A health care worker holds a dose of the Johnson & Johnson vaccine.
Phill Magakoe | AFP | Getty Images
An advisory board for the Centers for Disease Control and Prevention on Thursday recommended Pfizer and Modern‘s vaccines over Johnson & Johnson‘s shot for adults ages 18 and up after dozens of people found a rare blood clot after the J&J vaccination, all of whom were hospitalized and nine of them died.
The Advisory Committee on Immunization Practices has unanimously decided to recommend Pfizer and Moderna over the Johnson & Johnson vaccine. CDC director Rochelle Walensky has yet to accept the recommendation.
The CDC has confirmed 54 cases of people who develop blood clots and have low blood platelet levels, a new condition known as thrombosis with thrombocytopenia syndrome that mainly affects younger women. All patients were hospitalized, nine people died and 36 were treated in the intensive care unit.
The US has administered more than 17 million J&J doses since the Food and Drug Administration approved the emergency syringe in February.
“TTS case reporting rates after Janssen vaccines are higher in men and women in a wider age range than previous estimates,” said Dr. Keipp Talbot, chairman of the CDC’s vaccines and safety subgroup, the advisory body.
Although the panel’s recommendation was unanimous, some members struggled with the vote. The CDC experts could also have recommended giving up the shot altogether or restricting it to certain age or demographic groups.
Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University, said he was not recommending J&J admission to any of his patients, despite ultimately standing for the panel’s proposal.
“I just can’t recommend a vaccine associated with a disease that can lead to death,” Sanchez told the committee. “I don’t recommend it to any of my patients’ parents.”
Seven of the patients who died were women and two men, with a mean age of 45 years. Most of the deceased had previous health conditions such as obesity, high blood pressure and diabetes. The death reporting rate was 0.57 deaths per million doses administered, according to the CDC.
“In reviewing these cases, we noticed how quickly patient status deteriorates and leads to death,” said Dr. Isaac See of the CDC’s Vaccine Safety Team joined the advisory board.
According to the CDC, patients typically developed symptoms 9 days after vaccination and were hospitalized 5 days after symptoms appeared. The overwhelming majority of patients were women, 37 total, and the mean age was 44. Seventeen men developed TTS.
Johnson & Johnson’s director of global therapeutic vaccines Penny Heaton defended the company’s shot during the meeting, saying it “saves lives here in the US and on every continent around the world”.
“It’s easy to store and transport,” said Heaton. “In many low- and middle-income countries, our vaccine is the primary and sometimes even the only option in the US as its permanent protection may be the preferred choice for people who cannot or do not want to return for multiple vaccinations.”
Heaton said J&J recognizes the incidents of TTS related to the vaccine and that the condition can be fatal, although cases are rare. She said patient safety and wellbeing remain a top priority for J&J, and the company has several studies underway to identify risk factors related to developing TTS.
In April, the Food and Drug Administration and the CDC stopped briefly the use of the Johnson & Johnson single vaccine after six adult women developed blood clots and low platelet counts at the same time.
A week later, the FDA and the CDC did canceled the break on J&J shots after the independent advisory panel said the benefits of the shots outweigh the risks. At the time, the panel did not recommend restricting admissions based on age or gender. It suggested that the FDA put a warning label on for women under 50.
The FDA has advised health care providers not to give a J&J booster to people who have developed TTS in the past after the first injection. The FDA also said the J&J syringe should not be given to people who received the vaccine from AstraZeneca, even though AstraZeneca is not approved for use in the United States
CDC experts said Thursday that people who received J&J booster doses have not seen any cases of TTS, although the number of boosters is relatively small.
“Currently available evidence supports a causal relationship between TTS and the Janssen COVID-19 vaccine,” the FDA said in the factsheet for healthcare providers.
In October, the FDA and CDC approved authorized J&J boosters for all adults at least two months after receiving their first J&J syringe. More than 800,000 people have received J&J boosters, according to CDC data. People who received their primary vaccination with the J&J shot can also be boosted with the Pfizer or Moderna vaccines.
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