P1.4B dengue vaccine undispensed, mired in controversy

Gigi Grande, ABS-CBN News

Posted at Jun 21 2017 07:51 PM | Updated as of Jun 23 2017 05:09 PM

Refrigerators at the Research Institute for Tropical Medicine (RITM) in Muntinlupa City are like gold vaults.

Here, precious life-saving vaccines are tightly guarded. Access is restricted. Temperatures are meticulously inspected round the clock.
Among the cache are vials of Dengvaxia, the world’s first dengue vaccine.

The Philippine government procured 3 million doses in 2015 for P3 billion to strengthen its anti-dengue campaign. It was meant to immunize one million public school students.

Touted as the world’s first dengue vaccine, the cache of Dengvaxia is a remnant of the previous administration’s school based dengue immunization program.

Today, less than half a million children have been vaccinated. An estimated P1.44 billion worth of vaccines continue to sit idly in the ice-cold storage.

Boxes of Dengvaxia stored at the Research Institute for Tropical Medicine (RITM) in Muntinlupa City.

First in Asia to ok vaccine

The Department of Health (DOH) had recorded over 200,000 cases of dengue in 2015. Six hundred people have died due to the disease spread through the bite of the Aedes Aegypti mosquito.

By December 2015, the Philippines became the first country in Asia to approve the vaccine for individuals aged between 9 and 45 years old.

For the poor

The target beneficiaries were 9-year-old fourth graders in public schools in the National Capital Region (NCR), Region 3, and Region 4A, areas reported to have the highest incidence of dengue cases in 2015.

Each child was to be given three doses administered in over six-month intervals through a school-based immunization program.

“If the government has money, why not give it for services to the poor?” said former Health Secretary Janette Garin, who was at the helm of the DOH back then.

Too many vaccines?

But data from the DOH show only 729,287 students in Grade 4 fit the criteria, prompting some critics to raise questions about the haste or impropriety in the purchase of more vaccines than needed.

Of that figure, there were only 534,303 students whose parents consented to the immunization.

By the time the first phase of the immunization project was implemented in April, May and June 2016, only 491,990 students showed up.

When the second phase was administered in October, November and December 2016 under the Duterte administration’s Health Secretary Paulyn Ubial, even fewer students--415,681--turned up for vaccination.

The third phase of immunization is ongoing. 

Huge mistake

Dr. Anthony Leachon, past president of the Philippine College of Physicians, said the previous government should have purchased vaccines based on the number of parents who consented to the vaccination of their children, not the number of target beneficiaries.

“That’s a huge amount of money para magkamali,” said Leachon, a resource person during last year’s congressional hearing on the DOH’s dengue immunization program.
 
Ubial-Garin row

Garin blamed the low turnout on Ubial.

When she left the DOH, Garin said, one of the first announcements Ubial made was that she would stop the dengue vaccination program.

“Nagkaroon ng misinformation,” Garin said. “She actually kept mentioning that the safety (of Dengvaxia) is questionable, so as a parent matatakot ka talaga.”

But Leachon said the low turnout was a result of the failure of the DOH and the local governments to sufficiently educate the target beneficiaries. “Hindi alam ng mothers, hindi mo na-prepare ang community, so walang magco-consent. Yun ang unang mistake dun eh.”

Ubial’s options

Yet Ubial has been hesitant to expand the program her predecessor started. She said she’s keeping an eye on other dengue vaccines that may become available soon.
 
“We are looking at efficacy and cost effectiveness,” she said. “There are several vaccines in the process of clinical trials and will be available in the market by 2018, so we’re actually waiting for those vaccines.

There is information they are more effective than the current one we are using.”

Personal vendetta?

Ubial once said the timing of the dengue immunization program was unethical. “We don’t undertake major programs during an election year, maybe it will be promoting certain candidates, but in this case it happened,” she said.

Garin rebuffed Ubial.

”The allegation that it was a political event rather than a health event twisted everybody,” she said, adding Ubial has an axe to grind.

“The efficacy has been tested by experts all over the world- sino pa ang gusto nyang mag test ng efficacy? I think it boils down to personal vendetta.”
 
Garin was Ubial’s boss in the previous administration.

“Ano ang galit nya sa akin the last few months we were in office? Maybe there were requests that I disapproved, seminars and travels that I had to cut. Sometimes there should be people in the office, hindi pwedeng laging nasa labas kasi walang makaka-trabaho,” she said.

Campaign continues

With or without a vaccine, Ubial vowed the DOH would continue its anti-dengue campaign.

June is dengue-awareness month, and health officials have been advising local communities to search and destroy breeding sites for mosquitos, use mosquito repellants, wear protective clothing, and seek early medical consultation when warning signs of severe dengue occur.

