Johnson & Johnson says US health officials have extended the expiration date of millions of doses of its COVID-19 vaccine by an additional six weeks
WASHINGTON – Johnson & Johnson said Thursday that US regulators have extended the expiration date of millions of doses of its COVID-19 vaccine by an additional six weeks.
The company said a Food and Drug Administration review concluded the shots remain safe and effective for up to 4 1/2 months. The announcement came after state officials warned that unused doses in storage would expire before the end of the month.
Expiration dates for vaccines are determined based on data that the manufacturer submits to regulators, proving how long the shots last at the correct strength. The FDA originally authorized the J&J vaccine for use for 3 months after manufacture when it was stored at normal refrigeration levels. But J&J said the FDA extended the duration to 4 1/2 months, based on data from ongoing studies assessing the vaccine’s stability.
The FDA is reviewing expiration dates on three authorized vaccines as companies continue to test batches of samples in the months after the first shots were introduced.
The expansion will help maintain the supply of vaccines, even as the rate of new injections continues to decline. On average, about 800,000 new injections were administered per day in the country last week. This is down from a high of around 2 million per day two months ago. Government officials have turned to a growing number of incentives to encourage shots – from paid time off to a $1 million lottery prize.
As vaccination has slowed, it has become clear that it is unlikely to meet US President Joe Biden’s target goal, with 70% of American adults partially vaccinated by July 4. According to the Centers, about 64% of Americans over the age of 18 have taken at least one dose. For disease control and prevention.
J&J’s vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration requirements. The shot was expected to play an important role in vaccination campaigns in rural areas and low-income countries with limited health care infrastructure.
But rival drugmakers Pfizer and Moderna have already supplied enough doses to meet US demand, with more than 129 million Americans fully vaccinated with the companies’ two-dose shots. By comparison, only 11 million Americans have been vaccinated with the J&J shot.
The US is set to announce plans to donate 500 million Pfizer vaccine doses for global use next year, on top of the 80 million doses already pledged by the end of the month.
J&J’s vaccine uptake in the US has also been affected by contamination problems at the Baltimore factory that helps manufacture the shots. The facility was closed in April after an FDA inspection revealed several problems and none of the vaccines made there were distributed.
AP Health writer Linda A. Johnson contributed to this story
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