Talking Point #22 - Vaccine Advertisement Disclosure Requirements Finally Updated
Did anyone notice?
Since my article, “Vaccine Commercials Are Exempt from Disclosures,” was written in 2021, there have been some important updates regarding vaccine advertising on TV and radio, particularly in light of the COVID-19 pandemic. Here's a breakdown of the key changes:
Vaccine Advertising and the Emergency Use Authorization (EUA):
Vaccines that are authorized under the EUA (Emergency Use Authorization) are subject to specific advertising rules. Under the EUA, the FDA allows vaccines to be distributed without the usual full approval process, but this doesn't necessarily exempt them from disclosure requirements in advertisements. Advertisements for vaccines under the EUA do not need to provide the same level of detailed side effect information that pharmaceuticals might (remember that vaccines are classified as biologics, not pharmaceuticals), but the FDA does require that the ads include a prominent disclaimer that the vaccine is authorized under the EUA.
For example, a commercial or public service announcement (PSA) for COVID-19 vaccines might say, "This vaccine has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA."
Updated Rules for TV and Radio Commercials:
In the past, vaccines were treated differently from pharmaceutical drugs in terms of side effect disclosures in ads. After all, they are classified as biologics, not pharmaceuticals. While drugs (pharmaceuticals) are subject to detailed disclosures, vaccine ads have been more lenient, focusing more on benefits and not required to list every possible side effect unless there is a significant concern.
However, due to the nature of the COVID-19 vaccine rollouts, there have been clearer regulations on how information must be presented, especially with the EUA status. Ads promoting COVID-19 vaccines must inform viewers about the potential side effects and direct them to resources (e.g., the CDC or FDA) for additional information.
The FDA and FTC (Federal Trade Commission) have provided advertisers with guidance about what can and cannot be said in these ads. The key point is that any COVID-19 vaccine advertisement must be truthful, not misleading, and must balance the benefits and potential risks.
COVID-19 Vaccine Commercials:
Since the FDA granted Emergency Use Authorization for the COVID-19 vaccines, vaccines were advertised primarily through public service announcements (PSAs) rather than traditional marketing by pharmaceutical companies. The U.S. government invested heavily in these PSAs to promote vaccination, and they have been widespread across TV and radio, often encouraging people to get vaccinated for the public good.
As for the lack of commercials for COVID-19 vaccines (in late 2020 or early 2021) by pharmaceutical companies in the traditional sense (like those for other vaccines or drugs), this is largely because of the government-funded nature of the vaccine distribution. Vaccines were provided at no cost to consumers, funded by taxpayer dollars, and manufacturers typically were not marketing them like a regular product. The U.S. government (not pharmaceutical companies) took the lead in the messaging and campaign.
Additionally, there was a shift in the early stages of the pandemic towards public health messaging, rather than commercial-style ads, focusing on widespread vaccine acceptance. This trend has been due in part to government mandates and public health initiatives.
Current Regulatory Landscape:
Since 2021, the full approval of COVID-19 vaccines (e.g., Pfizer and Moderna) under the FDA’s Biologics License Application (BLA) has changed the regulatory landscape for vaccine advertisements. Now, FDA-approved vaccines fall under the same advertising regulations as other approved biologics, meaning any ad must include a more comprehensive list of potential side effects and contraindications.
For TV and radio ads, this could mean a greater emphasis on risk communication for the now FDA-approved COVID-19 vaccines, although ads for these vaccines will still tend to focus more on the benefits and accessibility of vaccination.
Summary of Changes:
COVID-19 Vaccine Advertising: Initially, under EUA, vaccine ads were not required to include detailed side effects, but clear disclaimers about EUA status had to be included.
With FDA approval for certain vaccines (like Pfizer and Moderna), ads must include detailed side effect information.
Advertising by Pharmaceutical Companies: Initially, government-funded PSAs took the lead, not traditional vaccine company marketing. The focus was on public health rather than commercial incentives.
Disclosure Requirements: The rules are evolving with FDA approval for COVID-19 vaccines, aligning them more closely with other approved biologics and requiring detailed risk disclosures.
REFERENCES:
FDA, COVID-19 Vaccines: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
FDA, Regulations on Biological Products: https://www.fda.gov/vaccines-blood-biologics
CDC, COVID-19 Vaccine Information: https://www.cdc.gov/covid/vaccines/
CDC, Vaccine Safety: https://www.cdc.gov/vaccine-safety/
FTC, Truth in Advertising: https://www.ftc.gov/news-events/media-resources/truth-advertising
HHS (U.S. Department of Health and Human Services), Public Health Campaigns: https://www.hhs.gov/programs/prevention-and-wellness/vaccines-and-immunizations/index.html
Federal Register, Federal Register Search for Vaccines: https://www.federalregister.gov/
HHS (U.S. Department of Health and Human Services), Vaccine Advertising
HHS Vaccine Ad Campaigns: https://www.hhs.gov/about/news/index.html