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Pfizer Covid-19 Vaccine Receives Full FDA Approval and Will Now Be Sold to the Public

Pfizer and BioNTech's coronavirus vaccine is the first to be fully approved by the FDA and will be able to be sold directly to consumers.

This article was translated from our Spanish edition. Opinions expressed by Entrepreneur contributors are their own.

Today, Monday, the United States Food and Drug Administration (FDA) announced that it has granted full approval to Pfizer and BioNTech's vaccine against Covid-19 . Until now, the drug had only been authorized for emergency use by the country's health authorities, but this declaration opens the door for its sale to the public .


The decision was based on updated data from the drug's clinical trial, which includes six months of safety and efficacy data evaluated among more than 40,000 vaccinated people.

"The FDA approval of this vaccine is a milestone as we continue to fight the Covid-19 pandemic," said Dr. Janet Woodcock, acting FDA commissioner, in a statement .

"As the first FDA-approved Covid-19 vaccine , the public can be very confident that this vaccine meets the high standards of safety, efficacy, and build quality that the FDA requires for a (fully) approved product," he added. the organism.

Mandatory vaccination, possible effect of approving the Pfizer / BioNTech vaccine

"No one can now argue with the effectiveness and safety of these vaccines ," Dr. Anthony Fauci , director of the National Institute of Allergy and Infectious Diseases (NIAID), told CNN.

"They were very careful to analyze all the information," added Fauci, who believes the approval would encourage "20-30%" of unvaccinated people to get vaccinated. In addition, he believes that this will lead to many companies, universities and organizations imposing vaccination as a requirement .

A recent poll by The Associated Press-NORC Center for Public Affairs Research found that about 6 in 10 Americans are in favor of requiring that people be fully vaccinated to travel on airplanes or attend public events.

"Obligation becomes much easier when you have full approval ," said Dr. Carlos del Río of Emory University, quoted by El Financiero . "I think many companies were waiting for it ."

With this in mind, many schools and businesses could purchase vaccines on their own and apply them to their staff and students. In fact, the US Department of Defense announced that it will order all active and reserve troops to be vaccinated against COVID-19, Pentagon spokesman John Kirby said.

Pfizer competition will have more obstacles

Pfizer's achievement closes the door for other drug companies to apply to the FDA for new authorizations for emergency use, because this is only possible while other fully approved options are not available.

Of course, this is a huge business advantage for Pfizer and BioNTech . If other competitors, such as Moderna or AstraZeneca , want to market their vaccine, they will have to wait for a longer approval process.

According to the statement, the Pfizer / BioNTech coronavirus vaccine will be marketed under the name Comirnaty . So far no more details have been released, such as the expected price to the public , points of sale or if there will be any requirement to buy it .

Who can get the Pfizer / BioNTech vaccine?

In mid-December 2020, the Pfizer / BioNTech vaccine was licensed for emergency use in the United States for individuals age 16 and older. In May 2021, the authorization was extended to those over 12 years of age, always under the supervision of the health authorities.

In the United States, there are more than 170 million people fully vaccinated against covid-19. Of these, more than 92 million (about 54%) have received the Pfizer / BioNTech vaccine.