F.D.A. Panel Meets on J.&J. Boosters
A study that found Johnson & Johnson recipients may benefit more from a booster dose of the Moderna or Pfizer-BioNTech vaccine will also be discussed.,
An F.D.A. panel is scrutinizing shortcomings in J.&J. booster data.
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 is discussing on Friday and is set to vote on whether to recommend authorizing booster shots of Johnson & Johnson’s one-dose coronavirus vaccine.
The session, which is being streamed on YouTube, comes a day after the same committee voted unanimously in favor of the F.D.A. granting emergency authorization of a half-dose booster of Moderna’s vaccine, at least six months after the second dose. An F.D.A. ruling on a Moderna booster could come within days.
Representatives from Johnson & Johnson presented their case Friday morning, 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.
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 dose had a low sensitivity, calling the results into question.
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.
The panel will vote in the afternoon. It is being asked to consider whether second doses of the vaccine should be offered to people 18 years and older at the two time intervals the company and F.D.A. discussed in their presentations.
The F.D.A. typically follows the panel’s advice.
Despite the limitations pointed out by F.D.A. scientists, the committee may still recommend the shots. 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.
After voting on a Johnson & Johnson booster, the panel will hear from a scientist who helped lead a study that found Johnson & Johnson vaccine recipients may benefit more from a booster dose 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 shot 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.
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.
In Friday’s morning session, Dr. Johan Van Hoof, a Johnson & Johnson executive, referred to that limited data, saying that a second dose of the vaccine 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. “It’s just a matter of, how much data does the F.D.A. need before making that recommendation?”
“I wouldn’t want to be in their shoes,” he added.
In its analysis this week, the F.D.A. did see a potential improvement in protection from the Johnson & Johnson booster given two months after the first shot, based on a large trial sponsored by the company.
“Although not independently confirmed by F.D.A. from data sets, summaries of the data suggest there may be a benefit in a second dose administered approximately two months after the primary dose,” the agency said in its report.