Johnson & Johnson's COVID-19 vaccine could be linked to "very rare" cases of blood clots, but that does not rule out the use of the one-shot dose, the European Medicines Agency (EMA) said.
The EMA Tuesday stated that its safety committee determined that a warning about unusual blood clots would suffice on the labels of J&J's vaccine, as it did with AstraZeneca's shots.
The announcement added another complication to the European Union's vaccination rollout and dealt the company a huge setback just a week after its vaccine was halted in the U.S.
The agency said that "the 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."
J&J immediately declared that it would revise its label in accordance with the request and resume vaccine shipments to the EU, Norway, and Iceland.
"The safety and well-being of the people who use our products is our number one priority," J&J said in a statement.
Meanwhile, the U.S. Centers for Disease Control and Prevention said on Monday that it is investigating a "handful" of confirmed adverse effects since people got the vaccine, and it is scheduled to release its own findings on Friday.
The EMA approved Johnson & Johnson's shot for use on Mar. 11, but it was not yet widely used.
The vaccine has been hailed as a potential game-changer in the pandemic because it is administered in a single dose, while most other approved vaccines around the world are given in two doses, at least a few weeks apart.
However, it is the second vaccine to be halted in Europe due to concerns that it may cause rare blood clots. The AstraZeneca vaccine was delayed for many days in several EU countries after a similarly small number of clotting cases surfaced.
