based on three numbers: 730K vaccinated, 87% previously infected (link) and 2 of 1000 risk (link) of severe dengue according to Sanofi among those vaccinated but not previously infected: “The increased risk identified from the new analysis translated to two additional cases of ‘severe dengue’ out of 1,000 previously dengue-uninfected people vaccinated over five years of follow-up,” the company said in an emailed statement. Certainly not good, but a far cry from the panic in a video (link) by “major blogger” Sass Rogando Sasot implying that 700 thousand kids were at risk.
Who said what
997 children got sick after vaccination (link) say a Philstar headline – in the article it says that the Department of Health (DOH) reported that between March 18, 2016 and Aug. 20 of the same year, there were 997 “adverse events following immunization, 30 of which were considered serious cases that needed hospitalization.” The 30 serious cases included two deaths. But the DOH said these “were not related to the immunization program,” which was launched in early 2016. Other cases are claimed outside the DOH statistics, and insufficient monitoring is alleged.
There is also a difference between articles that claim WHO recommended Dengvaxia (link) and clarifications by WHO itself that it (link) did not include a recommendation to countries to introduce the dengue vaccine into their national immunization programs. Rather, WHO outlined a series of considerations national governments should take into account in deciding whether to introduce the vaccine, based on a review of available data at the time, along with possible risks. Among other things recommending to vaccinate in areas with over 70% dengue exposure.
When what happened
Who published its position on the dengue vaccine in July 2016, based on a preliminary advice by an expert group from April 2016. The Philippines started vaccinating in April 2016 (link) – ignoring or setting aside opinions like those of UP College of Medicine Prof. Dr Antonio Dans, who warned that while the vaccine could reduce the number of dengue cases, it could later increase the disease’s severity, a phenomenon known as “antibody- dependent enhancement” – or Dr. Anthony Leachon who said the DOH should first wait for the WHO study – which came out in July 2016.
Further doubts Dr. Leachon had were also about long-term safety (link) especially with previously non-infected persons. Studies in September 2016 (link and link) and articles in CNN (link) and Voice of America (link) in late 2016 also mentioned those risks, but the DOH under a new administration continued the program (link) while having doubts on efficacy. There was a Senate hearing in December 2016 (link) but it seems it was more about the way the program was funded. The decision to end the program after the third round of vaccination was taken in May 2017 (link).
Still, it seems that 67 thousand kids in the Central Visayas got vaccinated in August 2017 (link). Other countries like Malaysia (link, June 2016) and India (link, Oct. 2016) were more reluctant – even in April 2017 (link) and November 2017 (link). Brazil was the other country that vaccinated, the observations from there are going to be interesting. Sanofi was right to pull the brakes in late November 2017. Imagine if, let us say 20 million Filipinos had been vaccinated at a prevalence of 80% – that would have been 0.2% of 20% of 20 million at risk of severe dengue, meaning 8000.
Science and Risk
A major derailment happened in Eschede in 1998 (link) when the German speed train or ICE was hardly a decade old. A train derailed and folded together at high speed due to wheel fracture (link). 101 people died, tabloids reported scenes of horror. Yet no witch-hunts. Causes (link) were analyzed and consequences (link) – also legal ones – were decided upon. The program was not stopped, instead ICE model 1 was improved, later new models came out, new routes were built. This Friday, the Munich-Berlin route (link) shall cross 623 km in about 4 hours. Using ICE 4 (link) trains.
A book I read (link) mentions how the aircraft industry and airlines improved a lot of things by analyzing black boxes from airplane crashes and other incidents – but mentions issues in introducing similar measures in medicine. I wonder if the touch of arrogance attributed to the medical profession in the book also applies to the pharmaceutical industry. Many circles also accuse the pharma industry using third world countries as guinea pigs. But only a modern, evidence-based approach will help prove what is true. And pin down possible accountability.
Capulet and Montague
There will probably be a hearing in aid of legislation at the Philippine Senate – once again. Which I do not expect much from. The usual political stuff, names of Presidents and Health Secretaries. VACC loudly claiming deaths NOW from last year (link) added to the fray, hardly looking credible.
Better not just allege deaths without proof as in hard evidence. Sanofi might go for an international case. Not like the De Lima case or the wannabe impeachment against Sereno. Real lawyers will be needed – like Sereno for Fraport or Carpio for ITLOS. The kind of talent the country hates (link).
One should also see that around half of the vaccinations were during the Aquino administration, the other half during the Duterte administration. Finding out the entire truth will be a long process – if the Filipino public is really interested in the truth and not just own emotional or group needs.
Galileo and Newton
The modern world is too complex for the petty village mentality on show in Filipino politics, the lack of getting the big picture. India seemed to have dealt with Dengvaxia way more maturely – but then again they send rockets into space (link). How could one deal with this in a rational manner?
200 kids are at risk, if one is to believe a certain set of numbers. What is the solution? First – monitor things. Senator Hontiveros wants that to happen in form of a database (link). Possibly, measures from this experience could be used to improve health monitoring in the Philippines.
Second – all lab data on present alleged cases (link) should be gathered in a transparent manner. Just in case there really was negligence on part of Sanofi, it can be proven in an auditable way. There is a certain self-discipline needed here, as Filipinos very often lack objective attitudes.
Third – look at the big picture. Few newspapers, few experts, few leaders in the Philippines are good at that. Data is not information is not knowledge is not wisdom. This Rappler timeline (link) of what happened locally is at least information. Knowledge? We know a little, need to learn more.
In some papers I read about 3.5 billion being for vaccines only. In some I read it was for the vaccines and the entire program including monitoring for five years. Some state that monitoring was insufficient in the beginning. How was the experience in Brazil? And the more cautious countries?
India wanted to make own tests with monkeys before starting, later on Assam state decided to make a random test to check for at least 70% prevalence before going for vaccination. Malaysia wanted to wait for fourth phase tests. All in the sources quoted above. Where is the best balance?
Finding scapegoats is too easy as well – especially if the issue could be caused by weak institutions with systemic problems (link) that go beyond individual leaders. Maybe Dengvaxia could be an opportunity to learn and reform some things? There is a lot of ground to be covered I think.
Irineo B. R. Salazar
Munich, 6 December 2017
