Both the Food and Drug Administration and the Centers for Disease Control and Prevention ended their pause on the Johnson & Johnson COVID-19 vaccine on Friday after a panel of CDC advisers voted to recommend reapproval for the single-shot vaccine ― albeit with a new warning about extremely rare blood clots.
The agencies concluded that the known benefits of the vaccine “outweigh its known and potential risks in individuals 18 years of age and older,” Acting FDA Commissioner Janet Woodcock said in a statement. “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.”
The FDA and the CDC halted distribution of the vaccine on April 13 “out of an abundance of caution” after some recipients developed a rare disorder involving blood clots and low blood platelets within two weeks of their vaccination.
“Our vaccine safety systems are working,” CDC Director Rochelle Walensky said of Friday’s decision. “We identified exceptionally rare events ― out of millions of doses of the Janssen COVID-19 administered ― and we paused to examine them more carefully.”
At a meeting of the CDC’s Advisory Committee on Immunization Practices on Friday, Johnson & Johnson executives said 15 cases have been reported so far, all in women, most of whom were younger than 50.
Of the 15, there have been three deaths, seven remain hospitalized and five have been discharged from the hospital. That’s among a population of nearly 8 million people who have so far received the vaccine.
The rate of 1.9 cases per million people given the shot compares to an incidence of 0.1 cases per million people in the general population, according to the company’s chief medical officer, Dr. Joanne Waldstreicher.
CDC projections estimate that for every 1 million doses of the J&J vaccine, also called the Janssen vaccine, given to women ages 18 to 49, 12 COVID-19 deaths and 657 hospitalizations would be prevented. Among that population, however, 13 cases of blood clots could be expected.
That rate is far lower among men in the same age range, where just two cases of blood clots could be expected per million vaccines administered, while preventing 11 COVID-19 deaths and 601 hospitalizations.
On Tuesday, the European Medicines Agency approved the resumption of J&J vaccinations in Europe after a similar pause there.
“The benefits of the vaccine continue to outweigh these risks, and we now have detailed information in the labeling that alerts to these risks,” EMA Executive Director Emer Cooke said. “We’re confident that it can be rolled out appropriately.”