J&J resumes roll-out of COVID-19 vaccine in EU
21st April 2021
Johnson & Johnson (J&J) is planning to resume the roll-out of its COVID-19 vaccine in the EU following updated guidance from the European Medicines Agency’s (EMA) safety committee.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed a small number of cases of very rare blood clots in combination with low platelet counts in individuals who have received the J&J vaccine.
According to J&J, these very rare adverse events can occur within approximately one to three weeks following injection with its COVID-19 vaccine.
The PRAC has confirmed the overall benefit-risk profile of J&J’s COVID-19 vaccine, although J&J must update the product information for the jab to include information on the diagnosis and management of this type of rare adverse event.
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Scientists criticise decision to suspend J&J vaccine in SA as ‘irresponsible and unethical’ Mark Heywood © Provided by Daily Maverick
A growing number of scientists are questioning the health regulator’s decision to suspend authorisation of the Johnson & Johnson vaccine and are calling for the decision to be urgently rescinded to save the lives of health workers vulnerable to Covid-19.
Professor Barry Jacobson, president of the Southern African Society of Thrombosis and Haemostasis, has sharply criticised the decision by the South African Health Products Regulatory Authority (SAHPRA) to suspend authorisation of the J&J vaccine currently being used as part of the Sisonke trial to vaccinate South Africa’s vulnerable healthcare workers.
Professor Barry Jacobson, president of the Southern African Society of Thrombosis and Haemostasis, has sharply criticised the decision by the South African Health Products Regulatory Authority (SAHPRA) to suspend authorisation of the J&J vaccine currently being used as part of the Sisonke trial to vaccinate South Africa’s vulnerable healthcare workers.
The background and reasons given by SAHPRA for the decision are explained here.
Jacobson is a practising clinical haematologist and an adjunct professor at Wits University. In a conversation with
Maverick Citizen on Friday he pointed out the “anomaly” that heparin, a blood-thinning drug commonly used in bypass surgery and to treat clots and deep-vein thrombosis, also has a rare side-effect in fewer than 1% of patients, causing paradoxical thrombosis. This is described as Heparin Induced Thrombocytopenia, a condition of clots in the veins of the brain and is associated with certain risk groups.