J&J recipients feel excluded from the deployment of booster injections



[ad_1]

But while J&J recently announced that a second injection significantly increases protection in a clinical trial, the company has not discussed a potential timeline for deployment, to the frustration of some of the nearly 15 million U.S. recipients. vaccine.

“I really feel left out and forgotten,” said Heath, senior gift manager for Combined Jewish Philanthropies of Boston. “In the general press, there has been very little or nothing written about the J&J recipients.”

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

“As a doctor and public health professional and as a person who is only on Twitter, I frequently get questions from patients, colleagues and strangers who say, ‘What about me? I have J&J, and no one is talking about me, ”said Ranney. “It is as if the world has forgotten that 14 and a half million people have received this vaccine.”

Forgotten or not, federal regulators and J&J have provided little advice to vaccine recipients, who represent only 8 percent of the more than 185 million Americans fully immunized. In Massachusetts, 336,269 people received the J&J vaccine on Wednesday, compared with 1.7 million who received the two doses of Moderna and 2.6 million who received the two doses of Pfizer, according to the Centers for Disease Control and Prevention. In Rhode Island, these figures are 52,941 for J&J, 263,170 for Moderna and 406,018 for Pfizer.

J&J said on September 21 that it shared clinical trial data with the Food and Drug Administration showing that people who received a second injection two months after the first dose had significantly higher protection against symptomatic illnesses. For those who received a second injection, protection against symptomatic illness has increased to 94% in the United States and to 75% worldwide. And two doses provided 100% protection against serious illness that could lead to hospitalization or death, regardless of where recipients lived.

But company spokeswoman Lisa Cannellos declined to discuss a recall deployment on Tuesday, saying, “All we can say at the moment is … the team has submitted. data to regulators. “

FDA spokeswoman Veronika Pfaeffle was also unwilling to discuss the matter, referring the questions to the drugmaker.

Anthony Fauci, the government’s top infectious disease doctor, told NBC News’ Meet the Press last Sunday that recipients of the J&J and Moderna vaccines “are by no means left behind” and that clinical data necessary are needed to clear the recall the shots could be in a few weeks.

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 visiting her mother in Hammond, Indiana for her 63rd birthday. Chemotherapy treatments for cancer suppressed his 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 returned from a vacation in Provincetown, the site of a widely reported outbreak of infections caused by Delta in fully vaccinated people. His illness was relatively mild, he said, but now he’s looking forward to a booster.

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

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

The FDA cleared the J&J vaccine for emergency use on February 27 after a large international clinical trial found it to be 72% effective in preventing moderate to severe disease in the United States and 66% in the world. In test sites in all regions, it was 85% effective in preventing serious illness and 100% effective in preventing coronavirus-related hospitalizations and deaths. The Pfizer and Moderna vaccines were cleared in December after preventing about 95% 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 that the J&J vaccine may offer less protection against the Delta variant than the Pfizer and Moderna vaccines, according to Dr Paul Sax, clinical director of the infectious diseases division of the Brigham and Women’s Hospital.

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

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

J&J beneficiaries, he said, need reminders now. He argues that federal regulators should allow recalls of either of the messenger RNA vaccines for recipients of J&J, as Canada and several European countries have done for recipients of the Oxford-AstraZeneca vaccine, which is similar to J&J.

Several American researchers are conducting clinical trials that mix and match vaccines, but the results have not yet been made public. In the meantime, Sax has co-authored a recent opinion piece in the New York Times that J&J recipients should ask their doctors for a Pfizer vaccine booster.

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, admitted that it had “slightly lower efficacy” than the two vaccines. MRNA and that J&J recipients had “breakthrough infections.” “

But he said the shot was found to be long lasting despite Delta and cited a recent study that has yet to be peer reviewed, co-authored by a professor of epidemiology at Harvard TH Chan School of Public Health. . The study of 390,000 J&J recipients found that the single-injection vaccine had an 81% effectiveness rate against COVID-related hospitalizations and 79% against symptomatic infections, with no evidence of decline from March through July.

“We believe that a second injection of the J&J vaccine significantly improves efficacy,” said Barouch. “Stimulation 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 researching an mRNA injection, but believes it would be best for them to wait for advice from federal health officials.

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

Rush said the groundbreaking infection he caught in Provincetown likely generated antibodies in addition to those stimulated by the vaccine, so he will wait to see what regulators advise.

“I don’t want to take a hit from someone else or have to try and mess with the system,” he said.

Heath said she didn’t want to go back to the early days of the vaccination campaign, when people frantically searched for shots at what she called a “thing of the wild and wild West”.

“I don’t believe in chaos,” she said. “I can wait to know something and find out what the right thing is.”


Jonathan Saltzman can be reached at [email protected].

[ad_2]

Source link