Tuesday, 12 December, 2017

Health Risk: Philippines Suspends Sale Of Sanofi Dengue Vaccine

Dengue Vaccine Controversy Gov't commits to bring full force of law on culprits behind vaccine
Marlene Weaver | 05 December, 2017, 16:51

The World Health Organisation said on Tuesday it supported the decision by the Philippines to suspend vaccinations with Dengvaxia until more information was available. The WHO Country Office said this position paper was "based on recommendations of the Strategic Group of Experts on Immunisation which met and published preliminary advice in mid-April 2016".

When asked about the status of vaccine in India, the company said it had submitted the vaccine regulatory file to the Indian authorities in October 2015.Awaiting approval for its dengue vaccine in India, French drug major Sanofi today said it has shared data with authorities here about the risk of administering its vaccine to patients who have not been infected with the virus previously.

"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", the regulator said in a statement.

The vaccine, given to anyone who had not already been infected, left people vulnerable to severe, life-threatening dengue in the event they were subsequently infected by wild type dengue.

"In this group, all fully recovered with proper medical treatment".

Starbucks to Go "Venti" in China
Starbucks' same-store sales in China rose 8 per cent during the most recent quarter, beating its global 2 per cent growth. He said China is on course to be the company's largest market in less than a decade.

"These included the following: first, use of the vaccine should only be considered in areas where a high proportion (preferably at least 70%) of the community had already been exposed to the virus; second, the vaccine should only be provided to people 9 years of age and above; and third, people being vaccinated should receive 3 doses", it said.

Sanofi spent $1.8 billion over more than 20 years to prep this launch, expecting to develop a new franchise worth $1.5 billion a year.

One 12-year old girl in Tarlac province, north of the capital Manila, who completed the three-dose vaccine treatment, showed symptoms of severe dengue, Health Undersecretary Gerardo Bayugo told Reuters by phone.

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 country's public immunization program was suspended on Friday.

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