A panel of experts from the Centers for Disease Control and Prevention voted Thursday to recommend that Covid vaccines other than Johnson & Johnson’s be given preference, citing mounting evidence that the company’s injections can treat a rare blood clot condition. now linked to dozens of cases and at least nine deaths in the United States in the past year.
The panel’s vote effectively discourages vaccine providers and adults from using Johnson & Johnson’s injection. New data showed that there was a higher risk of the blood clotting condition than previously known. The risk was highest in women ages 30 to 49, estimated at 1 in 100,000 who had received the company’s injection.
Still, some panelists expressed hope that Johnson & Johnson’s vaccine could still be used by people who didn’t have access to the more popular injections from Moderna or Pfizer-BioNTech, or who wanted the injection despite being informed. were of the increased risk of side effects.
The recommendation, which the CDC has yet to decide whether to accept, is the latest blow to a vaccine that has largely fallen out of favor in the United States. The company’s vaccine has failed to deliver on its early promise as a traditional, one-time format that could be easily deployed in more isolated or rural communities and among those timid about receiving two doses.
About 16 million people in the United States have received the Johnson & Johnson vaccine as their primary immunization, compared with 73 million fully immunized with Moderna’s vaccine and 114 million with the Pfizer-BioNTech injections. Of the Americans who received a booster, only 1.6 percent chose Johnson & Johnson.
Earlier this week, the Food and Drug Administration released updated guidance on the risks of the blood clotting disorder associated with Johnson & Johnson’s vaccine, but reiterated that the benefits outweighed the risks.
Dozens of countries have approved Johnson & Johnson’s vaccine and are using it as part of their immunization campaigns. But while it remains in high demand in some parts of the world, it has lost popularity in many countries due to safety concerns and relatively lower effectiveness against Covid.
Some governments have already taken steps to limit the Johnson & Johnson shot due to the risk of blood clotting. Finland, Denmark and Slovenia no longer use it, and several other countries have ranked it lower for use than the vaccines from Pfizer-BioNTech and Moderna. Some countries have also advised doctors to advise women under the age of 50 about the potential risk.
The CDC panel’s recommendation comes amid a global wave of virus cases, driven by the Delta coronavirus variant and Omicron, the latest version that is quickly beginning to spread in Britain and the United States.
Several lab experiments suggest that a single dose of Johnson & Johnson’s injection offers little protection against infection with Omicron. The company said late last month it was testing blood samples from clinical trial participants who had received the injection as a booster to see how their vaccine-induced antibodies fare against Omicron.
At Thursday’s meeting of the Advisory Committee on Immunization Practices, CDC officials went into detail about the clotting-related syndrome identified in 54 people in the United States who received the Johnson & Johnson shot before the end of August. Overall, the number of cases of the condition was 3.8 cases per million people who received the vaccine.
People who received a Johnson & Johnson shot months ago are not expected to be at risk for the clotting disorder, as the onset of symptoms usually occurred about nine days after vaccination in the diagnosed cases.
An increased risk of the condition, known as thrombosis with thrombocytopenia syndrome and can cause internal bleeding, has also been associated with the injection of AstraZeneca, which is not approved in the United States. It has not been associated with the Moderna or Pfizer vaccines.
A panelist, Dr. Pablo Sanchez, a pediatrician at Ohio State University, said he had turned families away from the Johnson & Johnson vaccine.
There is mounting evidence that one dose of Johnson & Johnson’s injection offers far less protection against infection than other vaccines. Federal health officials approved boosters in October for people who had received a single injection of the company’s vaccine at least two months earlier. They enabled a “mix and match” approach, allowing people to receive a second shot of a Pfizer or Moderna vaccine.
So far, most Johnson & Johnson recipients who received a booster have received other injections, and almost no people who were originally immunized with other injections chose Johnson & Johnson as the booster.
Despite their recommendation, some panelists said it was important to keep the Johnson & Johnson vaccine available as an option.
“However, it’s very important that we don’t completely eliminate this vaccine,” said Dr. Jason Goldman, an assistant professor of clinical biomedical sciences at Florida Atlantic University.
dr. Penny Heaton, a Johnson & Johnson executive, said the vaccine is making a “critical difference” in the pandemic response. “We are confident in the positive benefit-risk profile of our vaccine. It’s saving lives today here in the US and on every continent around the world,” she said.
In April, shortly after Johnson & Johnson’s vaccine began to be administered in the United States, federal officials briefly stopped using the injection due to concerns about the risk of blood clots. The cases kept piling up.
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Of all 54 Johnson & Johnson vaccine recipients diagnosed with the condition before the end of August, 36 were admitted to an intensive care unit and the longest hospital stay was 132 days. Eight of them died. A ninth person has died since September.
“We’ve noticed how quickly the status deteriorates and results in death,” says Dr. Isaac See, a CDC official.
The people who died ranged in age from 28 to 62 years. Seven were women and they were all white. Obesity was the most common underlying medical condition. Two of the people who died had no medical problems, said Dr. see.
The rate at which the condition would normally be expected in the general population is unknown, said Dr. see.
dr. See said more cases had been identified since previous CDC meetings due to delays in reporting and delays in identifying and confirming vaccine-related diseases.
On Thursday, CDC officials also reported on side effects in children ages 5 to 11 who have received the Pfizer vaccine in recent weeks. With 7.1 million doses administered, the CDC confirmed eight cases of myocarditis, or swelling of the heart muscle, and has an additional case pending. It follows five more cases.
It was previously reported that men between the ages of 16 and 29 had an increased risk of developing myocarditis. Nearly 11 out of 100,000 of them developed the condition a few days after being fully vaccinated. On balance, the injections for boys ages 12 to 17 were estimated to cause an estimated 70 cases of myocarditis but prevent 5,700 infections, 215 hospitalizations and two deaths, the CDC said. But most recovered within a short time.
Of the six cases in younger children with known outcomes, five recovered from myocarditis symptoms. The eight confirmed cases were evenly split between men and women.
An August study found that children under 16 who were infected with Covid-19 were 37 times more likely than other children to develop myocarditis. That study was completed before children under the age of 12 started receiving vaccines.
In the summer, the FDA warned that Johnson & Johnson’s vaccine could also increase the risk of a rare neurological condition known as Guillain-Barré syndrome, another setback.
A CDC presentation showed that despite clotting concerns, the Johnson & Johnson vaccine prevented thousands of U.S. Covid hospitalizations compared to three to a dozen cases of clotting syndrome, depending on age group. The over-64s avoided most hospital stays. Like those immunized with other vaccines, thousands avoided hospitalizations, the agency said.