The approved shelf life of Johnson & Johnson’s one-and-done COVID-19 vaccine has been extended by 50% amid reports millions of unused doses were nearing expiration, the company confirmed Thursday.
The Food and Drug Administration granted the new authorization after “data from ongoing stability assessment studies” proved that doses were still stable and effective 41/2 months after packaging when properly refrigerated, the company said.
The single-shot vaccine previously had an approved shelf life of only three months.
The 45-day extension comes at a critical time for the U.S. vaccination effort, with health officials scrambling to reach President Joe Biden’s goal of at least partially vaccinating 70% of Americans by July 4.
A combination of softening demand for COVID-19 vaccines overall and lingering safety concerns about the J&J shot, which was linked to extremely rare blood clots, left nearly half of the 21 million doses the company produced for the U.S. sitting unused, Reuters reported.
At least 13 lots of J&J shots carried expiration dates of June 27 or earlier, Reuters said.
The J&J shot is considered an important option in the global fight against COVID-19 because it’s easier to distribute to underserved and remote locations than competing mRNA vaccines, which require more intense refrigeration and two doses spaced weeks apart.
