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EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine

Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the overall benefit-risk profile of Johnson & Johnson’s (J&J) COVID-19 vaccine is positive.

The PRAC concluded in a meeting yesterday, however, that a warning regarding unusual blood clots with low blood platelets should be added to the product information for the vaccine, after finding a possible link between the rare adverse events and the jab.

The committee considered all currently available evidence in its review, including eight reports in the US of serious cases of unusual blood clots associated with low blood platelet levels – one of which was fatal.

These blood clots mostly occurred in ‘unusual sites’, including in veins in the brain (cerebral venous sinus thrombosis) and in the abdomen (splanchnic vein thrombosis) and in arteries, along with low blood platelets and sometimes bleeding.

PRAC noted that the cases reviewed in relation to the J&J vaccine were ‘very similar’ to cases that occurred with AstraZeneca/Oxford University’s COVID-19 vaccine.

Following its review, PRAC has also concluded that these events should be listed as very rare side effects of the J&J COVID-19 vaccine.

A ‘plausible’ explanation for the combination of blood clots and low blood platelets observed following vaccination could be an immune response, according to the EMA.

This leads to a condition that is similar to heparin induced thrombocytopenia (HIT) that can be seen in patients treated with the anticoagulant heparin.

‘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,’ stated the EMA.

J&J is now set to resume its shipments of its vaccine to the EU, Norway and Iceland, adding in a statement that it has provided updated guidance for use of the jab.

The Summary of Product Characteristics and Package Leaflet for the vaccine will now include information on the diagnosis and management of the rare blood clots identified in the PRAC review.

“We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally,” said Paul Stoffels, vice chairman of the executive committee and chief scientific officer of J&J.

“We are committed to equitable access and to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use,” he added.

In the US, J&J's vaccine remains on hold, with further discussion of the rare blood clot cases set to take place during a meeting of the US Centers for Disease Control and Prevention's (CDC)  Advisory Committee on Immunization Practices (ACIP) on Friday.

Article by
Lucy Parsons

21st April 2021

From: Regulatory



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