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 At the time, it seemed the Philippines could be on the cusp of a
breakthrough to combat a potentially lethal tropical virus that had
been endemic in large parts of the Southeast Asian nation for
decades.
Almost two years later, the program lies in tatters and has been
suspended after Sanofi Pasteur, a division of French drug firm
Sanofi, said at the end of last month the vaccine itself may in some
cases increase the risk of severe dengue in recipients not
previously infected by the virus.
Documents reviewed by Reuters that have not been disclosed until
now, as well as interviews with local experts, show that key
recommendations made by a Philippines Department of Health (DOH)
advisory body of doctors and pharmacologists were not heeded before
the program was rolled out to 830,000 children.
After Garin's announcement, the Formulary Executive Council (FEC) of
advisers urged caution over the vaccine because it said its safety
and cost-effectiveness had not been established.
After twice meeting in January, the panel approved the state's
purchase of the vaccine on Feb 1, 2016 but recommended stringent
conditions, minutes of all three meetings show.
"Based on the available scientific evidence presented to the
Council, there is still a need to establish long-term safety,
effectiveness and cost-effectiveness," the FEC told Garin in a
letter on that day. The letter was reviewed by Reuters.
The FEC said Dengvaxia should be introduced through small-scale
pilot tests and phased implementation rather than across three
regions in the country at the same time, and only after a detailed
"baseline" study of the prevalence and strains of dengue in the
targeted area, the FEC letter and minutes of the meetings said.
The experts also recommended that Dengvaxia be bought in small
batches so the price could be negotiated down. An economic
evaluation report commissioned by Garin's own department had found
the proposed cost of 1,000 pesos ($21.29) per dose was "not
cost-effective" from a public payer perspective, the minutes from
the meetings reveal.
For reasons that Reuters was unable to determine, these
recommendations were ignored.
"VERY ANGRY"
The DOH purchased 3 million doses of Dengvaxia in one lot, enough
for the required three vaccinations for each child in the proposed
immunization program and paid 1,000 pesos per dose, a copy of the
purchase order reviewed by Reuters shows.
It did conduct a "limited baseline study" in late February and March
2016, but the survey looked at "common illnesses" rather than the
prevalence of dengue, according to guidelines issued by Garin's
office at the time and reviewed by Reuters.
Garin, who was part of the government of former president Benigno
Aquino and replaced when President Rodrigo Duterte took power in
June, 2016, did not respond to requests for comment on why she
ignored the local experts' recommendations.
A physician, Garin has defended her conduct and a program that she
said was "implemented in accordance with WHO guidance and
recommendations".
"I understand the concern," she told Philippine TV station ABS-CBN
on Friday. "Even us, we're also very angry when we learned about
Sanofi's announcement about severe dengue. I'm also a mother. My
child was also vaccinated. I was also vaccinated."
DOH spokesman Lyndon Lee Suy also did not respond to text messages
or questions emailed to him.
Sanofi Philippines declined comment on the Philippines government
decision. However, Dr. Su-Peing Ng, Global Medical Head of Sanofi
Pasteur, told Reuters: "We communicated all known benefits and risks
of the vaccine to the Philippines government."
Rontgene Solante, former president of the Philippines Society for
Microbiology and Infectious Diseases, said health officials were
motivated to end the debilitating impact of dengue on the
Philippines, where there are about 200,000 reported cases each year
and many more unreported.
Over 1,000 people died of the disease in the country last year.
Two months after the FEC wrote to the health secretary, the DOH
began immunizing one million students around the age of 10 in all
three target areas in April 2016, in accordance with its original
plan but at odds with the FEC's recommendations to conduct a slow
roll-out of the vaccine.
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"The usual process for the DOH that has protected our children for
so many decades was not followed. That's a fact," said Susan
Mercado, a former Philippines health department undersecretary and
former senior official at the World Health Organization (WHO).
WHO said in April 2016 that the Philippines' campaign appeared to
meet its criteria for using Dengvaxia because the targeted regions
had high levels of dengue exposure; the vaccine would be provided to
children 9 years and older; and they would each receive three doses.
WHO was not involved in the deliberations of the FEC, according to
the minutes. It said in a statement last week that a position paper
on the dengue vaccine it published in July 2016 did not include a
recommendation for countries to introduce it.
Now, after Sanofi's warnings, WHO has said it agrees with the
government's decision to suspend the immunization program.
SHOULDN'T IGNORE EXPERTISE
The current secretary of health in the Duterte administration,
Francisco Duque, said he would carry out a "thorough analysis" of
the FEC's recommendations and the program before passing judgment.
He said the Council's recommendations were not legally enforceable.
"At the end of the day, the final decision is made by (the)secretary
of health," he told Reuters. "But because of the expertise that the
members of the FEC have, it is something that you don't want to
ignore."
Underpinning the concerns in 2016 about Dengvaxia, since confirmed
by Sanofi, were fears that the vaccine would act like a primary
infection for those who had never had dengue.
If they were bitten by a mosquito carrying the virus after the
vaccination, it could be akin to getting dengue a second time, which
often leads to far more severe symptoms and potentially death if bad
cases are not treated quickly.
The concerns were first raised by noted U.S.-based tropical disease
expert, Dr. Scott Halstead, who urged both Sanofi and the WHO to
proceed with caution.
In the Philippines, Dr. Antonio Dans, an epidemiologist from the
University of the Philippines, led a delegation of physicians to the
DOH in March 2016 where, citing Halstead's research, they pressed
for the campaign to be aborted.
"The data was not definitive but it was clear there were
uncertainties and risks. Why not wait for the complete studies to be
finished before endangering so many children?" Dans told Reuters.
In a Senate hearing late last year, Garin said she was aware of
Halstead's assessment but dismissed it. "This is a theory ... it has
not been proven," she said at the time.
FEAR AND CONFUSION
Two sources involved in the program said no antibody testing was
undertaken, as recommended by the FEC.
Antibody testing, while not 100 percent accurate, indicates whether
an individual has had dengue before.
Duque, the current health secretary, is demanding the company refund
the 3 billion pesos ($60 million) paid for the vaccinations and has
threatened legal action against Sanofi if it is proven to have
withheld information.
A criminal probe is underway into how a danger to public health came
about and two Congressional inquiries have been convened in the
Philippines.
Duque told Reuters he was concerned that the program was paid from
an "off-budget" allocation, meaning it bypassed Congressional
scrutiny. Reuters was unable to confirm this.
Until now, one child out of the 830,000 vaccinated, a girl who was
hospitalized with severe dengue, has been linked definitively by the
DOH to the campaign. But the department of health says it still does
not have complete data on those who fell ill after taking Dengvaxia.
(Additional reporting by Julie Steenhuysen, Manolo Serapio Jr and
Ben Hirschler; Editing by John Chalmers and Raju Gopalakrishnan)
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