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FDA rules have blocked COVID-19 vaccine makers from advertising on TV

PolitiFact | One Instagram post claims drug makers aren’t doing TV ads for their vaccines because they would have to list the possible side effects.
Doses of the Pfizer COVID-19 vaccine sit on a table before the start of a vaccination clinic as part of an outreach initiative by Henry Ford Health System at the Islamic Center of America in Dearborn on March 8, 2021.
Doses of the Pfizer COVID-19 vaccine sit on a table before the start of a vaccination clinic as part of an outreach initiative by Henry Ford Health System at the Islamic Center of America in Dearborn on March 8, 2021.
Published Oct. 25

Big Pharma seems to be on television all the time, advertising prescription medicines with three- or four-syllable names for treating all sorts of problems, large and small.

There have been many public-service TV ads promoting vaccination generally. But one Instagram post claims that drug makers aren’t doing TV ads for their own COVID-19 vaccines because they would have to list the possible side effects.

“Have you noticed there’s been no commercials for the death dart?” the post begins, falsely suggesting that the COVID-19 inoculations are lethal. “Here’s why. Because in the US they are required by law to list all adverse side effects to medications advertised on TV to consumers. Fact check that.”

The post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)

The actual reason is that Food and Drug Administration rules prohibit advertising of drugs that have not been fully approved by the FDA. Only one COVID-19 vaccine, Pfizer’s, has been approved, and that didn’t occur until August.

A Pfizer spokesperson said the company plans to take a “thoughtful approach” to marketing and will adhere to FDA requirements about disclosing any serious side effects.

Emergency authorization vs approval

During public health emergencies, the FDA has the legal power to grant emergency use authorization to certain products if they meet specific criteria, and when there’s no adequate, approved and available alternative to treat the malady. That’s what happened when COVID-19 was declared a pandemic in early 2020 and there weren’t any approved vaccines for it.

Emergency use authorization was granted to the Pfizer and Moderna vaccines in December 2020 and to the Johnson & Johnson vaccine in February 2021.

FDA approval, meanwhile, depends on more substantial evidence that the product is effective and that its benefits outweigh its risks.

Approved medical products must follow numerous FDA regulations, including rules for ads that make claims about what a product can do.

So far, only Pfizer’s vaccine has gained FDA approval, and only for people age 16 and over. That occurred Aug. 23. The FDA’s announcement noted that Pfizer would now market its vaccine under the name Comirnaty.

The approval allows Pfizer to advertise Comirnaty on TV, but the company has not announced plans to do so.

Pfizer spokesperson Steven Danehy said “we cannot share our specific plans at this time. But we plan to take a thoughtful approach to marketing and advertising Comirnaty.”

TV ads would be subject to FDA requirements, including that the ads must identify “the most significant risks of the drug.”

Side effects from the vaccines have generally been mild.

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Effects such as tiredness, headache or chills may affect your ability to do daily activities, but they are normal signs that your body is building protection, and they should go away within a few days, according to the federal Centers for Disease Control and Prevention. Serious side effects are rare.

More than 408 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020, through Oct. 18, 2021, according to the latest CDC figures. During this time, a reporting system run by the CDC and the FDA received 8,878 reports of death (0.0022 percent) among people who received a COVID-19 vaccine.

We have rated False claims that the vaccines have caused death. There is no clear evidence that the vaccines have caused any deaths.

Our ruling

An Instagram post claimed: “There’s been no” TV commercials for the COVID-19 vaccines because “they are required by law to list all adverse side effects.”

The vaccine manufacturers have been kept from advertising their vaccines because FDA rules don’t allow advertising for drugs that have only emergency use authorization and not full FDA approval.

For the vast majority of the time that the three COVID-19 vaccines have been administered in the U.S., they have been available through an emergency use authorization. On Aug. 23, Pfizer’s vaccine became the first to gain FDA approval. Pfizer plans to advertise its vaccine in compliance with the FDA’s disclosure rules, a spokesperson said.

We rate the statement False.

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