COVID-19 vaccines that use messenger RNA are preferable to the Johnson & Johnson vaccine, advisers to the Centers for Disease Control and Prevention said Thursday after reviewing data on an extremely rare but serious blood-clotting disorder linked to the J&J shot.
At least nine deaths from blood clotting have been reported among J&J recipients in the U.S.
CDC Director Rochelle Walensky accepted the recommendation hours after it was approved in a 15-0 vote by the Advisory Committee on Immunization Practices. She said there are 100 million mRNA vaccines available for immediate use and that Canada and the U.K. have made similar recommendations.
“Today’s updated recommendation emphasizes CDC’s commitment to provide real-time scientific information to the American public. I continue to encourage all Americans to get vaccinated and boosted,” Dr. Walensky said.
The preferential recommendation came after a lengthy discussion about the pros and cons of the vaccine and its relative benefits against the virus compared to other versions, given its lower efficacy ratings and reports of the rare clotting disorder.
The J&J shots will still be available, but the panel said the ones from Pfizer-BioNTech and Moderna should be “preferred” options for adults whenever they are available.
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The one-shot J&J vaccine has been a preferred option for immunizing the homeless and prisoners, so panel members said advising against the vaccine completely could expose vulnerable populations to COVID-19. They also said an adverse recommendation would cast a poor light on the vaccine in global hotspots where the J&J shot is the main option.
J&J hit on those points in a statement that said it “appreciated” the ACIP discussion and the need to educate people about the risk of clotting.
“Given its strong durability, the Johnson & Johnson COVID-19 vaccine remains an important choice in the U.S. for people who can’t or won’t return for multiple vaccinations or who would remain unvaccinated without an alternative to the mRNA vaccines,” the company said. “With ease of storage and transport, it offers a vital tool, and in many populations, including in low- and middle-income countries, our vaccine is a critical and sometimes only option.”
But Dr. Pablo Sanchez, an ACIP adviser and pediatrics professor at Ohio State University, took a hard line during the discussion, saying he doesn’t recommend the J&J to patients.
“I just have a lot of problems with this vaccine,” he said.
Government officials in April briefly paused the use of the J&J vaccine, which accounts for less than 4% of COVID-19 shots given in the U.S. The pause was intended to help doctors identify and treat the clotting disorder known as thrombosis with thrombocytopenia syndrome, or TTS.
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Scientists said ongoing monitoring found more instances of the clotting disorder in J&J recipients since the spring, prompting advisers to revisit the issue and update guidance.
CDC presenters on Thursday detailed 54 cases of TTS in the U.S. linked to the J&J vaccine. They said nine deaths occurred in seven women and two men. The average age of those who died was 45.
Officials said they are investigating two additional deaths that occurred before the April pause and featured the same clinical problems, yet were difficult to confirm.
All deaths occurred in non-Hispanic white persons after a single dose of the vaccine, which was designed as a one-shot vaccine but was recently approved as a booster shot, too. Presenters said they do not know of any TTS cases tied to boosters, though said the sample of boosters to date is rather small.
The highest case rate (about one per 100,000 doses administered) was in females ages 30 to 49.
A fact sheet from the Food and Drug Administration was updated this week to say persons who experience clotting after an initial dose of the vaccine should not receive another J&J shot.
Presenters said survivors of the rare clots could face ongoing problems such as mental impairment. Nine patients had to be released to a post-acute care facility instead of going home from the hospital.
The clotting problem phenomenon has been tied to the AstraZeneca vaccine, which is used in other countries and — like the J&J shot — uses an inactivated virus, or adenovirus, platform, prompting scientists to suspect an immune response to the specific technology is causing the issue.
The clotting issue hasn’t been linked to the Pfizer-BioNTech and Moderna vaccines that use messenger-RNA technology, although those options have been dogged by concerns about inflammation of the heart muscle, or myocarditis, in some recipients, especially young males after the second dose.
Scientists haven’t recorded any deaths from COVID-19 vaccine-related myocarditis.
Billed as a promising “one-and-done” option to efficiently vaccinate Americans, the J&J vaccine has run into a series of hurdles.
Its effectiveness against COVID-19 has generally rated lower than the mRNA options that require two doses up front, prompting experts to say the J&J vaccine probably should have been a two-dose regimen from the start. The J&J vaccine also ran into manufacturing problems at a Baltimore plant.
Roughly 16 million people have received the one-shot J&J version as their primary vaccine versus 113 million vaccinated with the Pfizer vaccine and nearly 73 million with the Moderna option.
Nearly 875,000 people have received the J&J shot as an extra dose compared to over 30 million Pfizer boosters and nearly 25 million Moderna boosters.
Penny Heaton, the head of global therapeutics for J&J, defended the vaccine, saying it staves off severe disease, offers durable protection and is a preferred choice in locations around the world, especially where the mRNA vaccines might present storage problems.
Dr. Heaton said people are at higher risk of clotting from the virus itself.
And while vaccine-induced clotting is quite rare, “unfortunately, cases of COVID-19 are not,” she said. “They are surging in the U.S. and around the world.”
For more information, visit The Washington Times COVID-19 resource page.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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