THE government on Tuesday suspended the sale and distribution of Sanofi’s dengue vaccine and may demand that the French pharmaceutical giant refund the P3.5 billion spent to procure the drug.
More than 733,000 schoolchildren have already received the Dengvaxia vaccine under the world’s first public immunization program for dengue that was suspended Friday, following Sanofi’s warning that the drug could worsen symptoms of people who had not previously been infected.
Authorities have now ordered a blanket suspension for private use as well.
The Food and Drug Administration, a regulatory agency under the Health department, said in a public advisory on Monday it had pulled the vaccine from the market to “protect the general public.”
The FDA ordered Sanofi to immediately suspend the sale, distribution and marketing of Dengvaxia and withdraw it from the market pending compliance with FDA directives.
Health Secretary Francisco Duque III said Tuesday that the government would ask Sanofi Pasteur to refund the P3.5 billion the government paid for the vaccine used in its vaccination program.
At present, some P1.4 billion worth of vaccines are still stored in the cold storage facility of the Research Institute for Tropical Medicine.
Senate President Pro Tempore Ralph Recto said the government has no choice but to follow the Procurement Law, which compels it to demand a refund of taxpayer’s money paid to the French manufacturer of ineffective dengue vaccines.
“RA 9184 has an anti-lemon provision. It is discussed extensively in Section 62, which deals with faulty, defective substandard goods and services. The bottom line is that the government is entitled to restitution,” Recto said.
Sanofi’s announcement has caused major fears, particularly for parents of children immunized in the public program.
More than 1,000 people in the Philippines died from dengue last year, out of more than 211,000 suspected cases, according to the government.
Sanofi on Monday sought to allay fears about the new study that led it to release the warning, saying Dengvaxia would not cause anyone who was immunized to die.
But local authorities have given conflicting messages on the safety of the vaccine.
Presidential Spokesman Harry Roque said Sunday that the government would “leave no stone unturned” in making those responsible for putting “hundreds of thousands of young lives at risk” accountable for their actions.
The Justice department then on Monday formally launched an inquiry over “the alleged danger to public health.”
But Roque also said on Monday there was “no danger” for people who had been immunized with Dengvaxia.
“The worst that can happen is for those who have not had dengue before… they may get infected with dengue but falling under our previous classification of ‘mild’, having fever and bruises,” Roque said.
Sanofi’s public relations officers were not immediately available to comment on the suspension of the vaccine’s sales.
The DoH is also asking for guidance from the World Health Organization on how to proceed with at least 500,000 children who have yet to complete the three doses of Dengvaxia dengue vaccine.
Health Assistant Secretary Lyndon Lee Suy said that the WHO is set to meet this week in Geneva to discuss Dengvaxia.
He said that among the issues that will be discussed is whether those who have begun the program complete the required three doses.
Lee Suy said more than 700,000 Filipinos, mostly public schoolchildren, have been vaccinated with Dengvaxia but only 200,000 were able to complete the three doses.
Lee Suy said the DoH will continue its five-year monitoring of those who have been vaccinated with Dengvaxia.
“We have a master list and addresses of [vaccinated schoolchildren] and we are coordinating with DepEd [Department of Education],” he said.
Meanwhile, Liberal Party senators urged the government to be fair and impartial in its investigation of the dengue vaccine program, which was approved during the previous administration, when the Liberals were in power.
“We support calls for investigation of this issue as thousands of children’s lives are at stake here. We must ensure that the investigation will not be selective and will cover all periods of implementation of the program,” said LP president Senator Francis Pangilinan.
Pangilinan pointed out that the program was implemented by the Health department during the last year of the Aquino administration and continued by the Duterte administration upon the recommendation of the new DoH leadership.
Senator Franklin Drilon said nobody should jump to conclusions.
“Let us first listen to independent health experts before we judge. If lawyers have their own individual interpretations of the law, the same is true of the medical community, which will have different opinions on this health issue,” he said.
“Of course Sanofi will say that the vaccine is safe. The same will be true for former and current health officials who endorsed the said vaccine. Those who oppose will also present their contrary arguments.”
The Palace said Tuesday that it would move against those who were responsible for the P3.5 billion vaccine purchase if an investigation proves their culpability.
Among those being investigated by the National Bureau of Investigation are former President Benigno Aquino III and then Health secretary Janette Loreto Garin. With John Paulo Bencito and AFP