CDC, FDA Lift Pause On Johnson & Johnson COVID-19 Vaccine
BALTIMORE (WJZ) — The US Centers for Disease Control and Prevention and Food and Drug Administration lifted their recommended pause on use of Johnson & Johnson's coronavirus vaccine Friday and said the label will be updated to warn of blood clot risks.
The agencies acted quickly after a vote by the CDC's Advisory Committee for Immunization Practices recommended lifting the pause.
"Together, both agencies have full confidence that this vaccine's known and potential benefits outweigh its known and potential risks in individuals age 18 years and older," said Dr. Janet Woodcock, acting commissioner of FDA.
Shots can resume once again nationwide 10 days after the CDC and FDA paused the vaccine's use, while they investigated the risk of rare and potentially deadly blood clots.
"The American public should feel reassured about the safety systems and protocols that we have in place around the COVID-19 vaccine," said Dr. Rochelle Walensky, director of CDC.
The single-shot dose now comes with a new warning, that in rare cases, the vaccine has caused blood clotting in women under the age of 50.
New data shows the risk is highest for women between ages 30 and 39.
The CDC is investigating nine more potential cases of the clotting disorder, 15 cases are confirmed out of the eight million who have taken the shot- all women- most under the age of 50. Three have died.
"Vast majority of patients have a headache, more severely affected patients can have seizures," said Dr. Michael Streiff, Johns Hopkins School of Medicine.
The reaction remains extremely rare.
"Considering all these factors, we're confident that the Jansen COVID-19 vaccine meets our standards for safety effectiveness and quality for a medical product that is used widely including in healthy individuals," Dr. Woodcock said.
The pause has raised concerns that it could lead to more vaccine hesitancy, but health officials are urging the public not to panic.
Health experts like Dr. William Moss with Johns Hopkins had predicted the vaccine will be unpaused, with a warning for doctors and patients to help identify and treat potential blood clots.
"There are still many advantages to the J&J vaccine, single dose, easy to store.. and prior to the pause, many people expressed preference for the single dose vaccine," Dr. Moss said. "So, we're going to have to see how this plays out, how the messaging goes. But I'm hopeful that we can restore confidence in the J&J vaccine and further increase vaccinations."
Dr. Moss said he's heard about 10 million J&J vaccine doses are on standby ready to be administered.
