Manufacturer disputes claim of deaths due to vaccine

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This file photo taken on April 4, 2016 shows a nurse showing vials of the anti-dengue vaccine Dengvaxia, developed by French medical giant Sanofi, during a vaccination program at an elementary school in suburban Manila. The Philippines said on December 1, 2017 it had suspended use of the landmark vaccine for the potentially deadly dengue virus after its manufacturer warned it could worsen the disease in some cases. The Philippines has vaccinated more than 700,000 children with the drug since 2016 when it became the first country to start using it on a mass scale. / AFP

By Arra B. Francia

FRENCH PHARMACEUTICAL company Sanofi Pasteur on Monday, Dec. 4, dispelled reports that three patients who received the dengue vaccine last year supposedly died because of the shot, saying the vaccine itself cannot trigger the infection.

“We try to correct this misinformation…hindi dapat tayo nag-ko-conclude on these things (we’re not supposed to make conclusions on these things). There is an independent expert committee that decides on these matters. And as of today, what we know is that it’s judged, not related to the vaccination,” Sanofi Medical Director Ruby Dizon said at a press briefing in Taguig City.

This is in connection with a claim by the Volunteers Against Crime and Corruption (VACC) that the Dengvaxia vaccine had caused the deaths of three children, after they took part in the P3.5-billion vaccination program of the Department of Health (DoH) using drugs licensed under Sanofi in April 2016.

“May na-receive na kami sa aming coordinator sa Central Luzon, tatlo na po ang namatay doon. Ang mga bata na tinurukan noong Abril 2016,” VACC chairman Dante Jimenez said in a separate press conference in Manila yesterday. (According to our coordinator in Central Luzon, three have died, children who had been inoculated.)

A prominent senator, Richard J. Gordon, told Reuters he was aware of two deaths — but gave no details — and said approval and procurement for the program was done with “undue haste.”

For his part, Presidential Spokesperson Harry L. Roque, Jr. said there had been no reported case of “severe dengue infection” since the vaccine was administered and urged the public “not to spread information that may cause undue alarm.”

An official of the DoH also said the deaths were not due to Dengvaxia.

Prior to VACC’s statements, the DoH already ordered the suspension of the vaccination program following a new study by Sanofi itself stating that the Dengvazia vaccine may cause severe dengue cases on patients who were inoculated but did not have a prior infection.

A total of 733,713 children aged nine years and above from Regions 3 (Central Luzon), 4-A (Calabarzon), and the National Capital Region received the vaccine last year. Of this number, the DoH said around 90% already had dengue beforehand, which means the remaining 70,000 face increased risks of getting the infection, going by Sanofi’s disclosure itself.

The World Health Organization (WHO) said in a July 2016 research paper that “vaccination may be ineffective or may theoretically even increase the future risk of hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination regardless of age.”

Sanofi Global Medical Head Ng Su Peing said at Monday’s press briefing: “We noted in the longer term an increased risk of hospitalized and severe dengue in the vaccinated people without a prior dengue infection history compared to the placebo.”

The company defined severe dengue to have the following symptoms: easy bruising, bleeding from nose and gums, low blood pressure, and profound shock.

On the other hand, the company said the vaccine retains its efficacy once the patient has received all three shots.

“With the three vaccine doses, majority of the people are protected. Whether you knew their infection status or not. Majority of people have fewer dengue cases, fewer hospitalizations with severe dengue,” Ms. Peing said.

When asked about precautionary steps that should be taken by those who received the vaccine but did not get the infection beforehand, Ms. Dizon said there are none as of the moment.

Should these patients get dengue, however, they should still practice the same measures as if they did not receive the vaccine. “So when your child has a fever, whether vaccinated…or not you still do the same thing…symptoms leading to dengue, you still bring the child to the doctors, it doesn’t really impact the management,” Ms. Dizon explained.

The company said it is coordinating with the DoH and the Food and Drug Administration (FDA) on how to move forward with the case.

“Our focus today is to communicate these results as proactively and as actively as we can to the FDA, to our Department of Health…to make sure that the mechanisms are in place. And we will decide how to move forward with the DoH,” Ms. Dizon said.

Meanwhile, the Department of Justice (DoJ) on Monday ordered the National Bureau of Investigation to look into “the alleged danger to public health … and if evidence so warrants, to file appropriate charges thereon.”

For her part, former Health secretary Janette Garin, who implemented the program under the administration of then-president Benigno S.C. Aquino III, said she welcomed the investigation.

“In the event that there will be authorities who will point culpability to me, I am ready to face the consequences,” she told ANC TV. “We implemented it in accordance with WHO guidance and recommendations.” — additional report by Reuters

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