Experts at the European Medicines Agency (EMA) have said that they have found a ‘possible link’ between Johnson & Johnson’s Janssen vaccine against Covid-19 and very rare blood clots, after a small number of cases were reported in the USA – but they have also confirmed that the vaccine’s benefits still outweigh the very small risks of recipients developing the clots.
The EMA has said a warning about the rare blood clots should be added to labels for the one-dose Janssen vaccine but that they should be considered as ‘very rare side effects’.
Spain had prioritised giving citizens aged between 70–79 jabs of the Janssen vaccine – but last week the Johnson & Johnson pharmaceutical group temporarily delayed their rollout of the vaccine in Europe, following the USA regulators’ recommendation to pause its use because of possible links to rare blood clots.
US officials had recommended a pause in the vaccine after they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated (up to 13 April).
In reaching its conclusions on Tuesday that the benefits of the vaccine outweigh the risks, the EMA said that it had taken into consideration ‘all currently available evidence including eight reports from the USA of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome’.
‘All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women,’ the EMA said. It went on to add that ‘the cases reviewed were very similar to the cases that occurred with the Covid-19 vaccine developed by AstraZeneca‘.
‘The benefits of the vaccine continue to outweigh the risks for people who receive it,’ the EMA concluded. ‘The vaccine is effective at preventing Covid-19 and reducing hospitalisations and deaths.’