3-Shot Guidance Leaves Some J&J Vaccine Recipients in the Dark

People with weakened immune systems who received the Johnson & Johnson Covid-19 vaccine are feeling frustrated and forgotten after federal health officials said recommendations for an additional dose don’t apply to them.

The Food and Drug Administration and the Centers for Disease Control and Prevention last week said immunocompromised people who got the Pfizer or Moderna vaccine should get a third dose, but there’s not enough data yet to recommend another shot for immune-impaired J&J recipients. The guidance left many debating whether they should just go ahead and get it anyway, and some doctors are giving patients the green light.

“The lack of guidance for J&J recipients overall has left 13 million people feeling as if they don’t matter because the advice that comes out always references Pfizer or Moderna, or the mRNA vaccine,” said Leana Wen, an emergency physician and visiting professor at George Washington University. “Very rarely does it reference the J&J vaccine.”

The Biden administration is also finalizing a plan to recommend a booster shot for people who got the Pfizer or Moderna vaccine eight months after their second dose. It wasn’t clear what will be recommended for J&J recipients.

Less Protection

Jenyfer Johnson, 60, of Sumter, S.C. is planning to ask her rheumatologist for his opinion when she sees him in a few weeks.

“I feel less sure about my protection,” she said.

Johnson has Type 2 diabetes and was diagnosed about eight years ago with ankylosing spondylitis, an autoimmune disease and type of arthritis that can cause the bones in the spine to fuse together. She got the J&J vaccine in March when she first became eligible and an appointment opened up at her local pharmacy. She didn’t know until she got there which vaccine she was getting.

Johnson now feels “pretty let down” because she didn’t get a choice nor was there any guidance telling immunocompromised people like herself to get Moderna or Pfizer. “I would have waited a week,” she said.

Approximately 13.9 million people received J&J’s Covid-19 vaccine, according to CDC data. Fewer than 1% of them, or 90,979 people, received additional doses of Covid-19 vaccines, according to a presentation from Kathleen Dooling, a CDC medical officer, before the agency’s Advisory Committee on Immunization Practices. That presentation didn’t say whether all of those additional doses were mRNA vaccines.

By comparison more than 300 million doses of Pfizer and Moderna have been administered. About 1.14 million individuals, or fewer than 1%, have received additional vaccine doses. “CDC and FDA are actively engaged to ensure that immunocompromised recipients of Janssen COVID-19 vaccine have optimal vaccine protection,” the presentation said.

The extra shot for the immunocompromised differs from booster shots administered after immunity has waned because cancer patients, organ transplant recipients, and others with weaker immune systems never develop the same level of protection in the first place.

Vaccine efficacy ranged from 59% to 72% among immunocompromised people and 90% to 94% among non-immunocompromised people after the second dose of an mRNA vaccine, according to Dooling’s slides. Immunocompromised people were also more likely to have a breakthrough infection.

Mixing Shots

Wen said she’s advised some patients who got the J&J shot to receive an additional dose of an mRNA vaccine even without a formal recommendation from the federal government.

“We shouldn’t let lack of perfect information lead us to not provide any guidance at all, which is what’s happening in the case of J&J,” she said.

It’s “very reasonable” to provide an mRNA vaccine booster shot to those who have had one shot of the J&J vaccine, said Monica Gandhi, a professor and associate division chief in HIV, infectious diseases, and global medicine at the University of California San Francisco and San Francisco General Hospital.

She cited both guidance from the CDC to provide those who are immunocompromised a third dose of the mRNA vaccine, and safety data coming from Canada after it deployed a mix-and-match strategy of an AstraZeneca shot followed by an mRNA vaccine.

AstraZeneca, which is not available in the U.S., and J&J both use a harmless form of an adenovirus, a common type of virus that causes everything from colds to pinkeye to pneumonia, for their vaccines.

“So, even though the data is limited, my opinion would be to definitely recommend a booster of an mRNA vaccine after J&J for those who are immunocompromised, and a doctor would readily be able to justify that to an insurance company,” Gandhi said.

A UK study in June found mixing AstraZeneca and Pfizer’s vaccines created a strong immune response.

Wen acknowledged rigorous clinical trial data doesn’t exist to show how much an additional dose of an mRNA vaccine would protect J&J recipients against severe disease or how much it would bolster their immune protection. “We don’t have that, but we also need to provide people with at least the ability to make a decision for their lives.”

Wen isn’t immunocompromised, but she did get the J&J vaccine after participating in a clinical trial and only receiving a placebo. She is considering getting an additional dose of an mRNA vaccine.

‘Hold Tight’

Preeti N. Malani, chief health officer and infectious disease professor at the University of Michigan, has been fielding calls from friends and family about what people who got the J&J shot should do. Right now, she said, there just isn’t enough data to provide clear guidance.

“I’ve been saying, hold tight, let’s see what they say,” Malani said, adding she takes some comfort in knowing most immunocompromised individuals got an mRNA vaccine.

Indeed, an FDA spokesperson said the vast majority of the immunocompromised population received either Pfizer or Moderna’s vaccine.

“Since members of this population were some of the first eligible for vaccination, many were vaccinated before J&J was even authorized. We believe it is a very tiny number of immunocompromised individuals who would have received J&J as their vaccination, and those individuals should talk to their doctor,” the spokesperson said.

Ultimately the decision to allow another shot rests with the FDA. But J&J said in a statement it’s planning additional studies to investigate the impact of an extra dose of its Covid-19 vaccine in this population.

Johnson, who’s been largely homebound since the start of the pandemic, said she’ll probably get the added mRNA vaccine dose regardless of what her rheumatologist recommends.

“I shouldn’t say it, but I would lie to get the extra protection,” she said.