EMA: Janssen Covid vaccine should be used despite "very rare" blood clots
The European Medicines Agency said that the Janssen Vaccine against Covid-19 has a "possible link" to eight cases of unusual blood clots forming in patients who also presented a low platelet count. The blood clots mostly formed in the cerebral veins, abdominal veins and arteries of the eight people, all of whom are under 60 years of age. The clots were primarily discovered in women within three weeks of vaccination.
"The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects," the EMA said in a statement. It noted that over seven million people in the United States received the Janssen Vaccine
"The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria," the EMA said. No specific common risk factors were identified in either the Janssen or AstraZeneca vaccine investigations.
The blood clots combined with low platelet counts can be caught and treated early, the EMA said. Symptoms may include shortness of breath, chest pain, leg swelling, persistent abdominal pain, and small blood spots below the skin at the vaccination point. Neurological symptoms like severe persistent headaches, or blurred vision, may also be identified in thrombosis patients.
Developed at the Janssen laboratory in Leiden, the one-shot vaccine is distributed by parent company Johnson & Johnson. The parent company itself asked the Dutch government, and all other national governments within the European Union, to suspend use of the product until an investigation in the United States was completed.
On April 14, the caretaker Cabinet of the Netherlands decided to delay the use of the vaccine. Health Minister Hugo de Jonge said he would wait until the EMA released the results of its investigation before announcing any next steps. De Jonge was also instrumental in disallowing the AstraZeneca vaccine from being used by people under 60, a decision met with heavy criticism by intensive care experts, blood clot experts, and a majority of Parliament.
The Netherlands has ordered a total of 11.3 million doses of the vaccine. The country took delivery of a first batch consisting of over 79 thousand doses on April 12, with three million in total due by the end of June. However, Johnson & Johnson said it would discontinue any further deliveries to European countries until an investigation in the United States has been completed. The EMA's PRAC safety committee carried out the study independent of U.S. authorities.
The Janssen vaccine offers 66 percent protection against the coronavirus disease, and was 85 percent effective at preventing more severe forms of Covid-19.