Fatima Arkin of Science writes that a prominent pediatrician and investigator in the Philippines was indicted over the failed and possibly improper testing of Dengvaxia in the Philippines. Dengvaxia was yanked from the market in 2017 due to safety issues. The investigator, Rose Capeding faces up to 48 years in prison. Capeding formerly headed up the department of the Research Institute for Tropical Medicine (RITM) in the Philippines.
The investigator (and 19 others) are being charged with “reckless imprudence resulting in homicide” as they rushed Dengvaxia’s approval and mass testing among Philippine school children. Other prominent research officials have been charged; including:
- Socorro Lupisan, former RITM head (Ms. Capeding’s boss)
- Janette Garin, former Department of Health (DOH) Secretary
- Other officials at Philippines FDA and DOH
What Happened? Arkin reports that the Philippine FDA approved the vaccine in December 2015, based on research funded by Sanofi Pasteur—apparently Capeding played a prominent role in that research. She was the lead author for a 2014 research paper in The Lancet about a study among 10,000+ children in five Asian nations that evidenced Dengvaxia was effective and safe. By April 2016 the Philippine government initiated a $67 million public-school targeted Dengvaxia immunization program.
Scientists became increasingly alarmed as the dengue virus is what Science reports as “peculiar: A first infection is rarely fatal, but a second one with a different virus type can lead to much more serious disease because of the antibody-dependent enhancement (ADE), in which the immune responses to the first virus amplifies the effect of the second type. Scott Halstead, who studies Dengue at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, argued that dengue vaccines could have the same effect, and warned that Dengvaxia should not be given to children never infected with dengue. But a vaccine panel at the World Health Organization (WHO) concluded in 2016 that Dengvaxia was safe for children aged 9 and under.”
Unfortunately, by 2017, Dr. Halstead’s concerns were accurate. Sanofi Pasteur issued a warning and the Philippines halted the vaccine program immediately. In alignment with Halstead, WHO now recommends that the vaccine only be used when children have had at least “one brush with dengue.”
Of course this doesn’t help the 830,000 schoolchildren’s parents who heard this news. Because most children had already been exposed to dengue they were not at risk; however, some had not been exposed. By September 2019, DOH Undersecretary Enrique Domingo announced that 130 of the vaccinated children had died; 19 had dengue, meaning ADE may have played a role. “Mass hysteria followed.” It is not clear what prosecutors will hold Capeding and others responsible for. Science notes the full case has not been disclosed to the public.
Some are coming to the investigator’s defense such as Tikki Pangestu, a Singapore-based advisor to the Asia Dengue Vaccine Advocacy Group noting “the indictment of Rose Capeding is an egregious, unjust and highly disturbing act.” On the other hand Halstead declares the trials were not designed well at all—they should have identified the ADE risk. It should be noted that WHO and Sanofi Pasteur designed the trials—not Capeding.
Sanofi gave a statement to Science noting the company “strongly disagrees with the DOJ’s findings against its officials (current and past) and we will vigorously defend them.” The trials haven’t started yet.Source: Science Magazine