This article is from the source 'nytimes' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at https://www.nytimes.com/2021/08/18/health/coronavirus-johnson-vaccine-booster.html

The article has changed 3 times. There is an RSS feed of changes available.

Version 1 Version 2
What to Know About Boosters if You Got the Johnson & Johnson Vaccine What to Know About Boosters if You Got the Johnson & Johnson Vaccine
(about 2 months later)
Aug. 25: This article has been updated to reflect new research about the Johnson & Johnson vaccine. Oct. 15: This article has been updated to reflect new research about the Johnson & Johnson vaccine and new regulatory developments.
Americans who received the Pfizer-BioNTech or Moderna coronavirus vaccines should get a booster shot eight months after their second vaccine dose, federal health officials said last week.
The boosters will be available beginning Sept. 20, if the Food and Drug Administration agrees to the plan. They will go first to health care workers, nursing home residents and older adults, who were the first to receive the initial round of vaccinations after they were authorized in December. 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.
But the recommendation does not apply to the nearly 14 million Americans who received the single-shot Johnson & Johnson vaccine. 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.
“For people who received the Johnson & Johnson vaccine, we anticipate vaccine boosters will likely be needed,” Dr. Vivek Murthy, the surgeon general, said at a White House news briefing on Aug. 18. 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.
A second dose of the single-shot Johnson & Johnson vaccine significantly boosts the levels of antibodies against the coronavirus, the company announced on Wednesday.” 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 look forward to discussing with public health officials a potential strategy for our Johnson & Johnson Covid-19 vaccine, boosting eight months or longer after the primary single-dose vaccination,” Dr. Mathai Mammen, the global head of Janssen Research & Development at Johnson & Johnson, said in a statement. “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.
In the meantime, here are answers to some common questions. 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.
All of the vaccines authorized in the United States provide strong protection against severe disease and death from Covid-19. But the booster recommendation was based on data suggesting that the protection provided by the mRNA vaccines against infection and mild disease has been waning over time, officials said on Wednesday. Here are answers to some common questions.
“Even though this new data affirms that vaccine protection remains high against the worst outcomes of Covid,” Dr. Murthy said at the briefing, “we are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death.” All of the vaccines authorized in the United States provide strong protection against severe disease and death from Covid-19.
But less data is available on the Johnson & Johnson vaccine, which was not authorized until the end of February, two months after the mRNA vaccines. (The Johnson & Johnson vaccine uses a modified adenovirus to deliver its instructions to human cells.) 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. 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.
More than 150 million Americans have gotten mRNA vaccines, far exceeding the 14 million who have received the Johnson & Johnson shot, according to data from the Centers for Disease Control and Prevention. 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.
Without robust data on the long-term effectiveness of the Johnson & Johnson vaccine, it is hard for health officials to recommend boosters, said John Moore, a virologist at Weill Cornell Medicine. “If you’re doing data-driven decisions and you don’t have the data, what can you do?” he said. “This is sort of the dilemma. Public confidence in vaccines generally depends on seeing how the sausage is made, seeing that it is a data-driven, transparent process.” 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.
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. However, it is hard to make direct comparisons between the vaccines, which were tested in different locations and at different times. 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.
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. The Johnson & Johnson vaccine is no exception. “You would expect there to be a degree of resistance against Delta, because there always is,” Dr. Moore said. However, it is hard to make direct comparisons between the vaccines, which were tested in different locations and at different times.
Small laboratory studies have turned up contradictory results on how well the Johnson & Johnson vaccine protects against Delta. Last month, Johnson & Johnson said that a single dose of its vaccine prompted a strong immune response against Delta and that the response lasted at least eight months. 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.
But data from another recent laboratory study suggested that a single dose of the vaccine elicited a relatively weak antibody response against Delta, which could make boosters more essential. 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.
The first real-world data on the vaccine’s efficacy against the variant was released this month. The data, which are preliminary results from clinical trial 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,” said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who 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.
On Wednesday, Johnson & Johnson released interim results from its research on booster doses. When trial participants received a second dose of the vaccine six months after their first shot, their antibodies against the virus increased to levels ninefold higher than after the first dose, the company said. The data have not yet been published in a peer-reviewed journal. “These vaccines are working,” said John Moore, a virologist at Weill Cornell Medicine.
Johnson & Johnson is also currently conducting a trial on the efficacy of receiving two doses of the vaccine two months apart. Data from that study are expected in the coming weeks. 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.
Federal health officials and outside experts said that they expected that boosters would ultimately be recommended for people who had received the Johnson & Johnson vaccine. 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.
“Given the hyperinfectious Delta variant, it is likely that people who received the J.&J. vaccine will be recommended for a booster shot at some point in time,” Dr. Barouch said. 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.
Dr. Moore agreed, adding that he expected that recommendation to come sooner rather than later. On the other hand, it appears that a second dose does improve protection against severe disease, with an estimated efficacy of 100 percent.
“I would be very, very surprised if that did not happen in the reasonably near future,” Dr. Moore said. He added, “I can’t pluck a date out of the air, but I know it’s on the radar screen.” Regulators have criticized the study’s short follow-up period.
It’s not clear yet. “The timeline for boosters will be determined in part by data that I expect to come out over the next several weeks,” Dr. Barouch said. The F.D.A. panel voted only on whether to recommend a second Johnson & Johnson shot on Friday.
The first Johnson & Johnson vaccines were not given until early March. If federal officials recommend the same eight-month timeline between vaccination and booster shots, the first Johnson & Johnson boosters would most likely start in November, Dr. Barouch said. 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.
Some scientists have suggested that mixing and matching vaccines may provide better protection than getting two doses of the same shot. And research suggests that people who follow a single dose of the AstraZeneca vaccine, which uses technology similar to the Johnson & Johnson shot, with the Pfizer vaccine have a more robust immune response than those who get a second dose of AstraZeneca. 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.
Some people who have received the Johnson & Johnson vaccine are seeking mRNA boosters on their own. San Francisco health officials have said that they will accommodate these requests as long as people consult with their doctors first. 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.
Although Dr. Barouch said he could not predict what kind of booster federal officials might ultimately recommend for people who had gotten the Johnson & Johnson vaccine, the data he expects to be released soon is from studies of two doses of the Johnson & Johnson vaccine, rather than an mRNA booster. “To me that data looked pretty solid,” said Dr. Moore, who was not involved in the research.
Indeed, Dr. Moore anticipated that if the government recommended a booster in the near future for people who had received the Johnson & Johnson vaccine, it would be for a second dose of the same vaccine. “There won’t be any data on J.&J. first, mRNA second,” he said. The F.D.A. has not yet scheduled an official vote on whether to recommend mRNA boosters for Johnson & Johnson recipients.
Sit tight, experts said. “The federal government is well aware of the J.&J. situation,” Dr. Moore said. “It’s not being overlooked.” “We have not reviewed those data in detail,” Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said on Friday.
Dr. Barouch agreed. “I do expect a substantial amount of data to come out in the next few weeks,” he said. “So, I understand that people who received the J.&J. vaccine want more information, and that information will be coming.” 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.
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.
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.