The European Medicines Agency (EMA) has given its backing to the Johnson & Johnson Covid-19 vaccine, saying the overall benefit-risk remains positive, despite warning about the very rare possible side effect of blood clots.
The EU drug regulator’s safety committee conducted an investigation into the side effects of the Johnson & Johnson vaccine after the US Food and Drug Administration (FDA) suspended its use in America earlier this month “out of an abundance of caution.”
The FDA’s move led to Johnson & Johnson delaying its rollout of the vaccine throughout Europe to allow for a full assessment of the risks, with the EMA looking into all eight complaints of clots – including one fatal – from among the 7 million doses administered in the US.
EMA’s safety committee (#PRAC) recommends adding ‘very rare cases of unusual blood clots with low blood platelets’ to the list of side effects for Janssen #vaccine.
Having conducted its review, the EMA said on Tuesday that a warning about “very rare cases of unusual blood clots with low blood platelets” should be added to the list of side effects for the vaccine, but that overall the benefits outweigh the risks.
The decision was welcomed by the president of the EU Commission, Ursula von der Leyen, who tweeted a message calling the EMA’s announcement “good news for the roll-out of vaccination campaigns.”
European Commissioner for Health and Food Safety Stella Kyriakides shared similar sentiments, stating in light of the EMA’s ruling: “I urge EU Member States to follow the opinion of our experts. Vaccinations save lives.”
The EMA will continue to monitor the vaccine’s safety as new data becomes available, but the decision should now facilitate its use across Europe, allowing states to bolster Covid-19 inoculation rollouts, which have been hampered by delays and supply issues. Meanwhile, US authorities are due to meet on Friday to discuss the possible resumption of the vaccine there.
