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The FDA Plans to Limit Access to Covid Vaccines. Here’s Why that’s Not All Bad.

  • The FDA plans to limit COVID-19 vaccine booster access this fall, approving them primarily for people over 65 and those with risk factors in the U.S.
  • This policy shift follows concerns about uncertain clinical evidence supporting boosters for healthy people under 65, prompting the FDA to require randomized trial data before approval.
  • Experts note the new FDA framework aligns with some international policies, but many criticize it for lacking transparency and possibly restricting access to vaccines for millions of healthy Americans.
  • Dr. Vinay Prasad described annual boosters as a "public health disaster," while other experts warn limiting access without proper insurance coverage might force some to pay out-of-pocket or forgo vaccination.
  • This change could reduce vaccination rates among healthy populations and raise concerns about balancing public health needs with scientific rigor during the transition from emergency to routine COVID management.
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Pharmaceutical Commerce broke the news in on Wednesday, May 21, 2025.
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