Debate about Dengvaxia

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IS Dengvaxia effective? Yes, the vaccine has a moderate efficacy in the range of 56% to 61% against dengue. In simpler terms it means that 6 out of ten individuals administered the complete course of the vaccine will be protected against dengue infection. It is not a perfectly effective vaccine but there is no such thing as a perfectly effective vaccine, just as there are no drugs that are 100% effective.

Is Dengvaxia safe? Yes, when used properly, the vaccine is “safe.” Just as there are no drugs that are completely side effect-free, there are no vaccines that are completely side effect-free. The dengue vaccine has side effects, and in uncommon instances, the side effect can be serious. For example, in patients who have never had dengue and are given the dengue vaccine, it may increase the risk of severe dengue by 0.10% to 0.20% (from 2 out of 1,000 to 3 or 4 out of 1,000). So safety is a relative term and has to be evaluated in the context of potential risks versus predictable benefits.

Did the DOH initiate the dengue vaccination program prematurely?Maybe.

Then again, maybe not. It is easy to say that the DOH should not have started the vaccination program so precipitately because of safety concerns that had not yet been resolved to everybody’s satisfaction. This contention seems to be supported by subsequent findings validating the slight increase in the absolute risk of severe dengue illness in those who have never had dengue and received the vaccine. However this data was actually available and had been taken into consideration when the WHO made recommendations on the use of the vaccine. The WHO noted the increased risk of severe dengue, conducted a risk benefit analysis, and arrived at the recommendation that the vaccine can be used in populations where the burden of dengue was high.

Thus the data could just as easily be said to have validated the basis for the DOH judgment that the risks are insignificant and the benefits overwhelming. Other countries (Brazil, Singapore, etc.) seem to have come to the conclusion that nothing in the subsequent findings precludes continuation of the dengue vaccination programs that they have started or its initiation in countries that have not.

What about all those deaths that have occurred in patients who have received Dengvaxia? About 20 deaths have been reported among the more than 800,000 children who were vaccinated with Dengvaxia. Investigations, including the autopsies performed on these unfortunate children have not provided evidence that the deaths were caused by the dengue vaccine that they received. To put things in perspective, every year, 400 of the 800,000 children who received Dengvaxia will die of various causes. So yes, it is unfortunate but true that one child who received Dengvaxia will die every day, but not, in all likelihood from having received the vaccine. The point is, more studies will need to be done to determine if the children who died actually died of severe dengue. If not, the possibility that they died due to Dengvaxia is remote. If the children did die of severe dengue, then even more studies will need to be done to say that the severe dengue was due to Dengvaxia.

What should parents of children who received Dengvaxia do now? Firstly, reduce the chances of the children getting dengue by cleaning their home and surroundings and making sure all containers and areas where water may collect are kept clean and dry or disposed of. Have children sleep under a mosquito net at all times if windows and doors are not screened. Use mosquito repellants, and make the children wear long sleeved shirts and long pants when going to areas with a lot of mosquitoes.

Secondly, observe the children. If a child develops a fever that lasts more than 3 days, consult a doctor. If the child has gotten dengue, proper medical care will greatly reduce their chances of developing complications and increase their chances of full recovery. Do not worry about the cost of hospitalization. PhilHealth has committed to picking up the cost of treatment of dengue.

Finally, keep calm, make sure the children are well-nourished, remain active, sleep regular hours, practice good hygiene and get all the other vaccinations required to prevent the many other illness that are vaccine preventable.

The last point is worth emphasizing. Already we are seeing a negative effect of the Dengvaxia controversy on the entire vaccination program of the government. Even deworming efforts are being met with suspicion and resistance, with many parents afraid to give consent. If this trend continues, we may find ourselves faced with more outbreaks of debilitating and lifethreatening diseases that are vaccine preventable. The only way to continue to prevent deadly epidemics of these infectious diseases is to sustain a high rate of immunization/vaccination in our population. All health care professionals must come together to make sure this happens.

Parents of children who have received the vaccine also want to know whether they will make their children complete the 3 doses of Dengvaxia or not. At the moment they have no say in the matter. The DOH has returned the remaining vaccines to Sanofi Pasteur and has stopped the dengue vaccination program. This actually leaves the children unable to benefit optimally from the protective effect of Dengvaxia but already exposed to the risk of the vaccine. The DOH has to make another risk benefit analysis and decide what to do. Many pediatricians and vaccinologists think the children who have received the vaccine should complete the program and want the DOH to bring back enough vaccines to enable the children to complete the three doses.

Was there corruption in the purchase of Dengvaxia?

Every peso of public money spent is subject to scrutiny and rightly so. Accountability should be exacted from all, particularly public servants. All of us have been exposed and are continuously being exposed to how our limited financial resources can be wasted on the wrong programs/projects or diverted to the pockets of corrupt individuals. So much so that now everybody is ready to believe the worst of others and each and every allegation of corruption is easily taken as truth. Thus are people now harshly judged in the court of public opinion, and often, not given the chance to challenge their accusers and prove their innocence in the courts of justice.

Sanofi Pasteur can and should take care of itself. Former President Benigno S. Aquino can and should take care of himself. And so can former DOH Secretary Garin and the other involved members of the Aquino Cabinet. While their underlings may not be in such a favorable position, they are, along with their bosses, all subject to the principle of innocence until proven guilty. By all means, let the investigations proceed and let all sides be heard until we arrive at the truth, until we can make a fair judgment and until we have made all accountable.