Moderna is recalling a batch of its COVID vaccine in Europe after a “foreign body” was found in a vial. Doses in the US are not affected.
WASHINGTON — Moderna’s coronavirus vaccine, now marketed as Spikevax, was approved by the U.S. Food and Drug Administration (FDA) for adults ages 18 and older on January 31, 2022, making it the second to receive full FDA approval after Pfizer’s vaccine.
Now, Moderna’s vaccine has once again returned to the news cycle, with people share information about Moderna potentially issuing a vaccine recall.
Google Trends data also shows that US residents are looking for information about the “Modern vaccine recall.”
Has the Modern COVID-19 vaccine been withdrawn in the United States?
No, the Moderna COVID-19 vaccine has not been withdrawn from the market in the United States. The drugmaker withdrew some doses of the vaccine in Europe after a “foreign body” was found in a vial.
WHAT WE FOUND
Moderna announced on April 8 that it would recall a batch of Spikevax produced at ROVI, a manufacturing company in Spain, after a “foreign body” was found in a vial.
The reported vial was “punctured and unadministered,” Moderna said in a press release announcing the recall. Moderna did not disclose what was found in the vial.
The batch consisted of 764,900 doses and was distributed in Norway, Poland, Portugal, Spain and Sweden from January 13 to 14, 2022, according to Moderna.
Moderna said no safety or health issues have been reported in people who received Spikevax from the recalled batch. In addition, there is no indication that the withdrawn doses that have already been administered are less effective than others, according to Moderna.
The lot is being removed “out of an abundance of caution,” Moderna said.
“Moderna does not believe this poses a risk to other vials in the lot and does not believe this will affect the significant benefit/risk profile of the vaccine,” the press release says.
The company said it is contacting health authorities as the investigation progresses.
A spokesperson for the Food and Drug Administration (FDA) told VERIFY that there is no recall of Moderna’s vaccine in the United States.
The FDA also has lists of vaccine recalls by year on its website, with the two most recent being in 2021 and not including other COVID-19 vaccines.
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