Sanofi maintains it did not hide information on Dengvaxia


Posted at Feb 26 2018 09:12 PM | Updated as of Dec 12 2019 05:34 PM

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Sanofi Pasteur on Monday reiterated it did not conceal information about the effects of Dengvaxia on children who have not yet been infected with dengue.

Testifying at a joint House committee investigation, Thomas Triomphe, head of Sanofi Pasteur Asia-Pacific, said they only learned about the risks of Dengvaxia on children above the age of 9 last year.

"From the time of the sale, until November 2017, we have zero information, zero data showing that in the population 9 and above, this product was not perfectly safe in the seronegative population," he said, adding that reports of increased risks are only applicable to children below the age of 9.

Seronegative population refers to people who have not previously been infected with the dengue virus.

"In the seronegative population, the observations were found out in November 2017," Triomphe added. 

Former Health Secretary Janette Garin supported Sanofi's claim, saying that the May 2016 report of the World Health Assembly mentioned that the risks were only applicable to the younger population.

"Yes, there were safety signals, and they wanted to clarify that in their report, they were referring to a younger population aged 2 to 5 years old," she said.

"However, they cannot categorically say that it is directly related to the vaccine because the younger the population is, the higher the seronegative," Garin added.

Food and Drug Administration Director Nela Charade Puno earlier revealed that as early as December 2015, Sanofi already knew that Dengvaxia should not have been given to patients who have not had dengue.

The FDA earlier ordered the suspension of the sale of Dengvaxia after Sanofi admitted that the vaccine could cause more severe symptoms of dengue if administered on those who have not had the mosquito-borne illness.

Sanofi's admission prompted the government to suspend its nationwide dengue immunization program, under which some 830,000 children were injected with the drug.