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)