An expert panel at the Centers for Disease Control and Prevention voted Thursday to recommend that Covid vaccines other than Johnson & Johnsons be preferred, citing growing evidence that the company’s shots could trigger a rare thrombotic disorder that is now linked to dozens of cases. and at at least nine deaths in the United States in the past year.
The panel’s vote effectively discourages vaccine providers and adults from using the Johnson & Johnson syringe. New data showed that there was a higher risk of blood clots than previously known. The risk was greatest among women aged 30 to 49, estimated at 1[ads1] in 100,000 who had received the company’s injection.
Nevertheless, some panelists expressed hope that Johnson & Johnson’s vaccine could still be used by people who did not have access to the more popular shots from Moderna or Pfizer-BioNTech, or wanted the shot despite knowing about the increased risk of side effects.
The recommendation, which the CDC still has to decide whether to accept, is the latest setback for a vaccine that has largely fallen out of favor in the United States. The company’s vaccine has not fulfilled its early promise as a traditional one-of-a-kind format that would be easy to distribute in more isolated or rural communities, and among people who are intimidated into receiving two doses.
Approximately 16 million people in the United States have received the Johnson & Johnson vaccine as their primary vaccination, compared with 73 million fully immunized with Moderna’s vaccine and 114 million with Pfizer-BioNTech syringes. Among Americans who have received a booster, only 1.6 percent chose Johnson & Johnson.
Earlier this week, the Food and Drug Administration issued updated guidelines on the risk of blood clotting disorders associated with Johnson & Johnson’s vaccine, but reiterated that the benefits outweighed the risks.
Dozens of countries have authorized Johnson & Johnson’s vaccine and used it as part of their vaccination campaigns. But even though it is still in demand in some parts of the world, it has lost popularity in many countries due to security concerns and its relatively lower effectiveness against Covid.
Some governments have already moved to put restrictions on Johnson & Johnson’s shots because of the risk of blood clots. Finland, Denmark and Slovenia stopped using it, and several other nations have rated it lower for use than Pfizer-BioNTech and Moderna’s vaccines. Some countries have also advised doctors to advise women under the age of 50 on the potential risk.
The CDC panel’s recommendation lands in the midst of a global increase in virus cases driven by the Delta coronavirus variant and Omicron, the latest version that has already begun to spread rapidly in the UK and US.
Several laboratory experiments suggest that a single dose of Johnson & Johnson’s syringe may offer little defense against Omicron infection. The company said late last month that it was testing blood samples from participants in clinical trials who have been shot as a booster to see how their vaccine-induced antibodies perform against Omicron.
At Thursday’s meeting of the Advisory Committee on Immunization Practice, CDC officials went into detail about the coagulation – related syndrome identified in 54 people in the United States who received the Johnson & Johnson shot before the end of August. In total, the frequency of the condition was 3.8 cases per one million people who were given the vaccine.
People who received a Johnson & Johnson shot months ago are not considered to be at risk for coagulation, as the 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 which can cause internal bleeding, has also been linked to the shot from AstraZeneca, which is not authorized 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 driven families away from the Johnson & Johnson vaccine.
Evidence has increasingly shown that one dose of Johnson & Johnson’s syringe provides much less protection against infection than other vaccines. In October, federal health authorities approved boosters for people who had received a single shot of the company’s vaccine at least two months earlier. They allowed a “mix and match” approach, so that people could get a new shot with a Pfizer or Moderna vaccine.
So far, most Johnson & Johnson recipients who have received a booster have turned to other shots, and hardly any people originally immunized with other shots have chosen Johnson & Johnson as a booster.
Despite their recommendation, a number of panelists said it was important to keep Johnson & Johnson’s vaccine available as an alternative.
“However, it is very important that we do not completely eliminate this vaccine,” said Dr. Jason Goldman, assistant professor of clinical biomedical science at Florida Atlantic University.
Dr. Penny Heaton, CEO of Johnson & Johnson, said the vaccine made a “crucial difference” in the pandemic response. “We are confident in the positive benefit-risk profile of our vaccine. It saves lives here in the United States today and on all continents around the world,” she said.
In April, shortly after Johnson & Johnson’s vaccine began being administered in the United States, federal officials briefly stopped using the shot because of concerns about the risk of blood clots. Things are still 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 the intensive care unit and the longest hospital stay was 132 days. Eight of them died. Since September, a ninth person has died.
“We have been struck by these cases of how quickly the status deteriorates and results in death,” said Dr. Isaac See, a CDC official.
The people who died ranged in age from 28 to 62. Seven were women, and all were white. Obesity was the most common underlying medical condition. Two of the people who died did not have known medical problems, Dr. See said.
The rate at which the condition would normally be expected in the general population is not known, Dr. See said.
Dr. See said that additional 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 side effects among children aged 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 under consideration. It follows up on 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 every 100,000 of them developed the condition a few days after being fully vaccinated. In all, it was estimated that for boys 12 to 17, the shots would cause an estimated 70 cases of myocarditis, but prevent 5,700 infections, 215 hospitalizations and two deaths, the CDC said. But most recovered in a short time.
Among the six cases in younger children with known outcomes, five recovered from the myocarditis symptoms. The eight confirmed cases were evenly distributed between men and women.
A study from August found that children under the age of 16 who had been infected with Covid-19 were 37 times more likely than other children to get myocarditis. The study was completed before children under the age of 12 began receiving vaccines.
In the summer, the FDA warned that Johnson & Johnson’s vaccine could also lead to an increased risk of a rare neurological condition known as Guillain-Barré syndrome, another setback.
A CDC presentation showed that despite concerns about coagulation, the Johnson & Johnson vaccine prevented thousands of US Covid hospitalizations compared to three to a dozen cases of coagulation syndrome, depending on the age group. Those over 64 avoided most hospital stays. Like those vaccinated with other vaccines, thousands avoided hospitalization, the agency said.