World’s 1st dengue vaccine launched in Manila

Update

MANILA — Medical authorities launched on Thursday what they said was the world’s first dengue vaccine in the Philippines.

Dr. Rose Delos Reyes, president of the Philippine Society of Microbiology and Infectious Diseases said during a press conference in Parañaque City that Dengvaxia has become available to patients with “private doctors.”

“It took more than 20 years to develop this vaccine,” Dr. Maria Rose Capeding, head of the Department of Microbiology Research Institute for Tropical Medicine, said.

Capeding said the vaccine–which would be injected–would be for the 9-to-45-year-old age group.

It is effective against the four strains of dengue, according to Delos Reyes and Capeding.

Capeding said the vaccine — which was developed and manufactured by Sanofi Pasteur and received Philippine Food and Drug Administration approval on Dec. 22, 2015 — involved a “robust clinical trial program in which 40,000 individuals participated in 25 clinical trials and in 15 countries.”

She said the two key efficacy trials for phase 3 of the vaccine clinical development were held simultaneously in Asia and Latin America.

The Asian countries involved, she said, were Vietnam, Thailand, Philippines, Malaysia and Indonesia.

The Latin American countries involved on the other hand were Mexico, Honduras, Colombia, Puerto Rico and Brazil.

“Our country has been (at the forefront) of clinical development of this dengue vaccine because (it is only here where) the three phases of clinical development — phase 1, 2, and 3 — were conducted,” Capeding, also the phase 3 principal investigator in the Philippines, said.

Capeding said the two efficacy trials in Latin America and Asia followed a similar design: Three doses were given to each subject at a six-month interval.

She said the subjects were “followed up on” 25 months after they received the first dose.

From those two trials, she said researchers found a 65.6 percent reduction in symptomatic dengue, 93 percent reduction in severe disease, and 80.8 percent reduction in hospitalized dengue.

“Visualize. You have this public health problem, dengue being a major, global, significant international public health concern. And apply this one, the results of the efficacy (trials). Visualize how many children and adults will be protected from dengue. And visualize the overall health benefits from dengue vaccination,” she said.

Dr. Cecilia Montalban, president of The Philippine Foundation for Vaccination, said that in figures, they could “guarantee that 8 out of 10 cases will be prevented from (being hospitalized). And 9 out of 10 will be prevented from having severe hemorrhagic fever” with the vaccine.

According to Capeding, the vaccine–which will be given to each subject also in three doses at a six-month interval — was effective against the four strains of dengue.

Asked how much it cost, Dr. Sally Gatchalian, president of the Pediatric Infectious Disease Society of the Philippines, said it came at a “very reasonable price.”

Zuellig Pharma is the distributor of the vaccine.  SFM

(Editor’s Note: The breaking version of this story was posted at 12:08 p.m., Feb. 11, 2016.)

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