The Pfizer BioNTech COVID-19 vaccine authorized under the Emergency Use Authorization (EUA) has a different label than the FDA-approved Comirnaty label for the vaccine, and Pfizer has said they will continue to distribute the vaccine made under the earlier label until stocks run out.
The EUA was granted before the risk of myocarditis for men under 40, caused by the vaccine, was known, and the Comirnaty package insert found on the FDA website includes warnings about the rare side effect. A fact sheet distributed with the EUA vaccine also includes a warning about the risk.
On Tuesday, an FDA official told The Virginia Star on background that the FDA has to ensure that EUA vaccine recipients are informed of the EUA, the extent and benefits of the vaccine, that the vaccine is optional, and of alternatives to the vaccine. Normally that data is communicated through a fact sheet for EUA vaccines. A package insert is used with fully approved vaccines like Comirnaty.
Pfizer is still providing Virginia distributors the Pfizer-BioNTech COVID-19 vaccine allowed by the FDA under the Emergency Use Authorization (EUA), not the Comirnaty-labeled identical-formulation vaccine that was fully approved by the FDA in August. Pfizer says it will use up its existing stock of vaccine made under the earlier label before distributing the new version.
“The FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and, according to the FDA labeling, can be used interchangeably to provide the COVID-19 vaccination series,” a Pfizer statement provided to The Virginia Star said. “The Pfizer-BioNTech COVID-19 EUA labeled product will still be shipped and usable until its expiry date, as long as authorized frozen storage conditions have been maintained.”
Former Trump attorney Sidney Powell announced Wednesday that she is suing the Defense Department in regards to their vaccine mandate.
According to The Hill, Powell is representing the Texas-based group “Defending the Republic” in a lawsuit against Defense Secretary Lloyd Austin in regards to the military’s mandatory vaccination requirements.
Roughly 41,709 Virginians have received first doses of the COVID-19 vaccines so far, according to the Virginia Department of Health (VDH), as the state continues its efforts to reach herd immunity and put an end to the coronavirus pandemic.
Last week, the VDH launched the COVID-19 vaccine data dashboard, which will be updated daily to keep the public informed about the number of vaccines distributed and administered as well as the demographics of recipients.
Roughly 140,000 doses of the Moderna COVID-19 vaccine are expected to arrive in Virginia on Wednesday after the state had initially placed an order with the company last week, the Virginia Department of Health (VDH) said in a news release.
Shipments of Moderna’s vaccine, approved for emergency use by the Food and Drug Administration on Friday, as well as Pfizer-BioNTech’s vaccine are being delivered to healthcare facilities and health departments across the Commonwealth this week. The two vaccines are going to 96 “geographically diverse locations” in the state, according to the release.