WASHINGTON DC – After an 11-day pause, the U.S. Centers for Disease Control and Prevention and Food and Drug Administration lifted their recommended pause on use of Johnson & Johnson’s coronavirus vaccine Friday in a 10-4 vote.
However, there will be an alert that warns of blood clot risks with the one-dose Johnson & Johnson (J&J) vaccine.
Roughly about 200,000 individuals in Massachusetts have received the J&J vaccine.
The FDA said the J&J vaccine could be administered again as soon as Saturday, April 24.
.”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,” acting FDA Commissioner Dr. Janet Woodcock said in a statement. “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.”
The CDC identified 15 likely cases of a rare blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS), with three deaths among people who got the vaccine.
“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,” said Dr. Rochelle Walensky
Among women over 50, the rate is 0.9 cases per million. No cases were seen among men.
CDC Director Walensky said Covid-19 is deadly. It’s killed more than half a million Americans.
“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,” Walensky said. “These are significant numbers and show the important impact of this vaccine in our country.”
Of the 15 US cases of rare blood clots associated with the J&J vaccine, 13 were in women under the age of 50.
Most patients with TTS develop a severe headache days to weeks after getting the vaccine, doctors told ACIP.