The European Medicines Agency (EMA) said Tuesday it found a “possible link” between rare types of blood clotting and the Johnson & Johnson Covid-19 vaccine, which is suspended in the U.S. while officials investigate, though the EMA emphasized that the vaccine’s benefits still outweigh the risks.
The EMA said it is recommending the vaccine include a warning on the possible but very rare side effect of the blood clots, which require specialized treatment compared to other types of clotting.
The regulator said it considered all available evidence on the shot, including eight reports of rare blood clotting in the U.S. that prompted regulators to pause the vaccine’s rollout in Europe and the U.S..
While all cases considered occurred in people under the age of 60, mostly women, the EMA said it was unable to determine specific risk factors for the clots.
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The EMA’s guidance comes ahead of an anticipated decision on the shot by U.S. regulators, which are investigating the same reports of blood clots. Dr. Anthony Fauci, President Biden’s chief medical advisor, predicts the American pause will end this week, though said he expects the shot to return with a restriction.
The EMA said the cases it reviewed were “very similar” to those seen with AstraZeneca’s Covid-19 vaccine. A raft of countries halted AstraZeneca vaccine rollouts in early March as a precautionary measure after a small number of reports that recipients suffered from a very rare form of blood clotting. Though the EMA ruled out a broad link to blood clotting and described the vaccine as “safe and effective” weeks later, the agency was unable to rule out a link between the shot and several extremely rare forms of clotting. It found a “possible link” upon further investigation, but still recommended the shot for use. In spite of this, a position shared by the WHO, a number of countries—including France, Germany, the U.K. and Canada—have restricted the shot to older populations, who are believed to be less at-risk of clotting.
8. Out of seven million receiving the shot in the U.S., the EMA said it was investigating eight reports of rare blood clotting.
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