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Debunking false claims that U.S. has not ‘fully approved’ Pfizer COVID-19 vaccine

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Posted: Tuesday, August 31, 2021. 3:54 pm CST.

By Aaron Humes: A reader has directed us to claims that last week’s approval of the Pfizer COVID-19 vaccine for children is not as it seems.

The gist is that the company was authorized to continue emergency use authorization (EUA) and clinical trials to study the effects of the drug over several years, while continuing to offer it under EUA license to children 12 to 15.

Some suggest the Food and Drug Administration (FDA) wanted to ensure continued immunity from liability for the ‘unlicensed’ version of ‘Comirnaty’ as the vaccine will now be known, and that a refined version will not be available for some time.

However, according to USA Today, Denise Hinton, chief scientist at the FDA, wrote in the August 23 letter that the agency had “approved the biologics license application” from Pfizer for its coronavirus vaccine “in individuals 16 years of age and older.” In a corresponding press release, the FDA said it had fully approved Pfizer’s vaccine and that it “will now be marketed as Comirnaty.” That’s different from an emergency use authorization, according to the newspaper and should not be conflated in terms of what has been approved and what has not.

In December, the FDA authorized Pfizer’s coronavirus vaccine for emergency use. That enabled Americans to get the unapproved shot because, in the context of the coronavirus pandemic, its benefits outweighed its risks. The FDA’s decision was based on data from clinical trials involving tens of thousands of participants, which found the vaccine was safe and effective at preventing symptomatic COVID-19.

The subsequent full application was made in May and is now approved, though the FDA noted that the vaccine has not been fully approved for all groups. Children ages 12 to 15, as well as immunocompromised individuals seeking a third dose, may receive the vaccine under an emergency use authorization. Children under 12 years old are not eligible for the shot at all.

We will seek comment from the Ministry of Health as to how it approves the usage of the Pfizer, AstraZeneca and Sinopharm vaccines as well as the new Johnson and Johnson vaccines it has received for use among Belizeans. We note that except for frontline workers as defined by regulation 2 of Statutory Instrument 74 of 2021, vaccine administration is not compulsory.

 

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