U.S. giant Pfizer plans to seek emergency clearance for its coronavirus vaccine from U.S. authorities during the third week of November, its CEO announced on Friday.
An authorization that will be given by the United States Medicines Agency (FDA) if the vaccine meets three conditions.
US pharmaceutical giant Pfizer plans to seek emergency authorization for its Covid-19 vaccine from US authorities in the third week of November, its CEO announced on Friday.
"Assuming the data is positive, Pfizer will apply for emergency use authorization in the United States, shortly after the safety milestone has been passed, during the third week of November," Albert Bourla said. in an open letter posted on its site.
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Two vaccines ready by the end of the year?
The United States could therefore have two vaccines ready by the end of the year, if the ongoing clinical trials were successful and if the Medicines Agency (FDA) authorized their distribution, since the Moderna company is also counting on the month of November, i.e. after the US presidential election.
President Donald Trump, who is running for a second term, said a vaccine could be available before the November 3 poll.
Pfizer has complied with instructions from the FDA, which last week instructed vaccine developers to wait two months after injecting the second dose in clinical trial participants to watch for possible side effects. serious.
Its stock gained more than 2% during electronic trading before the opening of the stock market.
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Three conditions for vaccine authorization
The CEO of Pfizer, a partner of German company BioNTech, said that in contrast, the ongoing trial of 30,000 participants may produce results on the effectiveness of the vaccine within the next two weeks.
"We could know if our vaccine is working or not by the end of October," wrote Albert Bourla.
But the FDA places three conditions on the authorization of a vaccine: Is it effective?
Is he sure?
And is the company capable of producing it on a large scale?
Pfizer believes that the three conditions will therefore be met by the third week of November, in a month.
This is about the same date as that put forward last week by the other company very advanced in clinical trials, Moderna, whose boss referred to November 25.
The two companies, funded by the US government, had launched phase 3 of their clinical trials at the same time at the end of July, and the two launched the production of doses as a precaution, in order to deliver several tens of millions of them to the United States. by the end of the year, if authorized.
The decision whether or not to authorize the vaccine, and for what populations, will rest with the FDA, which has promised to follow standard scientific procedures and not to let political power interfere.