June 10 (Reuters) - Johnson & Johnson said on Thursday the U.S. Food and Drug Administration has extended the shelf life of its single-shot COVID-19 vaccine from three months to four-and-a-half months, as millions of unused doses nationwide near expiration.
Safety concerns about J&J’s shot and flagging demand for vaccinations have left close to half of the 21 million doses the company has produced for the United States sitting unused.
The health regulator’s decision was based on data from ongoing studies, which demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius), the drugmaker said.
Reuters reported on Monday that at least 13 lots of J&J shots have expiration dates of June 27 or earlier. It is not clear how many doses that reflects. J&J has another 100 million doses on hand but shipment timing is uncertain.
A top White House official on Tuesday urged state governors to work with the FDA to extend the shelf life of J&J’s COVID-19 vaccine.
J&J said vaccine providers should visit its website to check expiration dates of vaccines currently available in the country.
Reporting by Mrinalika Roy in Bengaluru; Editing by Shounak Dasgupta