FDA Analysis Suggests J. & J. Submits Weak Data for Boosters


In a new analysis, the Food and Drug Administration questioned the strength of the evidence Johnson & Johnson provided in its application for booster shots. Suggesting that a key test used by the company was probably not sensitive enough, the agency added that it did not have enough time to independently review most of the raw data from the trials.

NS documentPublished ahead of a meeting of the agency’s vaccine advisors on Friday, it could have a significant impact on whether or not the 15 million Americans who receive a single dose get a second vaccine. a different brand of vaccine for added protection.

Here is the agency’s analysis: A report released on TuesdayJohnson & Johnson argued in favor of a booster, presenting data from a series of trials.

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

But the FDA on Wednesday said the test used by the company to measure the immune response of a six-month boost — known as the psVNA assay — was not sensitive enough for the task. The agency also questioned whether the increase in immune response was as large as the suggested data.

“The results appearing are likely to be due to the low sensitivity of the psVNA test used,” the FDA said in its report.

Based on a large trial sponsored by the company, the FDA saw potential improvement in protection from a J. & J. booster given two months after the first shot.

“Although not independently verified by the FDA from datasets, summaries of data suggest that a second dose administered approximately 2 months after the primary dose may have a benefit,” the agency said in its report.

The fact that the FDA had not independently verified key data was a departure from past briefing documents for other vaccines. The FDA said it didn’t have time to review much of Johnson & Johnson’s material before its meeting later this week.

Some public health experts scheduled a meeting of the agency’s external consultants before the company submitted its application for the higher dose – an unusual move.

“Except where noted, datasets were not submitted in sufficient time for the FDA to conduct an independent review to validate Sponsor’s analysis,” said the FDA report.

A spokesperson for Johnson & Johnson did not immediately respond to a request for comment.

FDA has already authorized an additional shot Pfizer-BioNTech vaccine For people over 65 or with health conditions or job risks that put them at higher risk. Moderna has also filed for a booster, which will be evaluated by FDA advisors on Thursday. You can also gain authority, Despite limited evidence of diminishing protection from the first two doses of Moderna.

When Johnson & Johnson’s vaccine was approved in February, it had several advantages over the other two. As a single shot, it was more convenient than the two-dose formulation of Moderna and Pfizer-BioNTech. It also didn’t have to be frozen to stay alive. But it also provided less robust protection.

What to Know About Covid-19 Booster Shots

FDA authorized booster shots For a selected group of people who have received their second dose of the Pfizer-BioNTech vaccine at least six months ago. This group includes: Pfizer recipients aged 65 and over or living in long-term care facilities; adults at high risk of serious Covid-19 due to an underlying medical condition; healthcare workers and others whose jobs put them at risk. with people weakened immune systems they are eligible to receive a third dose of Pfizer or Moderna four weeks after the second shot.

Regulators have not yet allowed booster vaccines for recipients of Moderna and Johnson & Johnson vaccines, but FDA panel scheduled to meet To weigh booster vaccines for adult recipients of Moderna and Johnson & Johnson vaccines.

The CDC said conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood diseases; 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 allowed boosters for workers whose jobs put them at risk of exposure to potentially infectious humans. The CDC says the group includes: emergency health workers; education workers; food and agricultural workers; manufacturing workers; correction workers; US Postal Service employees; public transport workers; grocery workers.

Not recommended. For now, Pfizer vaccine recipients are advised to receive the Pfizer booster vaccine, and Moderna and Johnson & Johnson recipients are advised to wait until booster doses from these manufacturers are approved.

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

A clinical trial, a dose of J. &. J. had an activity rate 66 percent against moderate to severe Covid-19 worldwide and 74 percent in the US. Its effectiveness against severe or critical illness was 85 percent stronger worldwide.

In a booster submission, Johnson & Johnson included the results of another large-scale study that began in November, where 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 activity had risen to 94 percent during the portion of the trial that took place in the United States. But the FDA report focused on results worldwide, where the increase was more modest, rising to 75 percent.

Against severe to critical Covid-19, the two shots had 100 percent effectiveness. But regulators warned that there is little data from this trial on the Delta variant, which currently causes the vast majority of infections in the United States, in the analysis published Wednesday.

“The small number of confirmed cases to be caused by the delta variant precludes any conclusions about efficacy against this variant,” they wrote.



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