Sunday, 10 December, 2017

World Health Organization backs Philippines suspension of Sanofi's dengue vaccine

Philippines government investigates Dengvaxia dengue vaccine Dengue Vaccine Controversy
Melissa Porter | 05 December, 2017, 16:51

The Philippines has ordered French pharma major Sanofi to stop the sales and marketing of its Dengvaxia dengue vaccine in the country after the company warned last week it could worsen the disease in some cases, according to media reports.

Representative Office Philippines on Tuesday clarified that it did not prescribe in mid-2016 the use of dengue vaccine Dengvaxia in the Philippines' national immunization program.

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.

"Only one in 800 of all dengue infections (including symptomless infections) could lead to a severe infection, and the increased risk identified from the new analysis translated to two additional cases of "severe dengue" out of 1,000 previously dengue-uninfected people vaccinated over five years of follow-up", the company said in an emailed statement.

On Nov. 29, the company disclosed that it would ask global health regulators to restrict use of its much-touted dengue vaccine to only people who have previously been infected by the virus.

Over 733,000 students from public schools in Metro Manila, Central Luzon and Calabarzon, nine years old and above, have received at least the first of three doses of the vaccine.

The Department of Health has recommended that she be moved to a Manila hospital for closer monitoring, but Bayugo said she had shown signs of improvement with her platelet count recovering.

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.

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 organization has said that it hoped to conduct a full review by the end of the year on the vaccine.

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.