Takeda Healthcare Withdraws Dengue Vaccine Applications in US and Singapore Due to Data Collection Requests

Takeda Healthcare Philippines voluntarily withdrew its dengue vaccine applications in the US and Singapore due to requested data collection. The company, a Japanese pharmaceutical manufacturer of the Qdenga (TAK-003) vaccine, has applied for a certificate of product registration (CPR) with the FDA.

The withdrawal was related to data collection requested by local health agencies. Takeda respects regulatory processes and is committed to working with health authorities globally.

Health Secretary Teodoro Herbosa mentioned that Qdenga is pending FDA approval in the Philippines and needs to fulfill two requirements, including a risk management plan. The company must also explain the withdrawal of the vaccine in other countries.

Takeda has submitted all requested information to Philippine agencies for evaluation. The vaccine is crucial for dengue prevention efforts in the country.

The DOH reported over 123,000 dengue cases nationwide this year, with a notable increase among children aged 5 to 9. The PMA has urged for expedited FDA approval of the vaccine.

Once approved, the Qdenga vaccine will be administered in clinics, not through mass-based immunization. This approach aims to ensure the vaccine's safety and efficacy.

The Dengvaxia controversy in 2016 highlighted the importance of careful vaccination practices. The DOJ dropped cases against officials due to lack of evidence linking the vaccine to reported deaths.

According to the source: Inquirer.net.