With all the commotion and fury targeting Sanofi’s Dengvaxia in the Philippines, the country has only now suspended the vaccine’s approval and fined the drugmaker a symbolic $2,000, Reuters reported.
The decision, sent to Sanofi Pasteur on Dec. 29, puts Dengvaxia’s marketing authorization on hold for a year. In a statement sent to FiercePharma, Sanofi said the Department of Health's suspension is not over the product’s quality, but “is linked to an alleged failure to comply with post-marketing requirements.”
Sanofi refuted the claim it didn't meet requirements, stressing it has conducted post-approval pharmacovigilance activities in compliance with international and Philippine laws.
After Sanofi released an analysis late November revealing that the dengue shot might cause more serious reactions in those who haven't had prior exposure to the virus, health authorities in the Philippines immediately halted the immunization program.
“Sanofi Pasteur will continue to cooperate in full transparency with the Philippines FDA and is committed to comply with the Philippines laws and regulations,” the company said in a statement.
The current punishment doesn't touch on the government's procurement process for the beleaguered vaccine, which is actually the subject of investigations and a civilian petition asking for criminal charges against government officials and Sanofi executives. Tougher penalties might still follow if any wrongdoings are found.
Some in the country have accused Sanofi of colluding with the previous administration to obtain fast approval for a $70 million mass immunization program, and some people have doubts about the shot’s safety profile. Sanofi has stressed its vaccine can provide a valuable benefit if given in the right situation.