CDC advisers recommend Pfizer, Moderna vaccines over Johnson & Johnson, citing rare blood-clot issue
Vaccine advisers to the Centers for Disease Control and Prevention voted unanimously Thursday to recommend that people seeking the safest and most effective vaccines and boosters go with the Pfizer-BioNTech or Moderna shots, instead of those made by Johnson & Johnson.
The expert panel said their preferential recommendation for the mRNA vaccines was based on the increased risk of a potentially fatal blood clot issue associated with the Johnson & Johnson shots. Nine deaths - among seven women and two men, ranging in age from 28 to 62 - have been confirmed in connection with the issue through September. Seven of those patients had underlying medical conditions, including obesity, hypertension and diabetes. Officials are looking at the possible inclusion of two more deaths, pending more complete medical information.
CDC Director Rochelle Walensky will decide later Thursday whether to adopt the panel’s recommendation as agency policy.
If it becomes policy, as expected, the move is likely to have a greater effect overseas than in the United States, where there are ample supplies of the other two vaccines, which are also more popular. Reports about the lesser effectiveness of the Johnson and Johnson vaccine have resulted in much lower use in this country, with about 17 million doses administered, compared to about 470 million for the Pfizer and Moderna shots.
Panel member Pablo Sanchez, a pediatrics professor at Ohio State University, said he had grave concerns about the Johnson & Johnson vaccine. “I just cannot recommend a vaccine that is associated with a condition that may lead to death,” he said, adding that he told families who are his patients to stay away from it.
The panel said exceptions to the policy should be made for those who have had allergic reactions to the mRNA vaccines, or where those vaccines are unavailable.
Federal officials initially halted the use of the Johnson & Johnson vaccine for 10 days in April after six women experienced the blood-clotting problem - the only known cases at the time among more than 7 million people who received the vaccine in the United States. One of the women died. The pause was lifted after an extensive safety review determined the vaccine’s benefits outweighed the risks and the FDA required a warning be attached.
But members of the Advisory Committee on Immunization Practices heard new data on Thursday that indicate the problem is broader than initially believed, albeit still rare. Fifty-four cases were confirmed as of August, out of about 14 million doses administered. Officials are also reviewing the data to ensure those numbers are not underestimated. All of the patients, including 37 women and 17 men, were hospitalized; the patients’ median age was about 44.
Those who died became sick quickly, going to the hospital on average three days after symptoms, and dying within one day of admission, according to the CDC presentation.
“We’ve been struggling reviewing these cases by how rapidly the patients’ status deteriorates, results in death,” said Isaac See, a CDC doctor who presented the data. “We have not yet seen any cases . . . after a [Johnson & Johnson] booster dose,” he added, although he noted the number of booster doses given has been small.
The panel heard an assessment of the risks of the Johnson & Johnson product compared with no vaccine, and also compared with use of the mRNA vaccines. That assessment included the risk associated with the mRNA vaccines of Guillain-Barré syndrome, an immune system condition that damages nerve cells that cause muscle weakness, and a rare heart condition known as myocarditis.
CDC official Sara Oliver said the panel’s work group supported a preferential recommendation based on stronger vaccine effectiveness and safety profiles of the mRNA vaccines. The panel rarely issues recommendations preferring one vaccine over another. In this case, members wrestled over the term “preferred,” saying it was not strong enough to reflect the strength of their recommendation.
That’s like saying “I prefer strawberry jelly over grape jelly,” said Helen Keipp Talbot, an infectious-diseases expert at Vanderbilt University. “It doesn’t seem to me to be strong enough.”
During the public comment session, Claire Hannan, executive director of the Association of Immunization Managers representing state, territorial and urban immunization officials, spoke of the “unique role” the Johnson & Johnson shots play, particularly for people experiencing homelessness, living in corrections facilities or getting discharged from hospitals. The vaccine is also easier to use because it doesn’t require ultracold storage.
“The one-dose completion also provides an accessible option for those completing vaccination for travel or employment, maintaining vaccine options,” Hannan said.
The impact of the panel’s recommendation is likely to be far greater in other countries where other options besides the Johnson & Johnson vaccine are more limited or unavailable. It is currently authorized for use in 90 countries, according to the World Health Organization.
The blood clotting condition, which has also been reported with the AstraZeneca vaccine, has resulted in policy changes in many higher-income countries, including Canada, which have access to alternative vaccines.
Jen Kates, senior vice president of the Kaiser Family Foundation, said there could be a potentially “chilling effect,” not only for the Johnson & Johnson vaccine, but also for the one made by AstraZeneca, in other countries “where most people haven’t had their first jab.”
Penny Heaton, chief of global research and development at Johnson & Johnson, said the company remains confident in its vaccine, while acknowledging the rare instances of the blood clots.
“The durability of the single shot Johnson and Johnson vaccine as a primary regimen could make crucial differences in saving lives in the U.S. and around the world,” Heaton said, emphasizing the benefits for those who cannot easily return for follow-up shots.
But several experts said that a prime advantage of the Johnson & Johnson vaccine as one-shot-and-done is no longer as relevant since boosters have become necessary to protect against waning immunity and a mutating virus.
“It’s not one dose and you’re done; it’s one dose and you still need another,” one practicing physician said during the public comment.