Medicine

Brazil recommends restrictions on Sanofi dengue vaccine

Brazil recommends restrictions on Sanofi dengue vaccine

While Sanofi's Dengvaxia is the first-ever approved vaccine for dengue, scientists already recognized it was not flawless and did not protect equally against the four different types of the virus in clinical tests.

The FDA added they are closely coordinating with DOH for any "adverse events and reactions" that may be reported by the recipients following their immunization of Dengvaxia, and vowed to immediately take appropriate measures to protect the public.

"In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA", FDA said in an advisory.

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. (WHO will now review Sanofi's safety data in more detail.) This followed an earlier warning that the vaccine should only be administered in countries where dengue is more than 50% prevalent. Moreover, the drug manufacturer needed to report any incidence that caused serious illness or death due to Dengvaxia.

The safety fears involve possible increased risk to people who had not previously been exposed to the dengue virus prior to vaccination with Dengvaxia.

More news: UK Car Registrations Decline In November: SMMT

Sanofi said the risk of severe dengue occurring in previously uninfected people who were inoculated with Dengvaxia was about two in 1,000 and these individuals recovered with treatment.

It was not known whether many people have taken the vaccine, if it was part of any government immunization program or if any illnesses or deaths linked to the drug have been reported to the government. Children have received at least one dose through the government program.

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

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 Brazilian government has not suspended the drug entirely, although the Philippine government has.

Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.


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