J&J Vaccine Recipients Seek mRNA Booster Without CDC Backing

A person receives a dose of the Johnson & Johnson Covid-19 vaccine during a Miami-Dade County Homeless Trust mobile vaccination outreach event in Florida, U.S. (Photographer: Eva Marie Uzctegui/Bloomberg)

J&J Vaccine Recipients Seek mRNA Booster Without CDC Backing

Some people who received the Johnson & Johnson Covid-19 shot in the U.S. are seeking out added doses of a messenger-RNA vaccine, fearing their initial inoculation won’t protect them from the virus.

Demand for the one-and-done J&J shot has suffered in part due to the perception that it’s inferior to the two-dose mRNA vaccines that showed higher efficacy in clinical trials. But it is unclear if mixing vaccines will safely increase protection, and there are fresh signs that J&J’s shot is a strong shield against variants.

Last month, the first suggestion that mixing may be helpful came in a study that found combining the Pfizer Inc.-BioNTech SE vaccine with AstraZeneca Plc’s shot, which is based on adenovirus vector technology similar to J&J’s vaccine, can provide a formidable shield against infection.

The U.S. Centers for Disease Control and Prevention recommends people don’t mix vaccines until robust clinical data validates the benefit and quells concerns about risks. Anthony Fauci, the top federal infectious-disease expert, said at a White House briefing on Thursday that there’s “no real fundamental scientific reason to do that right now.”

But anxiety about the highly transmissible delta variant that’s sweeping across the U.S., along with emerging data on the mix-and-match approach, has led some people, including pharmaceutical executives and the immunocompromised, to act.

J&J Vaccine Recipients Seek mRNA Booster Without CDC Backing

Terri Leslie is a case in point. She considers herself risk-averse when it comes to Covid. She has spent most of the pandemic in quarantine, ordering groceries online and avoiding gatherings. To get the message across, she recently bought a T-shirt, stating in capital letters, “When this virus is over, I still want some of you to stay away from me.”

But Leslie was willing to try the mix-and-match strategy.

The Mills River, North Carolina, resident jumped at the opportunity to get the J&J shot in March when a hospital called her and offered it. Since then, she’s lamented not receiving a mRNA vaccine. Leslie, 61, takes a rheumatoid arthritis medication that’s left her immune-suppressed, and she was worried about contracting the virus.

“I don’t want to live in fear of getting sick,” Leslie said.

On Tuesday, Leslie decided to take matters into her own hands. Like others before her, she’d been scrolling through tweets from biochemists, virologists and infectious-disease experts advocating that J&J recipients boost their immunity with an mRNA vaccine. Sure, there was backlash on Twitter. But with the blessing of her pediatrician husband, Leslie went to her primary care doctor and received a prescription for the Pfizer vaccine.

The pharmacist hesitated when presented with the prescription, she said, and stepped aside to research the issue. His comment when he returned, according to Leslie: “We’re flying in the dark.” But he then administered the first dose, and she is set to get her second in three weeks.

“Whatever we can do to protect ourselves, we must do it before it’s too late,” Leslie said. “Nobody is wearing masks anymore.”

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U.S. health agencies are monitoring the phenomenon. CDC Director Rochelle Walensky said on a podcast with Andy Slavitt, a former adviser to the Biden administration on the virus response, that she’s aware of the concerns about the J&J vaccine.

“Some people have said, ‘I’m just not going to tell anyone and I’m going to get an mRNA vaccine,’” she said. “We don’t have a huge amount of data on the safety or the side effect profile of getting the mRNA vaccine after Johnson & Johnson, or really the effectiveness of that approach.”

Still, when pressed by Slavitt, Walensky said, “It’s probably safe. But they are generating data to inform us one way or another.”

“You can’t give as a formal recommendation from a regulatory authority, or a public health authority, like the FDA and the CDC respectively,” Fauci said in an interview with NBC’s “Meet the Press” aired Sunday. “But what you’re seeing is that people are going ahead and making those decisions.”

When people mix the vaccines, it’s based “on a feeling” that it’s unlikely to be a problem, rather than official data, Fauci said.

That data could come from a National Institutes of Health trial launched in June in which fully vaccinated adults will receive booster doses of different Covid-19 vaccines. Similar studies are being conducted outside the U.S. as well, with the idea that mixing vaccines may not only be able to strengthen immunity in some people, but could could help overcome shortages in areas where it may be difficult to reliably obtain vaccine supplies.

“The situation right now is that people locally will be making those kinds of decisions, but you should only be making a formal recommendation based on clinical data,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases, at the White House briefing. “When those data become available, you will see recommendations change according to the data.”

Delta Performance

J&J’s vaccine hasn’t yet produced efficacy data against the delta variant that was first identified in India. But on Thursday J&J said its vaccine showed strong neutralizing antibodies for at least eight months against all variants including delta in a small number of clinical-trial participants.

Company officials dismissed the idea that their shot needed to be supplemented with another vaccine.

“There’s no reason or indication to do that to get full protection for severe disease, hospitalization or death,” said Paul Stoffels, J&J’s chief scientific officer, in an interview. “That has been clearly studied, and I wouldn’t recommend any other approach until the data have been generated. At the moment it’s all speculation.”

The company reported that the vaccine prompted a more robust immune response against the delta variant than even against the beta variant that was first detected in South Africa.

Only a single shot of the J&J vaccine is currently needed to shield against variants, Stoffels said, noting that J&J will evaluate boosting protection with its own formulation down the line.

Still, assurances from U.S. health officials and J&J that the vaccine continues to work haven’t stopped doctors and patients from theorizing about the potential benefits of mixing shots.

Interchanging vaccines of the same type -- such as those made using mRNA technology -- isn’t likely to provide an advantage over a standard two-dose course of one of them. But mixing vaccines that use different platforms, through a process known as heterologous prime-boosting, could offer a benefit, according to some scientists.

Different vaccine platforms could activate the immune system in different ways, they suggest, and mixing them up might generate immune responses that stimulate each other at a granular level.

Three Concessions

Paul Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital in Boston, continues to be approached by his peers and patients on what J&J recipients should do to bolster protection.

When advising them, he makes three concessions: First, J&J’s shot is less effective than the mRNA doses. Second, data from the U.K. show those most protected from the delta variant got two doses. And third, a study suggested you can boost an adenovirus-based vaccine like J&J’s with an mRNA version and see a good response.

After being presented with that information, one of Sax’s patients chose to move forward with a J&J-plus-mRNA regimen. Another decided to wait to see what happens over the summer since so few virus cases are currently being reported in New England.

“There’s a very good argument to be made that it’s worth doing, but since we don’t have any definitive data yet I can understand why it’s not formally in the guidelines,” Sax said.

Unvaccinated America

The Biden administration, meanwhile, is focused on increasing the number of people getting shots in unvaccinated pockets of the country. The gap between the most vaccinated and least vaccinated places in the U.S. has widened despite efforts to convince more Americans to get a Covid-19 shot.

Health-care providers in areas where interest is low see a significant role for the J&J vaccine. It can be stored in a refrigerator for long periods, making it a useful tool for pop-up clinics and mobile vaccine units. And because it’s a single shot, it’s an appealing option to those who can’t take multiple days off work.

“The public health goal is to prevent hospitalization, severe disease, and death, and so far, Johnson & Johnson has held up as 100% effective against those things,” said Shereef Elnahal, the chief executive officer of University Hospital in Newark, New Jersey. “Our main focus now should be to get J&J to more people in the community. We shouldn’t lose focus on that.”

©2021 Bloomberg L.P.

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