Gov’t dengue vaccination put on hold, says DOH Sec. Duque

Health Secretary Francisco Duque III on Friday said the government's dengue vaccination program has been put on hold after the manufacturer of the vaccine raised health concerns.

"Pinahinto muna natin. We're putting on hold ang dengue vaccination program hanggang magkaroon tayo ng rekomendasyon mula sa expert panel ng WHO—World Health Organization—na sa kasalukuyang tinutugunan itong advisory mula sa Sanofi Pasteur," Duque said in an interview on Dobol B sa News TV.

To be clear, the suspension of the dengue immunization program formally extends only to state-owned health care providers. Private practitioners, on the other hand, can make the call themselves.

"The private physicians have a different program altogether...It will be up to the health provider if he or she would like to put on hold implementing the program as well," Dr. Benjamin Co, Director IV of the Food and Drug Administration's (FDA) Center for Drug Regulation and Research, told reporters at a news briefing on Friday.

Duque specified at the same briefing that a group of experts from the WHO, along with representatives from Sanofi and the Department of Health (DOH), will be meeting on December 12 or 13.

Only after this, and a subsequent review of the contract with the global pharmaceutical firm, will they be able to say who may be held liable for the only-recently announced findings, Duque said.

On Thursday, pharmaceutical company Sanofi said the vaccine Dengvaxia is only safe and effective in the long run for people who have been infected with dengue before they were vaccinated.

It has advised against prescribing the dengue vaccine Dengvaxia to patients who have not been infected by the virus in the past, since it may cause severe diseases in the long run, or after the at-least-30-month period wherein a vaccinated person is prevented from being infected with dengue.

Duque said the WHO panel is expected to release its recommendation by the second week of December.

"Gayunpaman pinahinto muna natin ang pagbibigay ng dengue vaccine," Duque said.

'Severe diseases'

Duque added that they are still verifying what "severe diseases" may be contracted as a result of receiving the vaccine.

"They did not define what constitutes severe disease. So 'yun 'yung inaalam natin ngayon. Baka mamaya makakuha na tayo ng mas malinaw na kasagutan ano ba ang nasasaklawan nitong 'severe disease,'" he said.

Duque clarified though that there has been no report of death among those who got vaccinated. 

"Walang report of death because all these vaccination on children without prior exposure or without prior dengue infection, wala namang ganu'n na report," he said on Super Radyo dzBB.

Duque also said that not one of the over 700,000 individuals who received the vaccine have so far reported experiencing a "severe case" of the disease.

He also assured those who were vaccinated that they are protected from infection.

"'Yung mga nabakunahan naman walang issue dahil may protective, then may reduction ng hospitalization by 90 percent atsaka reduction in severe disease or symptoms by about more than 80 percent. Pero ang naging problema nga, itong sa mga hindi nagkaroon ng infection pero tumanggap ng first dose. Kasi ito, although nakatanggap sila ng first dose, 'wag naman mabahala dahil 'yung first dose ng vaccine, magbibigay 'yan ng protection for 30 months," he said.

"'Yung first dengue vaccine provides a 30-month protection. Well nagkakaproblema after that. Based on their more detailed report, after 30 months or two and a half years, du'n kailangan talagang magmamatyag ng mas intensified ang surveillance kasi du'n nila napuna based on their long term clinical trial data analysis du'n lumalabas 'yung severe disease," Duque said.

He allayed fears that children who have never had dengue prior to receiving Dengvaxia will automatically have a "severe" case of the disease in the future.

"Ang protective...benefits ng naturang bakuna lalong-lalo na para doon sa mga nagkaroon na ng dating impeksyon ay mataas ang benepisyo makukuha mula dito, in terms of much-reduced hospitalization...and much-reduced severity of illness," he said.

"...Even for those who have not had prior exposure to dengue, and received the dengue vaccination, meron pa rin po siyang protective period which is 30 months or two-and-a-half years," he added.

4S dengue campaign

Duque said the DOH will continue with its 4S anti-dengue program.

