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Monday, September 20, 2021

Explained: The US approves Pfizer’s Covid-19 vaccine; what this means

The Pfizer-BioNTech vaccine will now be marketed as Comirnaty, and will be used for the prevention of Covid-19 for individuals 16 years of age or more.

By: Explained Desk | New Delhi |
Updated: August 25, 2021 8:00:43 am
Pharmacy technician loads a syringe with Pfizer's Covid-19 vaccine at the Portland Expo in Portland, Maine. (AP/File)

The US Food and Drug Administration (FDA) on Monday fully approved the first Covid-19 vaccine in the country. The vaccine that has been known as the Pfizer-BioNTech vaccine will now be marketed as Comirnaty and will be used for the prevention of Covid-19 for individuals 16 years of age or more, the FDA has said.

However, this vaccine will continue to be available under the emergency use authorisation (EUA) for those in the age groups 12-15 years and for the administration of a booster dose (third dose) of the vaccine in immunocompromised individuals. In other words, for people falling in these categories, the vaccine has not been fully approved yet. The agency may take a call once new data is available.

With FDA’s full approval granted to Comirnaty, it is hoped that unvaccinated people will now come forward and make the public more confident about taking the vaccine, now that it has met the FDA’s highest standards for safety and vaccine effectiveness.

What EUA means

In the US, the Food and Drug Administration (FDA) grants an EUA only after it has been determined that the “known and potential benefits outweigh the known and potential risks of the vaccine” (or medicine). This means that an EUA application can be considered only after sufficient efficacy data from phase 3 trials has been generated. An EUA cannot be granted solely on the basis of data from phase 1 or phase 2 trials, although these too need to show the product is safe.

The Pfizer-BioNTech COVID-19 vaccine is in use in the US under EUA since December 11, 2020 in individuals 16 years or older. This EUA was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. EUA was expanded for those between the ages 12-15 years in May.

What does full approval mean?

Monday’s decision has come after the FDA reviewed updated data from clinical trials that supported the initial EUA. For its full approval, the FDA analysed effectiveness data from over 20,000 vaccine and 20,000 placebo recipients of the vaccine who were 16 years and older. For data on safety, evaluations were made based on 22,000 people who received the vaccine and 22,000 people who received a placebo. These participants were also 16 years or older.

Based on these results, the vaccine was found to be 91 percent effective in preventing Covid-19 disease. The agency also followed up with more than half of the clinical trial participants for safety outcomes for at least four months after the second dose. Under the EUA, vaccine manufacturers are required to give only two-months of follow-up data to quicken the process of making vaccines available.

Overall, approximately 12,000 recipients have been followed for at least six months. “The vaccine is effective in preventing Covid-19 and potentially serious outcomes including hospitalization and death,” the FDA said in a statement.

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