UPDATED: J&J to restart Covid vaccine shipments to Europe as EMA adds safety warning over rare blood clots
The European Medicines Agency’s safety committee on Tuesday recommended adding a warning to the J&J Covid-19 vaccine regarding the rare but sometimes fatal blood clots with low blood platelets. Shortly thereafter, J&J said it would resume shipments of the vaccine to the EU, Norway and Iceland, and update its vaccine’s Summary of Product Characteristics and Package Leaflet to include information on the diagnosis and management of these very rare adverse events.
The committee, which said the overall risk-benefit of the vaccine still remains positive, reviewed eight cases (including one that was fatal) of the rare side effects among almost 8 million Americans vaccinated with the J&J vaccine.
Emer Cooke, executive director of the EMA, said in a press conference the vaccine is due to be rolled out very shortly in Europe. Investigations into the rare events are planned to continue and J&J will conduct additional studies. She noted that because Europe has a very good pharmacovigilance system, very rare side effects can be spotted early, which is a sign the system works, especially as the safety committee made its recommendation prior to the vaccine’s launch in Europe.
The blood clots, which the committee said were “very similar” to side effects linked to AstraZeneca’s Covid-19 vaccine, 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.”
Peter Arlett, head of the pharmacovigilance and epidemiology department at the EMA, noted that as of April 13, in addition to the 8 total cases for the J&J vaccine, there have been 287 cases of the rare blood clots and low platelets following administration of the AstraZeneca vaccine, including 142 in the European Economic Area, and 25 cases among those vaccinated with Pfizer and five for Moderna. But in cases that occurred in the US, there was no low platelet count for Pfizer and Moderna vaccines, EMA clarified.
As far as why the blood clots with low platelets are occurring, the EMA said the most plausible explanation is an immune response leading to a condition similar to what can be seen sometimes in patients treated with heparin, called heparin-induced thrombocytopenia.
Meanwhile, J&J on Tuesday reported $100 million in Covid-19 vaccine sales in the first quarter of 2021. CSO Paul Stoffels said the company is trying to restore public confidence in its vaccine, and that the company remains committed to resuming shipments to Europe. The continent has purchased 200 million doses.
In the US, where the government signed a $1 billion deal for 100 million doses (and the potential for 200 million more), doses of the vaccine have been paused since last Tuesday. The CDC will hold another meeting of its advisory committee on Friday to discuss the safety issues further.
Manufacturing issues at an Emergent site in Baltimore also have raised questions about whether J&J, which has taken control of the facility, will be able to produce enough vaccines for the US. Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility last Friday. J&J said Tuesday that it’s premature to speculate on any timing issues with vaccine deliveries from the site, but it is working with FDA to close the inspection this week and will work to address any observational findings.