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Federal scientists’ data raises questions about J&K. booster shots

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Federal scientists’ data raises questions about J&K. booster shots

People who have received the Johnson & Johnson coronavirus vaccine may be better off with a booster shot from Moderna or Pfizer-BioNtech, according to preliminary data from a federal clinical trial published Wednesday.

The finding, along with a mixed review by the Food and Drug Administration of the case for authorization of its boosters by Johnson & Johnson, could lead to a heated debate about how and when to offer additional shots to 15 million Americans. Received a single dose vaccine.

The agency’s panel of vaccine advisors will meet on Thursday and Friday to recommend whether the agency allows Moderna and Johnson & Johnson to offer booster shots.

Despite questions raised by new data on the strength of Johnson & Johnson’s boosters, some experts speculate that the agency will steer clear of shots anyway, because the effectiveness of the one-shot vaccine is lower than that of two-dose mRNA vaccines. . by Moderna and Pfizer-BioNtech. And given the Biden administration’s push for boosters of all brands, the broader public will also be expecting authorizations.

Once the agency authorized a booster from Pfizer-BioNtech last month, “the die was cast,” said John Moore, a virologist at Weill Cornell Medicine.

The Pfizer and Moderna vaccines are by far the most commonly used in the United States, with more than 170 million people in the United States fully immunized with one or the other vaccine. When Johnson & Johnson was authorized in February, public health experts were eager to implement the “one-and-done” option, especially in communities with poor access to health care. But the shot’s popularity waned when the FDA later withheld its use to investigate rare blood clot cases.

For people who have received the Johnson & Johnson vaccine, the timing of booster authorization — of any brand — is still uncertain. The FDA panel is set to vote Friday only on whether the agency should allow a second dose of the Johnson & Johnson vaccine, a scenario that the Centers for Disease Control and Prevention’s own vaccine advisory committee will discuss next week. If both agencies believe an additional dose should be offered, people may seek them as early as next week.

Whether the FDA can authorize a mix-and-match approach, and how, is unclear. The strategy will be discussed at the agency panel meeting on Friday, but no vote will be taken. If regulators ultimately believe there is sufficient scientific support for the approach, they will likely need to update the authorization language of Moderna and Pfizer-BioNtech vaccines to allow their use in people receiving Johnson & Johnson.

In a study conducted by the National Institutes of Health, researchers conducted nine groups of about 50 people. Each group received one of three authorized vaccines, followed by a booster. In three groups, boost volunteers received the same vaccine. In the other six, they moved to a different brand.

Researchers found that those who got the Johnson & Johnson shot and then the Moderna booster, their antibody levels increased 76-fold within 15 days, while those who got another dose of Johnson & Johnson only did so over the same period. saw a fourfold increase. A Pfizer-BioNTech booster shot increased antibody levels 35-fold in Johnson & Johnson recipients.

The authors cautioned about the small size of the study and said they did not follow the volunteers long enough to identify rare side effects.

Scott Hensley, an immunologist at the University of Pennsylvania who was not involved in the new study, found the results compelling. However, he said the test only looked at antibody levels, which in itself is an insufficient measure of how well different combinations of vaccines will reduce COVID-19 infection and hospitalization.

“At the end of the day, people with Johnson & Johnson should probably get an mRNA booster,” he said. “It’s just a matter of, how much data does the FDA need before making that recommendation?”

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“I don’t want to be in their shoes,” he said.

Some scientists question whether the federal government is considering any brand of boosters, given the limited data provided not only by Johnson & Johnson, but also by other companies.

“There are some of us who would really like to see more data,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “And then there are some who just want to move on to boosters.”

Earlier on Wednesday, an FDA analysis questioned a key test the company is using, known as the psVNA assay, saying it may have skewed the findings.

“It is likely that the observed results are due to the low sensitivity of the PSVNA assay,” the FDA said in its report. Regulators also said they did not have enough time to independently review raw data from the company’s tests.

The FDA saw a potential improvement in safety from a Johnson & Johnson booster given two months after the first shot, based on a large trial sponsored by the company. Some scientists have argued that the vaccine should have been a two-dose shot from the beginning.

“Although not independently confirmed by the FDA from the data set, the summary of the data suggests that there may be benefit in a second dose approximately two months after the primary dose,” the agency said in its report.

