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.
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
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 may 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 the use of a different vaccine as a booster for Johnson & Johnson recipients was “possible.”
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. The F.D.A. typically follows the panel’s advice.
Federal regulators also presented on 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 regulators 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.
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.
The State of Vaccine Mandates in the U.S.
Vaccine rules. On Aug. 23, the F.D.A. granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for mandates in both the public and private sectors. Such mandates are legally allowed and have been upheld in court challenges.College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.Schools. California became the first state to issue a vaccine mandate for all educators and to announce plans to add the Covid-19 vaccine as a requirement to attend school, which could start as early as next fall. Los Angeles already has a vaccine mandate for public school students 12 and older that begins Nov. 21. New York City’s mandate for teachers and staff, which went into effect Oct. 4 after delays due to legal challenges, appears to have prompted thousands of last-minute shots.Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get vaccinated. Mandates for health care workers in California and New York State appear to have compelled thousands of holdouts to receive shots.Indoor activities. New York City requires workers and customers to show proof of at least one dose of the Covid-19 for indoor dining, gyms, entertainment and performances. Starting Nov. 4, Los Angeles will require most people to provide proof of full vaccination to enter a range of indoor businesses, including restaurants, gyms, museums, movie theaters and salons, in one of the nation’s strictest vaccine rules.At the federal level. On Sept. 9, President Biden announced a vaccine mandate for the vast majority of federal workers. This mandate will apply to employees of the executive branch, including the White House and all federal agencies and members of the armed services.In the private sector. Mr. Biden has mandated that all companies with more than 100 workers require vaccination or weekly testing, helping propel new corporate vaccination policies. Some companies, like United Airlines and Tyson Foods, had mandates in place before Mr. Biden’s announcement.
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.
After voting on a Johnson & Johnson booster, the panel was hearing from a scientist who helped lead a study that found Johnson & Johnson vaccine recipients may benefit more from a booster of the Moderna or Pfizer-BioNTech vaccine.
Preliminary data from the study — testing a strategy known as “mix and match” — 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.
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.