WHO asks Shantha Biotechnics to recall Shan5 vaccine

Company to present action plan in 2 months

The World Health Organisation (WHO) has recommended recall and destruction of all lots of the Shantha Biotechnics (India)-produced five-in-one, or pentavalent, Shan5 vaccines as a precautionary measure, after the discovery of undissolved white sediments in the vaccine.

Shantha Biotechnics plans to present an action plan to WHO within two months for resolving the issue, said French drug major Sanofi-Aventis, which owns Shantha Biotechnics.

Shantha Biotechnics supplied 24 million doses of the vaccine through Unicef and the Revolving Fund of the Pan-American Health Organization between November 2008 and February 2010. The vaccine is also procured directly by a number of countries such as Nepal, India and Pakistan. The vaccine offers protection against five diseases — diphtheria, pertussis, tetanus, haemophilus influenzae B and hepatitis B. The company did not disclose revenues earned from its sale.

“The WHO decision to suspend the use of Shan5 is based on information that is available to date, regarding its abnormal visual appearance. This information is insufficient to make conclusions about the potential cause for the sediment sticking to the sides of the vial,” said a spokesperson at Sanofi-Aventis.

Several investigations are going on to establish the exact cause. Neither safety nor efficacy issues have been reported, according to the spokesperson.

A statement from Sanofi-Aventis said transient flocculation was a ‘normal’ physical phenomenon in all such vaccines and might also be seen during some of the manufacturing steps of the product. In this kind of products, complex interactions occur between all components, leading to occurrence of flocculation phenomenon. That is why the “visual appearance” specifications for such vaccines very often refer to “whitish suspension” and “shaking” before use is a classic “instruction for use”.

“The recommendation is based on the advice of an ad hoc committee of experts convened on April 8, following incidents of white sediments sticking to Shan5 vaccine vials that were difficult or impossible to re-suspend. There have been no reports of any side effects from the use of Shan5,” said a press release from WHO.

During recent months, WHO received several complaints about the vaccine’s quality from Colombia, Comoros and Nepal, mainly on the detection of white sediments which would not re-suspend even after vigorous shaking.

On February 19, WHO recommended the temporary suspension of the distribution and use of specific lots of Shan5 vaccine as a precautionary measure pending investigation.