Dengue vaccine gets FDA nod

Posted on December 24, 2015

SANOFI PASTEUR may now start selling its dengue vaccine in the Philippines, following the approval of the Philippines’ Food and Drug Administration (FDA).

“The certificate of product registration and license has been signed the other day, released yesterday. That allows them to sell in the market and through doctors,” Health Secretary Janette L. Garin told BusinessWorld in a text message on Wednesday.

“This vaccine underwent three phases of clinical trial in the Philippines. The company can now sell their product,” Ms. Garin said.

In a statement dated Dec. 22, Sanofi Pasteur said the Philippines’ Food and Drug Administration approved Dengvaxia(r), tetravalent dengue vaccine, for the prevention of the disease caused by all four dengue types in individuals between nine and 45 years of age living in endemic areas.

“Sanofi Pasteur, the vaccines division of Sanofi, announced today that the Philippines have granted marketing approval to Dengvaxia(r), making it the first vaccine to be licensed for the prevention of dengue in Asia,” the company said.

Ms. Garin said dengue is endemic in the Philippines.

“Approval of the first dengue vaccine in Asia, which bears 70% of global disease burden, is a major milestone in dengue prevention and public health,” Olivier Charmeil, president and CEO of Sanofi Pasteur, was quoted as saying in the statement.

“Approval of Dengvaxia(r) in the Philippines, following closely the first approval in Mexico, is further evidence of Sanofi Pasteur’s long-standing commitment to introduce this innovative new vaccine first in countries where dengue is a major public health threat,” Mr. Charmeil said.

Sanofi Pasteur said 67 million people are infected by dengue annually.

“As an urban disease, dengue attacks populations of Asia in the form of unpredictable outbreaks capable of paralyzing health care systems, negatively impacting social and economic activity,” it said.

Dr. May Book Montellano, president of the Philippine Foundation for Vaccination, said dengue prevention is an “urgent and growing” medical priority in the Philippines.

“The approval of Dengvaxia(r), the world’s first dengue vaccine, in the Philippines will be a critical addition to the ongoing public education and vector control efforts currently directed towards dengue prevention in our country,” Dr. Montellano said.

Sanofi Pasteur said it is introducing the dengue vaccine in the tropical and subtropical countries in Asia and Latin America “where the vaccine has the greatest potential to reduce dengue burden globally and help to achieve the World Health Organization’s goal to reduce dengue mortality by 50% and morbidity by 25% by 2020 in endemic countries.”

It cited World Health Organization data that dengue is the fastest-growing mosquito-borne disease in the world today, causing nearly 400 million infections every year.

Earlier this month, President Benigno S. C. Aquino III had a business meeting with officials of Sanofi Pasteur in France for the introduction of dengue vaccine in the Philippines.

According to the Presidential Communications Operations Office (PCOO) statement, Sanofi Pasteur’s dengue vaccine candidate became the first to complete the phase 3 (advanced, pre-product launch) clinical studies in 2014.

“To test the efficacy of its dengue vaccine candidate, Sanofi launched 25 clinical studies (20 completed and five ongoing) involving over 40,000 subjects and these are being conducted in 15 dengue-endemic and non-endemic countries, including the Philippines,” the PCOO said.

According to PCOO, all three research phases were conducted in the Philippines. -- K. M. P. Tubadeza