Manila plans to sue Sanofi over dengue vaccine

Sanofi Pasteur's Dengvaxia vaccine could worsen symptoms for vaccinated people who were contracting the disease for the first time.
Sanofi Pasteur's Dengvaxia vaccine could worsen symptoms for vaccinated people who were contracting the disease for the first time. PHOTO: REUTERS

Pharma giant may also be asked for $40m refund after health risk warning: Minister

MANILA • The Philippines intends to sue French pharmaceutical giant Sanofi Pasteur after the authorities suspended its anti-dengue vaccine in response to the company's warning that the drug could lead to severe infections in some cases, the Health Secretary said yesterday.

Regulators froze the Philippines' world-first public dengue immunisation programme last week and suspended all sales of the Dengvaxia vaccine on Monday after Sanofi said it could worsen symptoms for vaccinated people who were contracting the disease for the first time, Agence France-Presse reported.

"Eventually, it's the court of law that is going to decide in so far as the liability of Sanofi is concerned," Health Secretary Francisco Duque said on ABS-CBN television.

The vaccination programme was launched by former president Benigno Aquino's administration last year, making the Philippines the first nation to use Dengvaxia on a mass scale.

About 830,000 schoolchildren had received at least one dose of the vaccine, Mr Duque said yesterday. Previously, the government said more than 733,000 people had been vaccinated.

Sanofi's announcement last week caused great concern in the Philippines - where the mosquito-born disease is extremely prevalent.

The French company sought to allay concerns on Monday, saying Dengvaxia would not cause anyone who was immunised to die, nor would it cause a dengue infection.

 

But Mr Duque said yesterday that Sanofi's recent statements on Dengvaxia were "confusing". He said he may ask Sanofi for a refund of 1.4 billion pesos (S$40 million), the cost of unused Dengvaxia supplies, and the government might demand that Sanofi set up an "indemnity fund" to cover the hospitalisation cost for children vaccinated under the public programme if they fall ill.

Asked if the government would sue Sanofi if allegations of a lack of transparency were proved, he said: "I'm sure it's going to get there."

Mr Duque added: "If it's found out that (Sanofi) withheld material information that would have changed the outcome of all of these problems and the decision makers of the Department of Health in the previous administration, then they are liable."

Sanofi said yesterday that it was surprised by Mr Duque's remarks, adding it would continue to comply with the Philippine authorities' legal directives. "Sanofi is a responsible company that has acted according to Philippine laws and regulations for the supply and sale of the vaccine according to the approved label in the country," the company told AFP in an e-mail statement.

The World Health Organisation, which has recommended that the vaccine be used only in people with prior dengue infection, said on Tuesday that it supported the Philippines' decision until more information was available, Reuters reported.

Dengvaxia has been approved in 19 countries and used in 11. In Singapore, the vaccine has been available since March, after the Health Sciences Authority (HSA) approved its use in patients between 12 and 45 years old in October last year.

HSA said on Wednesday that all healthcare professionals in Singapore have been issued advisories about the latest findings on the vaccine. It added that it will further strengthen the warnings and recommendations in the prescribing information of the vaccine.

A version of this article appeared in the print edition of The Straits Times on December 08, 2017, with the headline 'Manila plans to sue Sanofi over dengue vaccine'. Print Edition | Subscribe