MANILA - (UPDATE) The Food and Drug Administration said it ordered Sanofi Pasteur to suspend the sale of its dengue vaccine after the French drug-maker admitted that it could cause a more severe case of the disease in some instances.
Sanofi should "SUSPEND the sale/distribution/marketing and cause the WITHDRAWAL" of Dengvaxia, until it complies with regulators' orders, the FDA said in an advisory late Monday.
The company last week said that if Dengvaxia is administered to those who have not had the mosquito-borne illness before, it could cause "more cases of severe disease," prompting the government to suspend its public immunization program.
The vaccine however remained available on an individual basis in consultation with doctors until the FDA order late on Monday.
The FDA has also directed Sanofi to mount an information campaign through advisories, letters to doctors and patient fora.
The agency urged the public to report any incident that "reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury."
Sanofi had said that Dengvaxia would not cause anyone who was immunized to die and that potential cases of "severe dengue" would not be fatal.
"What is this severe (dengue)? When people think of 'severe', this already includes dengue shock that could lead to death, but no," Sanofi Pasteur regional head for dengue Joselito Sta. Ana told reporters on Monday.
Sanofi's definition of "severe dengue" merely referred to symptoms including 2 days of fever, a lower platelet count and bruising, said Sta. Ana.
Presidential spokesman Harry Roque also allayed the public's fears, saying there was "no danger" with the vaccine.
"The worst that can happen is for those who have not had dengue before -- which is 1 out of 10 (Filipinos) -- they may get infected with dengue but falling under our previous classification of 'mild', having fever and bruises," Roque said.
'NO UNTOWARD INCIDENTS'
Education Secretary Leonor Briones on Tuesday said there were no "untoward incidents" so far with regards to students vaccinated with Dengavaxia.
"So far no untoward reports of reactions yet," Briones said.
Health officials in schools are monitoring the situation in the regions where the vaccine was administered, including Metro Manila, Central Luzon, and Calabarzon.
Briones also said parents should not worry about the waivers they signed in relation to the vaccine in case there are Dengavaxia-related deaths or incidents, as those responsible would still be held liable.
The Department of Justice said Monday that the National Bureau of Investigation would investigate the vaccination program "over the alleged danger to public health." It warned in a statement that charges could follow.
The administration of former President Benigno Aquino launched the vaccination program in 2016, making the Philippines the first nation to use Dengvaxia on a mass scale. Some 733,000 people had been immunized under the initiative. -- with reports from Adrian Ayalin, ABS-CBN News and Agence France-Presse