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| What to Know About Boosters if You Got the Johnson & Johnson Vaccine | What to Know About Boosters if You Got the Johnson & Johnson Vaccine |
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| Oct. 15: This article has been updated to reflect new research about the Johnson & Johnson vaccine and new regulatory developments. | Oct. 15: This article has been updated to reflect new research about the Johnson & Johnson vaccine and new regulatory developments. |
| The Food and Drug Administration’s vaccine advisory panel unanimously voted on Friday to recommend a second dose of the single-shot Johnson & Johnson vaccine for adults who had received their first shot at least two months prior. | The Food and Drug Administration’s vaccine advisory panel unanimously voted on Friday to recommend a second dose of the single-shot Johnson & Johnson vaccine for adults who had received their first shot at least two months prior. |
| If the F.D.A., which typically follows the panel’s recommendations, authorizes a second shot, the 15 million Americans who received the Johnson & Johnson vaccine could soon begin receiving boosters. | If the F.D.A., which typically follows the panel’s recommendations, authorizes a second shot, the 15 million Americans who received the Johnson & Johnson vaccine could soon begin receiving boosters. |
| On Thursday, the same F.D.A. committee voted to authorize boosters for Americans who received the Moderna vaccine. The extra shots have already been authorized for Pfizer-BioNTech recipients. | |
| Johnson & Johnson says that a second dose of its shot boosts the levels of antibodies against the coronavirus and is more effective at preventing Covid-19. | Johnson & Johnson says that a second dose of its shot boosts the levels of antibodies against the coronavirus and is more effective at preventing Covid-19. |
| “We want to provide optimal protection against Covid,” Dr. Penny Heaton, global therapeutic area head for vaccines at Johnson & Johnson, said at Friday’s meeting. | |
| But F.D.A. staff have expressed doubts about the quality of the research. And a booster dose of one of the mRNA vaccines, either the Pfizer or Moderna shot, may offer even greater protection, preliminary data suggest. | But F.D.A. staff have expressed doubts about the quality of the research. And a booster dose of one of the mRNA vaccines, either the Pfizer or Moderna shot, may offer even greater protection, preliminary data suggest. |
| Here are answers to some common questions. | Here are answers to some common questions. |
| All of the vaccines authorized in the United States provide strong protection against severe disease and death from Covid-19. | All of the vaccines authorized in the United States provide strong protection against severe disease and death from Covid-19. |
| Over the summer, experts grew concerned that mRNA vaccines were losing some of their effectiveness against infection, although their effectiveness against hospitalization was largely unchanged. Last month, the F.D.A. authorized a booster of the Pfizer-BioNTech vaccine for certain populations at high risk from Covid-19; an advisory recommended a booster shot of Moderna’s vaccine on Thursday for the same populations. | Over the summer, experts grew concerned that mRNA vaccines were losing some of their effectiveness against infection, although their effectiveness against hospitalization was largely unchanged. Last month, the F.D.A. authorized a booster of the Pfizer-BioNTech vaccine for certain populations at high risk from Covid-19; an advisory recommended a booster shot of Moderna’s vaccine on Thursday for the same populations. |
| Unlike Moderna and Pfizer-BioNTech, the Johnson & Johnson vaccine uses a modified adenovirus to deliver its instructions to human cells, and that difference is reflected in how the vaccines are now performing. The Johnson & Johnson vaccine started out with a lower efficacy than the mRNA vaccines, but it has not shown much change in its effectiveness over time. Likewise, studies of antibody levels have found little change over eight months. | Unlike Moderna and Pfizer-BioNTech, the Johnson & Johnson vaccine uses a modified adenovirus to deliver its instructions to human cells, and that difference is reflected in how the vaccines are now performing. The Johnson & Johnson vaccine started out with a lower efficacy than the mRNA vaccines, but it has not shown much change in its effectiveness over time. Likewise, studies of antibody levels have found little change over eight months. |
| Data on the Johnson & Johnson vaccine has been slower in coming, in part because vaccine was not authorized until the end of February, two months after the mRNA vaccines. In addition, Johnson & Johnson vaccinations were temporarily paused while health officials investigated reports that a very small number of people had developed a rare blood-clotting condition after receiving the vaccine. | Data on the Johnson & Johnson vaccine has been slower in coming, in part because vaccine was not authorized until the end of February, two months after the mRNA vaccines. In addition, Johnson & Johnson vaccinations were temporarily paused while health officials investigated reports that a very small number of people had developed a rare blood-clotting condition after receiving the vaccine. |
