When the FDA looks only at clinical risks and benefits for individuals, it completely ignores all the benefits at the population level.
No doubt you’ve seen quotes from the FDA meeting flying around on social media; the sound bites were a nightmare for those of us working to stem the tide of vaccine hesitancy. The committee members used phrases like “the toughest decision,” “I’m having some challenges with this one,” and “close call.” Taken out of context, they made the vaccine sound downright dicey. For example, Dr. Eric Ruben—a member of the committee, M.D./Ph.D.
The FDA makes decisions about authorizing vaccines as if they’re aspirin. To decide whether Bayer should sell aspirin in the United States, we only need to know its clinical risks and benefits—the things that happen inside the body of the person who takes aspirin. Benefits: reduces pain, reduces fever, prevents heart attacks. Risks: serious gastrointestinal bleeding and other bleeding disorders.
prevent you from getting COVID-19 in the first place, and when you don’t have COVID-19, you cannot infect anyone else. Vaccines lead to fewer and fewer transmissions over time, until there are very few. That’s how vaccines
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