As of this writing, at least 58 Filipino doctors and scientists have signed a statement that offers their stand on the Dengvaxia controversy. These medical and health professionals support the suspension of the immunization program. However, they are urging the Department of Health (DOH) not to remove the dengue vaccine from the Philippine market entirely.
According to their statement, Dengvaxia gives “persistent, long-term protection” to those who have been infected with dengue. The next step is to wait for a “quick and cost-effective way to determine whether a person has had dengue in the past or not.”
Among those who signed the statement are Dr. Agnes D. Mejia, the dean of the College of Medicine of the University of the Philippines Manila, former DOH secretary Dr. Esperanza Cabral, and Dr. Salvacion R. Gatchalian, the vice president of the Philippine Pediatric Society. (Find the full statement below)
Clinical trials showed that the vaccine decreases the risk of hospitalization for severe dengue by more than 90% in children 9 years old and above. The dengue vaccine “is meant to reduce the risk of severe dengue infection. And it does this very well,” explained Dr. Edsel Maurice Salvaña, director of the Institute of Molecular Biology at the National Institutes of Health, in an article for Esquiremag.ph.
Vaccines, the doctors who signed the statement stressed, are integral to preventing deadly epidemics from infectious diseases. The fear and panic on Dengvaxia, which the doctors attribute to the wrong information provided to the public, may lead parents to resist having their children vaccinated for other diseases.
“We may find ourselves faced with outbreaks of debilitating and life-threatening diseases that we have already been able to control through our vaccination programs,” said the statement.
In December 2017, Sanofi Pasteur, the maker of Dengvaxia, released a statement on the findings of its Dengvaxia analysis. It showed that while “Dengvaxia provides persistent protective benefit against dengue fever in those who had a prior infection,” it increased the risk for severe dengue in those who have not been infected with the virus.
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Those findings alarmed the public especially the parents whose children had already been vaccinated. When the DOH administered the vaccine to 830,000 school children through a national immunization program in April 2016, it did not take into account whether the children who received the shots had dengue before or not.
Clinical epidemiologist Dr. Antonio Dans explained that if the immunization program was launched after the final findings of the most recent analysis by Sanofi Pasteur, then the Dengvaxia controversy could have been avoided. “If we had waited until now, it would have been one of the biggest and most successful vaccine programs of the country. We know how to properly use it [now],” he told Esquiremag.ph.
According to Dr. Salvaña, Sanofi and government officials “willfully ignored established norms.” He said, “Before going on to mass vaccination programs, most vaccines after approval are typically used in individual patients where risk can be managed on a one-on-one basis, and parents and doctors can discuss the overall benefits of the vaccine with close monitoring.”
Dengvaxia completed two "Phase 3" clinical trials. Dr. Salvaña explained, “An industry standard Phase 4 post-marketing study is usually sponsored by the manufacturer on these early patients to watch out for any adverse effects that were not detected in the initial trials.” Malaysia, which is a dengue endemic country like the Philippines, did not agree to sign off a full approval of Dengvaxia until the vaccine had undergone a Phase 4 testing.
Dr. Dans added in his article, “They pushed a drug before completion of a study, they exaggerated the benefits. Usually, you wait for many years of private use before making it a publicly used vaccine, they didn’t wait. They wanted it for public use right away.
“What we’re doing by informing people about it is we’re trying to restore vaccine trust.” The vaccine “should not have been used immediately for mass vaccination,” said Dr. Salvaña. “However, this should not discredit the scientific evidence that the vaccine works when used correctly.”
The recent statement released by the medical and health professionals provide the same stand. Dengvaxia is an effective vaccine when it is given to those who have had a dengue infection. (Recommendations from the Pediatric Infectious Disease Society of the Philippines also states that the dengue vaccine should only be given to those who have had a previously diagnosed dengue infection.)
"We urge the DOH not to remove the vaccine from the market altogether. Already we are faced with patients who have had dengue infection in the past, who are now at a loss because they cannot get their doses of Dengvaxia because it has been taken out of the market," read the statement.
It ended with: "We urge those who have documentary evidence that can truly shed light on the current controversy to please come forth with the truth. And we beg our legislators to be open to hearing both sides. Allowing half-truths to prevail is dangerous. It not only causes persistent confusion but has also caused mass demoralization among the dedicated and hard-working personnel and physicians of the DOH. This is both cruel and unjust."
Clinical records of 14 dead children vaccinated by Dengvaxia is being assessed by University of the Philippines-Philippine General Hospital “to determine whether or not Dengvaxia influenced their demise,” report Rappler. The results are set to be released this Friday, February 2.