Fact check: Blank packaging insert in J&J vaccine is on purpose, company says
The claim: J&J vaccine package insert left blank
Unboxing videos, where users open boxes on camera to show followers their latest shopping sprees, have become popular across all social media platforms. So much so that an unboxing of the Johnson & Johnson vaccine has gone viral, but not for the reasons one might think.
The Instagram video of a woman with a lab coat shows the package insert, which normally lists the ingredients, instructions and doses of a medicine, had been left mostly blank for the vaccine.
“A lot of the normal information that we would find in a package insert, like the ingredients, would all be found right here in the package insert,” the woman said as she unfolded the blank page.
The May 10 video has received about 34,000 views. It also appeared in a May 6 Instagram post and on Twitter on May 6.
The Instagram user behind the May 10 video didn’t reply to USA TODAY’s request for comment.
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Instagram user covfefe.2020, who shared the video on Instagram May 6 and has received about 22,000 views, told USA TODAY they shared it because “so many people have questions about the jab.”
But the explanation is not as suspicious as some viewers made it out to be: The page has instructions to access online fact sheets with the most up-to-date information about the vaccine.
Inserts have instructions to access information online
The woman in the video briefly shows the part of the insert that has a QR code — used to direct the recipient to a website — though it’s too far from the camera for viewers to read what it says.
But, in fact, that’s the part of the insert that states the front and back panels of the page were left blank intentionally, Lisa Canellos, J&J’s director of global corporate media relations told the Associated Press.
The decision was made so that vaccinators and consumers can access the most up-to-date information about the vaccine online, which has been made available in the form of two fact sheets — one for vaccinators, and one for recipients and caregivers.
The vaccinator fact sheet contains information about storage, dosage and administration, and warnings about possible allergic reactions to the vaccine. They will be available electronically as long as the vaccine maintains its emergency use authorization, Canellos told AP.
The fact sheets were most recently revised April 23 by the U.S. Food and Drug Administration, which authorized the vaccines.
There is also a fact sheet for recipients and caregivers, which details side effects, ingredients and guidance on who should and should not receive the vaccine.
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It’s worth noting the FDA authorized the emergency use of the J&J vaccine “despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.” (The Federal Food, Drug and Cosmetics Act requires that drugs, cosmetics and medical devices be labeled “with adequate directions for safe use,” according to the FDA.)
In its letter authorizing the use of the J&J shot, the FDA required that fact sheets be made available to vaccination providers and recipients, but it doesn’t specify if those must be physical copies or online.
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The FDA also has online fact sheets available for the Pfizer-BioNTech and Moderna vaccines.
Our rating: Missing context
We rate the claim that the Johnson & Johnson package insert is left blank MISSING CONTEXT, because without additional information it can be misleading. While it is true the insert has been left mostly blank, it has instructions on how to access the most up-to-date information online as authorized and revised by the FDA. That information includes instructions, ingredients and dosage, among other things.
Our fact-checking sources:
- User @Covfefe.2020, May 7, Instagram post
- Dustin Penner, May 6, tweet
- Associated Press, May 11, COVID vaccine package insert is blank because up-to-date information is online
- Janssen, accessed May 20, Fact Sheet for Vaccine Providers and full EUA PI
- Janssen, accessed May 20, Fact Sheet for Vaccine Recipients and Caregivers
- Janssen, accessed May 20, Janssen COVID-19 Vaccine Summary
- FDA, accessed May 20, Pfizer-BioNTech fact sheet
- FDA, accessed May 20, Moderna fact sheet
- FDA, February 27, Letter authorizing emergency use of J&J vaccine
- FDA, Nov. 27, 2018, Part II: 1938, Food, Drug, Cosmetic Act
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