Pfizer’s COVID-19 Vaccine With Comirnaty Label Still Not Available in US

Officials successful 19 states confirmed this week to The Epoch Times they person not received doses of Pfizer’s COVID-19 vaccine labeled Comirnaty. So did pharmacies successful New York, California, and Missouri.

A Pfizer spokesperson told The Epoch Times successful an email that determination are nary doses of Comirnaty successful the United States arsenic of Oct. 12.

“The FDA-approved Comirnaty and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine person the aforesaid formulation and, according to the FDA labeling, tin beryllium utilized interchangeably to supply the COVID-19 vaccination series,” a Pfizer spokesperson told The Epoch Times.

However, lawyers representing clients challenging vaccine requirements, accidental the deficiency of availability means vaccine mandates based connected the Food and Drug Administration (FDA) support are unlawful.

“Under the exigency usage authorization, everyone has an enactment to judge oregon garbage the product. And that means each person, subject and civilian. So this is critical. All of the mandates, from the subject to the civilian population, are violating national law,” Mathew Staver, president of Liberty Counsel, a Christian ineligible group, told The Epoch Times.

The concern would beryllium antithetic if Comirnaty was available, Staver said. “You cannot interchange BioNTech’s Cominarty with Pfizer’s [shot] from a ineligible standpoint. They are legally distinct.”

Contact with authorities and national officials and pharmacies revealed wide disorder regarding the differences betwixt the approved Pfizer-BioNTech vaccine and the mentation that received exigency usage authorization (EUA) successful December 2020 and continues to beryllium administered nether EUA now.

A fig of officials were unaware of immoderate differences and others insisted they were the aforesaid for each intents and purposes, including respective officials with the Department of Health and Human Services (HHS), which handles organisation of COVID-19 vaccines.

“It’s the aforesaid thing,” an HHS authoritative told The Epoch Times.

The U.S. Department of Health and Human Services (HHS) gathering is seen successful Washington, connected July 22, 2019. (Alastair Pike/AFP via Getty Images)

That’s a antithetic connection than that being sent to states, immoderate of which person been told by national officials not to expect doses of Comirnaty for a while.

“The CDC anticipates that Comirnaty volition statesman to vessel immoderate clip successful November astatine the earliest,” a spokesperson for the Arizona Department of Health told The Epoch Times successful an email, referring to the Centers for Disease Control and Prevention.

“The Maryland Department of Health has been told by the CDC that Comirnaty volition not vessel until the extremity of October/beginning of November,” a spokesperson with the Maryland Department of Health told The Epoch Times successful an email.

“According to the latest update DOH has received from the CDC, shipments of Comirnaty apt won’t statesman until adjacent month,” a spokeswoman with the Washington State Department of Health told The Epoch Times successful an email.

“We don’t expect vials with the marque sanction ‘Comirnaty’ affixed to them to beryllium delivered until aboriginal successful the year,” a spokesperson with the Idaho Department of Health told The Epoch Times successful an email.

A spokeswoman for the Tennessee Health Department said that the national authorities inactive has a ample magnitude of the authorized doses and determination is nary timeline connected erstwhile Comirnaty volition beryllium shipped.

The lone authorities expecting doses soon is Delaware. Officials determination were told 5,850 doses manufactured aft the Aug. 23 support day should get this week, a spokeswoman for the Delaware Department of Health said.

The FDA referred questions to the CDC and HHS. The CDC did not respond to repeated queries. The HHS authoritative who wasn’t alert of the differences alleged approved doses were available, but said she was “puzzled” by follow-up questions connected erstwhile they started being disposable and however galore are disposable and yet referred questions to the FDA. A antithetic HHS authoritative indicated the bureau is not tracking erstwhile approved doses participate the organisation system.

The FDA approved the Pfizer-BioNTech vaccine connected Aug. 23. On the aforesaid day, the cause regulator extended the EUA for existing doses and for children betwixt 12 and 15.

The support triggered vaccine mandates crossed the country, including for the Department of Defense. Many officials said they were waiting for the support to enforce mandates.

In the missive extending the EUA, Denise Hinton, the FDA’s main scientist, said the vaccines are “legally chiseled with definite differences that bash not interaction information oregon effectiveness.” The missive is nary longer disposable connected the FDA’s website, though the aforesaid connection is utilized successful an FAQ connected the approved vaccine, known arsenic Comirnaty.

The FDA has declined to accidental what the differences are. Pfizer told The Epoch Times antecedently that they notation to definite manufacturing processes.

Signage is seen extracurricular of the Food and Drug Administration (FDA) office successful White Oak, Md., connected Aug. 29, 2020. (Andrew Kelly/Reuters)

In a follow-up missive connected Sept. 22, Hinton wrote that the authorized and approved versions person “the aforesaid formulation” and that the products “can beryllium utilized interchangeably to supply the vaccination bid without presenting immoderate information oregon effectiveness concerns.”

Federal agencies successful assorted documents person indicated precocious determination is small oregon nary Comirnaty proviso successful the country.

Both of Hinton’s letters stated that determination is an insufficient proviso of Comirnaty successful the United States to administer to the U.S. colonisation successful its entirety.

A papers posted by the CDC past period said Pfizer “does not program to nutrient immoderate product” with caller labeling, referring to Comirnaty, “over the adjacent few months portion EUA authorized merchandise is inactive disposable and being made disposable for U.S. distribution.”

Sen. Ron Johnson (R-Wis.) has questioned (pdf) wherefore the existing doses were not approved and, fixed the deficiency of Comirnaty supply, whether the FDA was “de facto endorsing vaccine mandates utilizing EUA vaccines?”

The FDA declined to reply questions connected the support process. Several experts told The Epoch Times that national instrumentality appears to preclude approving existing authorized products.

To formed a wider nett connected the matter, The Epoch Times besides contacted 12 backstage companies, mostly pharmacies progressive successful vaccine administration.

Walgreens, Kroger, H-E-B Pharmacy, Publix Pharmacy, Thrifty White Pharmacy, the Mayo Clinic, and Novant Health did not respond to requests for comment. CVS referred questions to the national government. Northwell Health, a New York wellness attraction system, declined to comment.

The Legacy Specialty Pharmacy successful Queens, New York said they bash not person Comirnaty doses. A pharmacist astatine Lorena Pharmacy said helium was not alert of immoderate differences and thought the support successful August was lone for booster doses, indicating they bash not person Comirnaty. A pharmacist astatine Kilgore’s Medical Pharmacy successful Missouri said they lone get Moderna vaccine doses.