J&J recipients feel left out in rollout of booster shots

But while J&J recently announced that a second shot substantially increased protection in a clinical trial, the company hasn’t discussed a potential timeline for a rollout, to the frustration of some of the nearly 15 million US recipients of the vaccine.

“I feel really left out and forgotten,” said Heath, principal gifts officer for Combined Jewish Philanthropies of Boston. “In the general press, there’s been very little if anything written about the J&J recipients.”

Dr. Megan Ranney, an emergency physician at Rhode Island Hospital and associate dean at the Brown University School of Public Health, agreed.

“As a physician and as a public health professional and as someone who’s just on Twitter, I frequently get questions from patients, colleagues, and strangers who say, ‘What about me? I got J&J, and nobody’s talking about me,’ ” Ranney said. “It’s like the world forgot that 14½ million people got this vaccine.”

Forgotten or not, federal regulators and J&J have provided scant guidance to recipients of the vaccine, who make up just 8 percent of the more than 185 million fully vaccinated Americans. In Massachusetts, 336,269 people have received the J&J vaccine as of Wednesday, compared with 1.7 million who have received both doses of Moderna and 2.6 million who have received both doses of Pfizer, according to the Centers for Disease Control and Prevention. In Rhode Island, those numbers are 52,941 for J&J, 263,170 for Moderna, and 406,018 for Pfizer.

J&J said on Sept. 21 that it shared clinical trial data with the Food and Drug Administration showing that people who received a second shot two months after the first dose had significantly higher protection against symptomatic illness. For those who received a second shot, protection against symptomatic disease rose to 94 percent in the United States and 75 percent globally. And two doses were 100 percent protective against severe disease that can result in hospitalization or death, regardless of where recipients lived.

But a company spokeswoman, Lisa Cannellos, on Tuesday declined to discuss a booster rollout, saying, ‘All we can say at the moment is . . . that the team has submitted data to regulators.’ ”

FDA spokeswoman Veronika Pfaeffle also wouldn’t discuss the matter, referring questions to the drug maker.

Anthony Fauci, the government’s top infectious disease doctor, said on NBC News’ “Meet the Press” last Sunday that recipients of the J&J and Moderna vaccines are “not being left behind by any means” and that the necessary clinical data needed to clear booster shots might be a few weeks away.

The situation frustrates Nathan Rush. A 36-year-old higher education data analyst in Providence, he got the J&J shot at a local Stop & Shop supermarket pharmacy in late March shortly before he visited his mother in Hammond, Ind., for her 63rd birthday. Chemotherapy treatments for cancer have suppressed her immunity, he said, and he didn’t want to infect her if he caught the virus.

Despite his vaccination, Rush tested positive for a breakthrough COVID infection in July. He and two friends had just vacationed in Provincetown, the site of a widely reported outbreak of Delta-driven infections in fully vaccinated people. His illness was relatively mild, he said, but now he’s eager to get a booster shot.

“I want to be as protected as I can be for myself, for my friends, and for my family,” said Rush, who has scheduled a visit to Indiana again for Christmas.

Some J&J recipients are particularly concerned because the one-shot vaccine appeared to be less effective than either of the two-shot vaccines from the start, although it still provides robust protection.

The FDA cleared the J&J vaccine for emergency use on Feb. 27 after a large international clinical trial showed it was 72 percent effective at preventing moderate to severe disease in the United States and 66 percent globally. In trial sites across all regions, it was 85 percent effective at preventing severe illness and 100 percent effective at preventing coronavirus-related hospitalization and death. The Pfizer and Moderna vaccines were authorized in December after they prevented about 95 percent of symptomatic cases in large trials.

The Pfizer and Moderna vaccines use messenger RNA to stimulate an immune response. J&J uses a harmless cold virus to deliver part of the spike protein on the surface of the coronavirus into cells to trigger immunity.

In addition to having lower initial efficacy, there are signs the J&J vaccine may provide less protection against the Delta variant than the Pfizer and Moderna vaccines, according to Dr. Paul Sax, clinical director of the infectious diseases division at Brigham and Women’s Hospital.

Of the 346 infections diagnosed in fully vaccinated people in the Provincetown outbreak, he noted, a higher proportion occurred in J&J recipients than among those who received Pfizer or Moderna vaccines, when adjusting for the number of vaccines given.

“It looks like this one-shot strategy is less effective, period, and it’s exacerbated by the Delta variant,” Sax said.

J&J recipients, he said, need booster shots now. He argues that federal regulators should clear boosters of either of the messenger RNA vaccines for J&J recipients, as Canada and several European countries have done for recipients of the Oxford-AstraZeneca shot, which is similar to J&J.

Several US researchers are running clinical trials that mix and match vaccines, but results have not been made public yet. In the meantime, Sax coauthored a recent opinion piece in The New York Times that said J&J recipients should ask their doctors for a booster shot of the Pfizer vaccine.

Dr. Dan Barouch, head of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, which helped develop the J&J vaccine, acknowledged that it has “slightly lower efficacy” than the two mRNA vaccines and that J&J recipients have “slightly higher breakthrough infections.”

But he said the shot has proven durable despite Delta and cited a recent study that has not yet been peer-reviewed, cowritten by a professor of epidemiology at the Harvard T.H. Chan School of Public Health. The study of 390,000 J&J recipients found that the one-shot vaccine alone had an 81 percent efficacy rate against COVID-related hospitalization and 79 percent against symptomatic infections, with no evidence of decline from March to July.

“We do believe a second shot of the J&J vaccine substantially improves efficacy,” Barouch said. “Boosting with messenger RNA vaccines may or may not work. We don’t have the data yet.”

Barouch said he wouldn’t blame J&J recipients for seeking out an mRNA shot but thinks it would be best for them to wait for guidance from federal health authorities.

For now, that’s what Nathan Rush and Elisa Heath, the two J&J recipients, say they plan to do.

Rush said that the breakthrough infection he caught in Provincetown probably generated antibodies on top of those stimulated by the vaccine, so he will wait to see what regulators advise.

“I don’t want to take a shot from somebody else or have to try to game the system,” he said.

Heath said she doesn’t want to return to the early days of the vaccination campaign when people frantically searched for shots in what she called a “wild, wild West thing.”

“I don’t believe in chaos,” she said. “I can wait until I know something and I know what’s the right something.”

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.