By Leilani Junio
MANILA -- The Department of Health (DOH) on Friday announced that
it was putting on hold its dengue vaccination program until experts are able to
review new developments on the Dengvaxia dengue vaccine.
This developed after DOH on Nov. 29, received an information from
Dengvaxia manufacturer, Sanofi Pasteur, that a child who has not had dengue
before receiving the vaccine could suffer from severe dengue after a 30-month
period.
"In light of this new analysis, the DOH will place the dengue
vaccination program on hold while review and consultation is ongoing with
experts, key stakeholders, and the World Health Organization (WHO),"
Health Secretary Francisco Duque III said in a press briefing held at the DOH
media relations unit in Tayuman, Sta. Cruz, Manila.
Duque said they will coordinate with schools in Central Luzon,
Calabarzon and the National Capital Region and selected cities covered by the
program to trace those who have no history of dengue but received the vaccine.
The surveillance will also be made through rural health units, which
will monitor the health of these children, he added.
DOH spokesperson, Assistant Secretary Lyndon Lee Suy, said a total of
733,713 children have received the free dengue vaccine under the DOH’s
school-based immunization program launched in 2016.
The recipients -- nine-year-old public school students in the three
regions -- were given three doses of the vaccine, six months apart.
Lee Suy said these children, especially those who have not had dengue,
will be monitored.
"We will clear the numbers in terms of who these children
are," he added.
Lee Suy noted that this does not mean that all the children who
received the vaccine are at risk.
"Based sa data natin, roughly around 8-10
percent na nabakunahan yung (di pa nagkaroon ng dengue).
So, hindi
po lahat ng 700,000 plus ang at risk with severe dengue (Based
on our data, roughly 8-10 percent of the children who received the vaccine have
not had dengue. Not all of the more than 700,000 children are at risk of
contracting severe dengue)," he explained.
The department’s decision to put the dengue vaccination on hold only
covers the government program and not private clinics or private physicians.
"It will be up to the health care provider if he/she would like to
put on hold the immunization for dengue in their clinics,” said Dr. Benjamin
Co, director of the Food and Drug Administration’s (FDA) Center for Drug
Regulation and Research.
Co said private physicians are in a better position to make a decision
as they could check their patients’ medical history.
The FDA, he said, has proposed an update on the product information in
the literature found in every package of Dengvaxia – “the content, instruction,
who should use, when to use, and recommendation”.
When asked if the department is considering legal action against
Sanofi, Duque declined to give a concrete plan of action until they receive the
results of the review and recommendation of WHO experts.
"We cannot answer unless we have already reviewed all the
documents and contracts and analyzed all the circumstances surrounding the
issue of Dengvaxia," he said, citing the need to put facts and data
together for them to come up with an overall response.
He said that he also asked the department’s legal advisers to support
the review to be conducted by the Strategic Advisory Group of Experts (SAGE) of
WHO.
"In the meantime, the DOH is ready to help in the investigation,
in case there will be a risk on human population," said DOH Undersecretary
Gerardo Bayugo.
Meanwhile, Dr. Julius Lecciones, Philippine Children's Medical Center
(PCMC) chief, said Brazil has decided to continue the vaccination to prove that
they are looking at the beneficial side of the vaccine.
"There is a reduction of 93 percent in the severity of the
(dengue) disease and 82 percent in reduction in hospitalization. These are very
significant benefits" among those who had been infected by dengue before
and had received the vaccine, he explained.
On issues linking the vaccine to death, Lecciones said that so far, no
confirmed death has been attributed to the dengue vaccination program in the
country.
On the two cases of death reported last year that were linked to
Dengvaxia, he said there was no direct relation to the vaccine since it was
revealed that one of the patients had a pre-existing heart condition that was
complicated by diarrhea, while the other had Japanese Encephalitis. (PNA)
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