On Covid-19 booster shots, the FDA has overstepped its role


Booster shots for all adults six months after being vaccinated against Covid-19 are safe, effective, and badly needed. The United Kingdom and the European Union have authorized them for all adults. Israel won’t let anyone enter the country without one.

In the U.S., however, the FDA authorized a booster dose of the Pfizer/BioNTech Covid-19 vaccine only for individuals over age 65, those who face elevated risk due to their health conditions, or who work in jobs that put them at higher risk of infection.

In imposing these limits, the FDA overstepped its role for vaccine approvals.

The FDA fully approved the Pfizer vaccine — granting it a biologics license application — in August. The FDA’s role in approving the Pfizer Covid-19 booster is to review safety and efficacy. Its job does not include balancing “public” costs against benefits, nor deciding who gets priority to receive vaccines. Congress assigned the Centers for Disease Control and Prevention as the lead agency for public health policy for infectious diseases with input from the National Institutes of Health.



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