Yes, some COVID-19 vaccine doses are past their initial expiration date, but that doesn’t mean they’re unsafe

When the Pfizer-BioNTech and Moderna COVID-19 vaccines were first released to the public under emergency use authorization by the U.S. Food and Drug Administration (FDA) in December 2020, they had a shelf life of up to six months with optimal storage temperatures based on data from stability assessment studies. Meanwhile, Johnson & Johnson’s single-dose COVID-19 vaccine, which was authorized for emergency use in February 2021, had a shelf life of up to three months.

Now, nine months after some of the vaccines were first authorized, VERIFY viewer Tracey wants to know whether the COVID-19 vaccines in the U.S. are past their initial expiration dates.

THE QUESTION

Are some COVID-19 vaccine doses past their initial expiration date?

THE SOURCES

• U.S. Food and Drug Administration (FDA)
• Pfizer-BioNTech
• Johnson & Johnson

THE ANSWER

Yes, some COVID-19 vaccines are past their initial expiration date, but that doesn’t mean they’re unsafe. 

WHAT WE FOUND

According to the FDA, COVID-19 vaccines authorized for emergency use do not have fixed expiration dates because products that are not approved under a biologics license application (BLA) are still being studied. 

In June, the FDA authorized the extension of the Johnson & Johnson COVID-19 vaccine shelf life by six weeks. Then, in late July, the FDA extended it again for a total of six months.

In a statement, Johnson & Johnson said the decision to extend the expiration date was based on data from ongoing stability assessment studies, which demonstrated the vaccine is stable at six months when refrigerated at temperatures of 36 to 46 degrees Fahrenheit.

On Aug. 23, the Pfizer-BioNTech COVID-19 vaccine became the first COVID-19 vaccine to receive full approval from the FDA. 

Following approval, the FDA revised its fact sheet for health care providers administering vaccines to note cartons and vials of the Pfizer vaccine with an expiration date of August 2021 through February 2022 printed on the label may remain in use for three months beyond the printed date as long as approved ultra-cold storage conditions have been maintained.

Johnson & Johnson says vaccine providers can confirm the latest expiration dates of their vaccine at www.vaxcheck.jnj/

Moderna has not submitted data to extend its expiration dates. The VERIFY team reached out to the company and did not hear back by the time of publication. 

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