CDC and FDA Recommend Suspension of Johnson & Johnson Vaccines – NBC New England

WASHINGTON DC – United States federal authorities 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 which at least one woman has died until the moment.

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.

Federal authorities said in a subsequent press conference on Tuesday that all affected women are between the ages of 18 and 48. One woman has died and a second Nebraska woman is seriously hospitalized.

‘I know people are concerned. If they got the vaccine a month ago, don’t worry. If they got the vaccine a few days ago, they should be aware of whether they are experiencing any of the dangerous symptoms, ”CDC deputy director Anne Schuchat said during a conference call.

The “dangerous” symptoms are different from the flu-like symptoms that can be experienced in the hours or days after vaccine administration, Schuchat explained.

They can manifest in the first three weeks and include headache, abdominal pain, leg pain, or difficulty breathing three weeks after the injection.

More than 6.8 million doses of the Johnson & Johnson vaccine, which is a single dose, have been administered in the US.

Currently, this vaccine makes up only a small percentage of the vaccines administered in the US.

Jeff Zients, director of the team responsible for the federal government’s response to the pandemic, said the pause in the application of the Johnson & Johnson vaccine will not affect the national vaccination campaign.

“We have more than 25 million doses of Pfizer and Moderna vaccines available every week … that’s more than enough to continue at the current rate of about 3 million daily vaccinations,” Zients said in a statement.

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.

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