(Eagle News) — The vice-president of Sanofi Pasteur on Monday, February 26, admitted that the controversial Dengvaxia vaccine has not yet been approved by the European Medicines Agency EMA), the European Union agency which evaluates the safety of medicinal products for the EU.
Thomas Triomphe, Sanofi Pasteur Asia Pacifi head, said that Sanofi cannot distribute nor sell the Dengvaxia within the European Union as it had not yet passed the requirements needed for its safety certification by the EMA.
“We have already submitted documents,” Triomphe told a hearing on Monday, February 26, by the House committee on good government and public accountability.
“So you cannot sell to European countries?” asked committee chair Surigao del Sur Rep. Johnny Ty Pimentel.
Triomphe said that yes, Sanofi cannot do so unless they could secure an exemption from the EU “like what your government did.”
A check with the website of the EMA showed that Dengvaxia is not yet on EMA’s list of medicines which had been certified as safe.
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
According to its website, “EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.”
During the hearing in Congress on Monday,Triomphe admitted that the Philippines was its largest buyer of the Dengvaxia vaccine, and that it was the first country to buy the vaccine.
Lawmakers also questioned how the Dengvaxia vaccines were procured and acquired through shortcuts in the government procedure.
The Food and Drug Administration chief, Nela Charade Puno, also testified in the hearing that Sanofi committed violations when it kept on changing its risk management plan.
Puno also said that Sanofi did not inform the Philippines in December 2015 that the vaccine was not for children who have not had dengue before, although Sanofi already knew about the risks that the vaccine posed on those who have not yet contracted dengue.
Former President Benigino Aquino III also appeared in the congressional hearing to defend his decision to procure huge volumes of the Dengvaxia vaccine from Sanofi, saying that he felt then that it was the answer to the rising number of dengue cases at the time. He also said that he only based his decision on what was the given information by Sanofi Pasteur to the Philippine government.
It was only in November 2017 that Sanofi Pasteur issued a statement admitting that Dengvaxia was not for people who have not had dengue before.
“Dengvaxia provides persistent protective benefits against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however…more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” the Sanofi statement issued last November said.
“These findings highlight the complex nature of dengue infection. We are working with health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries,” said Dr. Su-Peing Ng, Global Medical Head, Sanofi Pasteur in a statement last November.