DMSc reports that Human papillomavirus (HPV) vaccines submitted for registration in Thailand have met the requirements.

6  ต.ค. 2560


     DMSc reports that all lots of HPV vaccines registered have been certified by the Institute of Biological Products (IBP), Department of Medical Sciences. Apart from vaccination with HPV vaccine against HPV infection, people should take care of their health, eating healthy food and fruit, doing physical activity consistently and using condoms when having sex with commercial sex workers.

Dr. Sukhum Karnchanapimai, Director-General of the Department of Medical Sciences, said that “there are 2 dossiers of HPV vaccines registered and approved by Thai FDA: (1) Cervarix (against 2 types of HPV) and (2) GARDASIL 4 (against 4 types of HPV). Recently, there has been 1 dossier of HPV vaccine (GARDASIL 9 against 9 HPV types) that is under the process of registration in Thailand. Before receiving the licence, dossiers of vaccines are reviewed and assessed, and tests are performed to determine chemical-physical properties, safety, identity, potency and stability in accordance with the specifications of the products by the IBP. For lot release, the IBP has to conduct the appearance test and review the summary production protocol of the products as well. According to the 2012-2017 data, all lots of Cervarix and GARDASIL 4 have met the specifications of the products. 


       The DG added that “HPV vaccine has been added to the EPI programme of Thailand, and up to now, there are approximately 100,000-200,000 doses of HPV vaccine passing lot release. Nowadays, many countries such as USA, France, Korea, India and China are interested in research and development on HPV vaccine including research on clinical trial. China is developing HPV vaccine (2 types; 16/18) and HPV vaccine (4 types; 6/11/16/18) that is expected to be finished soon. Before using the vaccines, they have to be certified by the IBP to ensure that the qualities, safety and efficacies of the products are in accordance with the international standards. HPV is mainly transmitted through sexual contact and most people are infected with HPV shortly after onset of sexual activity. So far, there has been no drug for treating HPV. There are many types HPV, and many do not cause problems. HPV infections usually clear up without any intervention within a few months after acquisition, and about 70% clear within 1 year and about 90% clear within 2 years. A small proportion (10-15%) of infections with certain types of HPV can persist and progress to cancer”.