Influenza A virus H5N1 vaccines - Nanotherapeutics

Drug Profile

Influenza A virus H5N1 vaccines - Nanotherapeutics

Alternative Names: A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated); Cell culture-based pandemic avian influenza (bird flu) vaccine - Shire; Cell cultured influenza H5N1 vaccine prototype; Cell cultured influenza pre-pandemic H5N1 vaccine; Celvapan H5N1 vaccine - Shire; H5N1 reverse genetic reassorted (RG) Indonesia strain (clade 2) vaccine - Shire/US Department of Health and Human Services; H5N1 Vietnam strain (clade 1) vaccine - Shire/NIAID; Pandemic influenza clade 2 strain vaccine candidate - Shire; Pandemic influenza vaccine H5N1 Shire; Vepacel; Whole virion, vero cell-derived influenza vaccine containing H5N1 HA antigen - Baxter Healthcare Corporation

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Baxter International
  • Developer Baxter International; National Institute of Allergy and Infectious Diseases
  • Class Influenza A virus H5N1 vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Influenza A virus H5N1 subtype
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Influenza A virus H5N1 subtype

Most Recent Events

  • 03 Jun 2016 Baxalta has been acquired and merged into Shire
  • 19 Mar 2015 The vaccine is approved in Iceland, Norway and Liechtenstein, is in phase-III development in Latin America and Asia, in phase-II development in Singapore and phase-I/II development in Hong Kong and Australia
  • 01 Apr 2014 Baxter Healthcare completes a phase III trial in Influenza-A virus H5N1 subtype infection (prevention in infants, children and adolescents) in Japan (NCT01911754)
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