By Analou De Vera
Pharmaceutical firm Sanofi Pasteur on Wednesday expressed optimism that its appeal to allow the distribution of its dengue vaccine Dengvaxia in the Philippine market will be reevaluated and granted by the Department of Health (DOH), as well as the Philippine Food and Drug Administration (FDA).
Sanofi Pasteur Philippines General Manager Jean Antoine Zinsou maintained that the vaccine has been “proven safe and efficacious.”
“We are very… we say optimistic on the fact that we will have the opportunity to discuss with FDA and see what are the requirement[s] we can agree upon to look forward,” said Zinsou in an interview.
“The fact is we have this revocation ongoing, and the fact is that we are open to any discussion with FDA because we want to turn to the future, for the benefit of the Filipinos. So, that’s what we want. We want to be able to discuss with FDA and see how this revocation can be reevaluated,” he added.
Zinsou said that the suspension of the Dengvaxia vaccine in the Philippines was not based on its safety and efficacy, but due to “some administrative consideration.”
“Through this appeal, we want to respectfully show that we disagree with the suspension, but also show that we are open to discussion with the FDA to move forward,” said Zinsou.
“The dengue vaccination issue has had an impact on many things here in the Philippines, so we definitely need to settle this issue–one way to do it is to discuss with FDA and see what is needed to have this revocation lifted,” he added.
The FDA permanently revoked the certificate of product registration of Dengvaxia last February. Two weeks ago, Sanofi Pasteur filed an appeal before the office of DOH Secretary Francisco Duque III.
Zinsou said that the vaccine is now registered in 20 countries.
“As a matter of fact, you know, this vaccine, on the based on the data, the same set of data that we submitted here in the Philippines but also in all the countries, including Europe, the European regulatory authority, the US FDA, the very same set of data.. all these bodies including WHO (World Health Organization) get the conclusion that this vaccine has a public health value–this is why market authorization was given,” he said.
Zinsou, meanwhile, sided with the health department that Dengvaxia was not a solution to the ongoing dengue outbreak.
“We could not agree more. The vaccines that we are mentioning is not a solution or a silver bullet for the ongoing outbreak,” he said.
“When you think about the vaccine, you need to think about the forthcoming outbreaks. What will be the impact of the vaccine on the forthcoming outbreak not on the ongoing outbreaks,” he added.
“If you consider the vaccine, it has to be on the forthcoming outbreaks and how we can optimize the usage of this vaccine based on the current indication. What we all need to focus on is how to help people understand that the fight against dengue starts by each and every one of us,” he furthered.
“The decision to implement a public vaccination program does not belong to us. The decision to implement it–[the] public vaccination program, belongs to the authorities. We are open to any discussion with the health authorities to see what is needed, what do they need for the future,” said Zinsou.
“Once the license is reinstalled, for sure the vaccine will be available for the private market but it takes time to put in place a public vaccination program. But once again, it is not up to us to decide whether they will be a public vaccination program, it’s the DOH with the local experts to take the decision based on the expected impact,” he added.