Two vaccines that the World Health Organization lists as priority vaccines for prequalification and that are made by Chinese vaccine manufacturers – bivalent Oral Poliomyelitis Vaccine (bOPV) and hepatitis A vaccine (HAV) – have just received prequalification by WHO. Prequalification means that WHO has given the vaccine its stamp of approval in safety and efficacy terms, and United Nations procuring agencies can now source this vaccine.
“Prequalification of bOPV is very good news for the Global Polio Eradication Initiative,” according to Dr. Fabio Scano, the Officer in Charge of the WHO Representative Office in China. “Following last year’s switch from trivalent OPV to bOPV, most countries are going to rely on a combination of inactivated polio vaccine and bOPV to complete the eradication of polio, and China will now help ensure a sufficient supply of this essential vaccine,” he continued.
Polio is a highly infectious disease caused by a virus that invades the nervous system and can cause total paralysis in a matter of hours. Due to a decades-long effort to eradicate polio, the world is on the verge of eradication of this deadly virus.
Hepatitis A is a viral liver disease that is caused by hepatitis A virus that can cause mild to severe illness and very large, explosive outbreaks that can lead to great suffering and substantial economic loss. A safe water supply, food safety, improved sanitation, hand washing, and hepatitis A vaccine are the most effective ways to combat this disease.
A critically important precondition of prequalification is that the vaccine-producing country must have a National Regulatory Authority (NRA) for vaccines that has passed WHO assessment. The China Food and Drug Administration and the National Health and Family Planning Commission comprise China’s vaccine regulatory authorities, and they passed WHO assessments in 2011 and 2014, paving the way for prequalification of vaccines made in China. China’s vaccine regulators ensure the safety and effectiveness of all vaccines made and used in China.
Prequalification of bOPV and hepatitis A vaccine brings to four the number of WHO-prequalified Chinese vaccines. The others are Japanese encephalitis vaccine and a seasonal influenza vaccine. “We are very pleased to see China’s innovation and production capacity bring lifesaving vaccines to the world through the WHO prequalification program,” said Dr Scano.