Dengvaxia: A Killer or Not?

by Himesh Evan Perera

The Philippines Department of Health (DOH) announced that a “casual association” has been
found between three paediatric deaths and the dengue vaccine, Dengvaxia.

Two of these deaths may have been caused by vaccine failure, according to a DOH press release.

The deaths were investigated by members of a Dengue Investigative Task Force (DITF) that was
created by the Philippine General Hospital (PGH) in response to concerns over the safety of
Dengvaxia. (Sanofi Pasteur) - the only licensed dengue vaccine approved for use by 19
regulatory authorities in endemic areas. Concerns arose in December after Sanofi Pasteur
released data showing Dengvaxia is effective in patients who had a prior dengue infection but
may cause more severe disease in non-immune patients who become infected after vaccination.
In light of these data, the DOH suspended an immunization program that used the vaccine to
prevent dengue virus infection, which is endemic in the country. During the immunization
program, more than 830, 000 children received at least one dose of Dengvaxia, according to the
DOH.

Scoot B.Halstead,MD, an adjunct professor in the department of preventive medicine and

biometrics, Unformed Services of the University of Health Sciences in Bethesda,Maryland
,previously told infection Disease News that live, recombinant vaccine may have triggered
antibody-dependent enhancement (ADE) in vaccine recipients with no prior infection. ADE,he
said, occurs when a patient who has recovered from infection with one type of dengue virus
develop antibodies that can react with other viruses ,making subsequent infection with dengue
more severe and potentially fatal.

In addition to the three deaths with “casual association” the PHG DITF report included
information on 11 other children who died after Dengvaxia vaccination. Three of these deaths
were considered “coincidental” and two had inadequate information. A temporal association was
established in the remaining six children – all of whom died within 30 days of receiving the
vaccine.

“These results strengthen our decision to suspend the Dengue Immunization Program as
Dengvaxia is not fit for mass immunization program that does not screen for prior dengue
infection and comorbidities of children before the administration of the vaccine”, the release
said. “In this light, the DOH will now hand over the PGH DITF report and the National Expert
Panel reports to the Department of Justice so that they may use them in the fulfilment of their
mandate to investigate and prosecute those who are possibly accountable.”

A spokesperson for Sanofi Pasteur told Infectious Disease News “there are no safety or quality
concerns about the Dengvaxia vaccine,” and the report shows “no evidence directly linking the
Dengvaxia vaccine to any of the 14 deaths.”
“Sanofi Pasteur has always followed the highest ethical standards and should there be any case
of injury due to dengue that has been demonstrated by credible scientific evidence to be causally
related to vaccination, we will assure responsibility,” the company spokesperson said.

Sanofi Pasteur had previously agreed to refund the Philippines for unused doses of the vaccine.
However, it recently declined the DOH’s request to refund the government for used doses and to
financially support an indemnification fund.

“When Sanofi Pasteur agreed to reimburse the Philippine government for unused doses of
Dengvaxia, we did so to show our continued commitment to cooperate with the DOH in ensuring
the best possible health outcomes for the people of the Philippines. The decision was not due to
any safety or quality concerns about the Dengvaxia vaccine,” the spokesperson said. “Agreeing
to refund the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not
the case. The data remains quite clear that, in absolute terms, dengue vaccination in the
Philippines will provide a net reduction in dengue disease, including severe dengue and, thereby,
reduce the overall public health burden associated with this disease.”