Chinese Vaccines Against Poliomyelitis and Hepatitis A Prequalified by WHO

Two vaccines that the World Health Organization (WHO) lists as priority vaccines for prequalification - bivalent Oral Poliomyelitis Vaccine (bOPV) and hepatitis A vaccine (HAV) – have just received prequalification by WHO.

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.

A critically important condition 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.

Dr. Fabio Scano, the Officer in Charge of the WHO Representative Office in China said “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,” he continued.

An objective of the Polio Eradication and Endgame Strategic Plan 2013-2018 calls for the transition in the vaccines used to eradicate polio and requires the removal of all oral polio vaccines (OPVs) in the long term. This will eliminate the rare risks of vaccine-associated paralytic polio (VAPP) and circulating vaccine-derived poliovirus (cVDPV).

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 vaccine (HAV) is the other vaccine that recently received prequalification from WHO. 

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.

“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.

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.

For more information on WHO pre-qualification please see this link.

In the USA, the FDA has approved vaccines for both polio and hepatitis A, which can be found at this website

Media please contact: Ms. Wu Linlin, World Health Organization | People’s Republic of China, E-mail: [email protected]