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Ban on use of Dengvaxia stays—DOH’s Duque

in News/Tabloid PH News
Ban on use of Dengvaxia stays—DOH’s Duque
image credit: twitter / @secduque

Despite calls from several groups to allow the limited use of Dengvaxia amid the dengue epidemic, the Department of Health (DOH) announced on Thursday (August 22) that the appeal of Sanofi Pasteur seeking to reverse the revocation of its certificate of product registration (CPR) for the dengue vaccine has been thumbed down.

Health Secretary Francisco Duque III said the denial of Sanofi’s appeal dated August 19 was due to the French manufacturer’s “continued failure to submit post-approval requirements.”

Dengvaxia’s CPR was canceled by the Food and Drug Administration (FDA) last February, effectively banning the use of the vaccine in the country.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” Duque said.

He added: “The DOH is committed to strong and strict implementation of our health laws and regulations. We know how critical this is to our efforts to rebuild public trust and confidence in our public health programs and in vaccines that have long been proven effective.” 

He, however, clarified that Sanofi can still apply for a new CPR for Dengvaxia, especially at this time when the country is in a state of national dengue epidemic, with the number of dengue cases about to breach 200,000 already this year.

Even President Duterte had said he is open to the use of Dengvaxia again. ”Now, compare it vis-à-vis to those who died, I want to hear the words of the experts, doctors, and we have enough bright people to tell us. I don’t need foreigners to tell me, my own Filipino scientists and doctors would tell me what to do. I will be guided by their announcements,” he said.

Sanofi failed to submit its third risk management plan (RMP), a post-marketing requirement meant to ensure public safety.

It also failed to submit fresh data on its “pharmacovigilance and post-marketing surveillance” programs. 

These reports should detail the monitoring of Dengvaxia’s effects on some 830,000 students vaccinated through the Dengue Immunization Program at the tail end of the Aquino administration in 2016.

Declaration of ‘national dengue epidemic’ likely

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Declaration of ‘national dengue epidemic’ likely
Image Credit: Gov.PH

The Department of Health (DOH) has set a meeting today to validate figures that will be used as basis in upgrading the current “national dengue alert” to a “national dengue epidemic” to enable the government to better mobilize resources in preventing the further spread of the deadly disease.

Interviewed at the ABS-CBN News Channel, DOH Undersecretary Enrique Domingo said they are now getting all the data from the previous weeks. They have found out that in just a span of one week—or in the third week of July—there were 10,000 cases of dengue reported.

Current estimated cases of dengue nationwide have reached 146,000 already.

Last July 15, Health Secretary Francisco Duque declared a national dengue alert. Data reaching Duque that time showed the dengue cases had risen to 106,630 from January 1 to June 29, 2019, from only 57,564 cases in the same period last year. Regions Mimaropa, Western Visayas, Central Visayas and Northern Mindanao had exceeded the epidemic threshold. Ilocos Region, Cagayan Valley, Calabarzon, Bicol, Eastern Visayas, Zamboanga Peninsula, Davao, Bangsamoro Autonomous Region in Muslim Mindanao and Cordillera Administrative Region, on the other hand, exceeded the alert threshold.

Today, Domingo said more regions exceeded the epidemic threshold, including Calabrazon, Bicol and Eastern Visayas and Zamboanga Peninsula. Bordering between alert and epidemic levels are Ilocos region, Central Visayas and BARMM.

A national epidemic can be declared if at least half of the country’s regions have reached the epidemic level.

“We are going to consolidate all the data today and have a meeting at the department for that,” Domingo said. “Once we get all the information in, yes, it is very likely (that we will declare a national dengue epidemic).”

He noted that by declaring a national epidemic, government resources and instrumentalities will be mobilized further.

“We get to work with other govt agencies, the DILG, PNP, Department of Education, and tighten up our activities a little more and raise up the bar, because when we have these cases going on. we really have to do everything to make sure they don’t increase,” he added. “You can activate the NDRRMC and (have) all the government (agencies) working together for one particular activity, in this case, prevention of dengue.”

