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“We are very close to submitting an emergency license application,” Burla said during a conference hosted by the Statenews website.
Pfizer’s CEO did not confirm or deny whether the application would be submitted this week, noting that he had previously said that the application would likely be submitted in the third week of November, that is, this week.
An emergency license is a temporary or conditional authorization granted by the United States Drug Administration (FDA) to respond to an emergency similar to the COVID-19 pandemic. The agency may revoke or amend this authorization if new data on the efficacy or safety of the vaccine subsequently emerge.
In Europe, the Medicines Agency uses an accelerated procedure that allows it to carry out a “continuous evaluation” of the data on the efficacy and safety of any vaccine or drug as soon as these data are published and even before the manufacturer submits an application official license.
The U.S. Food and Drug Administration did not say 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 dose of it.
The Pfizer vaccine is one of three experimental vaccines in which the European Medicines Agency continues to conduct clinical trials under the accelerated mechanism. The other two vaccines were developed, one Oxford / AstraZeneca and the other Moderna.
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 United States Drug Administration will authorize, during the second half of December, the commercialization of the vaccines. Pfizer and Moderna.