Johnson & Johnson said in a statement that it looks forward to discussing the data on Friday, when the panelists will also hear a presentation on the mix-and-match study.

What to know about COVID-19 booster shots

The FDA authorized booster shots for a select group of people who received a second dose of the Pfizer-BioNTech vaccine at least six months ago. That group includes: Pfizer recipients who are 65 years of age or older or who live in long-term care facilities; Adults who are at high risk of severe COVID-19 due to an underlying medical condition; Health care workers and others whose jobs put them at risk. People with a weakened immune system are eligible for a third dose of Pfizer or Moderna four weeks after the second shot.

Regulators have yet to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines, but an FDA panel is about to meet to weigh booster shots for adult recipients of Moderna and Johnson & Johnson vaccines.

The CDC states that conditions that qualify a person for a booster shot include: high blood pressure and heart disease; diabetes or obesity; cancer or blood disorder; weakened immune system; chronic lung, kidney or liver disease; Dementia and some disabilities. Pregnant women and current and former smokers are also eligible.

The FDA authorized boosters for workers whose jobs put them at high risk of coming into contact with potentially infectious people. The CDC says the group includes: emergency medical workers; education worker; food and agricultural workers; construction workers; improvement worker; US Postal Service employees; public transport workers; Grocery store workers.

It is not recommended. For now, Pfizer vaccine recipients are advised to get the Pfizer booster shot, and Moderna and Johnson & Johnson recipients should wait until booster doses are approved from those manufacturers.

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Yes. The CDC says the COVID vaccine can be administered regardless of the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.

Jason L. Schwartz, an associate professor of health policy at the Yale School of Public Health, said the FDA’s discussion this week of the Johnson & Johnson vaccine has major implications for the future of the shot in the United States. He said the vaccine was unlikely to get much acceptance in the country in the long run. And if the FDA eventually recommends a booster shot for a different vaccine for Johnson & Johnson recipients, he said, “it’s hard to see what will lead people to the J&J vaccine.”

The FDA has already authorized an additional shot of the Pfizer-BioNTech vaccine for people over the age of 65, or for those 18 to 65 with underlying health conditions or job exposures that would put them at high risk. Huh. Moderna’s application, which will be discussed Thursday, may also win authorization despite limited evidence that the protection provided by Moderna’s initial two-dose dose is diminishing.

Regulators wrote Wednesday that a shot of the Johnson & Johnson vaccine “still provides protection against serious COVID disease and death in the United States.” But he also said that the highest estimates of safety, including severe COVID, for Moderna and Pfizer-BioNTech shots were “consistently below the highest effectiveness estimates”.

A clinical trial showed that a single dose of J.&J. It had an efficacy rate of 66 percent against moderate to severe COVID-19 worldwide and 74 percent in the United States. Its efficacy was stronger against severe or severe disease at 85 percent worldwide.

In its application for the booster, Johnson & Johnson included the results of another large-scale trial that began in November 2020, in which it gave half of its volunteers a second dose two months after the first. The other half received a placebo.

In August, the company announced that in part of a trial that took place in the United States, efficacy increased to 94 percent. But in its report, the FDA focused on worldwide results, with the increase being more modest, rising to 75 percent.

Dr. Hensley cautioned that there was a wide range of uncertainty in estimates of efficacy from trials. “What that tells you is that the slight variation in effectiveness here may be due to chance,” he said.

Against severe to severe covid disease, the two shots had 100 percent efficacy. But regulators warned in an analysis posted Wednesday that there was little data from that trial on the delta variant, which now causes the vast majority of infections in the United States.

Johnson & Johnson’s emphasis on scaling up the vaccine with a second shot “reflects the fact that our booster conversations in recent weeks have shifted not only to preventing severe cases, hospitalizations and deaths. Gone is how we prevent infection, period,” said Dr. Schwartz. “J&J. Was lagging from the beginning.”

In August, when top health officials in the Biden administration announced plans to begin administering booster shots to recipients of Moderna and Pfizer-BioNtech in September, they said they had anticipated that those receiving Johnson & Johnson’s shots would also need one, although more data was needed.

Johnson & Johnson’s announcement “sets unreasonable expectations” for those receiving the vaccine, Dr. Schwartz said, and “made J&J. Conversations even more confusing.”

Sharon Lafrenier contributed reporting from Washington.

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