WHO Delists Panacea Biotec's Combination Vaccines From Pre-qualified List; Move Comes A Year After Action Against Sanofi's Shantha Unit

MUMBAI - In a stern signal intended to ensure product quality, the World Health Organization delisted combination vaccines made by Indian vaccine maker Panacea Biotec Ltd. from its list of pre-qualified suppliers.

The vaccines include Easyfive, Ecovac4 and EnivacHB, indicated for children to prevent diphtheria, pertussis, tetanus and hepatitis B. The international health agency periodically calls for global tenders from vaccine makers to allocate supply contracts to scores of developing nations.

The deficiencies related to quality management systems at the Lalru, India facility of Panacea Biotec used for the manufacture of the haemophilus influenza type B (HiB) and hepatitis B bulk that goes into the formulation of combination vaccines.

The WHO had asked Panacea to put on hold shipments of the combination vaccines until a final decision on the acceptability for UN supply was made by a WHO-convened ad-hoc committee which reviewed the findings of an audit team.

In its August 17 notice, the WHO said UNICEF and the Pan American Health Organization, through which prequalified vaccines are supplied to developing countries, were informed of the main conclusions of the audit team.

History Repeats, Names Change

In defense, Panacea said it has already initiated corrective measures and expressed confidence that a path forward could be accomplished. "Post this, we will come out with a final statement with respect to timelines very soon and then make a request for reassessment for a re-listing in the list of prequalified vaccines of WHO," the company informed investors.

The WHO move comes exactly a year after it delisted another Indian vaccines maker Shantha Biotechnics - now part of Sanofi - from its list of prequalified suppliers for Shan5, the pentavalent vaccine used for the prevention of the same diseases (Also see "WHO Does What It Warned: Delists Shantha Biotech's Pentavalent Vaccine Shan5; More Pains For Sanofi-Aventis?" - Scrip, 3 Aug, 2010.).

While the issue is still unresolved, Shantha recently made some high-level changes in its management team (Also see "Is Sanofi Planning High-Level Changes At India's Vaccines Unit Shantha? A Leading Biocon Scientist Joins Shantha" - Scrip, 26 May, 2011.).

In a notice to the Bombay Stock Exchange, Panacea Biotec informed, "During the site audit, which took place recently at the Lalru manufacturing site, it became clear to the WHO team that quality systems on this site do not meet the requirements required for the WHO pre-qualification."

Panacea Has A Face Saver

The company however highlighted that the WHO found no evidence of quality or safety defects with the batches of the vaccines already distributed and there was no need for any recalls.

"WHO's recommendation for such continued use emanates from the available evidences which include: testing by WHO-contracted laboratories that has been performed on batches of Panacea vaccines that have been supplied through the United Nations system in accordance with the continuous monitoring performed by WHO on pre-qualified vaccines; and review of complaints and reports of adverse events following immunization programs, national regulatory authorities or the manufacturer," the company added.

Panacea also added that four of its oral polio vaccines remain pre-qualified products and WHO has recommended the continued supplies of those products.

By the assessments made by the WHO and UN procurement agencies, the demand for the pentavalent vaccines can be filled by the existing pre-qualified suppliers.

"Options to ensure sufficient supply to meet demand for pentavalent vaccine in the mid- to long term are being reviewed," WHO said, noting that priority would be given for prequalification of new pentavalent vaccines.

"In the short-term, more countries may need to use an alternative liquid-lyophilized pentavalent vaccine," the agency said, adding that sufficient supply in the long term will depend on the entry of new suppliers of quality vaccines "and/or countries switching to a liquid-lyophilized presentation."

The agency said it would reassess the affected products for prequalification "as soon as it is appropriate to do so."

Panacea Biotec Managing Director Rajesh Jain declined to speak to PharmAsia News on the company's next moves. A company spokesperson refused to share the financial impact of the WHO delisting. The Panacea stock recorded a 20% fall on the Bombay Stock Exchange closing at 144 Indian rupees or $3.19 for each share.

- Vikas Dandekar ([email protected])