| The company’s clinical trials, conducted before the Delta variant was widespread, found that the Johnson & Johnson vaccine had 72 percent efficacy overall in the United States, lower than the roughly 95 percent efficacy of the Pfizer and Moderna vaccines. The vaccine’s protection against severe or critical disease was higher, at 85 percent worldwide. | The company’s clinical trials, conducted before the Delta variant was widespread, found that the Johnson & Johnson vaccine had 72 percent efficacy overall in the United States, lower than the roughly 95 percent efficacy of the Pfizer and Moderna vaccines. The vaccine’s protection against severe or critical disease was higher, at 85 percent worldwide. |
| However, it is hard to make direct comparisons between the vaccines, which were tested in different locations and at different times. | However, it is hard to make direct comparisons between the vaccines, which were tested in different locations and at different times. |
| All of the available vaccines appear to lose some effectiveness against Delta, which may be able to dodge some of the immune system’s antibodies. But data suggests that the Johnson & Johnson vaccine holds up well against the variant. | All of the available vaccines appear to lose some effectiveness against Delta, which may be able to dodge some of the immune system’s antibodies. But data suggests that the Johnson & Johnson vaccine holds up well against the variant. |
| Preliminary results from clinical trials of nearly 500,000 health care workers in South Africa suggested that a single dose of the vaccine had efficacy of up to 96 percent against death and 71 percent against hospitalization from infections caused by Delta. | Preliminary results from clinical trials of nearly 500,000 health care workers in South Africa suggested that a single dose of the vaccine had efficacy of up to 96 percent against death and 71 percent against hospitalization from infections caused by Delta. |
| It was “a very large analysis and very clear results showing that the single-shot J.&J. vaccine provided substantial protection against the Delta variant,” Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston, said in August. Dr. Barouch has conducted studies for Johnson & Johnson but was not involved in the South Africa trial. | It was “a very large analysis and very clear results showing that the single-shot J.&J. vaccine provided substantial protection against the Delta variant,” Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston, said in August. Dr. Barouch has conducted studies for Johnson & Johnson but was not involved in the South Africa trial. |
| The company also announced results from another real-world study, conducted in the United States, last month. The study, which has not yet been reviewed by experts, found that the vaccine’s effectiveness remained stable at 79 percent through July, suggesting that it continued to provide good protection against Delta. It was 81 percent effective at preventing hospitalizations. | The company also announced results from another real-world study, conducted in the United States, last month. The study, which has not yet been reviewed by experts, found that the vaccine’s effectiveness remained stable at 79 percent through July, suggesting that it continued to provide good protection against Delta. It was 81 percent effective at preventing hospitalizations. |
| “These vaccines are working,” said John Moore, a virologist at Weill Cornell Medicine. | “These vaccines are working,” said John Moore, a virologist at Weill Cornell Medicine. |
| Recently, Johnson & Johnson carried out studies that it claims show that a booster shot of its vaccine will help protect people against Covid-19. It will raise the effectiveness of the vaccine overall, the company argues, and be especially useful against new variants. But regulators have been critical of the company’s data. | Recently, Johnson & Johnson carried out studies that it claims show that a booster shot of its vaccine will help protect people against Covid-19. It will raise the effectiveness of the vaccine overall, the company argues, and be especially useful against new variants. But regulators have been critical of the company’s data. |
| Last month, the company announced the results of a clinical trial that found that two doses of the vaccine, given two months apart, have 94 percent efficacy in the United States against mild to severe disease, compared with 74 percent efficacy after a single shot. | Last month, the company announced the results of a clinical trial that found that two doses of the vaccine, given two months apart, have 94 percent efficacy in the United States against mild to severe disease, compared with 74 percent efficacy after a single shot. |
| Globally, however, the results were less convincing. Worldwide, the efficacy of a second dose of the vaccine was 74 percent, up from 66 percent after one shot. And the statistical uncertainties around those estimates make it hard to determine just how much better two doses are than one. | Globally, however, the results were less convincing. Worldwide, the efficacy of a second dose of the vaccine was 74 percent, up from 66 percent after one shot. And the statistical uncertainties around those estimates make it hard to determine just how much better two doses are than one. |
| On the other hand, it appears that a second dose does improve protection against severe disease, with an estimated efficacy of 100 percent. | On the other hand, it appears that a second dose does improve protection against severe disease, with an estimated efficacy of 100 percent. |
| Regulators have criticized the study’s short follow-up period. | Regulators have criticized the study’s short follow-up period. |
