WASHINGTON DC – Federal authorities in the United States on Tuesday recommended that the administration of the coronavirus vaccine developed by the pharmaceutical company Johnson & Johnson be “paused” 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 they were examining thrombi detected in six women in the days following vaccination, combined with a reduced platelet count.
According to The New York Times newspaper, all affected women are between the ages of 18 and 48. One woman has died and a second Nebraska woman is seriously hospitalized.
More than 6.8 million doses of the Johnson & Johnson vaccine, which is a single dose, have been administered in the US.
VACCINE USE STOPPED IN FEDERAL CENTERS IN THE UNITED STATES
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 vaccinations administered in the US and are unaffected by the interruption.
CDC’s Advisory Committee on Immunization Practices will meet on Wednesday to review the cases. The FDA has started its own investigation.
“Until the process is complete, we recommend a precautionary break from this vaccine,” said Dr. 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 DANGEROUS SYMPTOMS OF THE JOHNSON & JOHNSON VACCINE
The agencies recommend that those who have received the Johnson & Johnson vaccine and have had a headache, 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 in the “single treatment” of these blood clots.
JOHNSON & JOHNSON RESPONSE TO BLOOD CLOTS
Johnson & Johnson claimed it was aware of the clots, but insisted that a link to the vaccine has not yet been unequivocally established.
“We are aware of thromboembolic events, including some with thrombocytopenia, have been reported in association with vaccines against COVID-19,” the company said in a statement. “So far there is no clear causal link between these unusual events and the vaccine,” he added.
Johnson & Johnson’s vaccine was approved by the FDA in late February as an emergency aid with a grand ceremony, in the hope that it would spur the nationwide vaccination campaign by demanding a single dose and relatively easy storage conditions.
However, that vaccine makes up only a small percentage of the two administered in the US, due to delays and errors at the factory of one of its contractors in Baltimore.