EMA: Possible link between the Johnson & Johnson vaccine and unusual symptoms

There is a possible link between the Johnson & Johnson vaccine and unusual symptoms with a combination of blood clots in unusual sites, low levels of blood platelets and several cases of bleeding. A few cases have been observed in the USA. The frequency of these unusual symptoms is still being investigated.

The same rare but serious unusual symptoms with a combination of blood clots in unusual sites, low levels of blood platelets and several cases of bleeding, reported after vaccination with the COVID-19 vaccine from AstraZeneca, have also been observed after vaccination with the Johnson & Johnson vaccine. And it is likely that the vaccine is the cause.

This was established today by the European Medicines Agency, EMA. The announcement comes after the EMA fast-tracked an investigation of the case on 9 April. As a result, the possibility of this very rare syndrome will be included in the vaccine’s summary of product characteristics.

The frequency and risks groups are still being investigated

The vaccine has not yet been rolled out in Denmark and has been paused in the USA pending the results of further investigations that will look at risk groups and the frequency of the unusual symptoms in the USA. About 7 million Americans have received the Johnson & Johnson vaccine, and so far, 8 cases have been reported.  

The American authorities are expected to make an announcement later this week. The European drug regulatory authorities and the EMA are working closely with the U.S. Food and Drug Administration, FDA.

The vaccine from Johnson & Johnson was granted a conditional authorisation in the EU on 11 March 2021 because the vaccine’s efficacy in preventing COVID-19 disease outweighs the possible side effects.