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FDA’s Pfizer-BioNTech COVID-19 Vaccine Patient Factsheet Omits Critical Public Health Advice

COVID-19 Patient Fact Sheets Must Include Advice for Safe Public Health Practices, Along with Vaccination

WASHINGTON, D.C. – Pfizer-BioNTech’s COVID-19 vaccine FDA-approved patient fact sheet omits important information about safe public health practices and must be updated before mass vaccination, Sidney Wolfe, founder and senior adviser at Public Citizen’s Health Research Group said in testimony Thursday at an FDA advisory committee hearing.

The U.S. Food and Drug Administration’s emergency use authorization (EUA) guidance includes a requirement for an FDA-approved patient fact sheet to accompany the use of any EUA product “to ensure that recipients are informed about the [product] they receive under an EUA” and to inform them of “any available alternatives to the product and of the risks and benefits of available alternatives.”

Pfizer-BioNTech’s fact sheet accurately states that the vaccine may not protect everyone from COVID-19. However, it fails to mention the need for mask-wearing and social distancing after vaccination, despite general consensus from public health experts on the continued necessity of these practices.

“We are faced with a deadly surge of COVID-19 in this country with everyone being urged to wear masks and engage in social distancing,” Wolfe said. “The current absence of this successful public health advice in the FDA-approved patient vaccine fact sheets exacerbates people’s tendencies that once vaccinated, being less careful is justified.”

The FDA must update the Pfizer COVID-19 vaccine factsheet and assure that the Moderna fact sheet, to be issued with a Moderna COVID-19 EUA also includes this critical public health advice. The agency must also ensure that subsequent fact sheets for other vaccines also note the importance of continuing these practices.

“Even with current evidence that both vaccines are highly efficacious, there is still understandable concern about the danger of a false sense of security,” Wolfe said. “If those getting vaccinated no longer adhere to proven, preventive public health measures such as wearing masks and appropriate social distancing, the vaccine alone might not be protective.”