The agency’s committee in charge of assessing medicines has launched a review of the vaccine’s safety that will delve into the reports of post-vaccination blood clots.
“Four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with COVID-19 Vaccine Janssen. One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the USA. One of them was fatal,” the agency said in a statement.
Janssen is a subsidiary of Johnson & Johnson.
It is not clear yet whether there is a causal association between the vaccine and the blood clots, according to the European Medicines Agency.
The committee will probe the cases and decide whether regulatory action may be necessary.
The United States authorized Johnson & Johnson’s shot last month and has administered nearly 5 million doses as of Thursday morning.
The shot was authorized in the European Union on March 11 but the rollout of the shots has not started yet.
The Food and Drug Administration (FDA), America’s top drug regulator, told The Epoch Times via email that it was aware of the blood clots that occurred in people post-vaccination.
“At this time, we have not found a causal relationship with vaccination and we are continuing our investigation and assessment of these cases. Our analysis of the data will inform the potential need for regulatory action,” the agency said.
FDA documents detailing why it decided to authorize the shot include notes on a small number of patients in a late-stage clinical trial developing blood clots after vaccination. The agency determined that a causal relationship with the vaccine could not be determined, adding, “The assessment of causality was confounded by the presence of underlying medical conditions that may have predisposed individuals to these events.”
Johnson & Johnson told The Epoch Times via email that it prioritizes the safety and well-being of people who use its products and that the company shares all adverse event reports post-vaccination, along with its own assessment of each report, with health authorities.
“We are aware that thromboembolic events including those with thrombocytopenia have been reported with all COVID-19 vaccines. Our close tracking of side effects has revealed a small number of very rare events following vaccination. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” the New Jersey-based pharmaceutical company said.
“We continue to work closely with experts and regulators to assess the data and support the open communication of this information to health care professionals and the public to help ensure that, in the event of a very rare illness, appropriate steps can be taken for quick diagnosis and treatment,” the company said, adding that anyone who experiences symptoms such as swelling, shortness of breath, and neurological difficulties after vaccination should immediately seek medical assistance.
Another COVID-19 vaccine, from the UK-based AstraZeneca, was previously investigated by the European Medicines Agency after reports of post-vaccination blood clots.
The agency concluded this week that there was a “possible link” between the vaccine and clots but recommended countries still use the jab, ruling the benefits outweigh the risks. However, the agency advised AstraZeneca to include rare blood clots as a possible side effect for its vaccine.
That came after an agency official said “it is clear that there is an association” between the clots and the vaccine.
The United Nations’ World Health Organization committee said last month, based on a review of clinical trial data and safety data, that reported rates of post-vaccination clots were “in line with the expected number of diagnoses of these conditions,” noting that clots sometimes occur as a result of COVID-19.
The committee recommended continued use of the AstraZeneca shot.
From The Epoch Times