Pfizer-BioNTech’s COMIRNATY® becomes the first US FDA-approved COVID-19 vaccine

In what could be considered a significant milestone in the fight against the deadly COVID-19 pandemic, the US Food and Drug Administration (FDA) has given the green light to Pfizer-BioNTech’s COVID-19 vaccine.

On 23 August, Pfizer (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced that the US FDA had approved the Biologics License Application for their mRNA-based COVID-19 vaccine. The vaccine will now be marketed as COMIRNATY®.

Notably, this is the first vaccine obtaining FDA’s full authorization for COVID-19 prevention in individuals aged 16 years and above.

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Furthermore, the vaccine continues to be available for children of 12-15 years and as a third dose in some immunocompromised individuals under the emergency use authorization (EUA).

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Albert Bourla, Chairman and CEO of Pfizer, commented-

PFE-BNTX vaccine continues to be available for children of 12-15 years under EUA

Initially, the vaccine secured a EUA in December 2020. Since then, the vaccine has been available in individuals aged 16 years and above. In May 2021, the authorization was expanded to include children in the aged 12-15 years.

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The companies now anticipate submitting an additional BLA for supporting the FDA authorization of COMIRNATY for 12- 15 years individuals. For the moment, the vaccine remains available under the EUA.

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COMIRNATY® in a nutshell

• COMIRNATY contains messenger RNA (mRNA), a kind of genetic material.
• The vaccine is approved as a two-dose series for COVID-19 prevention in individuals aged 16 years and above.
• The mRNA in COMIRNATY is only present in the human body for a short period and is not incorporated into the genetic material of an individual.
• The vaccine’s formulation is similar to the EUA vaccine and is given as a series of two shots, three weeks apart.

Bottom Line

Obtaining full authorization from the US FDA for the COVID-19 vaccine is a significant milestone for Pfizer and BioNTech. Besides, public health experts anticipate that full and final FDA authorization would convince more Americans to get their jabs. The clearance would also boost the protection against the coronavirus at a time when the virus is mutating to more contagious forms.

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