The Food and Drug Administration (FDA) has agreed to extend the shelf life on Johnson & Johnson’s single-shot COVID-19 vaccine from four-and-a-half months to six months.
Health authorities in a number of states have warned that they may be forced to throw out thousands of doses of Johnson & Johnson’s vaccine absent an extension.
The FDA has been reviewing expiration dates on all three COVID-19 vaccines authorized for emergency use in the United States, as manufacturers have continued to test batches for stability following their roll-out. Pfizer and Moderna’s two-dose vaccines have a shelf life of six months.
Johnson & Johnson’s one-and-done vaccine was highly anticipated because it could be stored at relatively high temperatures and so facilitated distribution, particularly in developing countries with patchy cold-storage infrastructure.
“A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic,” the company said in a statement.
But use of the Johnson & Johnson COVID-19 vaccine has been hurt by several rare potential side effects.
In April, the FDA and the Centers for Disease Control and Prevention (CDC) recommended states temporarily halt using the Johnson & Johnson vaccine out of caution and investigated several women who developed cerebral venous sinus thrombosis along with low blood platelets within two weeks of getting the shot. But a CDC panel later in the month voted to resume usage of vaccine and recommended adding a warning.
Earlier in July, health regulators added a new warning to the vaccine about links to a potentially dangerous neurological reaction called Guillain-Barré syndrome.
In both cases, government health advisers said that the overall benefits of the Johnson & Johnson vaccine outweigh the risks associated with potential side effects.
