Data from federal scientists is J. Raise a question about & J.Booster shot

Those who have been vaccinated with Johnson & Johnson’s corona virus vaccine should use booster shots from Moderna or Pfizer-BioNTech. Preliminary data From a federal clinical trial published Wednesday.

The discovery is Mixed review According to the Food and Drug Administration in a case of Johnson & Johnson for booster approval, it’s fierce about when and how to provide additional shots to 15 million Americans who have received a single-dose vaccine. It can lead to discussion.

The agency’s Vaccine Advisors panel will meet on Thursday and Friday to vote on whether it recommends allowing the agency to provide booster shots to Moderna and Johnson & Johnson.

Despite the questions posed by the new data on Johnson & Johnson booster strength, some experts say that the one-shot vaccine is less effective than the double-dose mRNA vaccine. Authorities expected to clear the shot anyway, according to Moderna and Pfizer-BioNTech. Also, given that the Biden administration is promoting boosters for all brands, more people may be expecting approval.

When the agency approved the booster from Pfizer-BioNTech last month, “the die was cast,” said John Moore, a virologist at Weil Cornell Medicine.

Pfizer and Moderna vaccines are by far the most used in the United States and Over 170 million people In the United States, it is fully immunized with either vaccine. When Johnson & Johnson’s was approved in February, public health experts said, “One and DunOptions, especially in communities with inadequate access to health care.However, the popularity of shots plummeted The FDA later suspended its use Investigate rare cases of blood clotting.

For those who have been vaccinated with Johnson & Johnson, the timing of booster approval for any brand is still uncertain. The FDA’s committee is set to vote on Friday only to allow a second dose of Johnson & Johnson vaccine, a scenario that the US Centers for Disease Control and Prevention’s Vaccine Advisory Board will discuss next week. If both institutions believe that additional doses should be provided, people can look for them as early as next week.

It is unclear if the FDA will approve the mix-and-match approach and how. The strategy will be discussed at a meeting of the agency panel on Friday, but will not be voted on. If regulators ultimately believe that this approach has sufficient scientific support, the Moderna and Pfizer-BioNTech vaccine approval languages ​​should be updated for use by those who first received Johnson & Johnson.

In a study conducted by the National Institutes of Health, researchers organized nine groups of about 50 each. Each group received one of three licensed vaccines, followed by booster immunization. In three groups, volunteers received the same vaccine for boost. In the other six, they switched to another brand.

Researchers found that those who received a moderno booster following a Johnson & Johnson shot had a 76-fold increase in antibody levels within 15 days, whereas they were given Johnson & Johnson again. One found that it rose only four times over the same period. Pfizer-BioNTech Booster Shot increased antibody levels in Johnson & Johnson’s recipients by a factor of 35.

The authors warned of the small size of the study and stated that they had not followed 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 convincing. However, he said the trial examined only antibody levels, which in and of itself is an inadequate measure of how well different combinations of vaccines reduce Covid-19 infection and hospitalization. ..

“After all, people who have Johnson & Johnson should probably get an mRNA booster,” he said. “It’s a question of how much data the FDA needs before making that recommendation.”

“I don’t want to be in their position,” he added.

Some scientists have seen how the federal government is considering which brand of boosters, given the limited data provided by Johnson & Johnson as well as other companies. I’m wondering.

Dr. Celine Gounder, an infectious disease specialist at the Bellevue Hospital Center in New York, said: “And some people just want to move the booster forward.”

Earlier Wednesday, the FDA’s analysis questioned a major test used by the company, known as the psVNA assay, and said it could distort the findings.

“The results seen are likely due to the insensitivity of the psVNA assay used,” the FDA said in a report. Regulators also said they did not have enough time to independently review much of the raw data from the company’s trials.

The FDA has confirmed that protection from Johnson & Johnson boosters could be improved two months after the first shot, based on a large-scale trial sponsored by the company. Some scientists argue that the vaccine should have been given twice from the beginning.

“Although not independently confirmed by the FDA from the dataset, the summary of the data suggests that a second dose given approximately 2 months after the first dose may be beneficial.” Authorities said in a report.

