U.S. regulators limited who can receive the Johnson & Johnson (J&J) Covid-19 vaccine over concerns that it can cause serious blood clots on rare occasions.
The Food and Drug Administration (FDA) said in a statement that its investigation had revealed that people who get the J&J jab are at increased risk of developing a life-threatening blood clot.
Blood clots can cause a heart attack or a stroke when they get stuck and block the flow of blood to organs including the heart and brain.
The clotting condition associated with the J&J vaccine is called thrombosis with thrombocytopenia (TTS). There have been 60 confirmed cases, including nine fatalities through March 18, 2022 from the nearly 19 million doses administered nationwide.
The FDA is now only authorizing the vaccine to people who are 18 years and older where other vaccines are not accessible or clinically viable.
“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The J&J vaccine offered a one-dose option that many people preferred over the two doses offered by other vaccine makers.
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There are three covid vaccines – Pfizer-BioNTech, Moderna, and J&J – authorized for use in the U.S., but with this limitation, only the latter two remain as options.
Concerns over blood clots became widespread starting in April 2021, when the U.S. government put a pause on the J&J shot after six women who received it developed rare blood clots—and one died.
U.S. authorities have in recent months recommended that Americans starting their covid-19 vaccinations use the Pfizer or Moderna shots instead.
Photo: A health worker administers a Johnson & Johnson vaccine in the Medina neighborhood of Dakar, Senegal, July 28, 2021. (AP Photo/Leo Correa, file)