Introduction:

In the Philippines, diphtheria, tetanus, pertussis, measles and Hepatitis B are associated with high rates of illnesses and deaths in infants and children. These diseases can be prevented if significant proportion of the population is immunized. For example, polio is already near to global elimination phase due to successful immunization program against the poliovirus.

The Expanded Program on Immunization (EPI) of the Department of Health (DOH) provides the immunization against the above-mentioned diseases. The DOH EPI remains strong and continues to gain international recognition as a very successful program of the DOH. The coverage figures of EPI have reached more than 90% for infant vaccines and 70% for Tetanus Toxoid (TT). The success of the program can be mainly attributed to high routine immunization coverage, strong government commitment and availability of some locally produced vaccines such as Bacillus Calmette-Guerin (BCG), an anti-tuberculosis vaccine and TT.

Recently, the success of the EPI program is being threatened by rapidly increasing vaccine requirements due to high population growth rate, high cost of imported vaccines and limited resources of the former Biologicals Production Service (BPS) of DOH to produce high quality vaccines. For example, the requirements for Hepatitis B vaccine can increase to 10 million doses by the year 2002. By this time, the projected budget of the DOH to import 8.5 million doses only of Hepatitis B vaccines is P 196,000,000.00. The total estimated budget of DOH by year 2002 to import EPI vaccines is P 694,382,000.00.

On the other hand, local production of BCG and Tetanus Toxoid vaccine has been stopped since 1995 because of the inability of the old BPS production plant to meet the requirements for Good Manufacturing Practices as imposed by WHO and the Philippines’ Bureau of Food and Drugs (BFAD). BPS used to generate a savings of P 3,840,000.00 from local production of 8 million doses of BCG per year.

With renewed trust of the Philippine Department of Health to be self-sufficient in vaccines, the BPS, now part of the Research Institute for Tropical Medicine, has started construction of new vaccine production plant. The new plant adopted cost-effective approach that will ensure compliance to current GMP.

A Research and Development facility, which is part of this project, will also help accelerate biotechnology in the Philippines that will lead to acquisition or development of new technology that will discover indigenous raw materials for local vaccine production. GMP production facilities, highly trained personnel and availability of raw materials will make our country vaccine self-sufficient in the near future. Vaccine self sufficiency is attained when we have established local production of cheap, high quality and internationally accepted vaccines for most of the requirements of the EPI programs and other vaccine preventable diseases.

Implementation Schedule of the Establishment of the GMP Vaccine Production Facilities:

Phase I. The total budget appropriated by Philippine government to complete Phase I was P430,000,000.00. Seventeen million pesos (P17,000,000.00) appropriated for tax was included in year 2001 budget. Phase I is scheduled to be completed by July 15, 2000. The biotech plant was contracted by Pharmadule in Sweden.

Pharmadule is the only company that can design, construct and deliver GMP vaccine products without the risk of system mismatch, which is high in conventional construction approach. Pharmadule approach assured us of the following: attainment of self-sufficiency in vaccine production, acceleration of local biotechnology development and establishment of an internationally recognized vaccine production plant in the country. The plant, which include facilities for BCG and antivenin production, has been assembled in Sweden and certified for GMP compliance by Swedish Food and Drug Authority in December 2000. In January, the Plant was shipped to Manila by modules and will be reassembled at site in RITM compound.

The modules arrived at Manila Harbor by February 26, 2001 and were transported immediately to the site at RITM after customs formalities. The project has been ahead by 3 weeks of their time schedule. The Philippine Estate Authority is constructing the support facilities under the joint agreement of the Philippine government and Filinvest, using conventional approach.

Phase II. This will consist of 7 modules with complete filling line facilities and separate air handling for vaccines included in this phase. The same approach used in Phase I will be utilized in this phase to avoid system failure and to ensure compliance to GMP standard.