A new report outlines that Pfizer is still distributing a version of its vaccine that is not fully approved by the FDA.
They are giving out an earlier version of the vaccine which predated its full FDA approval.
Pfizer says this vaccine is the same as the one that was fully approved by the FDA.
Legally they are different, however.
Pfizer’s vaccine against COVID-19 has been fully approved by the Food and Drug Administration, yet the pharmaceutical giant is still providing distributors across the country with an earlier version of the vaccine that predates FDA’s full approval.
The Pfizer-BioNTech vaccine allowed under federal Emergency Use Authorization (EUA) in December 2020 and the Comirnaty vaccine approved by the FDA in August are identical, according to Pfizer and several experts.
However, the two vaccines are legally distinct, raising questions over the legality of vaccine mandates.
The EUA-authorized vaccine is being distributed and administered widely in Ohio, Virginia, and Pennsylvania, among other states. But while the product hasn’t received FDA approval, Pfizer says it’s made using the same processes as Comirnaty and no different in terms of safety and effectiveness.
Despite there being no chemical or ethical differences between Comirnaty and Pfizer-BioNTech, however, the FDA acknowledges the two “are legally distinct.” The agency explained in a statement to the Ohio Star that statutory authorities governing EUAs and biologics license applications, which are necessary for official FDA approval, “provide different legal requirements.”
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