Pfizer vaccine obtains full approval and may be sold directly

The FDA granted Pfizer full approval of its COVID-19 vaccine. It is the first pharmaceutical company to do so and this fact opens the door to direct marketing to consumers.

The US Food and Drug Administration (FDA) has granted full approval to the Pfizer/BioNTech COVID-19 vaccine, meaning it will now be able to market its shots directly to consumers. This historic approval could encourage schools and businesses to order vaccines on their own.

To gain full approval of the so-called biological license, vaccine manufacturers must provide six months of safety and efficacy data for their vaccine to the FDA. For emergency use, the same agency only requested two months of collection, during the current COVID-19 pandemic.

According to a survey conducted by the Kaiser Family Foundation , a third of unvaccinated adults in the United States confessed that they would be more likely to get vaccinated if there were full approval of the antigen by the FDA. Therefore, this step taken by Pfizer could encourage the hesitant to finally go for their vaccine.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, FDA approval of a vaccine may now instill additional confidence in getting vaccinated,” said Acting Commissioner Janet Woodcock. from the FDA to Reuters.

It is important to mention that, with this milestone, pharmaceutical companies can no longer request new emergency use authorizations from the FDA, as this option is only available as long as there are no fully approved options available. In commercial terms, this represents an advantage for Pfizer over other competitors such as AstraZeneca, which, if it wanted its injection to be available in the United States, would have to wait for a longer approval process.

The vaccine has been authorized for emergency use since December and has already been received by more than 204 million people in the United States, according to data available Sunday. Full approval is for use in people over 16 years of age.

Fuente/Texto: https://expansion.mx/mundo/2021/08/23/pfizer-aprobacion-total-fda-estados-unidos?fbclid=IwAR3U1305oipKsN9aQKqA9W1YCw4r3zm-NL70TkK0nYLDfEt5nNbumYrHyLg