US regulators lift pause of J&J’s Covid-19 vaccine

Washington, Apr 23 (EFE).- Use of the Covid-19 vaccine developed by Johnson & Johnson subsidiary Janssen can be resumed in the United States following a pause to investigate a possible connection between the shot and blood clots, the Food and Drug Administration said Friday.

The FDA announcement came hours after 10 of 15 experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted in favor of ending the pause.

Administration of the single-dose vaccine was halted last week after a rare and severe type of blood clot known as cerebral venous sinus thrombosis was detected in six women between the ages of 18 and 48 among the nearly 7 million people in the US who had received J&J’s shot.

“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work-identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

“We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality,” she said.

The CDC advisory panel recommended that language be added to the product label warning about potential health risks from the vaccine, which as of Friday is blamed for 15 cases of the blood clotting disorder.

All of those affected have been women, 13 of whom were between the ages of 18 and 49. Three of those people died.

The FDA said that the respective Janssen Covid-19 Vaccine Fact Sheets for Vaccination Providers and for Recipients and Caregivers have been revised to include information about the risk of the blood-clot syndrome.

Among those taking part in the vaccine advisory panel’s meeting were representatives of J&J, who said prior to the vote that the pharmaceutical giant had agreed with the FDA to add a warning about the blood clot risk to the product’s label. EFE


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