French drugmaker Sanofi has come under fire as Philippines has suspended the company’s Dengvaxia vaccine — the first promising vaccine for dengue— amid widespread fears about its safety and growing public anger over its use in 830,000 schoolchildren, reports The New York Times. Dengue is a disease spread by mosquitoes that infects about 400 million people worldwide. It puts 500,000 people in the hospital each year and kills 25,000, mostly in Latin America and South Asia.
“The newly revealed evidence, confirmed recently by Sanofi’s review of study data, found that in rare cases, Dengvaxia can backfire: If people who never had dengue are vaccinated and later become infected, the vaccine may provoke a much more severe form of the illness,” the report says.
The World Health Organisation (WHO) is reviewing the situation and has issued an interim recommendation that only people who have had a prior dengue infection be vaccinated.
Sanofi too has said that the vaccine should only be given to people who have been previously sickened with dengue.
Jack Cox, head of global media relations at Sanofi, told STAT , that “We propose that health care professionals would need to assess the likelihood of prior dengue infection in these individuals before vaccinating and for individuals who have not been previously infected by dengue virus, vaccination should not be recommended.”
However, the issue is most people do not know if they have been infected or no. Dengue could be a serious disease with severe complications. However, in many cases there are no or mild symptoms. In addition, there is no ‘readymade’ test available to determine is someone was infected in the past and now can be vaccinated.
The Philippines health secretary, Francisco T Duque III, had reportedly stated that the government is demanding a refund from Sanofi for the 3.5 billion Philippine pesos, or about $69 million, it spent on the vaccine. It is also asking the company to set up a fund to cover the treatment of any children who develop severe dengue.
According to a report from the New York Times, the Philippines government has begun investigations into the rollout of the immunisation program by Sanofi, which allegedly discounted early warnings that its vaccine could put some people at heightened risk of a severe form of the disease.
Death rates are highest among children, and just last week a 7-year-old girl who had not been vaccinated died from dengue in the Philippines, says the NYT report, quoting agencies.
Dengvaxia, the world’s first dengue vaccine, had been developed by Sanofi over decades of research and is approved in 19 countries.
Meanwhile, the Indian government is working on such vaccines and Phase 1 clinical trials of this vaccine is likely to be held in 2020. Minister of State for Health, Ashwini Kumar Choubey told the Rajya Sabha that DSV4, the vaccine developed by International Centre for Genetic Biotechnology (ICGEB)-Sun Pharma collaborative venture, is a recombinant vaccine on the Virus-Like Particles (VLP) platform with a tetravalent four-in-one VLP design; expressed in yeast, it elicits antibodies to all four DENV serotypes in a shorter schedule of 0, 1 and 2 months.
The other experiment involves the Panacea Dengue Vaccine, which is a cell culture-derived live attenuated, recombinant, freeze- dried, lyophilized tetravalent vaccine with the seed strain borrowed from the US-based National Institute of Health (NIH) and the Drug Controller General India had granted permission to conduct clinical Phase I/II studies, the Minister said.
Triggering public outrage, politicians in the Philippines are demanding information about Sanofi’s advertising campaign and their government’s aggressive push, against the advice of some experts, to vaccinate a million children. The backlash has alarmed researchers who worry that Sanofi’s stumble could stoke mistrust in vaccines around the globe.
Dr William Schaffner, an infectious disease expert at Vanderbilt University, said, “It’s hard to think of another circumstance when a major public health program was introduced with this much controversy.”
The episode could prove to be a cautionary tale for pharmaceutical companies, who have already been reluctant to invest in vaccines and drugs that are used mainly in the developing world.
Sanofi saw the Philippines as a key market. In the fall of 2016, the company initiated a “disease awareness” campaign that did not name Dengvaxia but directed people to a Facebook page where Sanofi was mentioned.
The company has told investors that it expects to lose 100 million euros, or about $117 million, as a result of diminished sales. Sanofi is one of the world’s biggest pharmaceutical companies, reporting sales of nearly 34 billion euros in 2016, or nearly $40 billion. Two other dengue vaccines are in late-stage development and could threaten future sales of Dengvaxia if they show better results.
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