By Hanna Park
(WASHINGTON) The Food and Drug Administration authorized on Thursday an extension of the expiration date of Johnson & Johnson’s COVID-19 vaccine, expanding the shelf life by six weeks shortly before millions of doses were set to expire.
A Food and Drug Administration review concluded the shots remain safe and effective for up to four and a half months, the company said. The announcement comes after state officials warned that several unused doses in storage would expire by June.
“The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit,” Johnson & Johnson said in a statement.
The expiration dates for vaccines are determined based on data the manufacturer submits to federal regulators demonstrating how long the shots last at the right strength. The FDA originally authorized J&J's vaccine for up to 3 months after manufacture when stored at normal refrigeration levels.
But the company said the FDA extended the period to four and a half months, based on data from ongoing studies.
The move gives states extra time to figure out how to use up the supply of the single-dose vaccine, as vaccination rates plummeted in recent weeks and local officials struggled to use up stockpiles of the shot.
In April, the vaccine took a major blow after a rare blood clotting disorder occurred in its recipients, prompting the FDA and CDC to recommend a pause in its use. According to the Centers for Disease Control and Prevention data, state officials have curtailed the use of the vaccine, and roughly 10 million doses delivered to states remain unused.
The pace of vaccinations has fallen in recent weeks for all three federally authorized shots. Biden administration has shifted its strategy from relying on mass vaccination sites to highlighting more targeted approaches, including some with incentives.