The Philippines’ Public Attorney’s Office (PAO) filed a lawsuit against Sanofi on Monday demanding compensation from the French pharmaceutical company for the parents of Anjelica Pestilos, a 10-year-old-girl who died in December. Lawyers claim her death was caused by Sanofi’s controversial dengue fever vaccine, Dengvaxia.
In November, Sanofi revealed that Dengvaxia, the world’s first dengue vaccine, might increase the risk of severe disease in people who had never been exposed to the virus. The news caused outrage in the Philippines, where more than 800,000 children over the age of nine were vaccinated from 2016 to 2017.
The Philippine Health Ministry halted Dengvaxia immunisations soon after and formed a 10-member panel of experts to determine whether the drug was directly related to the deaths of 14 children who were given the vaccine. According to Reuters, the government-ordered inquiry found that the anti-dengue vaccine could be connected to as many as three deaths in the country.
Sanofi, however, said it did not know of any deaths resulting from Dengvaxia. “In Dengvaxia clinical trials conducted over more than a decade and over one million doses of the vaccine administered, no deaths causally related to the vaccine have been reported to us”, the company said in a statement to Reuters.
Mosquito-borne dengue is the world’s fastest-growing infectious disease and affects up to 100 million people worldwide. Each year, the disease causes half a million life-threatening infections and kills about 20,000 people, most of them children. In the Philippines alone, there are 200,000 cases of dengue reported every year.
Sanofi said clinical evidence confirms dengue vaccination in the Philippines will provide a net reduction in the disease, including severe dengue. Even so, Philippines officials are concerned about the effect the controversy will have on future vaccination programs. Health Secretary Francisco Duque, for example, said the Dengvaxia controversy had “tainted the credibility” of the country’s immunisation program.
BBC News reports that Health Under-Secretary Enrique Domingo also noted the rise in public fears, commenting that many parents were refusing to vaccinate their children for polio, chicken pox, and tetanus.
The Public Attorney’s Office said Sanofi, as well as domestic distributor Zuellig Pharma Corp and several former and current health ministry officials, must be declared jointly liable for Pestilos’s death. PAO is seeking compensation of up to €66,000.
Pestilos should not have been given the vaccine because of a pre-existing condition, according to PAO. A forensic examination showed Pestilos had lupus at the time of vaccination. The report listed her immediate cause of death as acute respiratory failure, which was preceded by extensive pulmonary haemorrhage.
Sanofi recently rejected a request from the Department of Health to refund the government for used doses of the vaccine. Doing so would “imply that the vaccine is ineffective, which is not the case”, according to the company. The Philippines spent around €55 million on the Dengvaxia program.
While no conclusions have been made, the World Health Organisation (WHO) said that “until a full review has been conducted, WHO recommends vaccination only in individuals with a documented past dengue infection”.