The Centers for Disease Control and Prevention on Thursday recommended Pfizer and Moderna vaccines over Johnson & Johnson vaccination for adults after dozens of people developed a rare blood clot disease after being vaccinated with J&J vaccinations. All of these patients were hospitalized and nine died.
The CDC has confirmed 54 cases of people who develop blood clots and have low blood platelet levels – a new condition called thrombosis with thrombocytopenia syndrome, or TTS, that mainly affects younger women. 36 of them had to be treated in the intensive care unit.
In a statement on Thursday evening, the CDC said the US has a plentiful supply of Pfizer and Moderna vaccines. The agency stressed that people who do not want or cannot receive Pfizer and Moderna shots will still have access to the J&J vaccine.
The CDC’s Vaccine Expert Panel, the Advisory Committee on Vaccination Practices, voted unanimously in favor of the recommendation on Thursday. Hours later, CDC director Rochelle Walensky gave her approval.
“The recommendation, updated today, underscores CDC’s commitment to bringing real-time scientific information to the American public,” said Walensky.
The US has administered more than 17 million J&J doses since the Food and Drug Administration approved the emergency syringe in February. A total of 3.8 TTS cases per million doses administered have been reported, according to the CDC. The rates were highest among women aged 30 to 49.
Experts on the panel said the J&J syringe might still be useful for people who would have allergic reactions to the Pfizer or Moderna vaccines, or when a patient does not have access to another syringe.
However, the CDC recommendation takes another blow to confidence in the Johnson & Johnson vaccine. The US briefly halted the administration of the gunshots in April when TTS cases first surfaced.
“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. Janssen is the vaccine division of J&J.
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 nine days after vaccination and were hospitalized five 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 main and sometimes the only option. Even in the US, because of its permanent protection, it may be the preferred choice for people who cannot or do not want to return. “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 that the company has several studies underway to identify risk factors associated with developing TTS.
Although the CDC panel’s recommendation was unanimous, some members struggled to get the vote. The vaccine experts could also have recommended stopping the vaccination altogether or limiting it to certain age or population groups.
Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University, said he did not recommend the J&J syringe to any of his patients, despite ultimately voting 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.”
However, the members also had to weigh all the risks and benefits of their recommendation. Restricting the J&J vaccine to adults over 50, for example, would remove vaccination as an option for young men who are at risk of developing a rare heart condition called myocarditis, which has been linked to the Pfizer and Moderna syringes.
And stopping the J&J vaccine altogether could deal a blow to the shot worldwide. J&J said the vaccine is easier to distribute to hard-to-reach communities not just in the US but around the world because it is a single dose, reducing the logistical hurdles compared to the two-dose vaccines.
“I think we should really remember that our decision has, or is likely to have, global implications,” said Dr. Oliver Brooks, Chief Medical Officer at Watts Healthcare in California.
In April, the FDA and CDC temporarily stopped using Johnson & Johnson’s single vaccine after six adult women developed blood clots and low platelet counts at the same time.
A week later, the FDA and CDC lifted the hiatus on J&J shots after the independent advisory panel said the benefits of the shots outweighed 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 link between TTS and the Janssen COVID-19 vaccine,” the FDA said in the leaflet for healthcare providers.
In October, the FDA and CDC approved J&J boosters for all adults at least two months after their first J&J injection. More than 800,000 people have received J&J boosters, according to CDC data. People who received their primary vaccination with the J&J syringe can also get their booster vaccination with a Pfizer or Moderna vaccine.
