The Philippines spent US$70 million on the Dengvaxia immunisation programme in 2016 to address the 200,000 dengue cases reported every year.
In December, Manila stopped the sale and distribution of the drug after Sanofi, its French manufacturer, admitted that it could worsen symptoms for patients who had not previously been infected with the disease.
Sanofi said the vaccine would not result in deaths.
“Sanofi Pasteur will continue to cooperate in full transparency with the Philippines FDA [Food and Drug Administration] and is committed to comply with the Philippines laws and regulations,” the company announced in a statement.
The Philippine authorities appointed an independent panel of experts to review the cases and expected the findings later this month, health minister Francisco Duque said.
The FDA found Sanofi guilty of violating post-marketing surveillance requirements, he said.
“We asked them the question, number one: what they think is the cause of death, and then second, do they think it is related to the vaccination,” the assistant health secretary, Enrique Domingo, told the media.
More than 800,000 children aged nine and above were injected with Dengvaxia last year in the world’s first public dengue immunisation campaign.
Dengue was blamed for only four of the 14 deaths, Duque said, with lupus and meningococcemia suspected as the causes of the others fatalities.
“We need to watch out for 837,000 students who have been vaccinated and to us this is paramount,” Duque said.
Manila wanted to return unused Dengvaxia stocks, which cost about US$30 million, to Sanofi for a refund, he added.
Both the Senate and House of Representatives are conducting separate probes on the issue, which have now involved former former health ministers Janette Garin and Paulyn Ubial.
Sanofi has been accused of colluding with the previous administration of Benigno Aquino to obtain rapid approval for the US$70-million programme, allegedly ignoring doubts over the drug’s safety profile.
In November, a Sanofi study said Dengvaxia could lead to severe infections for those vaccinated who caught dengue for the first time.
The company urged the Philippines not to suspend the pioneering use of the vaccine, saying it was a crucial tool in fighting the virus, which is blamed for lowering productivity across much of the developing world.
Around 837,000 Filipino children were injected. Picture credit: Wikimedia