Pfizer Director General Albert Burla announced Tuesday that the US pharmaceutical group will submit an application “very soon” to obtain a license to market its COVID-19 vaccine in the United States, which, if all goes well, will allow vaccinations to start in December.
“We are very close to submitting an emergency license application,” Burla said during a conference organized by the Statenews website.
Pfizer’s general manager did not confirm or deny whether the application would be submitted this week, noting that he had previously said that the request would likely be submitted in the third week of November, that is, this week.
This experimental vaccine was developed by Pfizer in cooperation with the German company Biontech.
An emergency license is a temporary or conditional permit granted by the US Medicines Agency (FDA) to deal with an emergency similar to the COVID-19 pandemic. The agency can revoke or amend this authorization if new data on vaccine efficacy or safety emerge later.
In Europe, the Medicines Agency uses an expedited procedure that allows it to conduct a “continuous evaluation” of data on the efficacy and safety of any vaccine or drug as soon as these data are issued and even before the manufacturer submits an official license application.
The US Food and Drug Administration did not mention how long it would take to review data on the effectiveness and safety of the vaccine, which are the two main criteria for issuing an emergency license for it, in addition to the ability to produce large doses of it.
The Pfizer vaccine is one of three experimental vaccines the European Medicines Agency continues to conduct clinical trials on according to the expedited mechanism. The other two vaccines were developed, one Oxford / AstraZeneca and the other Moderna.
And on Monday, Moncef Al-Salawi, head of the team assigned to develop a vaccine against the Corona virus in the United States, expressed his hope that the US Drug Administration would license, during the second half of December, the marketing of the Pfizer and Moderna vaccines.
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