FDA added six weeks based on data from the company’s ongoing studies on the vaccine’s stability
FRIDAY, June 11, 2021 (HealthDay News) — U.S. regulators have extended the expiration date on millions of Johnson & Johnson coronavirus vaccine doses by six weeks, the company announced Thursday.
A U.S. Food and Drug Administration review concluded the shots remain safe and effective for at least 4.5 months, J&J said in a statement. In February, the FDA first authorized the vaccine for up to three months when stored at normal refrigeration temperatures.
J&J said the FDA added six weeks based on data from the company’s ongoing studies on the vaccine’s stability. The FDA change gives health providers more time to use shots sitting at pharmacies, hospitals, and clinics, the Associated Press reported. Many states have adopted a “first-in-first-out” approach to try and use their oldest vaccines first.
The J&J vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration. The shot was expected to play a key role in vaccination campaigns in rural areas and low-income countries with limited health care, the AP reported. Use of the J&J vaccine appears to have also been hurt by links to a rare blood clot disorder. That issue prompted U.S. health officials to “pause” use of the shot for 11 days. That hold was lifted in late April after officials concluded the vaccine’s benefits outweighed its risks.
Associated Press Article
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