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Panacea vaccine gets clean chit from WHO
20 May 2010, 0108 hrs IST,Khomba Singh,ET Bureau

NEW DELHI: Panacea Biotec said on Wednesday that the World Health Organisation (WHO) has found no link between the company’s five-in-one vaccine and

deaths of infants in Bhutan and asked it to resume supply that was stopped late last year.
The Delhi-based drugmaker took off the shelves a batch of the blockbuster medication sold as EasyFive after the WHO launched a probe October last year into the deaths of four infants in Bhutan who had reportedly taken it.

“Review of the clinical information did not provide any additional indication that a safety problem could be attributed to the use of EasyFive,” said Panacea Biotec joint MD Rajesh Jain, quoting a WHO letter.

Panacea bagged a $222-million contract to supply the vaccine — used to treat diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B in babies — to the United Nations Children’s Fund (Unicef) for three years to 2012.

“The vaccine was retested for abnormal toxicity and sterility in two additional reference laboratories and found to comply with (WHO) specifications,” Mr Jain said, adding that EasyFive remains on the list of WHO-approved vaccines.

Following the WHO probe, the drug regulator had written to pediatricians asking them to prescribe EasyFive with caution. In the letter, Drug Controller General of India (DCGI) Dr Surinder Singh pointed to the deaths of five infants in Sri Lanka who had used the medicine.

Dr Singh also asked pediatricians to report adverse reactions from the vaccine’s use. Panacea Biotec received the drug regulator DCGI’s approval to sell the vaccine in India in September 2007.

Though the vaccine was launch, the company is yet to submit a post-marketing surveillance report that examines its safety and efficacy, DCGI told doctors in the letter sent earlier this year.

Last month, Hyderabad-based Shantha Biotech had to recall 24 million doses of a similar vaccine after certain white sediments would not dissolve even after shaking.
http://economictimes.indiatimes.com /news/news-by-industry/healthcare/biotech/biotech/ Panacea-vaccine-gets-clean-chit-from-WHO/articlesh ow/5951171.cms
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flosz [Offline]
09:17 20/5/10
Vaccine arrival soon
2010-05-23
Himalayan News Service
KATHMANDU: Nepal is all set to receive the first consignment of the Pentavalent vaccine on May 26, easing the acute shortage the country is reeling under, the United Nation’s Children Fund (UNICEF) said. Dr Sudhir Khanal, programme officer at UNICEF, said that the UNICEF Supply Division in Copenhagen had already dispatched a consignment of 750,000 doses of the drug on May 17. The vaccine is used to immunise children under one years of age against Tetanus, Diphtheria, Pertussis, Hepatitis B and Haemophilus Influenza. On April 12, Nepal received the first consignment of the vaccine that was procured from the global company, Crucell Berna, after World Health Organisation (WHO) recommended the disposal of previously-used vaccines manufactured by the Indian company, Shanta Biotechs. A total of 131,600 vials were received under the first consignment. The UNICEF is witnessing problems to get required quantities of the vaccine as WHO has pre-qualified only few companies for global supply. Krishna Bahadur Chand, chief of Immunisation Programme at Child Health Division at the Department of Health Services, said they would dispatch the vaccine within two days once they receive them. — HNS
http://www.thehimalayantimes.com/fu llNews.php?headline=Vaccine+arrival+soon&NewsID=24 4964
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flosz [Offline]
19:56 23/5/10