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CDC recommends Pfizer, Moderna vaccines over Johnson & Johnson, citing rare blood-clot issue

Nine deaths, several dozen cases, have been confirmed in connection with the vaccine.

According to the CDC, at least nine people have died following blood-clotting incidents associated with the Johnson & Johnson shots. (Video: Reuters)

The nation’s top public health official recommended Thursday that people seeking the safest and most effective coronavirus vaccines and boosters go with the Pfizer-BioNTech or Moderna shots, instead of those made by Johnson & Johnson.

Rochelle Walensky, director of the Centers for Disease Control and Prevention, endorsed the policy several hours after the unanimous vote from the agency’s vaccine advisory panel, which cited concerns over the increased risk of a potentially fatal blood clot issue associated with the Johnson & Johnson shots.

“Today’s updated recommendation emphasizes CDC’s commitment to provide real-time scientific information to the American public,” Walensky said in a statement, encouraging all Americans to get vaccinated and booster shots.

Nine deaths — among seven women and two men — have been confirmed in connection with the blood clot issue through September. Seven of those patients, who ranged in age from 28 to 62, 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. Dozens more became severely ill.

Leana S. Wen, a visiting professor of health policy and management at George Washington University, addresses the rare side effects associated with the vaccine. (Video: The Washington Post)

The news is the latest blow to Johnson & Johnson, whose single-dose vaccine requiring no special storage was held out as a one-and-done solution that promised to make it extremely popular. But reports about the vaccine’s lesser comparative effectiveness, as well as the rare blood clot issue, have resulted in much lower use in this country, with about 17 million doses administered, compared to about 470 million of the Pfizer and Moderna shots.

The move is likely to make it harder to vaccinate the homeless and people in prisons, among others, because of the greater difficulty in using and transporting the two-dose vaccines. But the effect is expected to be greater overseas than in the United States, where there are ample supplies of the other two vaccines, which are also more popular.

The CDC noted in a statement that the U.S. supply of mRNA vaccines is abundant, with nearly 100 million doses in the field for immediate use. The CDC action follows similar recommendations from other countries, including Canada and Britain.

It’s rare for CDC and its Advisory Committee on Immunization Practices to recommend a preferential policy. Until now, the United States has treated all three coronavirus vaccines available to Americans as equal choices because early supplies were limited and large studies found they all offered robust protection.

Johnson & Johnson said in a statement that it “remains confident in the overall positive benefit-risk profile of its COVID-19 vaccine. Studies have shown that the Johnson & Johnson COVID-19 vaccine generates strong antibody and cellular immune responses and long-lasting immune memory and breadth of protection across variants.”

The company said the vaccine remains an important choice for those who “can’t or won’t return for multiple vaccinations, or who would remain unvaccinated without an alternative to the mRNA vaccines.” It noted its ease of storage and transport “make it a vital tool” for many in low- and middle-income countries where it is sometimes the only option.

But panel member Pablo Sanchez, a pediatrics professor at Ohio State University, said he had grave concerns about Johnson & Johnson’s vaccine. “I just cannot recommend a vaccine that is associated with a condition that may lead to death,” he said, adding he had urged the families who are his patients to stay away from it.

The panel said that exceptions should be made for those who have had allergic reactions to the mRNA vaccines, or where those vaccines are unavailable. Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to it.

The race to untangle the secrets of rare, severe blood clots after Johnson & Johnson vaccinations

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 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. All of the patients were hospitalized; the patients’ median age was about 44. Officials are reviewing the data to ensure those numbers are not underestimates.

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 race to untangle the secrets of rare, severe blood clots after Johnson & Johnson vaccination

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. 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.”

Panel members also discussed the ethics of limiting the use of the Johnson & Johnson vaccine. If it is not available, some might be deprived of a lifesaving treatment. If it continues to be given, however, some disadvantaged populations may be put at a greater risk.

During the public comment session, Claire Hannan, executive director of the Association of Immunization Managers, 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.

Still, 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. The vaccine is currently authorized for use in 90 countries, according to the World Health Organization.

Wynne Boelt, a WHO spokesman, said in an email that its global advisory committee on vaccine safety “is reviewing the data and will take into account CDC’s recommendations.”

Jen Kates, senior vice president of the Kaiser Family Foundation, was concerned about the international implications. She 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.”

But several experts said that a prime advantage of the J&J vaccine as one-and-done shot 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.

The panel also heard early data on vaccine safety among children 5 to 11 years old who have been receiving the Pfizer vaccine recently authorized by the Food and Drug Administration.

More than 7 million vaccinations have been given to that age group as of Dec. 9, with most side effects being mild or moderate and slightly more occurring after the second dose, according to a presentation by CDC official John Su. Most complaints were of fever, headaches and fatigue that passed quickly. Few children sought medical treatment, and about 1 percent missed school.

Eight children — four boys and four girls — developed mild cases of myocarditis, the rare heart inflammation that has been associated with mRNA vaccines. Two others with complicated medical histories died following vaccination, and their cases are still under review. One was a 5-year-old girl who had cerebral palsy and a seizure disorder, among other conditions. The other was a 6-year-old girl with a brain injury, among other issues, stemming from a near drowning. Ten days after being vaccinated, she developed fever and progressive weakness and later died.