Johnson & Johnson announced on Thursday that the U.S. Food and Drug Administration has extended the expiration date of its single-shot COVID-19 vaccine by six weeks.
The review from the regulator determined that the vaccines are safe and effective for up to four-and-a-half months, the company said, which comes amid concerns from state health officials that many unused doses were set to expire in the coming weeks.
“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 (2 – 8 degrees Celsius),” the company said in a statement.
Previously, the FDA authorized the vaccine for use for up to 3 months after manufacture when stored properly.
More than 11 million people have been vaccinated with the single-shot jab, which can be stored at normal refrigeration temperatures, unlike the other two COVID-19 vaccines authorized by the federal government, from Pfizer-BioNTech and Moderna, which require ultra-cold storage.
“A single-shot vaccine that provides protection and prevents hospitalization and death is an important tool in the global fight against COVID-19,” Johnson & Johnson noted, pointing to a Phase 3 study which they say demonstrates the efficacy of the single-shot vaccine, including against regional variants.
“Regardless of race and ethnicity, age, geographic location and comorbidities, these results remain consistent,” they added.
“We continue to work with the U.S. government and health authorities to support the use of our vaccine, which plays an important role in combatting the pandemic, including among those who wish to be fully vaccinated with one shot,” Johnson & Johnson concluded.
The FDA has been reviewing expiration dates on the three authorized vaccines as companies have continued to test samples of batches in the months since the shots first rolled out.
The extension will help maintain vaccine supplies even as the rate of new injections continues to slip. The country averaged about 800,000 new injections per day last week. That’s down from a high of nearly 2 million per day two months ago. Government officials have turned to a growing number of incentives to encourages shots — from paid time off to $1 million lottery prizes.
As the pace of vaccinations has slowed, the possibility of the U.S. missing President Joe Biden’s goal to have 70% of American adults partially vaccinated by July 4 grows more and more likely. About 64% of Americans older than 18 have had at least one dose, according to data from the Centers for Disease Control and Prevention.
The Associated Press contributed to this report.