Sanofi: No reported deaths due to Dengvaxia vaccine

Metro Manila (CNN  Philippines, December 4) — Pharmaceutical giant Sanofi Pasteur on Monday said no deaths were caused by its anti-dengue vaccine Dengvaxia.

"All study participants who got severe dengue, whether vaccinated or not, have fully recovered," Sanofi Pasteur General Manager Ching Santos said in a media briefing.

Since the dengue immunization was carried out in April 2016, 733,713 children from Central Luzon, the region of Cavite, Laguna, Batangas, Rizal, and Quezon, and Metro Manila were administered Dengvaxia. Eight to 10 percent or about 70,000 children have not had dengue yet, the Department of Health (DOH) said, putting them at risk.

Despite zero deaths, Sanofi said there is a higher chance of hospitalization for those who will be infected with dengue virus for the first time since getting vaccinated.

"In individuals who have not been previously infected by dengue virus, there is an increased risk of hospitalization (after vaccination)," Santos said.

Sanofi Pasteur, in its study released on November 29, said new clinical data analysis showed those not previously infected with dengue and received the vaccine could contract "severe disease."

Sanofi, however, clarified not all who had been vaccinated but did not have prior infection will get severe dengue.

Sanofi Medical Director Dr. Ruby Dizon clarified the "misconceptions" against Dengvaxia, saying the vaccine does not cause dengue, rather it is caused by the bite of an infected mosquito.

"Hindi nakukuha ang severe dengue from the vaccine. Hindi dahil nabakunahan ka, magkaka-severe dengue ka. Nakukuha mo siya dahil may subsequent exposure to the virus," she said.

[Translation: You don't get severe dengue from the vaccine. Not because you've been vaccinated, you'll get infected. You get dengue because you've been exposed to the virus.]

Sanofi categorized the meaning of "severe dengue" in four levels from mild to severe: easy bruising, bleeding from nose and gums, low blood pressure, and profound shock.

Sanofi officials said the release of the new study is only a preventive measure.

"All data we've seen has seen the completion of all three doses," Sanofi Pasteur Global Medical Head Dr. Ng Su Peing said.

Vaccinated Filipinos have so far received at least 2 doses of Dengvaxia.

Sanofi officials said the vaccine offers more benefits than risks.

"In dengue-endemic countries, the potential benefits of vaccination outweigh the potential risks in individuals….The majority of people are going to benefit from the vaccine," Ng Su Peing said.

In a press statement, Sanofi said it will propose an update to the current label to state the vaccination should only be recommended when the potential benefits outweigh the potential risks, such as in countries with high burden of dengue disease. It also proposes that vaccinations not be recommended for individuals who have not been previously infected by dengue virus.

The World Health Organization recommended the use of Dengvaxia in July 2016 in areas where dengue is highly endemic based on information available from Sanofi at the time.

In 2016, the Philippines became the first country to implement the use of Dengvaxia through a school-based dengue immunization program, which initially covered Grade 4 students in the National Capital Region, Central Luzon, and CALABARZON (Cavite, Laguna, Rizal, Quezon).

The Food and Drug Administration (FDA) said Dengvaxia underwent clinical trials to ensure safety and efficacy.

"It will not get an FDA approval if the documents are not complete," FDA Director Dr. Benjamin Co said.

The Health Department on December 1 temporarily halted its dengue vaccination program.

Health officials called on parents to follow the usual dengue prevention measures, including destroying possible breeding places of mosquitoes, seeking early consultation for fever lasting more than two days, and using mosquito nets and mosquito fogging.

Presidential Spokesperson Harry Roque on Monday said there is no need to panic over the dengue vaccination issue.

"We will tell you if there is a reason to be concerned. We will not hide anything from the public," he said in a media briefing.

The Department of Justice has ordered the National Bureau of Investigation to probe the purchase of P3.5 billion worth of vaccines.

Related: DOJ orders probe of dengue vaccine program

Meanwhile, the Health department is also looking into the possible accountability of Sanofi. The government has fully paid Sanofi for the vaccines. There are 800,000 doses that have not been used, amounting to almost P800 million. Most of which will expire in August 2018.