Sanofi clarifies 'misconceptions,' insists Dengvaxia 'safe'

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Metro Manila (CNN Philippines, Nov 12) — Dengvaxia manufacturer Sanofi Pasteur is insisting the controversial dengue vaccine is safe despite concerns it may lead to more severe forms of dengue in those not infected by the virus before.

In an official statement read by Sanofi Pasteur Asia-Pacific head Thomas Triomphe at the Senate joint hearing on the issue Monday, Sanofi assured the public Dengvaxia remains  "good, effective, and safe."

Triomphe said persons who had not been infected with dengue before have a 0.2 percent increased risk of getting "traditional dengue symptoms" like fever, low platelet count, or nose or gum bleeding. He argued, however, to remove it from the market based only on the small increased risk would be detrimental for Filipinos. 

"To permanently remove the vaccine from the Philippine market, on the basis only of the reported 0.02% (when we account for the whole population) increased risk of getting traditionally known symptoms, would be a regression in the country's approach to solving a major public health concern and a disservice to the Filipino people," he said.

Last November 29, Dengvaxia issued an update saying those vaccinated by Dengvaxia but had not contracted dengue before may suffer from "severe" diseases if later infected by the virus.
 

READ: Drug firm warns of 'severe disease' from dengue vaccine for people with no prior infection

This after the Health Department had administered the vaccine to over 830,000 students, according to Health Secretary Francisco Duque. An estimated eight to 10 percent of these students reportedly had no prior history of dengue.

The Senate has launched a joint committee hearing on the issue. Former Health Secretary Jannette Garin, has also come under fire for launching the vaccination program under her term. She has denied any wrongdoing in the deal.

READ: Ex-DOH Secretary Garin: No corruption in Dengvaxia purchase

Sanofi, however, insisted the benefits outweigh the risks when it comes to the vaccine.

According to Sanofi, despite its public disclosure of the increased risk, Dengvaxia continues to be used in all other countries where Dengvaxia is being marketed.

It also said an "overwhelming" 90 percent of Filipinos are seropositive or have been infected by the Dengue virus.

"It is an inescapable truth that, in the Philippines, dengue is not just a risk, it is a reality. It is not isolated or just here and there,"  Sanofi said. "It is endemic; it is everywhere. As such, the Philippines stands to benefit most from Dengvaxia."

More doctors urge DOH to closely monitor vaccinated kids

Meanwhile, doctors have urged parents and the Health Department to closely monitor children vaccinated with Dengvaxia.

Doctors group Philippine Society for Microbiology and Infectious Disease (PSMID) Vice President Dr. Mario Panaligan is urging the Health Department to closely monitor these children, and said they should be checked whether or not they are showing symptoms of the virus.

"All children that have been vaccinated should be closely monitored for any symptom of dengue certainly they have to be advised to consult to be brought to the hospital for immediate intervention to avoid any complication that is usually anticipated when you have dengue," Panaligan said.

Despite the controversy surrounding the vaccine, the group asserted Dengvaxia is safe and efficient for persons who are aged nine and above and have prior exposure to dengue, based on clinical data released by manufacturer Sanofi Pasteur.

Panaligan, however, said it is best to temporarily stop the Health Department's immunization program as more data about the vaccine is released.

Dra. Fatima Gimenez of the Pediatric Infectious Disease Society of the Philippines (PIDSP), meantime, clarified that vaccines are not without risk.

PIDSP was among the groups consulted by the DOH prior to carrying out the dengue immunization program. During that time, the group also recommended Dengvaxia based on available data.

Gimenez reminds parents getting vaccinated is not a 100 percent guarantee that a child will not get sick.

The doctors believe what is more important is for parents to understand that it is best to have a multi-pronged approach towards preventing dengue.

This includes making sure environmental risks are reduced by getting rid of stagnant water.

They also underscore the importance of early diagnosis, urging parents to get medical attention immediately if symptoms occur.

"Early seeking behavior is very important pag may sakit dalhin niyo na walang mawawala satin and not all of them need to be hospitalized," she said. "You can be given oral fluids, paracetamol, advised to go home...if there are any bleeding symptoms, abdominal pain, persistent vomiting, these might be warning signs that you need to go if not doctor, your nearest health center."

CNN Philippines' AC Nicholls and Amanda Lingao contributed to this storuy