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FDA analysis suggests J. and J. submitted weak data for boosters

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In a new analysis, the Food and Drug Administration has questioned the strength of the evidence provided by Johnson & Johnson in its request for recalls. A key test used by the company was probably not sensitive enough, the agency suggested, adding that it did not have enough time to independently review much of the raw data from the tests.

The document, released ahead of a meeting of the agency’s vaccine advisers on Friday, could have a significant influence on whether the 15 million Americans who received the single-dose vaccine will be allowed a second injection, or s instead, they will be asked to obtain a different brand of vaccine for additional protection.

The report’s authors took no position on whether the agency should approve Johnson & Johnsons’ request, and it was unclear whether the flaws they identified in the data would be considered sufficiently important to deny permission.

Despite FDA questions about the data, some experts predicted that the agency would allow Johnson & Johnsons boosters to meet public demand anyway. Once the agency cleared a recall of Pfizer-BioNTech last month, the die was cast, said John Moore, virologist at Weill Cornell Medicine.

Agency analysis follows a report published on Tuesday, in which Johnson & Johnson argued for a recall, presenting data from a number of trials.

A booster dose is recommended at 6 months or later, depending on the strength of immune responses, the company wrote.

But on Wednesday, the FDA said the test the company uses to measure the immune response to a six-month boost known as the psVNA test is not sensitive enough for the task. The agency also asked if the increase in the immune response was as large as the data suggested.

It is likely that the observed results are due to the low sensitivity of the psVNA test used, the FDA said in its report. Regulators have warned that it was difficult to compare the results of the company’s six-month and two-month recall studies.

The FDA saw potential improvement in protection against a J.&J booster given two months after the first injection, based on a large company-sponsored trial.

While this is not independently confirmed by the FDA from the data sets, the data summaries suggest that there may be a benefit in a second dose given approximately 2 months after the primary dose, said the agency in its report.

The fact that the FDA did not independently confirm key data was a departure from previous briefing documents for other vaccines. The FDA said it did not have time to review much of the Johnson & Johnsons material before the meeting later in the week.

The agency scheduled the meeting of its external advisers before the company even submitted its request for a booster dose, an unusual move, some public health experts said.

Unless otherwise noted, the data sets were not submitted in sufficient time for the FDA to conduct an independent review to verify the sponsors’ analyzes, the FDA said in its report.

Johnson & Johnson said in a statement they looked forward to discussing the data at Friday’s meeting, which will also include a presentation from federal scientists on mixing different brands of vaccines to boost the immune system.

The FDA’s discussion this week on the Johnson & Johnson vaccine has big implications for the future of injections in the United States, said Jason L. Schwartz, associate professor of health policy at the Yale School of Public Health. The vaccine was already unlikely to have much use in the country in the long term, he said. And if the FDA recommends a booster for Johnson & Johnson recipients of a different vaccine, he added, it’s hard to see what would point people towards the J.&J vaccine.

The FDA has already cleared an additional injection of the Pfizer-BioNTech vaccine for people over 65, or with health problems or occupational exposures that put them at higher risk. Moderna also submitted a recall request which will be assessed by FDA advisers on Thursday. He may also get clearance, despite limited evidence that the protection provided by two initial doses of Moderna is diminishing.

Regulators wrote on Wednesday that a single injection of the Johnson & Johnson vaccine still offers protection against severe Covid-19 disease and death in the United States, but that the highest efficacy estimates, including for the Serious Covid-19, were consistently lower than the highest. Efficiency estimates for Moderna and Pfizer-BioNTech shots.

What to know about Covid-19 booster injections

The FDA has cleared booster shots for a select group of people who received their second dose of the Pfizer-BioNTech vaccine at least six months ago. This group includes: Pfizer beneficiaries who are 65 years of age or older or who live in long-term care facilities; adults who are at high risk for severe Covid-19 due to an underlying medical problem; healthcare workers and others whose jobs put them at risk. People with weakened immune systems may receive a third dose of Pfizer or Moderna four weeks after the second injection.

Regulators have yet to clear the booster shots for Moderna and Johnson & Johnson vaccine recipients, but an FDA panel is due to meet to weigh the booster shots for adult Moderna and Johnson & Johnson vaccine recipients.

The CDC said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; 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 has cleared the boosters for workers whose work puts them at high risk of exposure to potentially infectious people. The CDC says this group includes: emergency medical workers; education workers; food and agricultural workers; manufacturing workers; correctional workers; workers in the US postal service; public transport workers; employees of grocery stores.

It is not recommended. For now, recipients of the Pfizer vaccine are advised to be vaccinated by Pfizer, and recipients of Moderna and Johnson & Johnson must wait until booster doses from these manufacturers are approved.

Yes. The CDC says the Covid vaccine can be given regardless of the timing of other vaccines, and many pharmacy websites allow people to schedule a flu shot along with a booster dose.

When the Johnson & Johnsons vaccine was cleared in February, it had several advantages over the other two. In one fell swoop, it was more convenient than the two-dose formulation of Moderna and Pfizer-BioNTech. It also doesn’t need to be frozen to stay viable. But it also offered less robust protection.

A clinical trial has shown that a dose of J. &. J. had an efficacy rate of 66 percent against moderate to severe Covid-19 worldwide and 74% in the United States. Its effectiveness against serious or critical illness was higher, at 85 percent worldwide.

In its recall request, Johnson & Johnson included the results of another large-scale trial that began in November, in which they gave half of their volunteers a second dose two months after the first. The other half received a placebo.

In August, the company announced that in the portion of the trial that took place in the United States, the efficiency increased to 94%. But in its report, the FDA focused on the global results, which increased more modestly, reaching 75%.

Against severe to critical Covid-19, two shots were 100% effective. But regulators warned in analysis released Wednesday that there was little data from this trial on the Delta variant, which now causes the vast majority of infections in the United States.

The small number of accumulated cases confirmed to be caused by the Delta variant precludes any conclusion regarding efficacy against this variant, they wrote.

The focus on the Johnson & Johnsons vaccine recall reflects the fact that our conversation on the recall has shifted in recent weeks to not just prevent severe cases, hospitalizations and deaths. It has shifted to how we prevent infections, period, said Dr. Schwartz, Yale health policy expert. J. & J. was lagging from the start.

In August, when senior health officials in the Biden administration announced plans to start giving booster shots in September to Moderna and Pfizer-BioNTech beneficiaries, they said they expected those who received an injection from Johnson & Johnsons would also need it, but more data was needed. .

The announcement created unreasonable expectations for those who had received the Johnson & Johnsons vaccine, Mr. Schwartz said, and made the J&J conversation even more confusing for these 15 million Americans and what to do in the future. over the next few weeks.

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2/ https://www.nytimes.com/2021/10/13/health/johnson-vaccine-booster-fda.html

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