Intradermal delivery significantly improved influenza vaccine immunogenicity compared with intramuscular delivery. Triple dose (45µg) virosomal vaccine did not demonstrate any benefit on vaccine's immunogenicity over 15µg commercial presentation. All treatments were generally safe and well-tolerated.
Vaccination of children with two doses of Epaxal Junior confers a real-time protection of at least 5.5 years. This protection is estimated to last approximately 25 years. Younger children showed lower antibody titers and a faster antibody decline than older children. Additional follow-up studies are needed beyond 5.5 years to further assess the long-term immunogenicity of Epaxal Junior.
Taken together, these quantitative analytical tools enable more rapid, in-depth, and comprehensive process monitoring, process optimization, and assessment of product consistency and stability.
In 1997 Dr Zhao joined Merck Research Laboratories (West Point, PA) as a Research Fellow and promoted to Senior Investigator and Distinguished Senior Investigator. During his time at Merck, Dr Zhao was involved in the development of a variety of viral and bacterial vaccines: Hepatitis A and B, varicella, influenza, pneumococcal and meningococcal conjugates, and most notably human papilloma virus (HPV). Dr. Zhao played a leading role in the quantitative analysis of vaccine in vitro potency for several vaccines at Merck.
as well as two patents related to the production of Hepatitis B and HPV virus-like-particles with improved properties
including the Industrial Biotechnology Award in 2006, provided by the American Chemical Society to the Team for the development of the quadrivalent HPV vaccine Gardasil®.
To supply the expanding markets for vaccines against hepatitis B and human papilloma virus (HPV), we made the very first ‘Comparability Exercise’ package for HBV (1998-9) given that the regulatory guidelines on Comparability went into effect in the mid-1990s and the second important Comparability Exercise package for Gardasil (2004-6) – the second vaccine (after hepatitis B) ever licensed for preventing an infection that can progress to cancer.
In addition, in the same spirit of Well-Characterized Biologics and Pharmaceuticals, I led efforts in modernizing the in vitro potency assays for hepatitis B and hepatitis A vaccines (Recombivax HB and VAQTA) using monoclonal antibody-based assays – to replace the animal-based potency assays.
Several years after the licensure of Gardasil®, it was gratifying to see a report published in mid-2013 by CDC scientists Markowitz et al that vaccine type HPV (HPV-6, -11, -16 or -18) prevalence among young females aged 14–19 years dropped by ~50% in the US when comparing clinical samples from 4 years (2007–2010) after Gardasil introduction with those before the vaccine introduction (2003–2006), thanks to the advent of an effective vaccine.
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