In an important ruling, one ignored by the mainstream media, a federal judge last month rejected the claim by the U.S. Department of Defense (DOD) that the Pfizer vaccine for COVID-19 currently used under the Emergency Use Authorization (EUA) is interchangeable with the company’s Comirnaty vaccine approved in August by the FDA as fully licensed.
As reported by Children’s Health Defense on November 30, U.S. Federal District Judge Allen Winsor of the U.S. District Court for the Northern District of Florida ruled that the DOD cannot mandate vaccines that only have an EUA. The story wrote that the judge’s acknowledgment recognizes the legal difference between a fully licensed vaccine and an EUA vaccine.
FDA Licensing of Pfizer Vaccine
The story points to the confusing phrasing of FDA in their approval of Pfizer’s Comirnaty COVID-19 vaccine in August this year. The statement read:
The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns.
At the same time, the statement said that the vaccine’s two versions are two “legally distinct” products.
The FDA statement also stated clearly that it is entirely up to a person whether to receive or not receive the vaccine and in case they choose not to get the shot, it will not change their standard medical care.
Since the law allows employers and schools to mandate a licensed vaccine, the issue of conflict centers over the licensed status of the Pfizer vaccine. In this context, the availability of Pfizer’s licensed Comirnaty vaccine renders the use of EUA vaccine illegal.
In this case, an EUA is considered illegal and invalid if there is a fully licensed alternative available. This appears to be the case with Pfizer’s licensed Comirnaty while its EUA Pfizer-BioNTech is still on the market.
In May this year, the Children’s Health Defense sued the FDA to make them refrain from licensing COVID vaccines and to revoke EUAs for the three existing COVID vaccines.