180+ chief medical officers to know | 2025

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vaccine shot :: Article Creator RFK Jr. Pledged Not To Revamp US Vaccine System, Yet 'massive' Changes Are On The Way Robert F. Kennedy Jr. Clinched the political support needed to become the nation's top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available. The Food and Drug Administration will soon "unleash a massive framework" for how vaccines are tested and approved, according to Commissioner Marty Makary. Details aren't yet public but the plan is being overseen by the agency's new vaccine chief, Dr. Vinay Prasad, an outspoken critic of the FDA's handling of COVID-19 boosters. Makary and other Trump administration officials already have taken unprecedented steps that raise uncertainty about next fall's COVID-19 vaccinations, including dela...
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nOPV2M4a Polio Vaccine — Precision Vaccinations - PrecisionVaccinations

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nOPV2M4a Polio Vaccine Description

nOPV2M4a Polio Vaccine candidate is derived from the live, infectious virus — but this time it has been ‘triple-locked’ using genetic engineering, to prevent it from becoming harmful. 

nOPV2M4a is genetically more stable than existing OPVs, with a lower risk of reversion to neurovirulence.

nOPV2M4a Polio Vaccine Indication

nOPV2M4a Polio Vaccine is indicated to prevent circulating vaccine-derived polio-virus (cVDPV) polio cases.

Most cases of cVDPV are caused by mutations in a strain of poliovirus called type 2.

nOPV2M4a Polio Vaccine News

October 29, 2020 - New polio vaccine which is designed to prevent harmful mutations poised to get emergency WHO approval

July 13, 2019 - The safety and immunogenicity of two novel live attenuated monovalent (serotype 2) oral poliovirus vaccines in healthy adults: a double-blind, single-centre phase 1 study

nOPV2M4a Polio Vaccine Clinical Studies

Clinical Trial NCT04544787: A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates

  • The Phase 2 study is designed to evaluate the safety and immunogenicity of both nOPV2 vaccines in adults before testing in young children and then infants.
  • The primary objectives of the Phase 2 study include the general safety and immunogenicity of the two candidate vaccines, primarily based on comparison with historical data obtained in the Phase 4 study of Sabin mOPV2 for OPV-vaccinated subjects, in order to establish non-inferior immunogenicity and acceptable safety profile.
  • Assessment of the general safety of the 2 candidate vaccines in IPV-only vaccinated subjects will be based on comparison with data from a placebo group

Clinical Trial NCT03430349: Phase 1 Novel Live Attenuated Serotype 2 Oral Polio Vaccine Study in IPV Primed Adults (nOPV2M4a)

  • This first-in-human (FIH) phase 1 study is designed to evaluate in contained conditions the safety, immunogenicity, shedding and genetic stability of both nOPV2 vaccine candidates in IPV-primed adults before testing in a larger adult and adolescent (> 15 y of age) population, and then in young children and infants.
  • The primary objectives of the subsequent Phase 1 and 2 studies will include the general safety, the shedding and genetic stability of the two candidate vaccines, primarily based on comparison with historical data obtained in the Phase 4 studies of Sabin mOPV2.


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