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Filipinos not made guinea pigs – Sanofi

EMPTY VIALS At the Manila Central Vaccine storage room in Santa Cruz, Manila, are empty vials of the dengue vaccine Dengvaxia given to schoolchildren in the city. The drug producer, Sanofi Pasteur Philippines, says the vaccine does not contain viruses that can cause severe dengue. —EDWIN BACASMAS

The Department of Justice ordered an investigation on Monday into the immunization of more than 733,000 schoolchildren with a dengue vaccine that has since been suspended as pharmaceutical giant Sanofi Pasteur denied that Filipinos were used as “guinea pigs” to test the vaccine Dengvaxia.

Malacañang asked the public to stay calm, saying Dengvaxia does not cause the deadly type of dengue.

Presidential spokesperson Harry Roque told a news briefing that only 10 percent of the 733,000 schoolchildren who had been vaccinated were at risk of infection.

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He added that those who would be infected would have fever and skin rashes only for “two days.”

“[P]eople should not panic about the dengue vaccine. There is no danger with the dengue vaccine,” Roque said.

Department of Health (DOH) spokesperson Lyndon Lee Suy said there were no deaths among patients who were classified by Sanofi as having “severe dengue.”

But why did health officials during the Aquino administration procure P3.5 billion worth of Dengvaxia without being sure about its safety?

Justice Secretary Vitaliano Aguirre II ordered the National Bureau of Investigation to find out.

“We have to know why [the DOH] ordered such a huge amount of vaccine and immediately vaccinated 733,000 schoolchildren. Is that appropriate?” Aguirre said at a news briefing.

Launched after warning

He said the DOH launched the immunization program just four months after Dengvaxia was developed and after Sanofi Pasteur “issued a warning.”

“So the next question is did the DOH heed the warning? What was the effect [of the vaccine]?” he said. “Then we have to look if there was criminal liability or graft and corruption aspect. But I don’t want to preempt the NBI.”

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Asked if former President Benigno Aquino III would be investigated, Aguirre replied: “Yes. Everybody who was involved will be included in the NBI investigation.”

The DOH halted the use of the Dengvaxia vaccine on Friday after Sanofi Pasteur said it must be strictly limited due to evidence it could worsen the disease in people not previously exposed to the infection.

Not clinical trial

The pharmaceutical company’s branch in the Philippines called a news conference on Monday to say that Dengvaxia would not cause people to die and that Filipinos were not used as guinea pigs to test the vaccine.

“The vaccination program is a public health program of the Department of Health, not a clinical trial, so Filipinos were not used as guinea pigs,” Joselito Sta. Ana, Sanofi Philippines senior director, said at the news conference.

Sanofi Philippines general manager Ching Santos said the government’s vaccination program started after the company had gotten a license for the vaccine.

“It means that we have completed the phase 1, 2 and 3 studies not just in the Philippines but for other countries in Asia and Latin America. All studies were put together and submitted to the Food and Drug Administration (FDA). FDA accepted and they licensed,” Santos said.

“All of these studies are in accordance with the World Health Organization (WHO). WHO played an important role in convening the regulatory bodies [that] actually have clearer understanding of these data. So Filipinos were not made guinea pigs. The product was released commercially because clinical data at the time of licensing showed it was safe and effective,” she said.

RISK ISSUES Dr. Ng Su Peing, global medical head of Sanofi Pasteur, and other officials of the pharmaceutical giant that produced the controversial dengue vaccine Dengvaxia answer queries about the drug’s risk factors during a press conference. —EDWIN BACASMAS

While Dengvaxia poses risks to people who have not yet been infected but already had themselves vaccinated, the vaccine has gone through rigorous tests and has been developed over 20 years, Santos said.

“The Philippines is actually one of those [involved] from phase 1, 2 and 3, which is really a robust study. All the information, documents were shared with our FDA, and even WHO. And in fact, it’s not just the Philippines. There are other countries that licensed and made it available [to their citizens],” she said.

Aguirre said, however, that only the Philippines tried the vaccine widely. Other countries wanted to know first the effects of the vaccine, he said.

Beneficial to Filipinos

Santos said the vaccine remained beneficial to Filipinos. She pointed out that nine of 10 Filipinos have been exposed to dengue by the time they reach adolescence, although only three-fourths of the cases are asymptomatic.

“For those who don’t know what their status is, the data still shows that overall, in highly dengue-endemic areas, the vaccine is preventing … there are far fewer cases, significantly fewer cases of severe dengue and dengue hospitalizations in those who’ve been vaccinated against those who didn’t receive the vaccine,” said Sanofi global medical head Ng Su Peing.

For people who have not had dengue before, Ng said “we would not recommend vaccination.”

The Sanofi officials also clarified that exposure to the dengue virus, not the vaccine itself, causes the disease.

“The dengue vaccine does not contain viruses that can make people ill with dengue or severe dengue. You do not get severe dengue from the vaccine. If you were administered with the vaccine it doesn’t mean you’ll get infected, that’s a little misinformation,” said Dr. Ruby Dizon, Sanofi Pasteur medical director.

“You get it because you had subsequent exposure to the virus, not because you were given the vaccine,” she added.

Sta. Ana said 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,” he said.

Sta. Ana said Sanofi’s definition of “severe dengue” merely referred to symptoms, including two days of fever, a lower platelet count and bruising.

The Sanofi officials also played down the claim of Volunteers Against Crime and Corruption that Dengvaxia caused the deaths of three schoolchildren in Central Luzon who were reportedly injected with the vaccine in April 2016.

“As far as we are made aware, there are no reported deaths that are related to dengue vaccination,” Dizon said. —WITH A REPORT FROM AFP

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TAGS: Benigno Aquino III, Dengvaxia, Department of Health, DoH, Harry Roque, Janette Garin, Lyndon Lee Suy, Noynoy Aquino, Sanofi Pasteur, Vitaliano Aguirre II
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