Questions and answers on the vaccine incident in China

Q17: What WHO did to evaluate this vaccine incident? Are there any data/investigation results available? How can WHO say the implicated vaccines cause no toxic reaction?

A17: The Chinese health authorities’ and police investigation into the vaccine reselling ring is ongoing. WHO’s position on the current situation and on China’s vaccine system more broadly is based on our expert, independent assessment of the information so far available, and on over 15 years of working closely with the national vaccine regulators. (In 2010 and 2014, WHO conducted in-depth, independent assessment of China’s vaccine regulation, finding both times that China’s regulatory system meets or exceeds WHO/international standards.)

Without careful handling, vaccines can lose some of their potency and effectiveness. Therefore there is a risk that children who received expired or improperly stored vaccines may not be protected from the disease the vaccine they received was supposed to prevent. However, decades of vaccine science tells us that unless the vaccine vial or prefilled syringe was damaged and the vaccine contaminated, it is very unlikely that administration of an expired or improperly stored vaccine will cause a toxic reaction.

Q18: Isn’t it the government’s responsibility to ensure that all vaccines, including category 1 & 2 vaccines, are safe?

A18: WHO is confident in the manufacturing and licensing of all Chinese vaccines. Both the vaccines that are distributed for free to all children through the Government’s Expanded Program on Immunization (EPI) (category 1 vaccines), and vaccines available for private purchase (category 2 vaccines), are subject to the same stringent regulations on manufacturing. Thus, all vaccines in China start life the same way – through a process that WHO has certified will produce safe, pure, and effective vaccines.

The problem that the current situation has exposed relates to the distribution of vaccines available for purchase on the private market. It is clear from this incident that there is a need for much stronger management, monitoring and oversight of privately purchased vaccines.

Q19: Should the Government expand the EPI program to cover more vaccines including pneumonia/meningitis vaccine and pneumococcus vaccine?

A19: WHO understands that vaccines and immunization programs are great societal investments in child health. They prevent a great deal of suffering and death of children, while at the same time they save costs to the health care system by reducing the need for treating illnesses at doctors’ offices and hospitals.

There are some vaccines only available on the private market in China that WHO recommends to be included in all countries’ national immunization programs. These include two vaccines against pneumonia and meningitis – Hib vaccine and pneumococcal conjugate vaccine; one vaccine against a cause of viral gastroenteritis – rotavirus vaccine; influenza vaccine; and inactivated poliovirus vaccine, which is planned for introduction later this year in China and many other countries.

Q20: Who is responsible for supervising the vaccine market? And who will be held responsible for this vaccine incident?

A20: The China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) are the national vaccine regulators in China. We expect that the Chinese authorities’ ongoing investigation into this matter will determine who should be held responsible for this incident.

Q21: Is it safe to be vaccinated in China now? Are Chinese vaccines reliable?

A21: WHO has confidence in the manufacturing and licensing of all vaccines in China, public and private: all vaccines made in China leave the factory safe, pure and effective. WHO is also confident in the distribution of vaccines through the Government’s Expanded Program on Immunization (EPI): these vaccines are distributed through a tightly managed, cold chain system. WHO and UNICEF have evaluated the management of China’s EPI program and found capacity to effectively manage vaccines is very strong. WHO urges all parents to continue to have their children vaccinated through the national program. This is the safest, and in many cases only way to prevent a range of debilitating and in some cases deadly childhood diseases.


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