European regulator investigating possible association between blood clots and J & J COVID-19 vaccine


According to the European Medicines Agency, a small number of people who received the Johnson & Johnson COVID-19 vaccine developed blood clots.

A committee of agencies responsible for drug evaluation has begun a vaccine safety review that delves into reports of blood clots after vaccination.

“Four serious cases of abnormal platelet-poor thrombosis have been reported after vaccination with the COVID-19 vaccine Janssen. One occurred in clinical trials and three occurred during vaccine deployment in the United States. One of them was deadly, “the authorities said in a statement.

Janssen is a subsidiary of Johnson & Johnson.

According to the European Medicines Agency, it is not yet clear if there is a causal link between the vaccine and blood clots.

The committee will investigate the case and decide if regulatory action is required.

The United States approved the Johnson & Johnson shooting last month, giving about 5 million doses as of Thursday morning.

The shot was approved by the European Union on March 11th, but the deployment of the shot has not yet begun.

The Food and Drug Administration (FDA), the highest drug regulator in the United States, has informed the Epoch Times by email that it is aware of blood clots that have developed in people after vaccination.

“At this time, no causal link to vaccination has been found and we continue to investigate and evaluate these cases. Analysis of the data reveals the potential need for regulatory action,” the agency said. I will.

Johnson & Johnson
On March 31, 2021, a vial containing the Johnson & Johnson single-dose COVID-19 vaccine can be seen at Vaxmobile at the Uniondale Hempstead Senior Center in Uniondale, NY. (MaryAltaffer / AP Photo)

The FDA document detailing why it decided to approve the shot includes a note about a small number of patients in late-stage clinical trials who develop blood clots after vaccination. Authorities determined that a causal link to the vaccine could not be identified, adding that “causal assessments were confused by the presence of underlying medical conditions that could predispose to these events.”

Johnson & Johnson prioritizes the safety and well-being of people using the product and shares all post-vaccination adverse event reports with health authorities, along with their own assessments of each report. I sent it by e-mail.

“We recognize that thromboembolic events, including thrombocytopenia, have been reported with all COVID-19 vaccines. Close tracking of side effects reveals some very rare events after vaccination. Currently, no clear causal link has been established between these rare events and the Janssen COVID-19 vaccine, “said a New Jersey-based pharmaceutical company.

“We will continue to work closely with professionals and regulators to evaluate the data and support open communication of this information to healthcare professionals and the general public, appropriate in the case of very rare illnesses. We will enable rapid action. Diagnosis and treatment, “he added, adding that anyone who experiences symptoms such as swelling, shortness of breath, or neuropathy after vaccination should seek medical assistance immediately.

Another COVID-19 vaccine from UK-based AstraZeneca was previously investigated by the European Medicines Agency following reports of post-vaccination thrombosis.

Authorities concluded this week that there was a “potential link” between the vaccine and the blood clot, but the recommending countries are still using jabs and have determined that the benefits outweigh the risks. However, authorities advised AstraZeneca to include rare blood clots as possible side effects of the vaccine.

It came after agency officials said there was a “clear link” between the blood clot and the vaccine.

The United Nations World Health Organization Commission said last month that the reported rate of blood clots after vaccination “is in line with the expected number of diagnoses of these conditions,” based on a review of clinical trial and safety data. , Blood clots may occur as a result of COVID-19.

The Commission recommended continued use of AstraZeneca Shot.

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