CHICAGO – A new dengue vaccine is a potentially risky way to prevent mosquito-induced disease, which infects nearly 400 million people each year.
Takeda Pharmaceutical Co. Ltd. plans to first seek the approval of an experimental vaccine in countries where the virus is endemic, rather than in the United States or in Europe, whose consistent reviews are often used as reference global standards. .
The strategy reflects that Sanofi SA, which approved the world's first dengue Dengvaxia in 2015, will try to obtain approval from Western regulators, and predicts $ 1 billion annually (109 billion yen).
The doctor could not reach this goal. By the end of 2017, Sanofi revealed that Dengvaxia may increase the risk of severe dengue in children who have never been exposed to the virus and have begun a governmental investigation in the Philippines where 800,000 school-aged children have already been vaccinated.
Fallout from Sanofi has increased the bar to demonstrate the safety of future dengue vaccines.
Takeda officials have a different outcome and hope that their approach will help avoid the barriers experienced by Sanofi.
On Tuesday, Takeda said her vaccine was effective in preventing all four types of dengue that met the main goal of her late stage of clinical trials. The company said there were no serious safety concerns, which raises the hope that it may be another viable tropical virus vaccine that kills up to 25,000 people each year.
Takeda will first apply for approval in each of the eight countries where her clinical trial took place: Brazil, Colombia, Panama, the Dominican Republic, Nicaragua, the Philippines, Thailand and Sri Lanka.
"We still expect to go first to endemic dengue countries with documentation, because we think it's where the most important use of the vaccine is," said Derek Wallace, who runs a global dengue vaccination program.
The success of TAK-003 is critical to Takeda's vaccines, as the Japanese pharmacist integrates Shire Plc's purchase of $ 59 billion.
"Global business was based on global products and global pipelines," said Dr. Rajeev Venkayya, Takeda's president in the field of vaccination.
Under pressure to cut costs after the Shire deal, Takeda needs strong performance from both of its experimental dengue and norovirus vaccines to prove the viability of global vaccine stores.
"Once these two programs are announced, we will map what our future looks like," Takeda director Andy Plump said in an interview last month. Venkayja said he has been accompanied by the results so far.
Dengue experts questioned whether Takeda may be a similar risk to Dengvaxia and the results published on Tuesday were not detailed enough to provide answers.
Takeda's managers said they had taken steps to ensure that their vaccinations did not address the same problems.
Takeda TAK-003 is based on dengue 2, which contains genes from the remaining three dengue viruses. Dengvaxia is based on a yellow fever virus with added dengue genotypes. Takeda hopes that all-day design will give you a more robust immune response.
Unlike Sanofi, Takeda researchers took blood samples from all 20,000 test participants before they received the vaccine. This should allow them to see differences in vaccine performance among people who had a previous dengue infection against those who did not have a dengue expert.
Takeda postponed release of test results for several weeks to characterize the immune responses of all participants. The company expects some of these data to be published soon in a peer-reviewed medical journal.
Earlier this month, Sanofi's chief vaccine chief, David Loew, told FiercePharma that the company regrets the launch of Dengvaxia in emerging markets before being reviewed by the US Food and Drug Administration or the European Medicines Agency. It was the first time Sanofi had ever adopted such a vaccine approach, he said.
"Other regulators often seek guidance from the FDA and EMA," Loew told Reuters.
Sharing data with endemic countries and answering questions about Dengvaxia, Sanofi attended a three-day meeting organized by the World Health Organization and the Dengue Vaccination Initiative in July 2015. Regulators from the seven countries where dengue poses the greatest threat, including the Philippines, were there.
Since then, Dengvaxia has gained European approval for people living in endemic areas who have documented a previous infection. The vaccine is also under the control of the FDA.
Dr. Joachim Hombach, senior health counselor at the WHO vaccination department, said that governments in countries in Latin America and Asia in dengue-endemic countries are now "very sensitive" to the potential risks of Dengvaxia.
"We will look at it very carefully," Hombach said of Takeda's data.
Takeda is intact.
The company plans to deliver in the United States and Europe within one year of administration in countries with endemic dengue disease, said Venkayya. Takeda and dengue experts are already planning ways to review these latest vaccine data by these regulators.
The Global Dengue & Aedes-Transmitted Diseases (GDAC), a group funded by pharmaceutical doctors who works closely with the World Health Organization, planned a meeting with regulators in at least six countries in Bangkok in early March. In-Kyu Yoon, Director of GDAC.
Yoon said the meeting is covered by the International Vaccine Institute, funded primarily by charities and the Korean government. It plans to ask countries whether they want a joint regulatory review similar to what Sanofi has visited in 2015.
"Right now is clear caution," Yoon said.