Ahead of an expected decision on use of the Johnson & Johnson coronavirus vaccine in the United States, European Union regulators said Tuesday that they had found a “possible link” between the one-shot dose and very rare blood clots.
The European Medicines Agency said a warning about very unusual blood clots should be added to labels for Johnson & Johnson’s COVID-19 vaccine. The agency said these blood disorders should be considered as “very rare side effects of the vaccine.”
Last Tuesday, U.S. officials recommended a pause on using the vaccine while they examine several cases of women who developed a serious blood-clotting disorder after receiving the Johnson & Johnson shots.
The U.S. Centers for Disease Control and Prevention’s independent vaccine advisory panel is expected to meet Friday to discuss whether the pause on the single-shot Johnson & Johnson vaccine should continue or be modified.
Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases and chief medical advisor to President Joseph Biden, said on Sunday that he believes the panel is likely to end the pause but could place restrictions or warnings on use of the Johnson & Johnson vaccine.
U.S. officials have not determined if the clots were linked to the vaccine.
Inoculations using the two-dose Pfizer and Moderna vaccines have continued during the pause.
“It’s not to be minimized but we need to emphasize that it’s a rare event,” Dr. Leonard Krilov, chairman of pediatrics and chief of pediatric infectious disease at NYU Langone Hospital — Long Island, said of the blood clots.
“It’s also proof that monitoring works … I hope this doesn’t further fuel vaccine hesitancy in general,” he said. “Our greatest hope for getting a hold on this disease is to vaccinate.”
Krilov said the vaccine is important and needs to be put in context. He noted more than 3 million deaths across the globe have been attributed to COVID-19.
“Vaccines are safe,” he said. “The problem is safe doesn’t necessarily mean harmless… We have to balance it against what COVID is doing.”
With AP and Lisa L. Colangelo
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