Facing growing demand from officials and lawmakers, Sanofi Pasteur agreed to refund the Philippine government for unused Dengvaxia doses worth about 1.4 billion Philippine pesos ($28 million). But safety questions continue to swirl after preliminary autopsy results came out from children who died after receiving Dengvaxia, though no causal link has been proven.
Sanofi said in a statement that the reimbursement decision is “not related to any safety or quality issue with Dengvaxia,” and that it has requested a meeting with the Department of Health to “contribute to their efforts to restore public trust in the value of vaccination.”
Despite Sanofi’s assurances that the vaccine is safe and its continued efforts to calm the situation, however, the Philippine government's trust has only proven harder to piece back together.
The Public Attorney’s Office recently performed autopsies on children who died after receiving Dengvaxia. Initial findings found common causes of death among some of the children, the agency’s chief Persida Acosta told Reuters, including bleeding in vital organs consistent with severe dengue, or dengue shock syndrome.
The DOH is waiting for final results from a separate examination conducted by experts at the state-owned Philippine General Hospital. The two separate studies returned compatible initial results, but DOH chief Francisco Duque III said Dengvaxia cannot be directly linked with those deaths unless experts reach that conclusion, the Philippine Daily Inquirer reported, citing remarks at a press conference.
Sanofi stressed that “there have been no deaths established to have been causally linked to the dengue vaccine, not even among the closely monitored 40,000 people involved in the clinical trials of the vaccine conducted across 15 countries.”
Back in November, the company released an analysis based on six years of clinical data that showed Dengvaxia could lead to more severe dengue infections for vaccine recipients who had not been previously infected. That announcement led to an outcry in the Philippines, which immediately suspended its mass dengue immunization program.
Officials also suspended the vaccine's approval for a year and fined Sanofi a symbolic $2,000 for allegedly failing to meet postmarketing surveillance requirements. The drugmaker said that allegation was false.
The company has also pointed to the World Health Organization’s December update on Dengvaxia, which maintains that the vaccine can provide useful protection in dengue-endemic areas. WHO said that for areas in the Philippines where officials used the shot, about 85% of the population had been previously exposed to dengue. Every severe dengue case in vaccinated, dengue-naïve people would be offset by 10 severe cases prevented by the shot, the agency said.
Aside from the scientific aspects of the vaccine, officials are also investing the procurement processes for the $70 million vaccination program, with some saying the government rushed into the program. Families with vaccinated children have also filed a request demanding criminal charges against government officials and Sanofi executives.