CDC and FDA Investigate Thrombi Detected in Six Women After Vaccination with Doses of J&J

Washington – The United States on Tuesday recommended “pausing” the administration of the coronavirus vaccine developed by Johnson & Johnson to investigate reports of potentially dangerous blood clots.

In a joint statement, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said Tuesday they were investigating thrombi detected in six women in the days after vaccination, combined with a reduced platelet count. In the United States, more than 6.8 million doses of J & J’s vaccine have been administered, which is a single application.

Federal distribution channels, including mass vaccination centers, will temporarily stop using the drug, and states and other providers are expected to do the same.

Two other vaccines, Moderna’s and Pfizer’s, comprise the vast majority of inoculations administered in the United States and are not affected by the hiatus.

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to study the cases. The FDA has started its own investigation.

“Until the process is complete, we recommend a pause in the use of this vaccine as a precaution,” said Drs. Anne Schuchat, deputy director of the CDC, and Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, in a joint statement.

The agencies recommend that those who have received the J&J vaccine and have experienced headaches, abdominal pain, leg pain, or breathing difficulties three weeks after the injection contact their doctor.

Authorities said they want to train vaccine manufacturers and healthcare professionals on the “singular treatment” for these blood clots.

Johnson & Johnson claimed it was aware of the clots, but insisted a link to its vaccine has not yet been unequivocally established.

“We are aware of thromboembolic events, including some with thrombocytopenia, have been reported in relation to covid-19 vaccines,” the company said in a statement. “So far, a clear causal relationship between these unusual events and the vaccine has not been established,” he added.

The J&J vaccine was cleared as an emergency remedy by the FDA in late February with great ceremony, in the hope that by requiring a single dose and relatively easy storage conditions, it would boost the vaccination campaign across the country. However, that vaccine constitutes only a small percentage of the two administered in the United States, due to delays and errors at the plant of one of its contractors in Baltimore.

 

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