A single dose of the Johnson & Johnson COVID-19 vaccine is being prepared at a clinic targeting members of the immigrant community on March 25, 2021 in Los Angeles, California.
Mario Tama | Getty Images
The European Medicines Authority said it was examining reports of rare blood clots in four people receiving Johnson & Johnson’s Covid-19 vaccine and expanded its AstraZeneca shot probe to include reports of a bleeding condition.
Of the four serious cases of coagulation and low platelets, three occurred in the United States during the launch of the J&J vaccine at its Janssen unit, the European Medicines Agency (EMA) said on Friday, adding that one person had died and that one case was reported in a clinical study.
It was the first news of the EMA survey on the J&J vaccine, while the AstraZeneca coronavirus vaccine has been subject for weeks to possible links with rare blood clots in the brain and abdomen, which was confirmed by the EMA.
J&J in the US said it is aware of reports of blood clots related to the Covid-19 vaccine and others and is working with regulators to assess the data and provide relevant information.
“Currently, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” the company said in an email.
The EMA also said that it is not yet clear whether there is a link between the two vaccines and the reported conditions and that its safety committee will decide if regulatory action is needed, such as label changes.
Some European and Asian countries have restricted the use of the AstraZeneca, Vaxzevria vaccine to younger people following the week updated by EU and UK regulators, which found a link between the events and the shooting.
Regulators said the benefits of the vaccine outweigh the risks.
J & J’s single-dose vaccine has been approved for use in the EU, but has not yet launched. It is currently used primarily in the United States.
The EMA also said that five cases of capillary leak syndrome related to the AstraZeneca vaccine have been reported.
The condition, in which blood flows from the smallest vessel to the muscles and body cavities, is characterized by swelling and low blood pressure. AstraZeneca did not immediately respond to a request for comment.
The J&J and AstraZeneca photos are two of the four Covid-19 approved vaccinations in Europe.