A small number of Comirnaty and Spikevax COVID-19 vaccine doses have become available in the United States in recent weeks, according to court filings and U.S. health departments.
Vials of vaccines labeled Comirnaty started being available to members of the U.S. military in May and tens of thousands of the vials have since been ordered, according to military officials. Dozens of vials were spotted at a clinic in Alaska in June, according to a Coast Guard officer.
Several states, meanwhile, confirmed to The Epoch Times that providers are now able to order the vials.
Comirnaty is the approved version of Pfizer's COVID-19 vaccine. Spikevax is the approved version of Moderna's COVID-19 vaccine. Approval means drug regulators granted a biologics license application (BLA). The U.S. Food and Drug Administration (FDA) in 2021 approved Comirnaty for adults 16 and older, and in January approved Spikevax for individuals 18 and up. Before that, the vaccines were available under emergency use authorization (EUA).
The differences matter due to federal law. A biologics license requires a higher threshold of evidence, and certain aspects of emergency clearance don't apply to approved products.
Military members, among others, have cited the unavailability of Comirnaty and Spikevax in legal actions against COVID-19 vaccine mandates.
Thousands of DosesU.S. regulators and health officials say the approved versions of the vaccines have the same formulations as the older versions, and that the versions are interchangeable. At the same time, the versions "are legally distinct with certain differences," according to the letters of approval.
The FDA has declined to explain what that means, while a Pfizer spokesperson told The Epoch Times previously that it refers to the differences in manufacturing information included in the submissions for authorization and approval.
Military officials have defended the COVID-19 vaccine mandate despite Comirnaty and, later, Spikevax not being available by claiming that the older versions can be treated as if they're the licensed versions, a claim challenged in legal cases.
They're maintaining that position, but also asserting that objections to the mandate centered on the vaccines' availability are no longer relevant.
The disclosures that Comirnaty has become available were made in the case Coker et al v. Austin et al.
StatesStates have also recently been able to start ordering vials of Comirnaty and Spikevax for the first time.
The Delaware Department of Health has ordered 300 doses of Comirnaty, but has not administered any due to lack of demand, a spokesperson for the department told The Epoch Times in an email.
South Carolina received over 38,000 doses of Comirnaty and nearly 53,000 doses of Spikevax, and has enabled health care providers to order them from the state, a spokesperson for the South Carolina Department of Health and Environmental Control told The Epoch Times in an email.
Providers in Arizona can also order the doses from the Arizona Department of Health Services, a spokesperson for the agency told The Epoch Times in an email, and some providers have already ordered some.
"There is supply to meet the demand. Because these vaccines are identical to the EUA-branded presentations, and because there are still large stocks available in the state, very few Spikevax/Comirnaty doses have been ordered," the spokesperson said.
States order vaccines from the U.S. Centers for Disease Control and Prevention (CDC), which makes them available for no cost.
Whistleblower ConcernsUnder the approvals, the vaccines must only be manufactured in certain locations, but vials at a Coast Guard medical clinic in Juneau, Alaska, may have been produced at a location that has not been approved.
Each vial has a lot number on it. Lt. Chad Coppin, with the Coast Guard, asked a Pfizer customer service representative where the lot number was produced, and she said that it was manufactured in France on Jan. 28, according to a recording reviewed by The Epoch Times.
"It's fishy," Coppin told The Epoch Times.
Pfizer, the FDA, the Coast Guard, and the Pentagon did not return requests for comment.