Sanofi had previously agreed to refund the Philippines $28 million for unused Dengvaxia doses, but the government’s demand hasn't stopped there. The Department of Health is now asking Sanofi to return some 2 billion Philippine pesos ($39 million) for used vaccines as well, according to the Philippine Daily Inquirer.
DOH health secretary Francisco Duque III told reporters that the agency sent the demand letter for a full refund on Friday, Jan. 26, “because the purported protection wasn’t felt, wasn’t there,” as quoted by the Inquirer.
He then went on suggest the decision was pegged to the Dengvaxia label change. “In fact they withdrew the label. They did a relabeling because they said you can no longer use this for seronegative children who never had past dengue infection,” he said.
Last November, Sanofi released findings from a long-term data analysis, which concluded that Dengvaxia could lead to more serious infections when given to dengue-naïve populations, and hence requested health authorities to change the vaccine’s label to reflect the risk. That marked the beginning of the whole controversy currently at play in the Philippines.
Several lawmakers, health experts and officials, Duque included, have since gone public with their intention to demand a full refund of about $70 million the government paid Sanofi for Dengvaxia procurement. But this is the first formal request sent directly to the French pharma.
In the face of mounting distrust and blame coming from all directions, Sanofi has stood firm about its dengue shot’s safety profile, stressing on several occasions that there was no report of deaths linked to the vaccination, but the company has at the same time been accommodative to the Philippine government’s requests.
After agreeing to pay back $28 million for unused Dengvaxia doses, which it said at the time the was “not related to any safety or quality issue," the drugmaker promised lawmakers last week that it will cover the cost of any adverse events proven to be caused by Dengvaxia.
Sanofi didn't immediately respond to a request for comment on the latest demand.