These include abdominal pain, persistent vomiting and bleeding following a fever, headache and rashes.

For all the warning, the number of dengue cases in the country is expected to rise in the coming months.

Few takers?

Ubial finally approved on June 5 a proposal the DOH-Dengue Vaccine Implementation Committee (DVIC) has been pushing since April to offer the vaccines to local governments in NCR for a community-based immunization program.

She approved the expansion of the dengue vaccination program to benefit 100,000 children more in Cebu.

But with all the confusion and controversy, the question remains if there would be any takers.

Nearing expiry

The number of dengue cases in the country is expected to rise in the coming months.

About a third of the vaccines in storage will expire in ten months; the rest, in August 2018.

“After allocating the vaccines…we have projected a large excess supply of Dengue vaccine,” DVIC Executive Director Julius Lecciones wrote Ubial on April 18, 2017.

Lecciones’ proposal was to make use of the vaccines by offering them to four cities in NCR with the highest incidence of dengue: Quezon City, Makati, Manila and Caloocan.

After three more letters to Ubial to follow up the “urgent concern”, the proposal was finally approved on June 5, 2017.

How safe?

Leachon also raised safety issues about the vaccine.

He said it was important to closely monitor vaccinees because some side effects or complications did not surface during the manufacturer’s clinical trials which only involved a small number of volunteers.

Twenty-nine-thousand volunteers received the vaccine during French manufacturer Sanofi Pasteur’s clinical trials that spanned over two decades in 15 countries, including the Philippines.

Not a cure?

The vaccines are not a cure for dengue. Sanofi Pasteur, however, claimed the vaccine boosted immunity to four types of dengue virus, reducing a person’s vulnerability.

DOH statistics show there have been 189 deaths due to dengue in the Philippines between January and May 2017. That figure might have grown more than double by the end of the year based on previous years’ data. 

Bigger hurdle

The next step is convincing local governments to agree to a community-based immunization program they have to fund.

The bigger hurdle, however, is convincing parents of target beneficiaries to give their consent.

The DVIC aims to inoculate 230,611 indigent children aged 9 to 14 years old. But reports have circulated about children who died the past year after being administered the dengue vaccine. Two children were from Bataan and one was from Bulacan. 

Deaths coincidental

Ubial said a “working committee” that reviews adverse events following immunization had ruled the dengue vaccine had nothing to do with the deaths.
 
“They came out with their report that the deaths are coincidental, they are not related to Dengvaxia,” Ubial said.

But because of the negative publicity, Lecciones said it wouldn’t be easy to find takers for the vaccine.

If either Quezon City, Makati, Manila or Caloocan reject the proposal, the DVIC would offer the vaccines to other areas like Marikina and Malabon, where a high number of dengue cases have been reported.

Post-vaccination monitor

Leachon has welcomed the move to make use of already available vaccines.

But Leachon said there should be an honest-to-goodness monitoring of individuals post vaccination, even if the Food and Drug Administration has already granted it a Certificate of Product Registration.

“The certificate of product registration is a license to market the product but there is no guarantee it will not be pulled out. That depends on findings in the future.”

Charge to experience

He advised against using up all the excess vaccines, instead suggesting that inoculation be limited to 100,000 children or less in NCR, where there would be easy access to doctors and health facilities in case of complications. “Ang issue ko ay safety, hindi sa akin yung kung masasayang eh. You just have to charge it to experience.”

Seropositive

Leachon said the target beneficiaries must be tested prior to vaccination to determine who among them have previously been exposed to one of the four dengue viruses.

“Kapag hindi ka pa na-eexpose, seronegative ka,” he said, referring to a study led by Neil Ferguson, director of the MRC Center for Outbreak Analysis and Modelling at Imperial College London published in Science online journal.

“Kapag na-expose ka na, seropositive ka. Ayon sa pag-aaral, kapag hindi ka pa na eexpose at nabigyan ka ng dose na ito, may posibilidad na in three years, magkakaroon ka ng severe hemorrhagic dengue. Yung mga na-expose na, kung magka-dengue, hindi na ganun ka-tindi.”

Wanted: Holistic approach

The vaccine is not a silver bullet.

The World Health Organization said its introduction to areas with a high burden of disease must be part of a comprehensive dengue prevention strategy.
 
“Dengue is not just a DOH concern, it’s an environmental concern, an LGU concern,” Leachon said.

“It’s everybody’s concern. Kahit na paliguan mo ng bakuna ang entire population at gumastos ka ng bilyun, pero malamok at madumi pa rin ang environment mo, hindi mareresolba yun. It’s mosquito and vector control,” he said.