WASHINGTON (AP) – Federal health regulators again extended the expiration dates for Johnson & Johnson’s COVID-19 vaccine on Wednesday, giving health workers an additional six weeks to use up millions of doses of the vaccine.
The Food and Drug Administration said in a letter to J&J that injections remain safe and effective for at least six months when properly stored and refrigerated. This is the second time the FDA has extended the shelf life of vaccines since June, when the agency said they could be used for up to 4.5 months. When first approved in February, the FDA said vaccines could be stored for three months at normal refrigeration levels.
Health officials in many states recently warned they could be forced to throw away thousands of doses of the single-shot vaccine without an extension.
The change gives healthcare providers more time to use leftover injections in pharmacies, hospitals and clinics. After plateauing earlier this summer, vaccination rates have started to climb again as the contagious delta variant increases in many parts of the country.
Vaccine expiration dates are based on information from drug manufacturers about how long the injections remain at the correct strength. J&J previously said it continues to perform stability testing in an effort to further extend the shelf life of the shot.
The FDA has looked at the expiration dates of the three vaccines authorized in the United States, as companies have continued to test batches in the months since the injections first launched. The vaccines from Pfizer and Moderna, approved in December, have a shelf life of six months.
J & J’s vaccine was highly anticipated due to its unique formulation and easy-to-ship refrigeration.
But rival drugmakers Pfizer and Moderna, which began shipping vaccines months earlier, have already provided more than enough doses to immunize all eligible Americans. More than 150 million Americans have been fully immunized with the companies’ two-dose injections. In comparison, only 13 million Americans have been vaccinated with the J&J vaccine.
The use of J & J’s vaccine has been affected by several rare potential side effects. Earlier this month, U.S. health regulators added a new warning to the vaccine regarding links to a potentially dangerous neurological reaction called Guillain-Barré syndrome.
This followed a hiatus in use of the vaccine in April after it was linked to a rare blood clot disorder. In both cases, government health advisers said the overall benefits of the bite still far outweigh the risks.
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