F.D.A. Panel Recommends J.&J. Boosters at Least Two Months After First Shot

Before the vote, a top agency official said that the F.D.A. might consider regulatory action that would allow Johnson & Johnson recipients to receive a booster shot of Moderna or Pfizer-BioNTech’s vaccines but gave no timetable for any decision.,


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An F.D.A. panel recommends J.&J. boosters at least two months after the first shot.

The effectiveness of Johnson & Johnson’s vaccine has long been lower than that of the two-dose mRNA vaccines made by Moderna and Pfizer-BioNTech, and vaccine experts have said that the 15 million people in the United States who have received the single-dose Johnson & Johnson shot are likely in need of additional protection.Credit…Robyn Beck/Agence France-Presse — Getty Images

Oct. 15, 2021Updated 2:41 p.m. ET

The Food and Drug Administration’s vaccine advisory panel unanimously voted on Friday to recommend authorizing booster shots of Johnson & Johnson’s one-dose coronavirus vaccine for people 18 years or older, at least two months after the first dose.

Before the vote, a top federal health official, Dr. Peter Marks, said that the agency might consider regulatory action that would allow Johnson & Johnson recipients to receive a booster shot of Moderna or Pfizer-BioNTech’s vaccines. But Dr. Marks, who oversees the F.D.A.’s vaccine division, gave no timetable for any decision, saying only that authorization of a different vaccine as a booster for Johnson & Johnson recipients was “possible.”

Many members of the panel said that a second dose was important because the first dose did not provide strong enough protection. Unlike the other vaccines available in the United States, Johnson & Johnson chose to seek authorization for a single dose — a decision that some members of the committee couched as a mistake in hindsight.

“I think this frankly was always a two-dose vaccine,” said Dr. Paul Offitt, an infectious disease expert at the Children’s Hospital of Philadelphia.

Representatives from Johnson & Johnson presented their case Friday morning during a meeting of the advisory panel, arguing that a second dose given either two months or six months after the first shot increased antibody levels, part of the immune response to vaccines. They also said that the single dose of the vaccine remained durable.

Federal vaccine experts also walked through the company’s data, repeatedly pointing out its shortcomings. They warned that the two-month booster trial only followed up with study volunteers for a short period of time after their second shot. They also noted that a key test used by the company to measure the antibodies produced by a booster had a low sensitivity, calling the results into question — a concern raised by members of the panel on Friday. (Watch the meeting here.)

Dr. Archana Chatterjee, an infectious disease expert at Rosalind Franklin University, asked the F.D.A. why the agency convened the panel if its own experts had not had time to verify the company’s data. Dr. Marks, the agency’s top vaccine regulator who has argued for a “harmonized” approach to booster policy, said it could have taken a month to verify all the data from the company’s largest-scale two-dose trial and several weeks to review the smaller studies.

“I think there was a thought that there was some solution needed potentially for boosting,” he said.

The regulators did not see any evidence of serious safety concerns in the booster trial, but they noted they were not afforded enough time to independently review much of the data that Johnson & Johnson provided in its application for authorization, including in its large, two-dose trial that the company said made a clear case for bumping up protection with an extra shot.

Some federal officials appeared skeptical of the claims the company made about the efficacy of one dose, and expressed worry that those who received it are not as protected as Moderna or Pfizer-BioNTech recipients.

“It was used as an outreach vaccine,” Dr. Marks said. “Many of the people who got that may not have been part of a health maintenance organization or an organized health care system.”

Dr. Amanda Cohn, a C.D.C. official, said that “the effectiveness or protection with a single dose of the J.&J. vaccine is not equivalent” to two doses of the Pfizer-BioNTech or Moderna vaccines, “and certainly not in the group who have now been authorized to receive a booster dose of an mRNA vaccine.”

Some committee members argued that the vaccine should have been used in a two-dose regimen from the start.

What to Know About Covid-19 Booster Shots

The F.D.A. authorized booster shots for a select group of people who received their second doses of the Pfizer-BioNTech vaccine at least six months before. That group includes: vaccine recipients who are 65 or older or who live in long-term care facilities; adults who are at high risk of severe Covid-19 because of an underlying medical condition; health care workers and others whose jobs put them at risk. People with weakened immune systems are eligible for a third dose of either Pfizer or Moderna four weeks after the second shot.

Regulators have not authorized booster shots for recipients of Moderna and Johnson & Johnson vaccines yet. A key advisory committee to the F.D.A. voted unanimously on Oct. 14 to recommend a third dose of the Moderna coronavirus vaccine for many of its recipients. The same panel voted unanimously on Oct. 15 to recommend booster shots of Johnson & Johnson’s one-dose vaccine for all adult recipients. The F.D.A. typically follows the panel’s advice, and should rule within days.

The C.D.C. has said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney or liver disease; dementia and certain disabilities. Pregnant women and current and former smokers are also eligible.

The F.D.A. authorized boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The C.D.C. says that group includes: emergency medical workers; education workers; food and agriculture workers; manufacturing workers; corrections workers; U.S. Postal Service workers; public transit workers; grocery store workers.

It is not recommended. For now, Pfizer vaccine recipients are advised to get a Pfizer booster shot, and Moderna and Johnson & Johnson recipients should wait until booster doses from those manufacturers are approved.

Yes. The C.D.C. says the Covid vaccine may be administered without regard to the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.

Panel members repeatedly conveyed concern about the size of the study Johnson & Johnson used to ask for authorization of a six-month interval. “I’m not sure why you’re asking for an indication that would apply to millions of patients with a data set that includes 17 patients,” said Dr. Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.

The F.D.A. typically follows the panel’s advice.

After voting on a Johnson & Johnson booster, the panel heard from Dr. Kirsten Lyke of the University of Maryland School of Medicine about a study in which she and her colleagues found that Johnson & Johnson vaccine recipients may benefit more from a booster of the Moderna or Pfizer-BioNTech vaccines.

Dr. Lyke and her colleagues carried out a “mix and match” study with different combinations of the three authorized vaccines. “It’s a real-world practical question that people want to know — is it safe to do that?” she said at the meeting.

Preliminary data from the study showed that those who got a Johnson & Johnson shot followed by a Moderna booster saw their antibody levels rise 76-fold within 15 days, whereas those who received another dose of Johnson & Johnson saw only a fourfold rise in the same period. A Pfizer-BioNTech booster raised antibody levels in Johnson & Johnson recipients 35-fold.

The trial only looked at antibody levels, which on their own are an insufficient measure of how well different combinations of vaccines would protect people. Dr. Lyke said that studies on immune cell responses were underway.

In Friday’s morning session, Dr. Johan Van Hoof, a Johnson & Johnson executive, referred to that limited data, saying that a booster was preferable. “These findings are important,” he said of the mix and match study, “but only a piece of the puzzle, and they don’t give the complete picture.”

Even so, some experts said the evidence was still pointing to switching vaccine platforms.

“At the end of the day, folks having the Johnson & Johnson should probably get an mRNA booster,” said Scott Hensley, an immunologist at the University of Pennsylvania.

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