EMA’s PRAC Recommends Warning on Very Rare Side Effects of Janssen’s COVID-19 Vaccine

Pharmaceutical Technology Editors

EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine, it was revealed in an April 20, 2021 press release.

As a result of its findings, PRAC has recommended that a warning be placed in the product information of Janssen’s COVID-19 vaccine about the potential side effect and specified that the events are listed as very rare. All currently available evidence were taken into consideration by PRAC before it made any conclusions. Evidence considered included eight reports from the US of serious cases of unusual blood clots associated with low levels of blood platelets.

PRAC confirmed that the blood clots that have occurred, have mostly been at unusual sites, such as the brain and the abdomen, along with low levels of blood platelets and sometimes bleeding. Similar cases have been seen with the AstraZeneca COVID-19 vaccine, Vaxzevria.

EMA has established that the benefits of Janssen’s COVID-19 vaccine continue to outweigh the risks, and as is the case with all vaccines, it will continue to monitor the safety and effectiveness of the vaccine and will provide the public with all the latest information.

Source: EMA