Comirnaty, Spikevax Become Available for 1st Time in United States

COVID-19 vaccine vials marked Comirnaty in Berlin, Germany, in a file image. Tobias Schwarz/AFP via Getty Images

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.

Even after the approvals were issued, no approved versions were available in the United States, according to the vaccine makers and federal and state officials.

Military members, among others, have cited the unavailability of Comirnaty and Spikevax in legal actions against COVID-19 vaccine mandates.

One lawsuit, for instance, said that “the only currently available COVID-19 vaccines are authorized under EUA only, and therefore cannot be mandated.”

Thousands of Doses

U.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.

“While it is the Defendants’ position that all EUA-authorized Pfizer-BioNTech doses for adults are interchangeable for the purposes of the mandate to vaccine, in order to address Plaintiffs’ assertions they were unable to obtain a Comirnaty or BLA-manufactured doses, I wanted to confirm in writing that any of the Plaintiffs still subject to the mandate may receive the Comirnaty-labeled vaccine,” Amy Elizabeth Powell, a government lawyer, said in an email in June to lawyers for service members challenging the mandate.

At the time, over 35,000 doses had been obtained by the military, with 3,300 available at specific bases.

The disclosures that Comirnaty has become available were made in the case Coker et al v. Austin et al.

A COVID-19 vaccine vial marked Comirnaty in Juneau, Alaska, on June 10, 2022. Courtesy of Lt. Chad Coppin

States

States 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.

The CDC did not respond to emailed questions.

Whistleblower Concerns

Under 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.

The FDA approved manufacturing of Comirnaty in Massachusetts and Belgium (pdf).

“It’s fishy,” Coppin told The Epoch Times.

Pfizer, the FDA, the Coast Guard, and the Pentagon did not return requests for comment.

Coppin outlined the concerns in a whistleblower report (pdf) to members of Congress, calling for an investigation to determine whether the Comirnaty lots are being properly manufactured. Army First Lt. Mark Bashaw also said in the report that the lot number in question was listed under emergency authorization in a CDC database.

Sen. Ron Johnson (R-Wis.), after reviewing the report, asked the Pentagon, the FDA, and the CDC for answers, calling for “complete transparency” regarding the vaccines.