An advisory panel for the Centers for Disease Control and Prevention on Thursday recommended Pfizer and Moderna’s vaccines over Johnson Johnson’s shot for adults 18 and over, after finding dozens of people developed a rare blood clot condition following JJ vaccination, all of whom were hospitalized and nine of whom died.
The Advisory Committee on Immunization Practices voted unanimously to recommend Pfizer and Moderna over the Johnson Johnson vaccine. CDC Director Rochelle Walensky still has to accept the recommendation.
The CDC has confirmed 54 cases of people developing blood clots and showing low blood platelet levels, a new condition called thrombosis with thrombocytopenia syndrome that mostly affects younger women. All of the patients were hospitalized, nine people died and 36 were treated in intensive care.
The U.S. has administered more than 17 million JJ doses since the Food and Drug Administration authorized the shot on an emergency basis in February. Overall, 3.8 TTS cases were reported per million doses administered, according to the CDC. The rates were highest among women 30 to 49 years of age.
The CDC panel’s recommendation delivers another blow to confidence in Johnson Johnson’s vaccine. The U.S. briefly paused administration of the shots in April when TTS cases first started emerging.
“The TTS case reporting rates following Janssen vaccines is higher than previous estimates in men as well as women in a wider age range,” Dr. Keipp Talbot, chair of the the CDC’s vaccine and safety subgroup, told the advisory panel.
Seven of the patients who died were women and two were men with a median age of 45. Most the people who died had underlying health conditions such as obesity, hypertension and diabetes. The death reporting rate was 0.57 fatalities per million doses administered, according to the CDC.
“We’ve been struck on reviewing these cases by how rapidly patient status deteriorates and results in death,” Dr. Isaac See, with the CDC’s vaccine safety team, told the advisory panel.
Patients typically developed symptoms 9 days after vaccination and were hospitalized 5 days after they developed symptoms, according to the CDC. The overwhelming majority of patients were women, 37 total, and the median age was 44. Seventeen men developed TTS.
Johnson Johnson’s Penny Heaton, global therapeutics area head for vaccines, defended the company’s shot during the meeting, saying it “is saving lives here in the USA and on every continent around the globe.”
“It’s easy to store and transport,” Heaton said. “In many low and middle income countries, our vaccine is the most important and sometimes the only option even in the US, given its durable protection it may be the preferred choice for people who can’t or won’t return for multiple vaccinations.”
Heaton said JJ recognizes the incidents of TTS associated with the vaccine and that the condition can be fatal, though the cases are rare. She said patient safety and well being remains JJ’s top priority, and the company has several studies underway to identify risk factors associated with the development of TTS.
Though the CDC panel’s recommendation was unanimous, some members grappled with the vote. The vaccine experts also could have recommended pulling the shot altogether, or limiting it to certain age or demographic groups.
Dr. Pablo Sanchez, a professor pediatrics at Ohio State University, said he is not recommending the JJ shot to any of his patients’ parents, though he ultimately voted for the panel’s motion.
“I just cannot recommend a vaccine that is associated with a condition that may lead to death,” Sanchez told the committee. “I am not recommending it to any of my patients’ parents.”