Philippines Halts Sale of Dengue Vaccine as Sanofi Downplays Risk


With the vaccine now widely available, the Philippines health authority rushed to vaccinate almost 734,000 children, as part of a program that cost the government 3.5 billion pesos.

The WHO suggested the vaccine be used only among people who have had dengue infection before.

Philippines halts sale of Sanofi's dengue vaccine MANILA: The Philippines has suspended the sale and distribution of Sanofi's dengue vaccine, authorities said on Tuesday, after the French pharmaceutical giant last week warned it could worsen symptoms for people who had not previously been infected.

The World Health Organization (WHO) had apparently already flagged the risks of the vaccine in 2016 in a report, in which it recommended that the vaccine only be used in people who have had a prior dengue infection.

The Philippine Food and Drug Administration (FDA), a regulatory agency under the health department, said in a public advisory on Monday it had pulled the vaccine from the market to "protect the general public".

"In this group, all fully recovered with proper medical treatment".

Dengvaxia, the first approved Dengue vaccine, had been forecast by Sanofi to eventually bring in almost $1 billion in annual sales.

The Provincial Health Office said it will monitor over 150,000 children who received the dengue vaccine Dengvaxia.

A spokesperson for Sanofi Pasteur, which makes seasonal Influenza vaccines, said, "In India, we have seen the flu vaccination market double in the past few years, reaching one million doses last year".

But even recent more modest analysts' sales forecasts are now looking unattainable given the safety issue and clinical evidence revealing unequal protection against different strains of dengue.

Singapore's Health Sciences Authority said last week it had flagged risks when the vaccine was approved in October previous year, and that it was working with Sanofi to strengthen warnings in the packaging of the drug of an increased risk to vaccinated individuals not previously infected by dengue. Although it is not as serious as malaria, it is spreading rapidly in many parts of the world, killing about 20,000 people a year and infecting hundreds of millions.