Back to Dengvaxia?

Now that a national dengue epidemic has been declared, would you take the Dengvaxia vaccine, if you’ve had dengue and don’t want to catch it again?

Doctors seem to be divided about it. One group is citing the alarming spike in dengue, with 146,062 cases and 622 deaths recorded so far from Jan. 1 to July 20 this year. They argue that the urgent need is there, and a vaccine is available, so why not use it?

Especially considering that as of July 8, the World Health Organization had effectively cleared Dengvaxia for global use, including it in the WHO 2019 List of Essential Medicines that are safe and effective for public health systems. The vaccine now carries the warning on possible adverse effects on zero-negative persons, or those with no history of dengue.

The warning was announced by the manufacturer itself, French pharmaceutical giant Sanofi Pasteur, in 2017 after further testing of its groundbreaking vaccine. Sanofi Pasteur, the world’s leading vaccine maker, warned that administering Dengvaxia to zero-negative persons could lead to a more severe form of the viral disease.

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We all know what happened in our country after the announcement.

The warning triggered claims that Dengvaxia was responsible for tens of deaths among some of the 800,000 school children who received the vaccine in the final months of the Aquino administration.

Understandly, parents panicked and refused to have their children receive any type of vaccine. Even after experts from the University of the Philippines – Philippine General Hospital finished their probe and announced there was no conclusive link between Dengvaxia and any death, parents kept their children away from the vaccination teams.

I wonder how many children, a few years from now, will be stricken by polio because of this. We have two colleagues who missed the polio vaccinations in our childhood. They were disfigured for life, with their immune systems possibly compromised. One died at 48 of unknown causes; one morning he just didn’t wake up. The other succumbed to stomach cancer at 53.

A more immediate impact of the anti-immunization hysteria was an epidemic of measles, which led to hundreds of confirmed deaths among mostly children, according to the Department of Health (DOH).

The deaths, reported nationwide, led to another panicked rush by parents to have their children receive the long tested and used vaccine MMR (measles, mumps, rubella or German measles).

We may never know how many kids also died of diphtheria and pertussis or whooping cough – often dismissed as ordinary diarrhea and cough – for failure to receive the vaccine for the two ailments plus tetanus.

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With dengue infection now officially a national epidemic, the government is taking a second look at Dengvaxia.

Doctors’ groups are urging the government to lift the ban on Dengvaxia. But another sector of the medical community is urging caution.

All drugs have contraindications, and instructions for proper use. Sometimes the adverse effects emerge belatedly.

The principal criticism of Dengvaxia in our country is that its use was rushed. Its inclusion in the WHO medicine list only last month tends to bolster this argument.

Officials of the Aquino administration who are now facing lawsuits for this alleged undue haste argue that at the time, there was an emergency that needed to be addressed quickly, and Dengvaxia was available. As former president Noynoy Aquino put it, they saw an opportunity to save lives, and they took it.

Still, even with the WHO’s recent stamp of approval, some sectors in the medical community continue to urge caution.

Dr. Susan Pineda Mercado, presidential envoy for global health initiatives, sums up the sentiment of this sector.

The spike in dengue cases is happening worldwide, Mercado told “The Chiefs” last week on Cignal TV / One News. “But we’re the only one jumping up and down to want to vaccinate… I don’t think we can afford to rush at this point… I would rather be slow and sure with a vaccine.”

Mercado stresses that reintroducing Dengvaxia for mass immunization must be a decision not of politicians but of the Food and Drug Administration, which must subject the vaccine to fresh vetting. She noted that the FDA had in fact approved Dengvaxia at the start as a prescription drug rather than a vaccine for state-sponsored mass immunization.

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The other side of the argument is that with the dengue epidemic and the WHO clearance for Dengvaxia, it’s time to lift the ban on what is so far the only anti-dengue vaccine in existence.

Pediatrician Lulu Bravo of the Doctors for Truth and Public Welfare, who also faced The Chiefs, reminded us that there is no such thing as a 100 percent safe or effective medicine.

Even the MMR vaccine, she stressed, carries the warning that it can cause death due to anaphylactic shock (severe allergic reaction) in one or two out of one million recipients.

This risk is “acceptable” from a public health perspective and can still justify the use of a vaccine for mass immunization, she pointed out.

Dengvaxia carries the risk of “severe” dengue for two out of 4,000 recipients. “Severe,” Bravo stressed, does not refer to the killer strain of dengue hemorrhagic fever.

“Clinical trials show that there is no death” linked to Dengvaxia, Bravo said.

Several vaccines come with the warning that the recipient might develop a fever for a while. I don’t know if this is also the case with Dengvaxia.

Bravo points out that about 20 countries including the United States and several members of the European Union have approved the commercial release of Dengvaxia. “What does that tell you?” she asked.

She noted presidential spokesman Salvador Panelo’s admonition to “listen to the experts” in deciding the fate of Dengvaxia in the Philippines. She asked: what other expert assessment do you need after the WHO?

“They have shown no evidence at all that Dengvaxia can kill,” Bravo told us.

She suggests that the government embark on “communication advocacy” for Dengvaxia similar to the highly effective “patak patak” campaign of the late health chief and senator Juan Flavier for the MMR vaccine, with people fully informed of the benefits and risks.

A compromise for Mercado is to reintroduce Dengvaxia in pilot areas while intensifying traditional methods of keeping away mosquitoes as well as promoting early diagnosis and treatment of the high fever, pains and rashes associated with the disease.

“The caveat really is do no harm,” Mercado said.

With an epidemic, unfortunately, doing no harm isn’t as simple as it sounds.