Dr Julie Milstein: A practical guide to vaccine pre-qualification in China

Julie Milstien world vaccine congress

What is the impact of increased participation of Chinese vaccine manufacturers on the international market?

Dr. Milstien discussed global vaccine market trends, the process of pre-qualification in general and how these specifically apply to the Chinese market at the World Vaccine Congress Washington.

Worldwide vaccine sales are projected to increase, while the useful half-life of vaccine products is decreasing. Recently, there is more pressure to bring forward innovative products more quickly. Public sector and UNICEF Vaccine Procurement increased between 1996 and 2010. The percent of GAVI-financed vaccines from emerging suppliers (BRICS countries) is also increasing. In 1986, only 5.7% of pre-qualified vaccines were produced in developing countries, while in 2008 it rose to 49%.

China National Biotec Group (CNBG) is the largest vaccine producer in China. Annual manufacturing capacity in China amounts to nearly 1 billion doses. Priority Chinese vaccines in use and in development are:

  • JE (ChengDu Institute Of Biological Products or CDIBP, live attenuated vaccine with 76 million vaccinated in Asia).
  • Recombinant cholera vaccine (Shanghai United Cell Biotech)
  • Pneumococcal vaccine (13 valent, Sinotec)
  • HPV (Biobridge Science)

Pre-qualification is a service to UN agencies that are purchasing vaccines, and is essentially a procurement activity. The goal is for safe, effective vaccines that meet the needs of immunization programs in their respective countries, for instance, having adapted their suitability for field usage. This relies on the national regulatory authority (NRA) of the producing country. They include randomized testing for compliance and monitoring of complaints from the field.

The process includes pre-submission, an application letter to the WHO and copy to the NRA, and the submission of supporting files. Deadlines end January, May, and September. There is then a screening process, and the whole process takes at minimum 1 year, though it does not end with production. There are assessments 3 months after, site audits, lab testing, etc. Chinese vaccines now need a certificate of compliance with the new Chinese GMP code.

The NRA informs the WHO of GMP problems, serious adverse events, license withdrawals, and other events potentially impacting the supply of the vaccine. The WHO provides support in investigating these events, and notifies countries of potential issues learned from other countries.

China has a newly qualified NRA, so the pre-qualification process is expected to be more stringent from here on out. Dr. Milstien also noted that many priority vaccines are not made in China and/or they do not have a large market in China. The priority list of vaccines is published on the WHO website, and every two years there is an update between the WHO, UNICEF and the PAHO Revolving Fund reviewing these.

With regard to safety and efficacy, clinical trials must meet good clinical practice, appropriate ethics review, and new Strategic Advisory Group of Experts (SAGE) on Immunization recommendations for vaccine use from the WHO (http://www.who.int/immunization/sage/en/).

Final remarks about current issues and needs within the vaccine market in China:

•    The new GMP code is a challenge
•    Sustainability of the State Food and Drug Administration (SFDA)
•    Improvements in English language capacity building
•    Vaccine pricing on private domestic market vs. international prices
•    Significant investment may be needed to reach international levels
•    Biggest challenges are not for infrastructure, but sustaining commitment of agencies to for strict compliance.

Watch the full video presentation here

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