Few, If Any, Doses of Spikevax or Comirnaty Available in United States, Despite FDA Approvals

Moderna's COVID-19 vaccine is prepared in Los Angeles, Calif., on Jan. 7, 2022. Frederic J. Brown/AFP via Getty Images

U.S. drug regulators have now approved the COVID-19 vaccines made by Pfizer and Moderna, but the approved versions of the vaccines don’t appear to be available yet in the United States.

The Food and Drug Administration (FDA) approved Moderna’s jab on Jan. 31, about five months after it approved Pfizer’s shot.

The approved vaccines are known as Spikevax and Comirnaty.

In a letter to Moderna, the FDA said that there is not “sufficient” supply of either approved vaccine.

“Although Spikevax (COVID-19 Vaccine, mRNA) and Comirnaty (COVID-19 Vaccine, mRNA) are approved to prevent COVID-19 in certain individuals within the scope of the Moderna COVID-19 Vaccine authorization, there is not sufficient approved vaccine available for distribution to this population in its entirety at” this time, the Jan. 31 missive states.

Comirnaty was not being distributed in the United States as of October, The Epoch Times found. Queries were sent to officials in all 50 states this week regarding the Comirnaty-branded version of the vaccine. Twelve states confirmed that they still haven’t received Comirnaty-branded vials.

“No states are receiving the Comirnaty product,” a spokeswoman for the Commonwealth of Kentucky Cabinet for Health and Family Services told The Epoch Times in an email.

At one time, the Pfizer shot with a gray cap, which uses a different buffer, “was anticipated to have the ‘Comirnaty’ label on it, but it does not,” according to a spokesman for the Washington State Department of Health.

The state has received about 235,000 doses of the grey cap formulation, and other states have also started receiving the gray-capped product.

“The CDC has not begun to distribute the branded product, Comirnaty, yet,” a spokeswoman for the Utah Department of Health told The Epoch Times via email, adding that “our immunization program staff have not heard a timeline from CDC regarding this change.”

CDC stands for Centers for Disease Control and Prevention.

The agency has not responded to requests for comment regarding the availability of Spikevax and Comirnaty.

The CDC says on its website that Pfizer “does not plan to produce” any of the Comirnaty-branded product since emergency use authorization (EUA) product is still available. The site hasn’t been updated with the Spikevax approval.

The FDA referred comment to the vaccine companies, which have not said when the approved vaccines will be available.

A Pfizer spokesperson told The Epoch Times last year that the company would be using the EUA-labeled product until its expiry date.

The lack of availability of the approved vaccines is significant because it means people still have the right to accept or refuse the products, according to Liberty Counsel, a legal group.

“There is currently no fully FDA-approved licensed COVID shot available to the population. Neither Comirnaty nor Spikevax are available. Everything that is available remain under the EUA law. That means that people have the option to accept or refuse the shots,” Mathew Staver, the group’s founder and chairman, said in a statement.

Liberty Counsel is representing plaintiffs in multiple cases challenging vaccine mandates, including a case against the U.S. military.

The FDA fact sheets (pdf) provided to people preparing to get a shot used to state that “under the EUA, it is your choice to receive or not receive” the vaccine, taking language from the Food, Drug, and Cosmetic Act, which lets the FDA grant EUAs.

However, some say the law doesn’t bar vaccine mandates.

The Department of Justice concluded in a legal opinion (pdf) last year that the act “does not prohibit entities from imposing vaccination requirements.”

The FDA says the authorized and approved versions of the vaccines “are legally distinct with certain differences that do not impact safety or effectiveness.” The FDA has declined to comment on this statement. Moderna did not respond to requests for comment. Pfizer has said that the products ”are made using the same processes, and there are no differences between them in safety or effectiveness.“ The statement, a spokesperson added, refers to ”differences in manufacturing information included in the respective regulatory submissions.”