HomeNewsPfizer requests emergency approval for its vaccine and becomes the first to...

Pfizer requests emergency approval for its vaccine and becomes the first to do so


Pharmaceutical company Pfizer has requested this Friday before the regulator of the medicine of the United States the emergency authorization for its vaccine against the coronavirus to be able to begin to distribute it, becoming this way the first one in doing it.

Pfizer, which has developed the vaccine with its German partner BioNTech, has applied to the U.S. Food and Drug Administration (FDA) for this authorization that would allow Americans to access the vaccine before it is given full approval.

The FDA is expected to spend the next few weeks reviewing the data, and the vaccine could be available in mid to late December.

In this sense, a group of external advisors of the FDA, experts in infectious diseases and vaccines, will meet on December 10, which will allow the data of the clinical trials to be examined in public to reinforce the confidence, a date in which some sources indicate that a decision on the application could already be made, as it is picked up by the television network CNN.

“It is with great pride and joy, and even a little relief, that I can say that our application for emergency use authorization for our COVID-19 vaccine is now in the hands of the FDA,” said Pfizer’s executive director, Albert Bourla, in a video this Friday.

“This is a historic day, a historic day for science and for all of us. Only 248 days have passed since the day we announced our plans to collaborate with BioNTech until the day of the presentation to the FDA,” said Bourla.

Earlier this week, the pharmacist announced that its COVID-19 vaccine candidate is more than 95 percent effective, following the “success” of the first interim analysis of its Phase 3 clinical trials.

However, the approval of this authorization is not equivalent to full approval; it is a tool that allows the products to be used in exceptional circumstances before all the tests are available, although the FDA has already qualified the application as “encouraging”.


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