Immunization standards

Update on quality and safety of Quinvaxem (DTwP-HepB-Hib) pentavalent vaccine.

5 July 2013

Key developments

On 20 June 2013, the Ministry of Health of Viet Nam announced the resumption of use of Quinvaxem, a prequalified pentavalent combination vaccine that protects against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b infections.

Background

On 4 May 2013, the Ministry of Health of Viet Nam announced the temporary suspension of Quinvaxem. This precautionary action was in response to reports of adverse events following immunization (AEFI) with Quinvaxem.

The Quality, Safety and Standards team of the WHO reviewed the AEFIs cases and investigation reports on the quality of the vaccine. The National Regulatory Authority (NRA) in the country of manufacture of the vaccine (Korean MFDS; Ministry of Food and Drug Safety) also reviewed the available information and performed an inspection to the manufacturing facilities to confirm compliance with good manufacturing practices (GMP) and testing to comply with the quality specifications. In addition, the Vietnamese authorities requested WHO to vaccine lots used in the AEFI cases by a WHO contracted laboratory. The Global Advisory Committee on Vaccine Safety (GACVS) during its meeting held on Wednesday 12 June 2013 reviewed the safety of prequalified pentavalent vaccines.

Outcomes

The outcome of the testing performed by a WHO contracted laboratory is that the vaccine lots comply with the quality specifications stated in the WHO Recommendations for Diphtheria, Tetanus, Pertussis, and Combined vaccines (WHO Technical Report Series No. 941, 2007), the WHO Recommendations for whole cell pertussis vaccine (WHO Technical Report Series No 941, 2007) and Manual for Quality Control of Diphtheria, Tetanus and Pertussis Vaccines (WHO/IVB/11.11 April 2013).

The review by the GACVS concluded the following: “Pentavalent vaccine introduction in Asian countries has illustrated how legitimate increased attention to AEFI can pose new challenges to national decision-makers. The review of the experience of four countries, their willingness to openly discuss all case information with external experts, the consistent causality assessment conclusions reached in all countries and the thoroughly managed reintroduction of pentavalent vaccines in Sri Lanka and Bhutan are valuable examples of the successful maturation of national vaccine safety systems. Pentavalent vaccines provide tremendous public health benefits related to the ability to protect against five major health problems in a single shot. Currently pentavalent vaccines from five different manufacturers are prequalified by WHO and considered to be safe, effective and of assured quality”.

The NRA of record concluded that the vaccine remained in compliance with international expectations of quality and safety.

Based on these findings, Quinvaxem remains on the list of prequalified vaccines. WHO continues to advise UN agencies that Quinvaxem is suitable for supply and use.

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