"'Yung 4S 'yun pa rin. 'Yung search and destroy, 'yung pamugaran ng mga lamok na nagkakalat ng dengue; self-protection measures kagaya ng pagsuot ng long pants, long sleeves, medyas o pag-apply ng mosquito repellant, o paggamit ng mosquito net; seek early consultation for fever lasting more than two days; and say yes to selective fogging kung may impending outbreak," he said.

Duque said the use of herbal concoctions have no basis. "Walang batayan," he said. 

As for the use of lotions with Diethyl-meta-toluamide (DEET), Duque advised consumers to check if these have license or approval from the Food and Drug Administration.

An average of 200,000 cases of Dengue is reported every year, he said at the briefing.

DOH gives assurance

Duque also assured parents of children who have been vaccinated that the DOH is on top of the issue.

"Huwag kayong mamamahala, ang DOH po ay nasa ibabaw ng issue na ito at ating paiigtingin ang surveillance," he said.

"Aatasan natin ang lahat ng DOH regional offices at ang mga health care providers mula sa mga ospital at sa RHUs (regional health units), national, local private hospitals ay bibigyan natin ng advisory tungkol dito. At babantayan natin ang mga anak ninyo. Makakasiguro po kayo na hangga't sa makakaya namin ay pipilitin namin na hindi kami magkukulang sa pangangalaga at pabibigay ng sapat na impormasyon at updates po," Duque said.

Duque added they will get the master list of all those who were vaccinated with Dengvaxia and will identify those who have not yet had dengue.

Given this new development, Duque said the DOH will review its dengue immunization guidelines and update its framework to include a stronger focus on mandatory history-taking, reporting, and post-vaccination surveillance mechanisms.

First Asian country to approve sale

In December 2015, the Philippines was the first Asian country to approve the sale of Dengvaxia,  the world's first dengue vaccine. It entered the Philippine market in January 2016.

The Department of Health began its dengue vaccination program in April 2016, targeting a million children.

The vaccine was to be given in three doses spaced six months apart.

However, Duque said, "Hindi pa naman (tapos ang vaccination) dahil matatapos by January 2018."

It was announced in May that the DOH will halt the dengue vaccination program after completing the third and final round of injections for recipients to await the results of the pilot program and make plans for a second iteration with their findings.

Around P2.9 billion more or less have been spent by DOH for the Dengvaxia vaccine, Duque said. Each dose costs P1,000.

The DOH secretary also said they will go over the contract between DOH and Sanofi and look into the circumstances around that time to determine if anyone should be held liable.

FDA on Sanofi

FDA's Co said Sanofi will have to apply for a product information change, after which the agency will issue an advisory.

What will be changed are the product information leaflets inside boxes of vaccines and other medication, said Co. The vaccine itself or its formulation will not be changed.

Dengvaxia doses already in the market cannot be sold until the corresponding product information has been changed, he also said.

"Whatever they have not sold yet, whatever is not yet out, there should be a product information leaflet change. Whatever that is out already because of the advisory that is provided, at least everybody knows that there should be a product information leaflet change," he said.

The DOH still has 789,000 doses out of the purchased 300 million. More than 500,000 of these is at the Research Institute for Tropical Medicine and will be expiring in August next year, said Health Undersecretary Dr. Gerardo Bayugo.

There are another 38,000 doses at the Philippine Children's Medical Center, half of which will be expiring in May 2018 and half in August of the same year, he added.

There are also stocks remaining in Region IV-A (62,000) and in the National Capital Region (134,900+). In both places, the stocks will expire by May 2018, he also said.

The government purchased each dose for P1,000, for a total of around P3 billion.

Senate probe

Senator JV Ejercito on Friday said the Senate blue ribbon and health committees must probe DOH's procurement of Dengvaxia.

"That should be investigated by Blue Ribbon Committee as primary, with Committee on Health as secondary committee since it’s about corruption and accountability," Ejercito said in a tweet. —KG, GMA News