Philippines halts sale of dengue vaccine as Sanofi downplays risk

Philippines halts sale of dengue vaccine as Sanofi downplays risk

Yesterday, the Philippines government ordered an investigation into the immunisation of more than 7.3 lakh children with the company's dengue vaccine. The order comes a week after the warning given to the French drug maker that its vaccine could have adverse effects in some cases.

Last week, the Philippines' health department suspended the vaccination after Sanofi announced evidence showing that people who receive the vaccine, known as Dengvaxia, without previous dengue infection could face the risk of their disease worsening.

"All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post-marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person", the FDA said in a statement.

Sanofi officials said on Monday in Manila that there had been no reported deaths related to the vaccine which was used to immunise almost 734,000 children aged 9 and over in the Philippines.

An estimate of 734,000 children aged over nine have received the first dose of the Dengvaxia through the country's dengue public immunization program, the world's first, according to officials. Children have received at least one dose through the government program.

The recent findings outline that sales forecasts may not be reached over the safety issues and clinical proofs that show unequal protection against various strains of dengue.

The company, which is under fire in various countries, including the Philippines and Brazil over the vaccine, however, said "supplementary analysis confirmed (its) significant and persistent beneficial value" in people with a prior history of dengue infection before vaccination. The organization has said that it hoped to conduct a full review by the end of the year on the vaccine.



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