The Brazilian government said on Monday it has suggested restrictions on the use of a dengue vaccine that has been suspended elsewhere after French drug company Sanofi SA said it could worsen the disease in some cases. In the meantime, WHO supports the Philippines Department of Health's (DOH) decision to suspend the ongoing vaccination programme until more information is available.
The Philippine Department of Health put on hold its 3.5 billion peso ($69.5 million) public dengue immunisation drive launched a year ago - the world's first such public programme - after the study was released last week.
However, Department of Health Undersecretary Gerardo Bayugo told Reuters the three referred to by the NGO died due to causes not related to the vaccine and Sanofi said no deaths had been reported as a result of the program.
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.
Health Secretary Francisco Duque III said the Philippines will wait for a recommendation to be released on December 12 or 13 by the Strategic Advisory Group of Experts on immunisation, an advisory body of the World Health Organization (WHO).
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"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.
Presidential Spokesman Harry Roque gestures during a news conference in Manila, November 28, 2017. (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.
Dengue is a mosquito-borne viral infection found in tropical and subtropical climates worldwide.
Sanofi's announcement late Friday that it would shutter its C. difficile vaccine program closed a damaging week for the pharma.