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COVID vaccine package insert is blank because up-to-date information is online

May 11, 2021 GMT

CLAIM: The packaging insert with the Johnson & Johnson COVID-19 vaccine is suspiciously blank, containing no information about ingredients and side effects normally found with a vaccine.

AP’S ASSESSMENT: Missing context. The paper insert states that it was intentionally left blank and that FDA-authorized fact sheets are available electronically, according to a J&J representative. This is intended to ensure vaccinators and consumers refer to the most up-to-date information about the vaccine during the FDA’s emergency use authorization, the representative said.

THE FACTS: The video shows a blonde woman in a white lab coat opening a J&J vaccine package. She finds a piece of paper folded on top, which she unfolds into a large sheet that is blank except for one small section of text.

“A lot of safety and efficacy data — in fact all of the normal information that we would find in a package insert, like the ingredients — that would all be found right here in this package insert,” the woman says in the video. “Must be magic. It’s all blank.”

Thousands of Twitter, TikTok and Instagram users shared the video this week, along with claims that J&J’s vaccine package was “hiding” important information from pharmacists.

However, Lisa Cannellos, J&J’s director of global corporate media relations, explained that the section of text on the paper includes instructions to access that information online.

“The package insert states that the front and back panels of the insert were intentionally left blank, with Fact Sheets made available electronically for the duration of FDA’s Emergency Use Authorization,” Cannellos told The Associated Press in an email. “This process ensures vaccinators and consumers have the most up-to-date Fact Sheets available to them, withwww.vaxcheck.jnj reflecting any revisions made in alignment with the FDA. The Fact Sheets contain detailed prescribing information, including ingredients, dosage and administration, warnings and contraindications.”

J&J’s single-dose COVID-19 shot was authorized for emergency use in the U.S. on Feb. 27. Health officials later paused J&J vaccinations for 11 days, but restarted them on April 23 after scientific advisers decided the shot’s benefits outweighed a rare risk of blood clot found in 15 vaccine recipients out of nearly 8 million people given the shot. Health officials determined that the risk could be handled with warnings to help younger women — who made up the majority of those who developed the clot — decide if they should use the J&J vaccine or an alternative.

The J&J vaccine package insert instructs providers to go online to view the FDA-authorized fact sheet, which was most recently revised on April 23, for dosage and other information.

The package insert also includes J&J contact details and information about the safe storage of the vaccine.

A separate fact sheet is provided for J&J COVID-19 vaccine recipients and their caregivers. It includes vaccine ingredients, a list of side effects and information about who should and should not receive the shot.

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This is part of The Associated Press’ ongoing effort to fact-check misinformation that is shared widely online, including work with Facebook to identify and reduce the circulation of false stories on the platform.

Here’s more information on Facebook’s fact-checking program: https://www.facebook.com/help/1952307158131536