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BAIT AND SWITCH: COVID-19 vaccine from Pfizer that recently gained FDA “approval” is not available in the US


Last month, the FDA finally gave official approval to a COVID-19 vaccine from pharmaceutical giant Pfizer and its German partner, BioNTech. It was a significant ruling as it gave weight to vaccine mandates that were dependent on full approval and alleviated some people’s concerns about the current vaccines’ lack of FDA approval. However, many people do not realize that the Pfizer vaccine that was just granted approval in the U.S. is not actually available here yet and is not technically the same shot as the one that has been administered over the last several months in the country.

The Pfizer vaccine that is currently circulating is the one that was given emergency use authorization (EUA) when the COVID-19 vaccines first hit the market. However, the fully approved vaccine from Pfizer and BioNTech is known as Comirnaty and no one knows when it will be available to Americans.

Health officials from various states told The Epoch Times that they do not have any doses of Comirnaty nor are they expecting to receive any. For example, a spokesman for Arizona’s Department of Health Services said in an email: “Comirnaty-labeled doses are not yet in circulation in the U.S. yet,” while a Tennessee Department of Health spokeswoman said there was no timeline for when the product would be shipped.

Officials in Wyoming, Washington, North Dakota, Illinois, West Virginia and Georgia said they have not received any Comirnaty doses, either, while a Massachusetts official said they are not expecting them until October at the earliest.

Similar, but not the same

So, what is the difference? Both vaccines are made by the same companies and have the same basic formulation, but the FDA says that the vaccines “are legally distinct with certain differences that do not impact safety or effectiveness.”

Although the FDA declined to elaborate on that when questioned, a Pfizer spokesperson said there are differences in the manufacturing information that was included in their submissions for authorization and approval. A spokesperson for the company said: “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers.”

It is not known whether the same manufacturers who produced the vaccine used under EUA will produce the new Comirnaty doses. However, an FDA representative told reporters last week that their approval process involved inspecting the facilities where the vaccine was being manufactured and reviewing thousands of pages of information and data regarding its manufacturing quality, safety and effectiveness.

The companies’ product has already been distributed in Europe for several months under the Comirnaty brand.

The U.S. plans to continue to distribute the originally labeled vaccine before the branded and approved product is released, but it doesn’t look like the current supplies are close to being exhausted. There are believed to be hundreds of millions of doses remaining, with Oklahoma alone having more than 210,000 doses of the Pfizer vaccine as of August 30.

There is not enough supply of the approved vaccine for distribution to adults aged 16 and older – the age range for which the approval was granted – while a significant amount of the EUA doses remain.

Some states are not planning to keep a separate count of who has received which version of the vaccine. There seems to be a lot of confusion about the differences, with some officials appearing to be unaware of the legal difference between the existing EUA doses and the approved-but-not-yet-available Comirnaty doses.

How does this affect vaccine mandates?

This could have repercussions when it comes to vaccine mandates as many of them were dependent on FDA approval. For example, some workplace vaccine mandates stated that employees would have one month after full FDA approval to get vaccinated or face losing their job. However, with the approved vaccine unavailable in the country at the moment, these people will either have to get a vaccine that was not technically approved – the EUA version of the vaccine – or find themselves without a way to support their family.

Sources for this article include:

TheEpochTimes.com

FDA.gov

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