TUESDAY, April 20, 2021 (HealthDay News) -- A warning about a possible link to rare blood clots should be added to the Johnson & Johnson/Janssen single-dose COVID-19 vaccine, the European Union (EU) drug regulator said Tuesday.
But the European Medicines Agency (EMA) also said the vaccine's benefits still far outweigh its risks and it did not recommend that member nations avoid using the vaccine, The New York Times reported. "The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects," the agency said in a statement about its nonbinding recommendation.
The rare clots associated with the Johnson & Johnson vaccine are "very similar" to those associated with the AstraZeneca vaccine, for which the EMA made a similar recommendation, The Times reported.
"Health care professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination," the agency advised. It said an immune response may be one possible explanation for the rare blood clots.
The Johnson & Johnson vaccine has already been given to nearly 8 million people in the United States. However, U.S. regulators last week paused use of the vaccine due to concerns about six cases of the rare blood clots. That led Johnson & Johnson to delay the vaccine's rollout in the 27 EU member states, The Times reported. U.S. health officials said Monday they are investigating "a handful" of new, unconfirmed cases that have emerged since use of the vaccine was paused.