Companies
For India, finally a dengue vaccine in sight
Summary
Takeda is in talks with the Indian drug regulator to seek approval for its dengue vaccine, which has been shown to prevent hospitalizations in 83.6% of trial participants and 62% reduction in dengue illness
Japan’s Takeda Pharmaceutical Co. is in talks with the Indian drug regulator to seek approval for its dengue vaccine, which has been shown to prevent hospitalizations in 83.6% of trial participants and 62% reduction in dengue illness.
If approved, Takeda’s TAK-003 will be the first dengue vaccine to be cleared for use in India.
The vaccine prevented severe disease in children and adults, clinical trials showed.
“We have a wealth of global data. We are currently in dialogue with regulators in India to explore the requirements we need to fulfil to bring that product to India," Simon Gallagher, general manager (interim)- India, Takeda, said in an interview. “We are aiming to bring the vaccine as soon as possible, but it is really up to us to have that clarity of discussions with the regulators on what is it that we need to comply with."
Dengue is an endemic disease in India, affecting nearly 100,000 people a year. Though dengue deaths in India have been falling, the number of people infected by the vector-borne disease remains high. Currently, the only way to avoid dengue is by preventing mosquito bites. However, an effective vaccine will help reduce dengue deaths.
Takeda has sought regulatory approval for the vaccine in the European Union and is also seeking to introduce it in Asian countries, where dengue is prevalent.
TAK-003 is a tetravalent vaccine based on the live attenuated dengue serotype 2 and acts against all four dengue strains.
Takeda’s clinical trials, results of which were announced in March, showed the vaccine efficacy held up even after 48 months of receiving a dosage.
Globally, this is the second dengue vaccine that has shown favourable results in clinical trials. The other vaccine for dengue is by French drugmaker Sanofi.
However, the vaccine’s reputation took a hit when the company faced criminal charges in the Philippines, where the vaccine seemed to have increased the risk of severe conditions among those who received it.
In January 2020, the US Food and Drug Administration, however, approved the vaccine, with a caveat that those who received it and were not previously infected with the dengue virus “may be at risk of developing severe dengue if they get dengue after being vaccinated".
Sanofi’s efforts to introduce the vaccine in India, however, hasn’t made headway as it did not get approval.
Takeda said it is waiting for clarity from drug regulators in India.
“The data is well advanced from a global perspective. Now we need to understand whether there are any additional efforts that we need to fulfil to meet the expectations of regulators in India. If there are additional elements we need to fulfil, that gives the confidence that is required locally, we will look into it", Gallagher said.
If there are opportunities to accelerate the company’s launch ambition in a scientific manner, the company is willing to work with regulators," he added.
