FDA grants full approval to Pfizer’s Covid-19 vaccine in major pandemic milestone

  • Many hope the move from the US federal agency will spark confidence in the BioNTech jab and encourage more people to get vaccinated against coronavirus
  • In the US, around 85 million eligible people have yet to get the vaccine, which was approved for emergency use eight months ago
Tribune News Service |

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The Pfizer BioNTech Covid-19 vaccine has officially been approved by the US Food and Drug Administration. Photo: AP Illustration/Peter Hamlin

The US Food and Drug Administration (FDA) granted full approval to the Covid-19 vaccine developed by Pfizer and BioNTech on Monday, meaning the shots are the first to move beyond emergency status since the pandemic began.

The highly anticipated announcement was expected to boost confidence in the vaccine, potentially encouraging some of the 85 million unvaccinated Americans to get the shots. It may also spark a wave of vaccine mandates by employers and schools as the country faces a surge of infections and hospitalisations largely driven by the deadly delta variant.

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For now, the full approval is effective only for people 16 and older getting their first or second shot. The vaccine will remain available under emergency-use status for children 12 through 15 years old and for a third dose in individuals with certain underlying medical conditions, according to the FDA. Pfizer and BioNTech said they will seek full approval for young teens and the third dose once they have enough safety and efficacy data.

Monday’s decision comes eight months after Pfizer was granted emergency use authorisation to distribute the shots in the US. Since then, more than 200 million Pfizer shots have been administered nationwide, with many more around the world - a major undertaking that provided overwhelming evidence to federal health officials about the safety and efficacy of the vaccine.

An FDA review of about 22,000 people who received the vaccine and 22,000 who received a placebo found that Pfizer’s shots were 91 per cent effective at preventing Covid-19, according to the agency.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said in a statement.

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The Biden administration hopes Monday’s announcement will nullify one of the main arguments among anti-vaxxers, who claimed that a vaccine with temporary approval could not be trusted. The two other Covid-19 vaccines available in the US - Moderna’s and Johnson & Johnson’s - remain under emergency use authorisation.

“While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the US”

About 40 per cent of Americans age 12 and older still have not been vaccinated, according to the US Centres for Disease Control and Prevention’s latest vaccination data.

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The full approval also means Pfizer and BioNTech will be allowed to market their vaccine, which is not permitted under emergency status. The two companies plan to market the shots as Comirnaty, the FDA said.

Pfizer Chairman and CEO Albert Bourla celebrated the accomplishment on social media.

“Every day, I wake up proud of our team at @Pfizer. Proud of the work we do. Proud of the difference we are making. And I am especially proud today,” Bourla tweeted.

“It is our hope that this news will instill even further public confidence in our vaccine and the science that made it possible,” he said.

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