Pentavalent vaccine, Easyfive, removed from WHO list of prequalified vaccines
17 August 2011 – Following a routine audit conducted by a WHO team of one of the manufacturing sites of the vaccine manufacturer, Panacea Biotec, and the subsequent conclusions of an ad hoc committee convened by WHO, the pentavalent vaccine, Easyfive, has been delisted from WHO’s list of prequalified vaccines.
Easyfive, containing diphtheria, tetanus, whole cell pertussis, hepatitis B and haemophilus influenzae type b components, and two other vaccines — a DTwP-hepatitis B vaccine and a monovalent hepatitis B vaccine — produced by Panacea, were delisted as a result of deficiencies in quality systems found at the company’s Lalru manufacturing site.
The decision to delist was made because of the risk, unless corrective action is taken by the manufacturer, that the quality and safety of future batches of these vaccines will be compromised.
Batches of these vaccines already distributed to countries should not be recalled and should continue to be used. This is because there is no evidence of quality or safety defects with batches already distributed whereas there is a real risk, if immunization is withheld, of death or morbidity from the diseases against which the vaccines protect.
With regard to vaccine supply, the main concern brought about by this situation relates to sufficiency of supply of the pentavalent vaccine. WHO and UN procurement agencies have assessed that demand for pentavalent vaccine in 2011 can be filled by existing suppliers of prequalified pentavalent vaccine. Options to ensure sufficient supply to meet demand for pentavalent vaccine in the mid- to long term are being reviewed.
The prequalified oral polio virus vaccines manufactured by the company remain prequalified, given that they are produced at a different site to that which was recently audited and the fact that there is no evidence available to WHO of inadequate quality assurance.