Johnson & Johnson said in a statement that he was looking forward to discussing the data on Friday. Panelists will also hear a presentation on mix-and-match research on Friday.

What you need to know about Covid-19 booster shots

FDA approval Booster shot For a selected group of people who received a second dose of the Pfizer-BioNTech vaccine at least 6 months ago. The group includes: Pfizer recipients over the age of 65 or living in a long-term care facility. Adults at high risk for severe Covid-19 due to underlying illness. Healthcare workers and other people whose work puts them at risk.Who has Weakened immune system Eligible for a third dose of Pfizer or Moderna 4 weeks after the second shot.

Regulators have not yet approved booster shots for recipients of Moderna and Johnson & Johnson vaccines, FDA panel I will meet Weigh booster shots of adult recipients of Moderna and Johnson & Johnson vaccines.

The CDC states that the conditions covered by booster shots include: High blood pressure and heart disease. Diabetes or obesity; cancer or blood disorders; weakened immunity; chronic lung, kidney or liver disease; dementia and certain disorders. Pregnant women, current and former smokers are also eligible.

The FDA has approved boosters for workers who work at high risk of being exposed to potentially infected people. According to the CDC, this group includes: Education workers; Food and agriculture workers; Manufacturing workers; Correction workers; US Postal Service workers; Public transport workers; Grocery shop workers.

Not recommended. For now, Pfizer Vaccine Recipients are advised to take Pfizer Booster Shots. Moderna and Johnson & Johnson recipients will have to wait until booster doses from these manufacturers are approved.

Yes. According to the CDC, the Covid vaccine may be given at any time, and many pharmacies allow flu vaccinations to be scheduled at the same time as boosters.

This week’s FDA discussions on the Johnson & Johnson vaccine will have a significant impact on Shot’s future in the United States, said Jason L. Schwartz, associate professor of health policy at the Yale School of Public Health. He said the vaccine is already less likely to be more accepted domestically in the long run. And if the FDA finally recommends booster shots to Johnson & Johnson’s recipients of another vaccine, he adds: vaccination. “

FDA has already approved additional shots Pfizer-BioNTech Vaccine People over the age of 65, or people between the ages of 18 and 65 who are at high risk because of their underlying health and work exposure. The Moderna application, which will be discussed on Thursday, may also win approval. Despite limited evidence that protection provided It is declining due to Moderna’s first two-dose regimen.

A single Johnson & Johnson vaccine “still provides protection against serious Covid disease and death in the United States,” regulators said Wednesday. However, they also said that the highest estimates of protection, including serious Covid, were “consistently lower than the highest efficacy estimates” of the Moderna and Pfizer-BioNTech shots.

In clinical trials, J. &. J.Effective rate is 66 percent It is 74% in the United States, compared to moderate to severe Covids worldwide. Its effectiveness against serious or serious illness is stronger, at 85% worldwide.

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

In August, the company announced that it had increased efficacy to 94% in some of the trials conducted in the United States. However, in that report, the FDA focused on global results, with a modest increase, rising to 75%.

Dr. Hensley warned that there is a fairly wide range of uncertainties in estimating efficacy from trials. “The slight change in effectiveness here may be due to chance,” he said.

Two injections were 100% effective against severe to severe Covid’s disease. However, regulators warned in an analysis posted Wednesday that little data from the study on delta variants is currently causing the majority of infections in the United States.

The focus on fortifying the Johnson & Johnson vaccine on the second shot reflects the fact that booster conversations have not only prevented severe cases, hospitalizations and deaths in recent weeks. That has shifted us to ways to prevent infection, the period, “said Dr. Schwartz. “J. & J. I was late from the beginning.”

In August, when Biden’s top executives announced plans to start giving booster shots to Moderna and Pfizer-BioNTech recipients in September, those who received Johnson & Johnson’s shots would also need booster shots. As expected, I needed more data.

The announcement “set unreasonable expectations” for Johnson & Johnson vaccinated people, said Dr. Schwartz, “creating J. & J. The conversation is even more confusing.”

Sharon LaFraniere contributed to the report from Washington.

Data from federal scientists is J. Raise a question about & J.Booster shot

Source link Data from federal scientists is J. Raise a question about & J.Booster shot

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