The AstraZeneca and Johnson & Johnson (J&J) COVID vaccines came under scrutiny again this week as more reports of deaths — largely due to blood clot disorders — surfaced in Belgium, Canada and Greece.
Adding to the vaccine makers’ woes is a new report out of London from researchers who identified the first cases of strokes occurring in young adults who received the AstraZeneca vaccine, which was co-developed by the University of Oxford University in the UK.
Belgium suspends use of J&J vaccine
Belgium said Wednesday it was suspending vaccinations with J&J vaccine, for people under the age of 41, following the death of a woman from blood clots after she received the shot. This is the second time Belgium has paused the one-shot vaccine.
“The Inter-ministerial conference has decided to temporarily administer Janssen’s vaccine to the general population from the age of 41 years, pending a more detailed benefit-risk analysis by the EMA,” said a statement issued by Belgium’s federal health minister and seven regional counterparts.
The woman, who was under the age of 40, died May 21 after being admitted to the hospital with severe thrombosis and platelet deficiency, Reuters reported.
The government asked for urgent advice from the European Union’s drug regulator, the European Medicines Agency (EMA), before it would consider lifting the suspension.
The EMA said it is reviewing the death of the woman in Belgium, along with other reports of blood clots, with the Belgian and Slovenian medicines agencies, and has asked J&J to carry out a series of additional studies to help assess a possible link between the shot and rare blood clots.
J&J said April 20 it would resume the roll-out in the EU of its COVID vaccine, marketed under the company’s Janssen subsidiary — with a warning on its label — after several countries, including Belgium, first paused the vaccine amid concerns of its possible link to blood clotting disorders.
The EMA confirmed a “possible link,” but concluded the vaccine’s benefits outweighed the risks. The drug regulator’s safety committee (PRAC) said a warning should be added to the product label, but the blood clot-related disorders should be listed as “very rare” side effects of the vaccine.
On April 23, the Centers for Disease Control and Prevention (CDC) voted to resume the use of J&J’s vaccine without restrictions after the vaccine was paused to investigate reports of rare blood clots. The recommendation by the CDC’s advisory panel said the link between blood clots and J&J’s COVID vaccine was “plausible,” but concluded the vaccine’s benefits outweighed the risks and recommended use for persons 18 years of age and older in the U.S. under the FDA’s Emergency Use Authorization.
J&J has said no clear causal relationship has been established between its vaccine and blood clots.CHD Calls on FDA to Take COVID Vaccines Off the Market – Submit a Comment
Researchers identify strokes in young adults after AstraZeneca shot
The first cases of large-vessel arterial occlusion strokes in young adults linked to AstraZeneca’s vaccine were described in detail for the first time in a letter published online in the Journal of Neurology Neurosurgery & Psychiatry.
The three cases, one of which was fatal, occurred in two women and one man in their 30s or 40s who developed characteristics of vaccine-induced immune thrombotic thrombocytopenia (VITT), a reaction associated with the AstraZeneca vaccine.
“These are the first detailed reports of arterial stroke believed to be caused by VITT after the AstraZeneca COVID vaccine, although stroke has been mentioned previously in the VITT data,” senior author, Dr. David Werring, professor of clinical neurology at the Stroke Research Centre, University College London Queen Square Institute of Neurology, told Medscape Medical News.
“VITT has more commonly presented as CVST (cerebral venous sinus thrombosis) which is stroke caused by a venous thrombosis; these cases are showing that it can also cause stroke caused by an arterial thrombosis,” Werring explained.