EMA finds a possible - very rare - link to blood clots for Janssen vaccine
The European Medicines Agency (EMA) safety committee has concluded (20 April) that a warning about unusual blood clots with low blood platelets should be added to the product information for the COVID-19 Vaccine developed by Dutch company Janssen, also known as the Johnston and Johnson vaccine.
The new advice comes after eight reports of serious cases of unusual blood clots in the United States, which has already used this product to vaccinate more than seven million people. One of these cases resulted in a fatality. All cases occurred in people under 60 years of age within three weeks of vaccination, the majority in women. The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
It will be up to individual EU countries to decide whether they want to use this vaccine. The Janssen vaccine has the notable advantage of only requiring a single-shot, rather than a two-dose process.
The EMA are clear that the use of the vaccine continues to outweigh the risks for people who receive it. The vaccine is effective at preventing COVID-19 and reducing hospitalisations and deaths.