WHO suspension: Shantha says no safety issue with pentavalent vaccine
This article was originally published in Scrip
Shantha Biotechnics has said that investigations conducted so far by its Q&A cell and the World Health Organization (WHO) suggest that there is "no safety issue" with its pentavalent vaccine, Shan5, procurement of which has been temporarily suspended by the WHO.
The WHO had, last week, temporarily stopped the purchase and suspended the use of Shan5 (DTwP-hepatitis B-Hib), following the detection of a "white sediment" in some batches of the product.
"No adverse events have been reported so far. Yes, the storage conditions are known to play a critical role to maintain the quality and this is well known by the WHO. Further experiments to evaluate the cold chain impact are in progress to assess (this) as a part of the root cause analyses," Shantha Biotechnics, which was acquired by Sanofi-Pasteur last year, told Scrip. The WHO has also said that information currently available did not suggest a safety problem with Shan5 and nor had there been adverse events reported following immunization with the product.
In the interim, the WHO has advised all countries to place any remaining batches of the vaccine in quarantine until further notice. It has also recommended that countries continue vaccination using pentavalent vaccines from an alternative suppliers.
GlaxoSmithKline, Berna Biotech Korea and India's Panacea Biotec are some of the other companies that have similar pentavalent vaccines, which have been cited on the WHO's website as UN prequalified as of March 2010. Shan5 had been supplied through UN agencies or by direct procurement to several nations including Central African Republic, Chad, Colombia, Nepal, Pakistan and Tanzania.
white sediment
On February 19th, the WHO had, as a precautionary measure, temporarily suspended the distribution of certain lots of Shan5 pending investigation of quality complaints from Colombia, Comoros and Nepal.
A white sediment that stuck to the glass of the vaccine vial and was difficult or impossible to re-suspend with vigorous shaking was detected in specific lots of Shan5. Some countries, such as the Democratic Republic of the Congo, too reported similar problems, while Médecins Sans Frontières also reported a similar complaint to the WHO.
Shantha said that it has been working in "complete transparency" with the WHO on the matter by sharing its quality assurance investigation reports and discussing the experiments to analyze the "root cause" of the sediment.
A WHO statement also said that Shantha has investigated and undertaken a review of batch records for deviations; made changes in the manufacturing process including raw materials; reviewed the cold chain during transportation of the vaccines (temperature monitoring devices); and retested retention samples. "Additional R&D department experiments are being performed by the manufacturer," it said.