Takeda Dengue Vaccine’s EU Go-Ahead Sets the Stage for More Approvals

After gaining its first global approval in Indonesia, Takeda’s dengue fever vaccine, Qdenga, recently got a green light from the European Commission (EC) to market the vaccine in Europe, laying the foundation for further approvals in dengue-endemic regions like Latin America.

We are one step closer to achieving our aspiration to help reduce the global burden of dengue

Gary Dubin, president, Global Vaccine Business Unit

Last August, Takeda had a momentous first global approval for its dengue vaccine, Qdenga, from the Indonesian National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM). This month the drug has been approved by the EC to protect against dengue in people aged 4 and older as a two-dose series, following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last October.

Although the vaccine will provide a new tool for dengue prevention in Europe, protecting those who travel to dengue-endemic regions, the approval is also a milestone the company hopes will pave the way for further global approvals. “The European Commission’s approval marks an important turning point for QDENGA as we are one step closer to achieving our aspiration to help reduce the global burden of dengue,” said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda in a company release.

Dengue’s global burden

Dengue is a disease that continues to threaten about half the world’s population today. Its global incidence has risen eight-fold in the past 20 years and according to the World Health Organization (WHO) dengue is now endemic in more than 100 countries with the Americas, South-East Asia and Western Pacific regions being the most seriously affected.

The Takeda vaccine, Qdenga, which protects against all four dengue serotypes and demonstrated in clinical trials the prevention of 84 percent of hospitalized dengue cases and 61 percent of symptomatic dengue cases, is a significant advancement towards preventing the spread of the disease.

Special regulatory protocol paves the way for further approvals

“The EMA approval was a very important step forward, not only because it comes from one of the world’s most important regulatory agencies, but because the approval process was run with a special protocol, ‘EU-Medicines for all’ or ‘EU-M4all’ (previously known as Article 58),” says Maria Gabriela Pittis, head of South Cone, Andean Region, Mexico & Central America and Caribbean at Takeda in a recent PharmaBoardroom interview.

Under EU-M4all, regulatory agencies from other countries were invited to be a part of the evaluation process and access data at the same time as the EMA, something particularly significant for dengue-endemic regions like Latin America where approval processes may be accelerated as a result.

“Representatives of the Argentinian National Administration of Drugs, Food and Medical Devices (ANMAT), the Brazilian Health Regulatory Agency (ANVISA), the Colombian National Food and Drug Surveillance Institute (INVIMA), and the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) have therefore had access to information on Takeda’s dengue vaccine at the same time as EMA. Takeda has also submitted dossiers within these four countries, which – following EMA approval and given the amount of time that these four national regulators have had with the dossiers – should expedite the approval process,” Pittis confirmed.

Expectations for LatAm

We have already had a positive recommendation from the new molecule committee in Mexico and are confident of obtaining in-country approvals in the next calendar year

Maria Gabriela Pittis, head of South Cone, Andean Region, Mexico & Central America and Caribbean

The launch of the vaccine in Indonesia is set for February of this year, an event Takeda sees as a potential accelerator in other parts of the world, namely in LatAm. “The approval of the vaccine in Indonesia should also be a catalyst for a quicker market entry process in LatAm. We have already had a positive recommendation from the new molecule committee in Mexico and are confident of obtaining in-country approvals in the next calendar year,” says Pittis.

To this effect, the company has already begun working with local governments to incorporate the vaccine into their national immunisation programmes. “We are already starting to work with the governments because we believe that the dengue vaccine should be incorporated within national immunisation programs,” Pittis confirms.

Although vaccine adherence is known to be high in the region with 80 percent of the total population vaccinated with a full dose against COVID-19, a unique approach will be needed for each country, according to Pittis. “In Argentina, for example, dengue is only present in certain areas and therefore a full national immunisation program would not be necessary. However, in Brazil, Mexico and Colombia it is endemic across almost the entire country and a different strategy will be needed. Regardless, in all countries we will need to sit down with authorities, medical societies, NGOs, and various ministries to understand how to address dengue in a holistic way. It is not only about adding the vaccine to a national program but working collaboratively to make this a real success.”