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“We’re still expecting to go first to dengue-endemic countries with a dossier because we think this is where the vaccine’s most important use is,” Derek Wallace, who runs Takeda’s global dengue vaccine program, told Reuters. The success of TAK-003 is crucial to Takeda’s vaccine ambitions as the Japan-based drugmaker integrates its $59 billion purchase of Shire Plc. “The global business was predicated on global products and a global pipeline,” Dr. Rajeev Venkayya, president of Takeda’s vaccines business, said in a telephone interview bronze cufflinks australia.
Under pressure to cut costs after the Shire deal, Takeda needs a strong performance from both its dengue and norovirus experimental vaccines to prove the viability of the global vaccines business. “Once those two programs declare themselves, we’ll then map out what our future looks like,” Takeda research chief Andy Plump said in an interview last month. Venkayya said he is encouraged by the results so far. Dengue experts have questioned whether Takeda’s vaccine may pose similar risks to Dengvaxia, and the results released on Tuesday were not detailed enough to provide answers bronze cufflinks australia.
Takeda executives said they had taken steps to ensure their vaccine did not run into the same issues. Takeda’s TAK-003 is based on a dengue 2 virus, with genes from the remaining three dengue viruses added in bronze cufflinks australia. Dengvaxia is based on a yellow fever virus with dengue genes added in. Takeda hopes the all-dengue design will trigger a more robust immune response. Unlike Sanofi, Takeda researchers took blood samples from all 20,000 trial participants before they received the vaccine. That should allow them to see differences in the vaccine’s performance in people who had a previous dengue infection versus those who had not, according to dengue experts..
Takeda delayed the release of its trial results for several weeks to characterize the immune responses of all participants. The company expects some of that data will soon be published in a peer-reviewed medical journal. Earlier this month, Sanofi vaccines chief David Loew told FiercePharma that the company regretted launching Dengvaxia in emerging markets before it was reviewed by the U.S. Food and Drug Administration or the European Medicines Agency. It was the first time Sanofi had taken such an approach with a vaccine, he said bronze cufflinks australia.
“Other regulatory authorities often look to the FDA and EMA for their own guidelines,” Loew told Reuters via email. To share its data with endemic countries and answer questions on Dengvaxia, Sanofi took part in a three-day meeting hosted by the World Health Organization and the Dengue Vaccine Initiative in July 2015. Regulators from seven countries where dengue poses the biggest threat, including the Philippines, were there. Dengvaxia has since won European approval for people living in endemic areas who have a documented prior infection. The vaccine is also under FDA review bronze cufflinks australia.