Dengue vaccine to be out soon

CEBU, Philippines - A vaccine for the prevention of dengue may soon be released before 2016.

After 20 years of clinical study, Sanofi Pasteur, said their dengue vaccine is now in the final stage or Phase 3 of clinical development and they expect to release the vaccine soon.

“Today we are very excited to be in the last stage of clinical development. We are confident that we will be the first with a dengue vaccine within a few years. A dengue vaccine will fulfill an unmet medical need and change the lives of millions of people across the world,” said Olivier Charmeil, the president and CEO of Sanofi Pasteur, in a statement.

Sanofi Pasteur is the largest company in the world devoted entirely to human vaccines.

The dengue vaccine has been evaluated in clinical studies on adults and children in the United States, Asia and Latin America during phases 1 and 2 of the development.

For Phase 3 they conducted the clinical study in two areas in the Philippines namely in Barangay Guadalupe, Cebu City, and San Pablo, Laguna. A total of 3,500 Filipinos aged between two to 14 years old were tested with the vaccine.

The subjects have already received three doses of the vaccine and are now under surveillance phases, namely the school-based and the hospital-based surveillance phases.

The five-year hospital surveillance phase, which started in June 2011, was initially intended for only two years, but it was extended so they will have complete information.

Alain Bouckenooghe, the associate vice president for Clinical Research and Development and Medical Affairs of Sanofi Pasteur Asia-Pacific, said that an effective vaccine is the most effective means to fight dengue.

“A safe and effective vaccine against dengue is clearly the most effective means against this disease. Though there are challenges in the development of a vaccine we at Sanofi Pasteur, remain optimistic that we can and will succeed in this endeavor,” said Bouckenooghe.

Bouckenooghe was one of the speakers of the 4th Asian Vaccine Congress (ASVAC) yesterday at the Radisson Blu Hotel in Cebu City.

ASVAC is aimed at enhancing the overall knowledge of vaccines as well as facilitating the exchange of best practices towards improving vaccine coverage and compliance among Asian countries.

Bouckenooghe oversees the regional medical affairs management of Sanofi Pasteur’s licensed vaccines portfolio. He is also in charge of directing Sanofi Pasteur’s new vaccine developments in the Asia-Pacific region.

Sanofi Pasteur senior director Dr. Joselito Sta. Ana, who is in charge of the dengue vaccine launch for Asia-Pacific, said that by 2014 the clinical study will be done and they are going to submit the outcome of the study to the local Food and Drug Administration by early 2015 for registration, since the latter will still evaluate the study the vaccine before it can be used.

Sta. Ana, who is also the regional head of dengue vaccines for Asia-Pacific and Japan, said that among all the companies trying to develop a dengue vaccine, Sanofi Pasteur is the most advanced.

“We have tested the vaccine already through our studies, so once the vaccine is available, we can say na itong vaccine na ito ay tested na. Since we tested the efficacy of the vaccine through our studies, we would like to make sure that those vaccinated at nagkaka-dengue o hindi. Sa lahat ng trials we concluded that the vaccine is safe,” Sta. Ana said.

As of now, while the vaccine is not yet available for public use, Sanofi Pasteur is making sure that they support and partner with the Department of Health in their advocacy of preventing dengue and even collaborated with the department in the celebration of ASEAN Dengue Day today.

Sta. Ana assures that the Philippines will be one of the first countries to have the vaccine once it will be available.

As to the price of the vaccine, Sta. Ana said that this is not yet an issue, as for now they are prioritizing finalizing the development of the vaccine.

“Dengue is an important health concern, people have to be aware about dengue and how to prevent it because dengue cannot only make you sick but it also entails a big economic burden not only to the family, but as well as to the community and the whole country,” said Sta. Ana.

Today, the country celebrates the 3rd ASEAN Dengue Day. A ceremony will be held at the Plaza Sugbo in Cebu City; cities in Thailand, Myanmar, Cambodia, Malaysia, Singapore, Laos, Brunei Darussalam, Indonesia and host country Vietnam will also hold their own activities.

One of the highlights of the event will be DOH’s re-launching of the “four o’clock habit”, which aimed at motivating and encouraging the community to help in the initiative.

It is in partnership with the Department of Interior and Local Government and Sanofi Pasteur.

More than 3,000 participants from different sectors of the society are expected to participate in the event. This afternoon the recorded dance of DOH Undersecretary Dr. Eric Tayag with Cebu provincial Detention and Rehabilitation Center inmates will also be shown.

Sanofi Pasteur, based in Lyon, France, distributes more than 1 billion doses of vaccine each year. It is also the leading vaccine company in the Philippines.  —/BRP (FREEMAN)