Johnson & Johnson on Tuesday morning asked federal regulators to authorize a booster shot for adults, becoming the third coronavirus vaccine manufacturer to do so.
The company said that a second shot of its vaccine about two months after the first significantly boosts protection, to 94 percent, against moderate to severe disease. Other coronavirus vaccines have been given in two doses, but Johnson & Johnson’s is a single dose.
The Food and Drug Administration last month authorized boosters for many recipients of Pfizer-BioNTech’s vaccine, and Moderna is seeking authorization for boosters of its inoculation. Regulators could decide on both Moderna’s and Johnson & Johnson’s applications as early as this month.
Senior federal health officials have been privately convinced for some time about the need to offer a booster shot to recipients of Johnson & Johnson’s vaccine.
A recent study by the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was 71 percent effective against hospitalization from Covid-19, compared with 88 percent for Pfizer-BioNTech’s and 93 percent for Moderna’s two-dose vaccines. Other research found that Johnson & Johnson recipients were more likely to suffer breakthrough infections or symptomatic Covid-19 than recipients of the other two vaccines.
Johnson & Johnson’s own study cited better results, finding its vaccine was 81 percent effective against hospitalization and 79 percent effective against infection. The company has said that its study also found that the protection its vaccine provides does not wane over time as does protection from Pfizer-BioNTech’s vaccine.
Nearly 15 million Americans have been inoculated with Johnson & Johnson’s vaccine, compared with 102 million fully vaccinated with the Pfizer-BioNTech vaccine and nearly 69 million with Moderna’s.
On Tuesday afternoon, Dr. Peter Marks, the F.D.A.’s top vaccine regulator, suggested that federal officials favor extra shots for all three vaccines. “The data seem to demonstrate that booster shoots seem necessary,” he said.
Speaking at a virtual town hall held by the Covid-19 Vaccine Education and Equity Project advocacy group, he added: “I think the maturing data will make it clear that a larger group of people, perhaps in the individuals 18 and older, will be eligible for booster shots. But we’ll have to see what our advisers say.”
It is unclear to some scientists whether it would be better to give a booster shot of Johnson & Johnson after about two months or six months. Johnson & Johnson’s submission to the F.D.A. shows that when a booster shot was given six months after the initial injection, antibody levels increased ninefold within a week and 12-fold within a month.
Some research from the National Institutes of Health also indicates that Moderna’s vaccine may work even better as a booster for Johnson & Johnson’s shot.
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.
“We look forward to our discussions with the F.D.A. and other health authorities to support their decisions regarding boosters,” said Dr. Mathai Mammen, a key research and development leader within Johnson & Johnson. “At the same time, we continue to recognize that a single-shot Covid-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
The F.D.A. and the Centers for Disease Control have been grappling with whether to shore up vaccine effectiveness with booster shots for weeks. After fraught debates with experts on outside advisory panels, the agencies decided late last month to offer a booster shot to a broad swath of adult recipients of the Pfizer-BioNTech vaccine.
The eligible include those 65 and older and those who live in long-term care facilities, who have underlying medical conditions or who are at higher risk of exposure to the virus because of their jobs or institutional settings.
Federal officials are expected to push this month for the same eligibility categories for booster shots of the other two vaccines. There is also a push to include middle-aged people among those generally eligible. The F.D.A.’s advisory panel is scheduled to take up the issue of a third shot of Moderna’s vaccine on Oct. 14, one day before it is to consider Johnson & Johnson’s request.
“Our goal at the end of that is to hopefully have a harmonized approach to boosters for the three different vaccines,” Dr. Marks said at the town hall. His remarks were reported by CBS News and other media organizations.
On Monday, federal regulators for the European Union went farther than U.S. regulators, authorizing booster shots for all Pfizer-BioNTech recipients 18 or older.