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Epoch HealthFDA Approves New COVID-19 Vaccines


The FDA has approved new COVID-19 vaccines from Moderna and Pfizer-BioNTech, targeting the KP.2 strain. This decision comes in response to waning immunity from previous vaccinations and virus exposure. The approval process and lack of clinical trial data have sparked some controversy.

Key Points:

  • The FDA approved new mRNA-based COVID-19 vaccines from Moderna and Pfizer-BioNTech on August 22, 2024.
  • These vaccines target the KP.2 strain of the virus.
  • Approval was based on animal studies showing neutralizing antibody production.
  • Critics note the absence of published clinical trial data for these new vaccines.
  • Previous vaccine effectiveness against hospitalization peaked at 31% and declined to 4% after several months.
  • The new vaccination schedule varies by age group and prior vaccination status.
  • The most prevalent COVID-19 variant as of August 17, 2024, was KP.3.1.1.

“Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
– Dr. Peter Marks, FDA’s Center for Biologics Evaluation and Research


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