Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have lifted the recommended pause on J&J COVID-19 vaccine. The use of Johnson & Johnson vaccine was paused due to the cases of appearance of a rare blood clot in people.
The FDA says that they have revised their emergency use authorization for the vaccine and have include a new warning about the “plausible” risk of rare but serious blood clots in adult women under 50. The decision of resuming the J&J vaccine was made after a panel of advisers to the CDC voted to resume the use of Johnson & Johnson vaccine.
According to the reports, a federal health told the panel on Friday that the vaccine can be resumed after “CDC director approves its recommendations and the Food and Drug Administration publishes an update to its emergency use authorization for the vaccine.”
FDA said that the vaccines can be resumed from Saturday. The 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. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”
Meanwhile, the CDC Director, Dr. Rochelle Walensky said, “I support the ACIP’s recommendation that the Johnson and Johnson COVID-19 vaccine be used for persons 18 years of age or older in the United States population under the FDA emergency use authorization, and I have signed this recommendation. “With these actions, the administration of Johnson and Johnson’s COVID-19 vaccine can resume immediately.”
According to the CDC, their risk-benefit analysis made it an easy decision. As of now, 15 cases of rare blood clot (Thrombosis with Thrombocytopenia Syndrome) have emerged, out of which three women have died due to the condition.
Walensky told in a news conference, “Based on an in-depth analysis, there is likely an association but the risk is very low. What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 49 years, there was an approximate 7 cases per million. “For every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women aged 18 to 49, and this vaccine could prevent over 4,700 hospitalizations and nearly 600 deaths among women over 50. These are significant numbers and show the important impact of this vaccine in our country.”