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  • 2021-10-07 (xsd:date)
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  • What’s in a name? Louisiana lawmakers wrongly say name change scuttles FDA COVID-19 vaccine approval (en)
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  • In August, the Food and Drug Administration gave full and final approval to the COVID-19 vaccine developed by Pfizer for people 16 and older. But 10 Republican Louisiana lawmakers allege there is no FDA approval for the Pfizer BioNTech vaccine for COVID-19. The state representatives put that in bold at the top of a Sept. 29 letter to Louisiana Gov. John Bel Edwards. No, it’s not like those lawmakers didn’t get the memo on FDA approval. They saw it, but they tried to make the argument that it didn’t count. One of their main arguments focuses on the new name for the vaccine. The drug that had gone by the prosaic name of Pfizer-BioNTech COVID-19 Vaccine is now called Comirnaty. The initial vaccine has been used for months under an emergency use authorization, or EUA. Going forward, the final approval applies to Comirnaty. For the Louisiana lawmakers, this changes everything. As they see it, the FDA approved Comirnaty, not the Pfizer-BioNTech COVID-19 Vaccine. These two drugs are legally distinct, they wrote. Aaron Lottes at Purdue University spent many years as an FDA regulator. Lottes told us the lawmakers didn’t read the fine print. This is an interesting legal argument, but from a scientific basis, the EUA-version and the Comirnaty version are identical, Lottes said. The FDA’s notice of final approval did include the words, the products are legally distinct, but then immediately noted that the differences do not impact safety or effectiveness. The differences include things such as labeling, Lottes said. The EUA vaccines obviously have a different label and accompanying information than the approved version will have. The Pfizer press office told us that the vaccine’s contents and the way it is made remain the same, but the manufacturing site and the sourcing of some raw materials might vary, subject to FDA oversight and approval. The lawmakers’ letter correctly stated that the FDA said the original version and Comirnaty could be used interchangeably, but then the letter went on to incorrectly state the FDA labeling on Comirnaty contradicts this statement: ‘There are no data available on the interchangeability of Comirnaty with other Covid-19 vaccines to complete the vaccination series.’ Let’s parse what the FDA actually has said . The plain meaning of its guidance is that it doesn’t know about mixing Comirnaty with other vaccines, like getting one shot of Moderna, followed by a second shot of Comirnaty. The FDA did not, however, say it lacked data on swapping Comirnaty with the Pfizer vaccine in a two-shot series; in fact, it plainly said you can. Because so far as your body is concerned, the drugs are the same. The lawmakers’ letter makes another point: The approved drug Comirnaty is unavailable for distribution in the U.S., it says. Drugs are experimental under EUA and cannot be legally mandated. The lawmakers oppose vaccine mandates, and one of their arguments is that governments can mandate only those vaccines that have final approval. Unless clinics are stocked with a drug labeled Comirnaty, they say, no mandate is valid. But, as the lawmakers acknowledge, the FDA says that Pfizer BioNTech COVID-19 Vaccine and Comirnaty can be used interchangeably. According to Pfizer, when the country works through the current stockpiles of vaccine, boxes bearing the label Comirnaty will start arriving. Until then, the vaccines produced under the emergency use authorization remain in use. If the EUA were revoked, then this product, which is identical in formulation to the approved product, would be legally unusable, Lottes said. I would expect this is easily on the order of tens of millions of doses. The lawmakers’ letter also references the health warnings that come with the approved vaccine, saying approval was premature. Lottes said the FDA approves many drugs with guidance on when they should not be used. The vaccine approval is no different. We reached out to Louisiana State Rep. Kathy Edmonston, a key author of the letter, and did not hear back. The lawmakers that signed their name to the letter include: Reps. Beryl Amedee, R-Houma; Raymond Crews, R-Bossier City; Kathy Edmonston, R-Gonzales; Larry Frieman, R-Abita Springs; Valerie Hodges, R-Denham Springs; Dodie Horton, R-Haughton; Sherman Mack, R-Albany; Danny McCormick, R-Oil City; Chuck Owen, R-Rosepine; and Rodney Schamerhorn, R-Hornbeck. Christina Stephens, a spokesperson for Edwards, dismissed the letter. This letter is ridiculous, Stephens said. The governor hasn’t read it and he doesn’t intend to. It's rife with disinformation, which is particularly dangerous to share during a pandemic and could result in immense and irreparable harm to families across this state. Our ruling Ten Louisiana lawmakers said, There is no FDA approval for the Pfizer BioNTech vaccine for COVID-19. This is wrong. The FDA approved that vaccine. The only change was in the vaccine’s name, but chemically and biologically, the vaccine called Pfizer BioNTech COVID-19 Vaccine and the newly named Comirnaty are identical. We rate this claim False. (en)
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