Free dengue vaccine questioned by scientists over safety

Critics of the previous administration's free dengue vaccination program raised concerns over the safety of the vaccine again after recent studies questioned its efficacy, Cesar Apolinario reported on News To Go on Wednesday.

Philippine College of Physicians (PCP) Dr. Anthony Leachon and other physicians questioned Dengvaxia after a study by a group of scientists published in Science in September indicated that the dengue vaccine by Sanofi Pasteur may expose those inoculated to worse strains of dengue and increase their risk of hospitalization.

Leachon, an ardent opponent of the vaccination program, said Dengvaxia should have been put through a more stringent testing process before it was used in a mass inoculation program.

"Hindi ako kumporme na public vaccination kagad or mass vaccination. Dapat optional and private muna, tapos gawa ka ng physician-lead clinical trial," Leachon said.

He also pointed out that the vaccine was not prequalified by the World Health Organization (WHO).

WHO prequalification "aims to ensure that diagnostics, medicines, vaccines and immunization-related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy, in order to optimize use of health resources and improve health outcomes."

Executive Order 49, series of 1993 states that drugs must be approved the Philippine National Drug Formulary (PNDF), which uses concepts from the WHO, before they can be purchased by the government.

Dengaxia was given an exemption from this assessment by former Health Sec. Janette Garin in February, though an invitation to bid and a purchase request was prepared in January.

Department of Health (DOH) Department Order No. 2014-0088 states that exemptions can only be granted for "a current or potential urgent health situation" and "for concerns that are of public health importance upon decision and endorsement of the Secretary of Health."

Garin explained that the purchase request would not have pushed through had the exemption not been approved.

"Kunwari nagkaroon ng Purchase Request pagkatapos wala pang exemption, hindi 'yan magpu-push through. Kung kunwari naman hindi binigyan ng exemption, ika-cancel 'yan automatically," she said.

Garin insisted that Dengvaxia was proven to be safe in clinical trials completed by WHO-accredited laboratories in Brazil and Mexico.

She added that these results were transmitted to the Philippine Food and Drug Administration before its approval of the drug and any "undue haste" in acquiring it was from the time of former Health Sec. Enrique Ona.

"'Yung sinasabing 'undue haste,' panahon pa po ni Sec. Ona. Ang tagal na niyang plinano."

Should there be any side effects from the vaccine, Private Hospitals Association of the Philippines (PHAP) President Dr. Rustico Jimenez said, physicians would be able to detect them by now as the second round of vaccinations took place in September.

Jimenez added in an interview on Balitanghali that parents of schoolchildren in the program were asked for permission before they were given Dengvaxia.

"Kung meron magkakaroon ng side-effects, we expect it this month after the giving. Kaya nga ang ginagawa ng DOH diyan... humihingi sila ng consent sa magulang para at least alam nila yung possible side effects, at least nag-consent sila," he said.

Jimenez believes the vaccine to be safe but lacked subjects for its trials, and may have diverted too much attention and funding from the government to find and fund cures for other common diseases.

"Hindi mako-cover lahat ng age group kasi hindi effective yan sa ibang age group. At isa pa, yung mahal. Kasi baka iko-concentrate sa isang sakit samantalang yung ordinaryong TB hindi pa natin nako-cure," he said. "And yung number one killer dito sa Pilipinas, yung pneumonia."

Three shots of Dengvaxia are required to provide full coverage for students. The DOH said it was able to procure the vaccines at P3,000 for all three doses.

Jimenez added that experts do not need to worry about ordinary citizens getting access to the vaccine due to the DOH's campaign for stricter rules on antibiotics.

Since the DOH began its free immunization program in April, almost 500,000 Grade 4 students in Metro Manila, Regions 3 and 4 have been inoculated. — Rie Takumi/BM/KG, GMA News