The European Medicines Agency (EMA) reached the conclusion of its asesssment today.
It said a warning about unusual blood clots with low blood platelets should be added to the product information for the vaccine – but noted the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects..
Its scientific committee PRAC also concluded that these events should be listed as very rare side effects of the vaccine.
Ireland is due to receive over 600,000 doses of the one shot vaccine before the end of June.
In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed.
PRAC noted that the blood clots occurred mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding. The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
It said healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.
COVID-19 is associated with a risk of hospitalisation and death. The EMA said 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 it will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.
Prof Karina Butler , chair of the National Immunisation Advisory Committee (NIAC) said it will be examining the detail of the EMA's decision on the Johnson and Johnson vaccine.
She said additional information is coming from the EMA looking at blood clotting events in wider context with more detail on age-related risk.
Prof Butler was appearing before the Oireachtas health committee and was replying to Sinn Fein TD David Cullinane.
This comes after the EMA ruled that the benefits of the Oxford-AstraZeneca vaccine far outweighed the risks after it had been linked to multiple but very rare clotting events.
Over seven million people have received the J&J vaccine with seven suspected blood clots linked to the drug: one man during clinical trials and six women during the US vaccine rollout.
Despite the EMA’s ruling on AstraZeneca’s benefits outweighing the risks, Ireland’s National Immunisation Advisory Committee (NIAC) restricted its use to over-60s in an “abundance of caution”.
Dr Ronan Glynn yesterday said NIAC were awaiting the EMA’s decision on J&J before any changes to the interval between vaccine doses would be considered.
Earlier this week the HSE moved to update the vaccine roll-out on the “working assumption” that there are no supplies of the Johnson & Johnson vaccine.
“Given the uncertainty and the ongoing review by the EMA of the Johnson & Johnson vaccine, our current plans have been updated with the working assumption that there are no supplies of J&J,” a HSE note to members of the Oireachtas Health Committee read.
More to follow..