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COVID-19

FDA's Shocking Reversal: COVID Vaccines Will Only Be Approved for Those Over 65 or at Greater Risk

Strategic Insights

— 2 min read

The US Food and Drug Administration (FDA) has announced a drastic change in its COVID-19 vaccine policy, only approving updated vaccines for adults over 65 and other Americans who may be at greater risk if they get infected. This move, driven by the antivaxxer ideologies of FDA Commissioner Marty Makary and vaccine czar Vinay Prasad, is a shocking reversal of the previous federal COVID response, which emphasized getting the vaccine to everyone over six months old, with a particular emphasis on older Americans and those with complications.

Key Takeaways:

  • The FDA's new policy restricts the approval of updated COVID-19 vaccines to adults over 65 and other Americans who may be at greater risk if they get infected.
  • This change in policy will likely result in insurance companies no longer covering the vaccines for those outside of the specified groups, making it difficult for people to manage their own healthcare.
  • Dr. Paul Offitt, an actual vaccine expert, warns that this policy will make vaccines less insurable and less available.
  • The new policy was announced in an op-ed in the New England Journal of Medicine by FDA Commissioner Marty Makary and vaccine czar Vinay Prasad, both of whom have a history of being antivaccine advocates.
  • Makary and Prasad claim that the US must have an "evidence-based" policy on vaccinations, despite previously downplaying the seriousness of the COVID-19 disease and exaggerating the potential risks of the vaccine.
  • The op-ed mentions that vaccine manufacturers must conduct new randomized controlled trials of their booster shots to show that the vaccine is safe and effective for healthy people aged six months to 65 years.
  • The FDA's announcement upends the normal federal process for vaccine recommendations and approval, which usually begins with discussions about a vaccine's safety and efficacy by the FDA's independent vaccine advisory group.

Statistics:

  • Less than 25% of Americans received boosters each year, ranging from less than 10% of children younger than 12 years of age in the 2024-2025 season to 50% of adults over 75 years old (New England Journal of Medicine).
  • Even health care workers remain hesitant, with less than one third participating in the 2023-2024 fall booster program (New England Journal of Medicine).
  • A study found that the COVID-19 pandemic led to a significant increase in measles-mumps-rubella (MMR) vaccine refusal, with 1 in 5 parents reporting that they were less likely to get their children vaccinated due to concerns about COVID-19 (Source: abcnews.go.com).

Sources:

  • [1] "FDA Announces New Requirements for COVID-19 Vaccines" (WaPo)
  • [2] "Evidence-Based Policy on Vaccinations" (New England Journal of Medicine)
  • [3] "Marty Makary's COVID-19 Policy Criticisms" (KFF Health News)
  • [4] "Vaccine Expert Warns of Consequences of FDA's New Policy" (AP)
  • [5] "NBC News: FDA's Top Vaccine Scientist Quits Amid Disagreements Over COVID-19 Vaccine Policy" (NBC News)
  • [6] "Trump Officials Set New Requirements for COVID-19 Vaccines" (abcnews.go.com)
  • [7] "Study Finds COVID-19 Pandemic Led to Increased Measles-Mumps-Rubella Vaccine Refusal" (abcnews.go.com)

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