"Speaking on Fox News Saturday morning, FDA Commissioner Marty Makary said the agency would no longer "rubber-stamp new products that don't work," claiming it made a "mockery of science." Makary's comments came the day after FDA's top vaccine regulator, Dr. Vinay Prasad, told his team the agency would change its annual flu vaccine framework, update vaccine labels to be "honest," and make other changes to how it reviews vaccines,"
"Prasad wrote that the FDA would also no longer authorize vaccines for pregnant women without stricter requirements. And for pneumonia vaccines, manufacturers will have to prove they reduce disease rather than show they generate antibodies. He also raised questions about giving multiple vaccines at the same time, which is standard practice. The changes could make it much more difficult and expensive for vaccines to get approved, further limiting the availability of vaccines,"
The FDA intends to strengthen vaccine approval standards and avoid authorizing products that lack demonstrated effectiveness. Agency leaders raised specific concerns about COVID-19 vaccines for children and signaled changes to the annual flu vaccine framework and labeling to present more honest information. New policies will require stricter authorization criteria for pregnant women, demand pneumonia vaccines show disease reduction rather than antibody generation, and reevaluate simultaneous administration of multiple vaccines. These changes could increase development costs, slow approvals, and reduce vaccine availability. Existing post-approval studies and surveillance systems such as VAERS continue to monitor vaccine safety. A claim linked COVID shots to ten child deaths without detailed evidence.
Read at www.npr.org
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