How would you feel if you agreed to receive a vaccine as protection against a dangerous disease –only to find out a year later that you are at risk of developing a much more severe form of that disease as an “uninformed, unwilling recipient” of a drug still undergoing clinical trials?

Well, that is what exactly happened in the Philippines. It is when our Department of Health (DOH) officials signed a multi-billion peso. It was a deal to buy about 3.8 billion pesos (US$ 75,544,000) worth of anti-dengue vaccines for public school students in 2015. Now, there is a large outcry against those officials. It started since the vaccine manufacturer, big pharma player Sanofi, announced that Dengvaxia, the first vaccine against dengue, should only be administered to individuals who have been infected previously with the dengue virus.

This means 733,713 public school children, starting from the age of 9 years old and above from the National Capital Region, Region III, and Region IV-A of the country, were basically “guinea pigs” for Dengvaxia, which was still undergoing clinical trials.

But why should a little detail like “still undergoing clinical trials” stop a full speed, high intensity vaccination roll-out program on unwitting participants with a vaccine that still had not received prequalification approval by the WHO? 

In December 2015, the Philippines became the first Asian country to approve the dengue vaccine. Which was designed for persons aged 9 to 45 years old. Seems odd to approve something not known to be effective, that is, it was also still undergoing clinical trials – at least that is how it looks to me and numerous other health professionals. But, that little detail didn’t stop the endorsements for Dengvaxia from the Philippine Society for Microbiology and Infectious Diseases (PSMID) and the Philippine College of Physicians (PCP). 

It was also noted in a CNN article that a study by the University of the Philippines National Institute of Health claimed the vaccine is expected to reduce dengue cases in the country by over 24 percent in a span of five years. How exactly can they arrive at a hyped up conclusion like that when this vaccine hasn’t even been shown to be effective?

Back in 2015, the DOH bought P 3.8 billion worth of Dengvaxia allocated for at least 1 million public school children in the areas that were reported to have the highest incidence of dengue. Those areas would be in NCR, Region III, and IV-A, as well as Region VII. The price point seems to be far in excess of the expense for this vaccine in ANY other country.

Dengvaxia claims to reduce the severity of dengue cases by 93%, and to lower the hospitalization rate by 82%, said the health officials. Sanofi previously didn’t claim that the vaccine was a cure against dengue; it declared that Dengvaxia only attempts to boost the immunity of the person to 4 types of dengue virus and reducing his/her vulnerability to it. Anyone with even a basic knowledge of virology knows how quickly and easily viruses can mutate, creating untold variations of the original virus, rendering a “vaccine” obsolete.

But, the recent public statement of Sanofi has everyone, including the government officials who orchestrated the purchase of the drugs in 2015, up in arms against Sanofi. Why didn’t Sanofi inform them of the risks involved for those who haven’t had dengue and then were administered the vaccine?

Yet, it was not totally true that the Philippine government was not warned about the serious effects of Dengvaxia on those who haven’t had dengue before. Senator Richard Gordon who called for the investigation of the anomalous procurement of the Dengvaxia vaccines last year said health experts have already warned them of the severe effects of the vaccine against those who did not have dengue before. He also plainly remarked that “the vaccine was not yet ready for distribution.”

Gordon also said that since they were informed of the negative effects of the vaccine, that the deal to sell the drugs to the Philippines was “hastily done” and approved in such a short period of time without thinking whether the drug was completely safe to administer to the general population. Gordon also stated that at the time the DOH procured the vaccines, an official of the World Health Organization (WHO) previously warned that the vaccines had not even been given pre-qualification approval.

But the DOH had already administered the Dengvaxia vaccine to at least 400,000 children in schools in Metro Manila, Central Luzon, and Calabarzon. Why so hasty? Tsk tsk tsk!

Dr. Leachon and the “Midnight Deal” of Dengvaxia Vaccines

Dr. Tony Leachon, past president of the Philippine College of Physicians, already raised his reservations about administering the vaccine to many students. It is because it was a totally new product and it would take years to determine if it has any side effects or complications when administered.

Dr. Leachon also was the health expert being consulted by the government in previous hearings about the Dengvaxia purchase. He was also the health expert who mentioned about the adverse effects of Dengvaxia on vaccine recipients. Citing a study published in the Science Online Journal by Neil Ferguson, the director of the MRC Center for Outbreak Analysis and Modelling at Imperial College London.

Leachon declared that those who had the vaccine but never had dengue before, have a greater possibility of developing severe hemorrhagic dengue three years after the inoculation. But for those recipients who have had dengue before and somehow, contracted it again, will not experience dengue as severely as they have experienced it before.

So, whose fault is this fiasco now? Is the Philippine government at fault for inking a price inflated deal with big pharma and executing a public vaccination program as a political initiative to gain favor from voters in an election year? Or is it Sanofi’s fault that they did not emphasize from the very start the risks of the new vaccine? 

Personally, I think both are at fault. But I’d rather see how the Senate will settle this. Or is it too late for the 733,713 students who are now at risk of developing severe hemorrhagic dengue?

Let us know your opinions about Dengvaxia in the comments section below!

 

Image by Phil Warren / CC BY 2.0