A CDC panel voted Thursday to recommend the Pfizer-BioNTech and Moderna COVID-19 vaccines be preferred for adults over the Johnson & Johnson vaccine due to a small number of very rare but dangerous blood clots.
Out of approximately 17 million people in the United States who have gotten the J&J vaccine, there have been nine deaths from the condition called thrombosis with thrombocytopenia, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices said Thursday.
The CDC acted hours later, accepting the panel’s recommendation.
Among those who died from the condition, the median age was 45. There were seven women and two men, all non-Hispanic whites. Among them, seven were obese, three had hypertension and two had diabetes. Two of the patients had no known medical condition.
The cases of TTS have been reported in a wide range of individuals 18 years and older. The highest reporting rate was among women ages 30 to 49, where it was one case per 100,000 doses administered. Overall, 15% of TTS cases have been fatal, the Food and Drug Administration said.
While the 15% fatality rate for TTS sounds “scary,” “these are small numbers, it’s a rare event,” said Dr. Wilbur Chen, a professor of medicine at the University of Maryland School of Medicine and a committee member.
Getting the J&J vaccine was still much safer than any risk of the rare side effect because getting COVID-19 is much more likely to cause severe disease or death, ACIP members said.
When the side effect first came to light in April, federal health officials halted its use for 10 days. The pause was lifted after the FDA conducted a safety review.
The discovery of the nine deaths among more than 239,000 million Americans vaccinated shows the strength of the U.S. vaccine surveillance system, said Dr. Matthew Daley, a senior investigator with the Institute for Health Research at Kaiser Permanente Colorado and a committee member.
“Just to remind everyone, surveillance continues daily and that includes surveillance of all vaccines platforms and rounds of booster doses,” he said.
The majority of COVID-19 vaccines given in the United States use the mRNA platform. Between them, Pfizer and Moderna have provided 468 million doses so far, according to the CDC.
“We appreciate today’s discussion and look forward to working with the CDC on next steps,” said Dr. Mathai Mammen, global head of Janssen Research & Development, a Johnson & Johnson company. “In addition, we strongly support education and generating awareness of rare events, such as Thrombosis with Thrombocytopenia Syndrome and how to effectively manage it.”