Dengue vaccine rolls out nationwide in PHL

The world's first tetravalent dengue vaccine, Dengvaxia, is set to roll out nationwide in hospitals across the Philippines.

"The Philippines has been at the forefront of the development (of this vaccine)," said Dr. Rose Capeding, head of the Department of Microbiology at the Research Institute for Tropical Medicine (RITM) at a press briefing on Thursday.

Dr. Rose de los Reyes, president of the Philippine Society of Microbiology and Infectious Diseases, said that the vaccine for four types of dengue is already available in some private hospitals and government storehouses.

"The vaccines are already licensed with our Food and Drug Administration and they’re available. In fact, they’re already available in some private doctors," she said, adding the vaccines "are ready for distribution to private physicians and also to the government areas."

Developed and manufactured by French pharmaceutical company Sanofi Pasteur and distributed by Asia's Zuellig Pharmaceutical, the vaccine's price will be "reasonable," acording to Dr. Sally Gatchalian, Pediatric Infectious Disease Society of the Philippines (PIDSP) President.

However, Dr. Gatchalian declined to provide concrete pricing information.

"We’re not in the position to answer because we don’t know. Like I said, I think in private practice, the important thing is the vaccine is available," she said.

20 years in the making

Dr. Capeding told GMA News Online that Sanofi Pasteur took 20 years to develop the vaccine, with clinical tests taking place in multiple countries around Asia and Latin America.

"Latin America and Asia-Pacific because we are one of the highly-endemic countries. Dito mataas ang incidence ng dengue cases," Capeding said.

Testing began in the Philippines in 2005 and took place at San Pablo City and Cebu City. About 145 children and adults participated in phase one of the study and 200 to 250 took part in phase 2.

At least 3,501 children participated in the efficacy trial or CYD14 stage (phase 3), the stage before the post-marketing release (phase 4). A total of 10,275 individuals from Asia alone participated in the CYD14 trials.

From phase one to phase three, 40,000 individuals were tested in 25 clinical studies in 15 countries. Studies into the long-term efficacy of the vaccine will continue until November 2017.

"We prevent eight out of 10, we prevent hospitalization. Nine out of ten we prevent having the severe form of dengue… Of course, there is no vaccine that is 100 percent effective or protective. All vaccines, whether the new or the old, you can never give a 100 percent guarantee," Dr. Cecilia Montalban, Philippine Foundation for Vaccination (PFFV) president, said.

No notable side effects

According to Capeding, two test groups—a group injected with the live vaccine and a placebo control group—were observed for systemic and localized reactions.

"Kung gusto mong tingnan ang effects ng vaccine is you have to look into the systemic [reactions] — 'yung mga lagnat, headache, yung mga joint pains, weakness, muscle pains," Capeding said.

"'Pag local naman, ang tinitingnan mo 'yung injection site. Kung may namamaga ba, may redness ba, may swelling ba, length and duration," she added.

These were not considered to be notable side effects.

"Ang reactions na nakita, in terms of reaction rate, same from those rate sa bata na hindi naka-receive ng dengue vaccine," Capeding said.

The vaccine is to be taken in three shots at six month intervals, by any healthy individual aged 9 to 45, unless immunocompromised.

Global dengue epidemic

Dengue is estimated by the World Health Organization (WHO) to infect almost 400 million people globally every year. Some 3.9 billion or half of the world's population live in dengue endemic countries.

Out of 390 million persons infected per year, 96 million exhibit symptoms, 500,000 require hospitalization, and 2.5 percent of persons with severe dengue will die.

WHO describes dengue as the fastest mosquito-born disease in the world, with global costs for dengue rising to P276 billion annually.

The Philippines became the first Asian country to approve the sale of Dengvaxia last December, just days after Mexico approved its use.

However, the vaccine's Philippine launch was delayed pending the World Health Organization's prequalification guidelines and recommendations.

A month later, its distribution was announced by Health Secretary Janet Garin, who noted that P3 billion was already allocated for the rollout.

According to Garin, P16 billion of the Philippines' yearly budget is spent to combat dengue, with most incidences occurring in the National Capital Region (NCR), Region III, and Region IV-A. — TJD/KBK, GMA News