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Complex case

by Dr. Ramon Ricardo A. Roque, CESOI, Diplomate

Dengvaxia, the now infamous protection for the deadly dengue virus, has become the most-feared “drug” in the Philippines and it will retain such reputation for a long time.

With how things currently stand on Dengvaxia, will the government still continue using it as part of its health program? Even if, for argument’s sake, it does, will Filipino parents allow the vaccination of their children using Dengvaxia?
The Dengvaxia case in the Philippines is complex.

Given the November 2017 advisory from manufacturer Sanofi Pasteur that the Dengvaxia vaccine should not be recommended for individuals who have not been previously infected by dengue virus because of their risk of getting severe dengue disease if they were to be vaccinated, a public uproar and investigations from both chambers of the Philippine Congress ensued.

It is now clear that the Dengvaxia vaccine was used in the national immunization program of the Philippines without the benefit of complete clinical trials that will determine its efficacy and safety.

Sanofi Pasteur and officials from the Aquino Administration cannot assert the completeness of the clinical trials prior to the use of the vaccine simply because the November 2017 advisory of Sanofi Pasteur is evidence that of the fact that the inappropriateness of Dengvaxia for those who were not previously infected by the dengue virus was only established recently.

Those who are defending Dengvaxia can assert though that it is normal and accepted practice to continue testing a drug even after it has been given to humans. But even given such assertion, they need to justify why the Dengvaxia vaccine was given to more than 700,000 Filipinos, majority of whom are children.

In a statement of former Health Secretary Paulynn Obial, the pilot test of Dengvaxia vaccine should have involved only about 20,000 individuals. This position is consistent with the recommendation of the Formulary Executive Council (FEC) to introduce the vaccine through small-scale pilot tests and phased implementation.

Former Health Secretary Janette Garin obviously did not adopt FEC’s recommendation because Dengvaxia vaccine was given to three regions – Central Luzon, National Capital Region, and Southern Tagalog. In the Senate investigation, Dr. Garin maintained that the recommendation program advisers from the Department of Health was different from that of FEC and the same supported the implementation of the Dengvaxia program in that scale.

We do not know all the factors that were at play when Dr. Garin made the decision as Secretary of Health. We do not know as well how the FEC recommendation was weighed but many are wondering why the government opted not to proceed with extreme caution, particularly with such recommendation from FEC, considering that the issue was a serious health matter.

(to be continued)