WHO prequalifies Takeda’s dengue vaccine, firm to make 50 million doses with Hyderabad’s Biological E

In February 2024, it was announced that Takeda Pharma would partner with Hyderabad-based Biological E to make 50 million dengue vaccines.

WHO recommends TAK-003 in children aged six–16 in settings with high dengue burden and transmission intensity. The vaccine should be administered in a two-dose schedule with a three-month interval between doses.

“The prequalification of TAK-003 is an important step in the expansion of global access to dengue vaccines, as it is now eligible for procurement by UN agencies including UNICEF and PAHO,” said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification.

“With only two dengue vaccines to date prequalified, we look forward to more vaccine developers coming forward for assessment so that we can ensure vaccines reach all communities who need it,” he added.

Also Read: First-time dengue infections can be as severe as later ones, reveals study

The other vaccine

The WHO prequalification list also includes CYD-TDV vaccine against dengue developed by Sanofi Pasteur.

The CYD-TDV vaccine, sold under the brand name Dengvaxia, is a live attenuated tetravalent vaccine used to prevent dengue fever in humans. It is administered as three separate injections, with the initial dose followed by two additional shots given six and 12 months later.

CYD-TDV is a chimeric vaccine made using recombinant DNA technology by replacing the PrM (pre-membrane) and E (envelope) structural genes of the yellow fever attenuated 17D strain vaccine with those from the four dengue serotypes.

It triggers an immune response against all four types of dengue virus.

The vaccine has been approved in 19 countries and the European Union, but it is not approved in the US for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown.

Evidence indicates that CYD-TDV is partially effective in preventing infection, but may lead to a higher risk of severe disease in those who have not been previously infected and then do go on to contract the disease.

CYD-TDV has been shown to elicit a strong immune response in a dengue-immune population including adolescents and adults. Common side effects include headache, pain at the site of injection, and general muscle pains. Severe side effects may include anaphylaxis.

CYD-TDV is the first licensed dengue vaccine, but its use is limited to individuals with prior dengue infection due to safety concerns in seronegative individuals.

Also Read: Kerala, Karnataka top the list of dengue cases in the country

Dengue

Dengue is a vector-borne disease transmitted by the bite of an infected mosquito. Severe dengue is a potentially lethal complication which can develop from dengue infections.

It is estimated that there are over 100-400 million cases of dengue worldwide each year and 3.8 billion people living in dengue endemic countries, most of which are in Asia, Africa, and the Americas.

The largest number of dengue cases reported was in 2023 with the WHO Region of the Americas reporting 4.5 million cases and 2,300 deaths. Dengue cases are likely to increase and expand geographically due to climate change and urbanisation.

(Edited by Majnu Babu).