Pfizer BioNTech's COVID-19 vaccine.
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  • The FDA has fully approved Pfizer-BioNTech's coronavirus vaccine.
  • The two-dose shot is now the first and only Covid-19 vaccine to get full approval.
  • The shot was previously OK'd under emergency-use authorisation, a more flexible regulatory standard.
  • For more stories visit Business Insider.

The US Food and Drug Administration issued the first full approval Monday for a coronavirus vaccine, marking a pandemic milestone.

Pfizer was approved for emergency use in South Africa in March 2021. South Africa has ordered more than 30 million doses of the Pfizer vaccine, which will be used to achieve 38% of government's herd immunity target. 

The two-dose jab developed by the New York pharmaceutical giant Pfizer and the German biotech BioNTech is now the first and only fully approved Covid-19 vaccine in the US. It will be marketed under the brand name Comirnaty.

Public-health officials, virologists, and legal experts anticipate that full approval could help persuade more hesitant people to get vaccinated, embolden more organizations to require immunization, and allow vaccine developers to market their shot to the public.

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Coronavirus vaccines developed by Moderna and Johnson & Johnson are still covered by emergency-use authorization, a more flexible regulatory standard that the FDA uses in times of crisis. Moderna said it expects to finish its application for full approval with the FDA in August.

The full approval covers people 16 years and older getting Pfizer's vaccine. It will remain available to 12-to-15-year-olds under emergency use authorization.

See also | SA approves Pfizer update, extending vaccine storage times in normal fridges to 31 days

Overall, about 171 million Americans have been fully vaccinated, with more than half receiving the Pfizer vaccine. Top US health officials are already planning booster doses, where people would be offered a third shot eight months after completing their initial vaccination.

Approval could address vaccine-hesitant talking points and spur more mandates

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.
Mandel Ngan/AFP via Getty Images

The shift to full approval could persuade some vaccine-hesitant people in the US to get the shot. A common talking point among skeptics of the Covid-19 shots has been that they're not fully approved and are technically experimental medicines under emergency OKs. Pfizer's vaccine winning standard approval directly addresses that concern.

A survey of 1,888 adults conducted in June by the Kaiser Family Foundation found that about 30% of the unvaccinated respondents said they were more likely to get the shots if they received full approval.

Additionally, full approval could embolden more organizations and groups to institute vaccine mandates. As the rate of new cases surged in recent weeks in the US, many businesses have already started to require the vaccine for their workers. Legal experts previously told Insider that certain organizations may feel more comfortable implementing mandates for a vaccine that's fully approved.

See also | If you go to Dis-Chem you’ll probably get the Pfizer vaccine

Dr. Anthony Fauci, the nation's leading infectious-disease expert, told USA Today in August that full approval would lead to "a flood" of vaccine mandates in the US.

"Organizations, enterprises, universities, colleges that have been reluctant to mandate at the local level will feel much more confident," Fauci said.

The FDA's actions would also allow Pfizer and BioNTech to begin advertising its vaccine directly to consumers.

See also | Pfizer's Covid-19 vaccine works very well against the Delta variant - but only after 2 doses

At a Goldman Sachs investment conference in June, Ryan Richardson, BioNTech's chief strategy officer, said full approval would open up the "ability to promote, to educate the market on the product more broadly."

He added that this "could lead to more individual decision-making or preferences for specific vaccines over the other, which hasn't really played a big role so far," a transcript provided by the financial-research firm Sentieo showed.

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