United States FDA Grants Full Approval to Pfizer-BioNTech Covid-19 Vaccine

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The move is expected to lend considerable authority to vaccine mandates in the US; other countries may soon follow suit.

Eight months after first authorising the Pfizer-BioNTech COVID-19 vaccine for emergency use in the United States, the Food and Drug Administration (FDA) has issued its full stamp of approval to the widely used Covid-19 vaccine.

“The vaccine has been known as the Pfizer-BioNTech Covid-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of Covid-19 disease in individuals 16 years of age and older,” the FDA said in its announcement on Monday.

The mRNA vaccine jointly developed by Pfizer and BioNTech, which is also authorised in Malaysia, is the first Covid-19 vaccine to earn full FDA approval in the US. (The Pfizer vaccine comprises the majority of vaccine stocks which have been secured by Malaysia.)

Now that the two companies’ detailed, so-called biologics license application has been granted, it’s widely expected that vaccination against Covid-19 will be required by many companies, schools, and other entities. 

The FDA decision also clears the way for the companies to freely market their vaccine, which is not permitted without full licensure.

The FDA confirmed late last year through a more streamlined evaluation process that the vaccine, from pharmaceutical giant Pfizer and its partner German startup BioNTech, was safe, effective and could be reliably produced.

Meet Comirnaty, the brand name for Pfizer’s vaccine. With FDA approval allowing free marketing, you’ll likely see it referred to this way more often now | Image Credit: Reuters


Due to the seriousness of the pandemic, vaccine makers originally applied for emergency use authorisations because that process takes less time than the many steps required for full approval.

In July, pharmaceutical company Pfizer announced that the FDA granted its vaccine a priority review, and the FDA had been bringing in extra help from across the agency to accelerate the final approval of the vaccine.

Now, the progression from authorised to approved will not only pave the way for more vaccine mandates, but will also allow manufacturers to market and directly distribute their vaccines – and perhaps even sway sceptics who have been hesitant to get the vaccines to do so of their own accord.

A significant share (about 30%) of unvaccinated people – millions of people, according to polling – say that full FDA approval will increase the likelihood that they’ll get a Covid-19 vaccine. These people may have been reluctant “because they know there will be much more data available at the time of an approval … three times as much data on safety and three times as much data on effectiveness,” explained Sidney Wolfe, founder and senior adviser at the health research group at Public Citizen.


“While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated,” added Janet Woodcock, acting commissioner of the FDA, in a statement on Monday.

Kaiser Family Foundation survey of US adults released in July indicated that among the one-third of adults surveyed who were not yet vaccinated, 16% said the vaccine was too new, too unknown, or not tested enough. Some indicated that they wouldn’t get a vaccine until it had full approval or was required.

While companies are legally allowed to require the vaccine – and many large businesses, such as United Airlines, Walmart, Disney, Google, and Microsoft already have announced plans to do so – some experts believe more companies will make it a requirement now that a vaccine is fully approved by the FDA. Legal precedent to mandate vaccines which have FDA approval has long been established in the United States.

The immense scale of real-world data amassed on the Pfizer-BioNTech vaccine far exceeds the stress tests most consumer products endure prior to regulatory approval. In the US alone, over 92 million people have received this brand of vaccine. Worldwide, the number is far higher. The sheer volume of data has shown with indisputable clarity the safe and effective nature of the vaccine.

Hopefully, now that this vaccine has full FDA approval, those who may have been hesitant thus far will have an added incentive to get the shot – both in the United States and elsewhere in the world.

Though “free” didn’t convince everyone in the US to get vaccinated, “fully approved” will certainly motivate quite a few holdouts | Image Credit: Getty Images

Reporting from CNN, USA Today, Vox Media, and the Associated Press contributed to this article.

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