Janssen vaccine's overall benefit-risk ratio remains positive, says EMA
The European Medicines Agency (EMA) has said that the overall benefit-risk ratio of the Janssen Covid-19 vaccine remains positive and that unusual blood clots with low blood platelets should be listed as very rare side effects.
The agency said its safety committee (PRAC) took into consideration all currently available evidence "including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome," in relation to the Janssen (Johnson & Johnson) vaccine.
It added that as of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States.
It concluded that the reported combination of blood clots and low blood platelets was very rare, and that the overall benefits of the vaccine in preventing Covid-19 outweighed the risks of side effects.
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.— EU Medicines Agency (@EMA_News) April 20, 2021
Overall benefit-risk remains positive.
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The agency also stated that, based on the currently available evidence, specific risk factors have not been confirmed. It also pointed out that healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.
Following reports of rare blood clot cases in the US, Johnson & Johnson last week said it was delaying the rollout of its single dose vaccine in Europe.
Last week, South Africa suspended its use of the vaccine in the wake of the US pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage.
The EMA published a similar positive assessment of the AstraZeneca Covid-19 vaccine on 7 April.
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