The problem, he said, will likely persist up to September due to the rainy season, noting that water that remained stagnant for three days is enough to breed mosquitoes. 

The best thing to do on the part of the public for now, Domingo added, is to ensure they maintain cleanliness in their surroundings, remove all stagnant water and have proper attire for kids. 

The hospitals are ready to treat patients suspected with dengue, especially those with continuous fever for three days.

Dengvaxia back in Philippine spotlight

in News/Tabloid PH News
dengvaxia

Manila, Philippines — Controversial dengue vaccine Dengvaxia is hugging the headlines in the country anew, with doctors and scientists urging the government to lift the ban on the Sanofi-made vaccine following the doubling of dengue cases in the Philippines this year.

Data from the Department of Health (DOH) showed dengue has already claimed the lives of 561 people as of July 13. Nationwide, the number of dengue cases rose to more than 130,000, nearly doubling the 67,690 recorded in the same period last year with 367 deaths. Children aged 5 to 9 were the most vulnerable with about 30,000 cases year-to-date. From July 7 to 13 alone, the DOH recorded 8,295 cases already.

Western Visayas, which includes the provinces of Negros Occidental, Capiz, Aklan, Antique, Iloilo and Guimaras, had the most incidence with 18,943 cases and 95 deaths.

With the alarming rise in dengue cases, the Doctors for Truth and Public Welfare (DTPW) said it is high time the government lifted the ban on Dengvaxia. 

“The Philippines has the highest incidence and death rate from dengue in this part of the world. Yet it is the only country in the world that has banned it,” Dr. Minguita Padilla, DTPW co-convener, was quoted in a report of the Philippine Daily Inquirer.

Led by former Health Secretary Esperanza Cabral, DTPW is composed of physicians, scientists, educators, former secretaries of health, and past and present heads of various professional medical associations and nongovernmental organizations.

“The vaccine need not be included in the Expanded Program of Immunization (EPI) of the government so that [the] government need not spend for it. But at least make it available to physicians to offer for the millions of patients who can benefit from it,” Padilla said. 

The Food and Drug Administration (FDA) canceled the certificates of product registration (CPRs) of Dengvaxia last February due to Sanofi Pasteur, Inc.’s alleged disregard of the agency’s rules and regulations.

One month later, the Department of Justice (DOJ) indicted former Health Secretary Janette Garin and 19 health officials and drug executives for the deaths of children who received Dengvaxia shots.

Garin was the DOH secretary in the tail end of the Aquino administration when the P3.5-billion mass dengue immunization program was implemented by the government.

They were charged for “inexcusable lack of precaution and foresight” and because they “totally disregarded the identified risks and adverse effects of the vaccine”.

Former President Benigno Aquino III said the Dengvaxia issue was just used to demonize the former administration and that the rise in dengue cases would have been avoided if the program was continued.

“The thing that could have protected the health of our citizens cannot deliver anymore because of politics and a lot of bad motivation,” Aquino said in a report of the Philippine Star. “The protection that could have been given to a lot of people was not given… It is like a scandal and an alarm. If there are people who were killed, they should be held liable.”

Aquino, who was also investigated for his role in the controversy, is turning the tables on his detractors, saying those behind the plot to scare away Filipinos from the use of Dengvaxia should be held accountable.

It was actually President Duterte’s Spokesman Salvador Panelo who first floated the idea of allowing the use of Dengvaxia in the country again in response to the rise in dengue cases.

“If we know that Dengvaxia could be used for seropositive patients, then why don’t we try it? We will just consider it. We have to make a study. As I said earlier, it needs, requires a serious study before we can use it,” he told reporters. “Why not use Dengvaxia for those who already had dengue before? Because it would surely work there. Mine is only a suggestion. But didn’t they say that the dengue cases are worsening? We need a vaccine for that.”

Photo Credit: PhilStar / Kriz John

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