The Philippines has ordered French pharmaceutical giant Sanofi Pasteur to recall its dengue vaccine, the world’s first vaccine for the disease that had been found to pose health risks in people not previously infected.
The Food and Drug Administration (FDA) ordered Sanofi to “suspend the sale, distribution and marketing” of Dengvaxia in an advisory on Monday (Dec 4).
It also ordered Sanofi to “conduct an information dissemination campaign” through advisories, letters to doctors and patient fora.
The FDA instructed all drug retail chains and health professionals to report “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”.
In a statement, Sanofi said it would work with the FDA “to review the implementation” of their order.
“We will continue to seek constructive and transparent dialogue with them,” it said.
The World Health Organisation (WHO) said on Tuesday that it supported the FDA’s decision and it will review evidence next week.
In a report in mid-2016, the WHO had recommended that Dengvaxia be used in people who had prior dengue infection.
Last Friday, the Department of Health put on hold its 3.5 billion-peso (S$94 million) dengue vaccination programme after an alert by Sanofi that said “for those not previously infected by dengue virus..more cases of severe disease could occur” if the persons get infected despite vaccination.
Sanofi has since downplayed the concerns. Dr Joselito Santa Ana, the company’s regional director, said: “ ‘Severe’ may just be two days of fever, lower platelet count, haematoma or vomiting.”
Despite this, government prosecutors have begun building a case against officials who sanctioned the programme, including former president Benigno Aquino.
Health officials started vaccinating over a million children in April last year (2016) with Dengvaxia, despite safety concerns from public health advocates.
At least 730,000 children have received the first of three doses of the vaccine as of Nov 17.
The health department ordered three million doses at 1,000 pesos each for the vaccination programme. Health Secretary Francisco Duque said there are 789,000 doses left and most will expire by August next year (2018).
Dengvaxia was also sold by drug retail chains, but Sanofi did not respond to queries on how many doses were sold by these retailers.
The vaccine has so far been approved in 19 countries and launched in 11. Most sales are in the Philippines and Brazil. Brazil has already recommended restricting the use of the vaccine to those previously infected, but it has not suspended the use of the vaccine entirely.
Brazilian health regulator Anvisa told Reuters news agency that it had not received any reports of people dying or falling severely ill because of the vaccine.
A spokesman for Singapore’s Health Sciences Authority said last week that it is working with Sanofi to “strengthen the package insert” to include the warning of an increased risk of hospitalisation for dengue and clinically severe dengue in vaccinated individuals not previously infected.