AMSTERDAM - Deliveries of the Johnson & Johnson vaccine against Covid-19 to the European Economic Area, including the Netherlands, will be delayed as part of a new review of data to determine if the vaccine is linked to six blood clot cases in the United States. Authorities in the U.S. recommended that use of the vaccine, developed in Leiden by subsidiary company Janssen, be suspended until the review is completed.
"We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine," the parent company said in a statement issued on Tuesday. "In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe."
Earlier on Tuesday, the Medicines Evaluation Board in the Netherlands told broadcaster NOS that the vaccine should continue to be used in the Netherlands. So far, 6.8 million people have received the Janssen vaccine, with six reports of a the rare blood clot side effect in women aged 18 to 48. One of those women died, while another was in a hospital in critical condition. It was still too soon to conclusively prove a connection, a representative for the MEB told the broadcaster.
"If there is reason to take action, such as adjusting the product information and package leaflet, we will inform the relevant authorities, consumers and healthcare providers," the MEB representative said.
The decision could cause further turmoil in the Netherlands, which has already suspended use of the AstraZeneca vaccine for most people under 60 due to the same rare side effect. The suspension was panned by many healthcare officials, and it caused further confusion with people over 60 who are concerned about the vaccine's safety. A review of the vaccine by the European Medicines Agency found that fewer than .001 percent of AstraZeneca vaccine recipients suffered from the side effect. That includes eight women in the Netherlands, one of whom died from a pulmonary embolism.
In response to the first reports of blood clots combined with low platelet counts, the European Medicines Agency's safety committee PRAC said last week that it was closely monitoring all reported side effects linked to the Janssen vaccine. "These reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions. PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information."
The Netherlands took delivery of a first batch consisting of over 79 thousand doses of the vaccine this week. The country has ordered 11.3 million doses in total. The vaccine, approved in Europe for use on March 11, only requires one shot to offer maximum protection against Covid-19, whereas the other three vaccines used in the Netherlands require two doses.
