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 Amid mounting public concern, Sanofi explained its "new findings" at
a news conference in Manila, but it did not say why action was not
taken after a World Health Organization (WHO) report in mid-2016
that identified the risk it was now flagging.
A non-governmental organization (NGO) said it had received
information that three children who were vaccinated with Dengvaxia
had died and a senator said he was aware of two cases.
However, Department of Health Undersecretary Gerardo Bayugo told
Reuters that the three referred to by the NGO died due to causes not
related to the vaccine, and Sanofi said no deaths had been reported
as a result of the program.
"As far as we know, as far as we are made aware, there are no
reported deaths that are related to dengue vaccination," said Ruby
Dizon, medical director at Sanofi Pasteur Philippines.
Last week, the Philippines Department of Health halted the use of
Dengvaxia after Sanofi said it must be strictly limited due to
evidence it can worsen the disease in people not previously exposed
to the infection.
In a statement, Sanofi said the long-term safety evaluation of the
vaccines showed significantly fewer hospitalizations due to dengue
in vaccinated people over 9 years old compared with those who had
not been vaccinated.
Nearly 734,000 children aged 9 and over in the Philippines have
received one dose of the vaccine as part of a program that cost 3.5
billion pesos ($69.54 million).
The Department of Justice 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."
There was no indication that Philippines health officials knew of
any risks when they administered the vaccination.
However, the 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."
Singapore's Health Sciences Authority said last week that it flagged
risks when Dengvaxia was approved there in October 2016, and was
working with Sanofi to strengthen risk warnings on the drug's
packaging.
According to Sanofi in Manila, 19 licenses were granted for
Dengvaxia, and it was launched in 11 countries, two of which – the
Philippines and Brazil – had public vaccination programs.
"A SHAMELESS SCAM"
A spokesman for Philippines President Rodrigo Duterte said on Sunday
the government would hold to account those responsible for the
program.
"We will leave no stone unturned in making those responsible for
this shameless public health scam, which puts hundreds of thousands
of young lives at risk, accountable," spokesman Harry Roque said in
a statement.
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Former Health Secretary Janette Garin, who implemented the program
under the administration of then-President Benigno Aquino, 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."
Roque 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".
Volunteers Against Crime and Corruption, an NGO, said it was
checking a report that three children on the northern island of
Luzon had died since being vaccinated in April 2016, but the
Department of Health said the deaths were not due to Dengvaxia.
"When we evaluated the clinical records, it was not related to the
dengue vaccination," Undersecretary Bayugo said.
A prominent senator, Richard 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".
Dengue is a mosquito-borne tropical disease. Although it is not as
serious as malaria, it is spreading rapidly in many parts of the
world, killing about 20,000 people a year and infecting hundreds of
millions.
While Sanofi's Dengvaxia is the first-ever approved vaccine for
dengue, scientists already recognized it was not perfect and did not
protect equally against the four different types of the virus in
clinical tests.
A new analysis from six years of clinical data showed that Dengvaxia
vaccine provides persistent protective benefit against dengue fever
in those who had prior infection.
But for those not previously infected by the virus, more cases of
severe disease could occur in the long term following vaccination,
Sanofi said.
(Additional reporting by Karen Lema in MANILA and by John Geddie in
SINGAPORE; Writing by John Chalmers; Editing by Raju Gopalakrishnan)
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