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Merck & Co. Inc. tested its RotaTeq vaccine on about 70,000 babies in 11 countries - one of the biggest vaccine trials ever conducted. But doctors said it was impossible to design clinical trials big enough to catch all possible side effects that might show up when millions of babies are vaccinated.
The European Commission has granted approval of another brand, Rotarix, for marketing in the European Union, allowing active vaccination of infants. Rotarix, produced by GlaxoSmithKline Biologicals, will be the first vaccine available to children in Europe, where the disease annually causes hospitalization of 87,000 babies and over 700,000 visits to the doctor. An estimated 3.6 million of the 23.6 million children under five suffer from rotavirus gastroenteritis in the EU each year.
Rotavirus causes great discomfort for children, with diarrhea and vomiting continuing for several days, which can lead to severe dehydration, and if left untreated can be fatal.
"The availability of a safe and effective vaccine like Rotarix is exciting news, as it will not only prevent these distressing symptoms that many children suffer, but will also help to reduce the burden on healthcare resources," commented Prof. Timo Vesikari of the University of Tampere in Finland.
Rotavirus is the leading recognized viral cause of diarrhea-related illness among infants and young children, with 95% worldwide experiencing an episode by the time they reach five.
Due to the large number of hospitalizations and outpatient visits, it bears a high economic price.
The vaccines' manufacturers maintained that safety was shown in recent trials that caused fewer serious adverse events then placebo. The safety analysis of the trials also showed that there is no attributable risk for intussusception - a complication involving the infolding of one part of the intestine into another, which was observed with the Wyeth vaccine. Recently, Brazil, Panama and Venezuela included the rotavirus vaccine free in their national official vaccination schedules.
As for Israel, Health Ministry sources commented that the rotavirus vaccine probably would not be included soon in our immunization basket, but "ultimately, probably yes."
Ministry experts said they wanted to be absolutely sure it was safe, as the Wyeth vaccine had been withdrawn from only in post-marketing surveillance, just as Israel was about to adopt it.
'UNIQUE' BURN THERAPY IN PIPELINE
MediWound, an Israeli biotechnology company that has developed a "unique" drug for the treatment of second- and third-degree burns, is entering Phase III clinical trials before being marketed in the European Community.
Phase III is the final stage before approval of the product, which the company expects to receive next year.
Recently, the drug was granted Orphan Drug Status, establishing exclusivity of sales in EC and the US for 10 and seven years respectively from the time the drug is approved.
DGD (Debrase Gel Dressing), MediWound's leading product, is a debriding agent that selectively removes damaged tissue, thus initiating the healing process of the wound.
This innovative treatment presents an alternative to lengthy, complex and dangerous surgical procedures.
The clinical effectiveness of the drug developed by MediWound has been demonstrated in over 400 patients in 20 leading medical centers in Europe, the US, Asia and Israel.
The target population is extremely broad, as in the US alone some 700,000 patients - half of them children - are admitted to hospital for this reason each year. The company estimates the initial market as $500 million in yearly sales.
Founded in 2001, MediWound is backed by Clal Biotechnology Industries, Israel's largest life-science investment company. Headquartered at Yavne's industrial zone, the company employs 20 and has raised $14 million. MediWound CEO Prof. Marian Gorecki says the technology at the heart of DGD answers the pivotal need to selectively remove damaged tissue and eliminate the need for unnecessary excision of healthy tissue. This spares patients significant suffering, expedites the burn's healing and eliminates needless scarring and substantial skin graft harvesting.
The company is working to expand technological applications to the treatment of minor burns and chronic wounds.