The US Centers for Disease Control and Prevention and Food and Drug Administration lifted their recommended pause on the use of Johnson & Johnson's coronavirus vaccine Friday and said the label will be updated to warn of blood clot risks.
Vaccinations could resume as soon as Saturday, the FDA said
The agencies acted quickly after a vote by the CDC's Advisory Committee for Immunization Practices recommended lifting the pause.
"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."
US has more than 9 million Johnson & Johnson doses ready to go if pause lifts
"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," CDC Director Dr. Rochelle Walensky said Friday.
"With these actions, the administration of Johnson and Johnson's COVID-19 vaccine can resume immediately."
ACIP members worried that taking one of only three vaccines out of the mix available to Americans would slow efforts to immunize the population against a virus that has killed more than half a million people in the United States. Plus, they agreed that having a one-shot vaccine that doesn't need to be stored in freezers was valuable and would be preferred by many people who do not want to come back for a second dose, or who would struggle to make two vaccination appointments.
Walensky said a CDC risk-benefit analysis made the decision an easy one. The agency searched and found 15 likely cases of a rare blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS), with three deaths among people who got the vaccine.
Blood clots versus Covid deaths
"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," Walensky told a news conference. Among women over 50, the rate is 0.9 cases per million. No cases were seen among men.
Walensky noted that Covid-19 is deadly. It's killed more than half a million Americans. The analysis looked at what would happen with and without the vaccine available across the country.
"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." she added.
The ACIP agreed, voting 10 in favor of lifting the pause, four opposed, with one abstention.
"This is a very rare event -- a very rare event," Dr. Jose Romero, who chairs ACIP and who is also the top health official for Arkansas, told the meeting.