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Prior to Friday's meeting on J&J boosters, FDA rips into J&J for deeply flawed studies that don't justify approval for a booster...
Posted by: Sarcany
Date: October 13, 2021 10:24PM
I want a Moderna booster.

[www.medscape.com]

In the briefing document published ahead of the meeting, the FDA questioned the drug company's methods, saying that, while results of its 6-month booster study met its recommended criteria, the results come from a small study of just 17 healthy adults ages 18 to 55.

The agency notes that the study wasn't originally designed to measure differences in immune response after a primary and secondary dose; that was done after the study was already under way, making the results subject to bias.

The FDA also notes that the results appear to have been affected by the use of a less sensitive test to measure neutralizing antibody levels in vaccine recipients.

In the original vaccine trial of the Johnson & Johnson shot, study volunteers had a good response to the vaccine a few weeks after they got the shot. But in the booster trial, the FDA notes, only 12% of study participants developed a measurable immune response a month after their first shot. After 6 months, 59% of study participants had a measurable response.

That wasn't a problem with the vaccine, the agency states, but with the test used to measure the antibodies, which appears to have been less sensitive than the antibody tests used to measure response in study volunteers in the original trial. They note that the new test has not yet been validated or qualified.

That less sensitive test appears to have made the booster dose look more effective, as antibodies after the booster were compared with antibodies after the primary dose. After the booster dose, 100% of people in the study developed measurable antibodies to the SARS-CoV-2 virus.

"No reliable conclusions can be drawn," the FDA wrote in its summary of the 6-month booster dose data.

At the same time, no safety signals were identified in the results. The most commonly reported side effect after a booster was a sore arm, followed by headache, fatigue, and nausea.




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Re: Prior to Friday's meeting on J&J boosters, FDA rips into J&J for deeply flawed studies that don't justify approval for a booster...
Posted by: RgrF
Date: October 14, 2021 02:17AM
Quote
Sarcany
I want a Moderna booster.

Did a Moderna 3rd.
Brought wife in 2 weeks later for her third and found they shut that window. They refused her. Really pisses me off since she's suffering congestive heart along with kidney failure.
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