registered cases among the participants, 162 received placebo and 8 the vaccine, according to reports from the manufacturers.
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