Philippines Suspends Troubled Dengue Drug After More Than 730,000 Immunized -- 2ndUpdate
December 04 2017 - 10:40AM
Dow Jones News
By Jake Maxwell Watts
The Philippines suspended a dengue fever vaccine that was given
to thousands of children and launched an investigation, after the
drug's manufacturer said new evidence showed it could worsen
symptoms in some cases.
The tropical country last year became the first nation to widely
distribute the vaccine, branded Dengvaxia, after a fast-track
approval process. The government says more than 730,000 people,
mostly children older than nine, were given the vaccine,
manufactured by the vaccinations division of French pharma giant
Sanofi SA.
A person can be infected by dengue as many as four times due to
the existence of different strains. Subsequent infections are often
more severe.
Sanofi said last week new data found the vaccine was effective
for people who had already had dengue, but for those who hadn't,
"more cases of severe disease could occur following vaccination."
The company said it had asked regulators to change the vaccine
label to recommend that people don't take the vaccine if they
haven't been infected previously.
It isn't the first time warnings have surfaced about the
vaccine. In a July 2016 report, the World Health Organization noted
that the vaccination "may be ineffective or may theoretically
increase the future risk of hospitalized or severe dengue illness"
in those who have not had dengue at the time of vaccination.
Philippines presidential spokesman Harry Roque said Sunday that
Manila vowed to "leave no stone unturned" in making accountable
those responsible "for this shameless public health scam."
On Monday, however, the government said it had a record of all
the children who had received the vaccine and would monitor them
for five years for signs of the disease. It played down the impact
of the new findings, noting that the threat of a severe dengue
contraction was a risk only for those who had not had dengue
before, but had been given the vaccine.
The government last week suspended its vaccination program.
Though no deaths or cases of severe dengue have been definitively
linked to the vaccine, some politicians have pointed to cases of
children who have died since receiving it. "This is our most urgent
task. Laxity is not an option. We are racing against time," said
opposition Senator Risa Hontiveros.
Philippine Health Secretary Francisco Duque III told local media
Monday that the government would assess responsibility for the
vaccine, which was approved under the previous administration, and
consider charges against its manufacturer. The case has quickly
turned political, as allies of President Rodrigo Duterte call for
an investigation into the vaccine's approval process.
In a reply to a request for comment, Sanofi said it doesn't
comment on legal topics, but noted that "the vast majority of those
vaccinated to date live in high endemic settings and, therefore,
will have had a prior dengue infection before vaccination." It said
the company had "not seen any evidence of increased incidence of
severe dengue in vaccinated individuals in the real world
experience with the vaccine."
In a statement last week, Sanofi Pasteur, the firm's
vaccinations division, said the new analysis of clinical data
highlights the complex nature of dengue infection. "We are working
with health authorities to ensure that prescribers, vaccinators and
patients are fully informed of the new findings, with the goal of
enhancing the impact of Dengvaxia in dengue-endemic countries,"
said Su-Peing Ng, global medical head of Sanofi Pasteur.
Dengvaxia was recommended for use by the World Health
Organization in April last year. It was the first of its kind,
targeting a mosquito-borne disease that afflicts some of the
world's poorest countries.
Dengue infects about 390 million people a year globally, 96
million of whom require treatment, according to the WHO. Of those,
about half a million are admitted to hospital, and 2.5% of all
cases are lethal. The virus causes a severe flulike illness marked
by painful joints and extreme fatigue.
Write to Jake Maxwell Watts at jake.watts@wsj.com
(END) Dow Jones Newswires
December 04, 2017 10:25 ET (15:25 GMT)
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