FRENCH pharmaceutical giant Sanofi on Monday told the Philippines it would not refund the cost of used doses of a dengue vaccine after the vaccination program was suspended over health concerns.
The Philippines had asked Sanofi to refund a total P3.2 billion ($62 million) spent on the public vaccination program after the company said the vaccine could worsen symptoms in some cases, Health Secretary Francisco Duque III said.
Sanofi last month agreed to reimburse the Philippine government P1.6 billion ($31 million) for leftover doses of Dengvaxia. But it said Monday it would not pay for doses that were already used.
“Agreeing to refund the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case,” Sanofi Pasteur said in a statement.
The refund offered for unused Dengvaxia doses was not due to safety or quality concerns but simply to show that the company was cooperating with Manila, it added.
Dengue or haemorrhagic fever, the world’s most common mosquito-borne virus, infects an estimated 390 million people in more than 120 countries each year, killing more than 25,000, according to the World Health Organization.
The Philippines has one of the highest dengue fatality rates in the world, with 732 deaths last year, the country’s Health Department said.
The country launched the world’s first public dengue vaccination program in 2016, but suspended it and stopped the sale of Dengvaxia in December after Sanofi warned that the injections could make symptoms worse for vaccinated people who contracted the disease for the first time.
The announcement caused panic among parents of some 830,000 school children vaccinated under the public dengue immunization program in 2016 and 2017, the Health Department said.
The government is also investigating Dengvaxia’s alleged role in the deaths of at least 14 vaccinated children.
Health officials on Friday said public immunization programs for other preventable diseases were suffering in the wake of the panic, with many parents wary of getting their children vaccinated following the controversy.
However, Sanofi has insisted that no one has been proven to have died from Dengvaxia.
On Monday, Sanofi rejected a separate Health Department request to set up an indemnification fund to cover the hospitalization and treatment for vaccinated children who contract severe dengue.
“Should there be any case of injury due to dengue that has been demonstrated by credible scientific evidence to be causally related to vaccination, we will assume responsibility,” it said.
Sanofi said the data remains quite clear that, in absolute terms, dengue vaccination in the Philippines will provide a net reduction in dengue disease, including severe dengue and, thereby, reduce the overall public health burden associated with this disease.
For that reason, Sanofi said if the Department of Health decides to reinstate the community-based dengue vaccination program following a more complete evaluation of the new data on the vaccine, Sanofi said it would be willing to provide new doses of the vaccine free of charge.
“These new doses would allow people who previously received one or two doses of the vaccine in the public program to complete the three-dose schedule and, thus, have the opportunity to benefit from the full potential of Dengvaxia’s ability to protect against dengue,” said Sanofi.
On Monday, Senate President Pro Tempore Ralph Recto said the DoH has a P634 million advertising budget for this year, “which it should use to fight the fake news that all vaccines are bad.”
He noted that the DoH’s “advertising war chest” is big enough “to calm unfounded concerns that immunization causes harm.”
“Science must trump superstition,” Recto said in calling on the DoH to launch an information drive so that the dengue vaccine controversy would not erode public confidence in government health programs.
He said doctors and scientists had warned that the Dengvaxia controversy could trigger a “vaccine backlash,” and if this happens, Recto said, “it would put millions of children, seniors, women at risk.”
Recto said the government is buying P7.4 billion worth of vaccines this year, “in quantities that will benefit millions.”
“Whether we like it or not, one side effect of this Dengvaxia controversy is that people are asking if the vaccines to be bought using taxpayers’ money are safe,” Recto said.
“I know that they ought to be, but the DOH must still go out of its way to assure the public that vaccines meet the highest standards,” he added.
Costing P7.43 billion, the 2018 public vaccination program targets full immunization of 2.7 million infants, of which 1.4 million infants will be given pneumococcal vaccine.
All 2.7 million infants will also be administered Japanese Encephalitis vaccine.
In addition, 2.1 million Grade 1 and 1.7 million Grade 7 pupils will benefit from anti-Tetanus-Diptheria, and Measles shots.
Tetanus vaccine will also be given to 2.7 million pregnant women while 1.2 million flu shots and 1.3 million pneumococcal vaccines will be administered to seniors.
According to the DoH brief submitted to the Senate, full immunization for infants cover inoculations against Hepatitis, Polio, Pneumonia, Measles, Mumps and Rubella.
Aside from the DoH, local governments also buy vaccines.
The Department of Education likewise conducts its own health programs, like its bi-annual deworming drives.
In the House of Representatives, lawmakers slammed Sanofi Pasteur and some officials of the Department of Health for allowing the entry of Dengvaxia despite the absence of a certificate of pharmaceutical product.
At the hearing conducted by the joint committees on good government and public accountability, and on health, Iloilo Rep. Ferjenel Biron said Sanofi Pasteur had no business to distribute Dengvaxia vaccines in the Philippines.
Sanofi Asia-Pacific head Thomas Triomphe admitted during the hearing the European Medicines Agency had not registered its vaccine before its approval in the Philippines.
“What is your business of exporting your product in other countries if it has not been registered to the European FDA?” Biron asked.
“If you were not able establish safety in your country, you have no business exporting your product…. We should have waited for this product to be approved in the country origin,” he added.
Melody Zamudio, officer-in-charge of the Food and Drug Administration’s Center for Drug Regulation and Research, also admitted that Dengvaxia was not registered by France’s food and drug administration.
“In case the product is not registered in the company of origin, we require certification that this product is only for export,” Zamudio said.
But Biron said the FDA provides that a product, be it for export or domestic consumption, must be registered in the country of origin.
“What is happening is that Sanofi is making us a guinea pig. We should have been strict; and have required strictly that this product be registered by the French FDA before we allowed it to be exported to our country,” Biron said.
Zamudio said, “in case the absence of certificate of pharmaceutical product, we require good manufacturing compliance and certificate of resale.”
Triomphe said the registration was still pending with EMA when Dengvaxia was exported to the Philippines. With AFP
