MANILA/LONDON (Reuters) – The Philippines has ordered French drugmaker Sanofi to stop the sale, distribution and marketing of its Dengvaxia dengue vaccine in the country after the company last week warned it could worsen the disease in some cases.
The order comes days after the Southeast Asian nation suspended a government program to immunize hundreds of thousands of children with Dengvaxia following Sanofi’s findings released last week. Sanofi shares slid more than 1 percent on Tuesday to a 10-month low.
“In order to protect the general public, the Food and Drug Administration 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 Philippine government agency said in a statement on its website released late on Monday. bit.ly/2je0L8Y
The World Health Organisation said on Tuesday it supported the decision by the Philippines to suspend vaccinations with Dengvaxia until more information was available. It said its Strategic Advisory Group of Experts on Immunization would meet to review evidence next week.
“Like many others in the Philippines, WHO is awaiting the expert analysis of new data and advice about its implications for use of the vaccine,” the WHO said in a statement on its website.
The Philippine Food and Drug Administration also directed Sanofi to conduct an information dissemination campaign and said all drug establishments should report any incidents if the vaccine was suspected to have caused any deaths or serious illnesses.
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.
“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.
“In this group, all fully recovered with proper medical treatment.”
Sanofi officials said on Monday in Manila that there had been no reported deaths related to the vaccine which was used to immunize nearly 734,000 children aged 9 and over in the Philippines.
They have received at least one dose of the vaccine as part of a government program that cost 3.5 billion pesos ($69 million).
SEVERE DENGUE CASE
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 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.
Dengvaxia, the first approved dengue vaccine, had been forecast by Sanofi to eventually bring in nearly $1 billion in annual sales.
But even recent more modest analysts’ sales forecasts are now looking unattainable given the safety issue and clinical evidence revealing unequal protection against different strains of dengue.
The WHO said on Monday it hoped to review safety data this month on Sanofi’s dengue vaccine which the company said was approved in 19 countries and launched in 11.
Most sales have come from the Philippines through its government immunization program, and Brazil, where the state of Parana has seen a three-fold increase in dengue in the past few years.
Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.
Reporting by Manolo Serapio Jr. in Manila and Ben Hirschler in London; Additional reporting by Karen Lema in Manila and Tom Miles in Geneva; Editing by Raju Gopalakrishnan