Indian vaccine to replace Quinvaxem vaccine from June

On the afternoon of April 16, the Ministry of Health informed about some new vaccines that will be deployed in the Expanded Immunization Program this year. It is expected that from June and July, the ComBE Five vaccine will be introduced into vaccination nationwide, replacing the 5-in-1 Quinvaxem vaccine. 11,000 vaccination points in the Expanded Immunization Project in the four provinces of Ha Nam, Binh Dinh, Dong Thap, and Kon Tum will use ComBE Five first.

ComBE Five is a combination vaccine that prevents five dangerous infectious diseases in children: diphtheria, whooping cough, tetanus, hepatitis B, pneumonia, and purulent meningitis caused by Hib bacteria. The ingredients of ComBE Five are similar to the ingredients of the Quinvaxem vaccine produced in Korea.

Dr. Tran Nhu Duong, Deputy Director of the Central Institute of Hygiene and Epidemiology, said that the safety and effectiveness of the new vaccine are similar to those of 5-in-1 vaccines with the same ingredients. In 2016, this new vaccine was used in the field in 4 districts of Ha Nam province. As a result, after vaccination, only a few common reactions were recorded on the first day after vaccination, including pain at the injection site, red halo at a rate of 5-15%; about 34-39% of children had fever after vaccination. These indicators are similar to vaccines containing whole-cell pertussis. The health sector did not record any severe reactions in children after vaccination with the new vaccine.

Dr. Duong affirmed that the ComBE Five vaccine, as well as other vaccines imported into Vietnam, must comply with strict regulations. These vaccines must be registered for circulation, including necessary testing, and must ensure they meet standards according to Vietnamese regulations and the World Health Organization.

Each batch of vaccine imported into Vietnam is inspected by the National Institute for Control of Vaccines and Biologicals and meets safety standards before being included in the expanded immunization program.

The immunization schedule for ComBE Five vaccine remains unchanged from the current Quivaxem immunization schedule. Children under one year of age need to receive three doses at 2, 3 and 4 months of age. If the child misses the vaccination schedule, he/she should receive the next dose as soon as possible without having to repeat the first dose.

Children who have received one or two doses of Quinvaxem vaccine can continue with the next dose of ComBE Five vaccine and do not have to start over.

The vaccine is being administered free of charge at all commune and ward health stations nationwide and at some service vaccination points.

ComBE Five vaccine is packaged in one vial per dose. The vaccine vial is fitted with a temperature indicator (VVM) to monitor the temperature exposure of each vial during storage and transport before use.

According to the National Expanded Immunization Project, ComBE Five vaccine has been used for over 400 million doses in 43 countries and in India for over 5 years. Of these, 337 million doses were supplied through UNICEF during 2013-2017 for use in expanded immunization in other countries. This vaccine has also been awarded for use in expanded immunization in India.

Quinvaxem vaccine is produced by Korea and has been included in the Expanded Immunization Program in Vietnam since June 2010 under the aid program. In 2013, Quinvaxem vaccine was temporarily suspended for re-evaluation due to 43 babies having severe reactions after vaccination. The results of the WHO's independent evaluation later showed that among the babies with reactions, 27 died unrelated to vaccination, 9 cases could be considered related to vaccination but all recovered. The remaining cases were not related to vaccination and vaccine quality. By November 2013, this vaccine was continued to be injected into children until now. In December 2016, the manufacturer stopped producing Quinvaxem.

There are 6 types of 5-in-1 vaccines (whole-cell pertussis components) in the world that have met the pre-qualification standards of the World Health Organization, including 2 types from Korea and 4 types from India. There are 2 types registered for circulation in Vietnam: Quinvaxem vaccine (from Korea, discontinued in December 2016) and ComBE Five (from India). ComBE Five vaccine is also in the supply system of the United Nations Children's Fund.