Chris_Halkides
Penultimate Amazing
- Joined
- Dec 8, 2009
- Messages
- 12,591
CIDRAP reported, "Twelve former US Food and Drug Administration (FDA) commissioners yesterday published a commentary calling out Vinay Prasad, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, for proposing sweeping changes to vaccine safety regulation based on what he claims, without presenting evidence, are 10 deaths in children caused by COVID-19 vaccines...The memo [from Prasad] offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation."
CIDRAP also covered the recent FDA memo, "In the future, the FDA will "demand pre-market randomized trials assessing clinical endpoints for most new products," including vaccines, Prasad wrote. He noted that COVID-19 vaccines have not been tested in randomized controlled trials (RCTs) in pregnant women. Such trials are the most rigorous type of study, but they can cost millions of dollars and take years to produce results. "We will not be granting marketing authorization to vaccines in pregnant women" without such evidence, Prasad wrote.
CIDRAP continued, "Demanding an RCT would prevent pregnant women from receiving most vaccines, said Jake Scott, MD, a clinical associate professor of infectious disease and geographic medicine at Stanford University School of Medicine. That's because pregnant women are almost never included in RCTs of vaccines or other drugs due to potential risks to the fetus, Scott said. Instead, the FDA does careful safety monitoring and measures antibody levels in women's blood, which can show whether the vaccine is generating an immune response."
CIDRAP also covered the recent FDA memo, "In the future, the FDA will "demand pre-market randomized trials assessing clinical endpoints for most new products," including vaccines, Prasad wrote. He noted that COVID-19 vaccines have not been tested in randomized controlled trials (RCTs) in pregnant women. Such trials are the most rigorous type of study, but they can cost millions of dollars and take years to produce results. "We will not be granting marketing authorization to vaccines in pregnant women" without such evidence, Prasad wrote.
CIDRAP continued, "Demanding an RCT would prevent pregnant women from receiving most vaccines, said Jake Scott, MD, a clinical associate professor of infectious disease and geographic medicine at Stanford University School of Medicine. That's because pregnant women are almost never included in RCTs of vaccines or other drugs due to potential risks to the fetus, Scott said. Instead, the FDA does careful safety monitoring and measures antibody levels in women's blood, which can show whether the vaccine is generating an immune response."
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