| The F.D.A. panel voted only on whether to recommend a second Johnson & Johnson shot on Friday. | |
| But some scientists have suggested that mixing and matching vaccines may provide better protection than getting two doses of the same shot. And preliminary data from a study conducted by the National Institutes of Health suggests that the approach has promise. The study, which has not yet been reviewed by experts, involved nine different groups of participants, of roughly 50 people each. | But some scientists have suggested that mixing and matching vaccines may provide better protection than getting two doses of the same shot. And preliminary data from a study conducted by the National Institutes of Health suggests that the approach has promise. The study, which has not yet been reviewed by experts, involved nine different groups of participants, of roughly 50 people each. |
| Each group received a different vaccine and booster combination; some people received a booster dose of the same brand as the original vaccine, while others switched to a different brand for their booster. | Each group received a different vaccine and booster combination; some people received a booster dose of the same brand as the original vaccine, while others switched to a different brand for their booster. |
| Researchers found that Johnson & Johnson recipients who received a Moderna booster experienced a 76-fold increase in their antibody levels, compared with a fourfold increase after a second Johnson & Johnson dose. A Pfizer booster prompted a 35-fold increase in antibodies. | Researchers found that Johnson & Johnson recipients who received a Moderna booster experienced a 76-fold increase in their antibody levels, compared with a fourfold increase after a second Johnson & Johnson dose. A Pfizer booster prompted a 35-fold increase in antibodies. |
| “To me that data looked pretty solid,” said Dr. Moore, who was not involved in the research. | “To me that data looked pretty solid,” said Dr. Moore, who was not involved in the research. |
| The F.D.A. has not yet scheduled an official vote on whether to recommend mRNA boosters for Johnson & Johnson recipients. | The F.D.A. has not yet scheduled an official vote on whether to recommend mRNA boosters for Johnson & Johnson recipients. |
| “We have not reviewed those data in detail,” Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said on Friday. | “We have not reviewed those data in detail,” Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said on Friday. |
| The agency may authorize an mRNA booster for Johnson & Johnson recipients in the future, he said, although he did not provide any more information about the timing of such a decision. | The agency may authorize an mRNA booster for Johnson & Johnson recipients in the future, he said, although he did not provide any more information about the timing of such a decision. |
| At Friday’s meeting, Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital and a member of the advisory committee, encouraged regulators to move swiftly, noting that many Johnson & Johnson recipients had already sought out unauthorized mRNA boosters on their own. | |
| “In the real world, all these kinds of combinations or extra boosters are already happening, so I think it’s a matter of some urgency for F.D.A. to help sort out what is admittedly a complicated and challenging scenario,” he said. | |
| The F.D.A. will review the panel’s recommendation and issue a final decision, which could come within a few days. | The F.D.A. will review the panel’s recommendation and issue a final decision, which could come within a few days. |
| Next week, a vaccine advisory panel to the Centers for Disease Control and Prevention will make its own recommendation on Johnson & Johnson boosters. Its members will decide whether to recommend the shots at all, as well as who should be eligible. | Next week, a vaccine advisory panel to the Centers for Disease Control and Prevention will make its own recommendation on Johnson & Johnson boosters. Its members will decide whether to recommend the shots at all, as well as who should be eligible. |
| The C.D.C.’s director, Dr. Rochelle P. Walensky, will then issue the agency’s formal guidelines on boosters. These guidelines are highly influential for doctors, pharmacies and health care providers. | The C.D.C.’s director, Dr. Rochelle P. Walensky, will then issue the agency’s formal guidelines on boosters. These guidelines are highly influential for doctors, pharmacies and health care providers. |
| For now, sit tight. No booster has yet been authorized for Johnson & Johnson recipients — the process is still underway. | |
| “I imagine by this time next week, the federal government’s health experts will have made a recommendation to the American people about what they should do,” Dr. Moore said. | |
| But it is possible that regulators will authorize a second Johnson & Johnson shot before they authorize mRNA boosters for J.&J. recipients. If that happens, people who got the Johnson & Johnson shot will be “on the horns of a dilemma,” said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases and a vaccine expert at Vanderbilt University. | |
| People should consult with their doctors about whether it makes sense to get a Johnson & Johnson booster as soon as it is authorized or wait for a possible mRNA booster, Dr. Schaffner said. | |
| “A lot depends on where you are and who you are,” he said. People who are at high risk for serious disease and live in places where the virus is surging may not want to wait, he said. |