Video misleads on patient access to Covid-19 vaccine safety data

·3-min read

A video shared on social media shows a person suggesting Covid-19 vaccine safety information is being concealed from patients because a US pharmacist provided a blank sheet from a manufacturer when asked for data on the shots. This is misleading; both the US Food and Drug Administration and the pharmacy chain say the information is available online.

"How is it informed consent when all of the safety studies, placebo safety studies are not listed from the manufacturer?" the person asks a pharmacist in the video posted on Facebook on December 23, 2021.

The video was filmed at a CVS store, one of the largest drug store chains in the US. In the clip, the person asks for information about Covid-19 vaccines, including the "insert from the manufacturers that shows the safety studies."

"It's in the box," the person tells the pharmacist, who then brings out a folded piece of paper that says "intentionally blank."

Screenshot of a Facebook post taken on January 13, 2022

Comments on the video claim that the exchange is proof that Covid-19 vaccines are dangerous, and that manufacturers and health authorities are trying to conceal this fact. "Now we all can see it, so can peeps start believing us yet?" one wrote.

The video was also shared on YouTube and Bitchute, a video streaming service often used by individuals banned from YouTube, while other people filmed similar interactions at different US pharmacies, also pointing out the "intentionally blank" inserts in Moderna and Johnson & Johnson Covid-19 vaccine boxes.

Covid-19 shots have been the subject of misinformation since their authorization by the Food and Drug Administration (FDA) in 2020. AFP Fact Check has debunked various inaccurate claims about vaccines here.

The vaccine insert videos are misleading, as the blank papers are meant to ensure individuals have access to the latest information on the shots, not to conceal it.

"The information on those inserts is communicated in a patient 'fact sheet' which are posted on our website," FDA spokeswoman Alison Hunt told AFP, adding that "for an approved vaccine, information is communicated in a package insert."

"Fact Sheets typically are not shipped with the vaccine," said Hunt, adding that the vials of the vaccines feature QR codes that providers of the shots can be used to download the latest available information.

AFP confirmed that fact sheets for the Pfizer-BioNTech, Moderna and Johnson & Johnson shots all appear on the FDA's website.

Patients can also request more information from their pharmacists. Matthew Blanchette, spokesman for CVS, said "patients are provided an FDA-approved fact sheet for the corresponding vaccine electronically and/or printed upon request."

The Johnson & Johnson and Moderna Covid-19 vaccines received Emergency Use Authorizations, and the FDA's page on this status says the agency must ensure that information on the shots is provided to patients. Fact sheets for both vaccines were revised in January 2022.

Moderna did not return AFP requests for comment by the time of publication, but Johnson & Johnson explained why its package inserts are left blank.

"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," said Richard Ferreira, spokesman for Johnson & Johnson.

"This process ensures vaccinators and consumers have the most up-to-date Fact Sheets available to them, with www.vaxcheck.jnj reflecting any revisions made in alignment with the FDA," he added.

The US Centers for Disease Control and Prevention recommends that everyone over the age of five receive a Covid-19 shot, emphasizing that the immunization is safe and effective, including for children and teens.

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