April 20 (UPI) -- The European Union's top medicines regulator said Tuesday a warning should accompany Johnson & Johnson's COVID-19 vaccine with information that says it has been linked to cases of blood clotting.
The European Medicines Agency made the ruling, while noting that the clotting risk appears to be "very rare," considering that millions of people have received the vaccine with no problem.
"Based on the currently available evidence, specific risk factors have not been confirmed," the agency said in a statement.
"The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca."
The EMA said health providers and recipients should be aware of the possible risk. The vaccine, manufactured by Johnson & Johnson subsidiary Janssen, has been suspended in the United States pending further review.
Earlier Tuesday, Johnson & Johnson said it's generated $100 million in sales of the vaccine during the first three months of the year.
The company detailed the sales figures in its first-quarter earnings report, which noted that Johnson & Johnson saw overall quarterly growth of 8%.
The pharma company reported $22.3 billion in total sales.
"The ability to deliver these results while simultaneously advancing our robust pipeline of life-enhancing medicines, products and solutions during these times is a testament to the strength and resilience of our business," Johnson & Johnson CEO Alex Gorsky said in a statement.
Clotting was seen in at least six women after they received the one-dose vaccine, which was approved for emergency use in the United States at the end of February. It's the third approved coronavirus vaccine in the United States but the only one that's adenovirus-based. Two-dose shots from Pfizer and Moderna are based on messenger RNA.
Federal regulators have not yet lifted the pause for the Janssen vaccine, but Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he expects the Food and Drug Administration and Centers for Disease Control and Prevention to make a determination sometime this week.
In its report Tuesday, Johnson & Johnson said it saw a 3% decline in its consumer health division, which includes products like mouthwash and items for baby care, skin and beauty.