Health Undersecretary Eric Domingo has noted that Dengvaxia cannot be used in the Philippines because it is not registered with the Food and Drug Administration (FDA) as among the drugs allowed to be sold in the country.
READ: Palace eyes Dengvaxia return
“There was a permanent revocation of the Certificate of Product Registration of Dengvaxia by the FDA due to non-compliance with regulatory requirements,” Domingo said Saturday, adding “an appeal was sent to the office of the secretary (of health) and it is still for evaluation.”
Domingo said this why the vaccine could not be administered amid the Department of Health’s recent declaration of a “national dengue alert” although they were “cool” to the proposal of the Doctors for Truth and Public Welfare (DTPW) to lift its ban.
In a related development:
• A pro-life party-list congressman on Saturday warned the government, specifically the DoH, against implementing high impact solutions to make it appear that it was doing something to contain the outbreak of dengue that has killed hundreds so far this year.
“The government should not be stampeded into re-implementing the use of Dengvaxia vaccine amid the continuing increase in the number of dengue cases nationwide,” Buhay party-list Rep. Lito Atienza said.
The Benigno Aquino III administration injected the vaccine on close to one million school children just before it stepped down in 2016.
Reports said almost 100 children injected with the vaccine died when they got afflicted by the disease.
Continuing testing on the victim by its manufacturer, Sanofi-Pasteur of France revealed that the vaccine exacerbated the symptoms of dengue in patients who were vaccinated although they have not been afflicted by the disease.
Dr. Minguita Padilla, DTPW co-convenor, has called on the DoH to lift the ban on the vaccine amid the current rise in dengue cases, saying “[Dengvaxia] remains banned in the Philippines.''
DTPW is a group of physicians, scientists, esteemed members of the academe, former secretaries of health, and past and present heads of various professional medical associations and NGOs.
DTPW believes the national dengue alert shows the Philippines falls under the “high-risk populations” that the WHO recommends the anti-dengue vaccine.
There have been over 130,000 dengue cases and more than 500 deaths in the first six months of this year alone, causing concern from various sectors all around the nation.
Former Philhealth Director, health advocate Dr. Anthony Leachon, admitted they had no qualms or issues about reintroducing the controversial vaccine, but he insisted there were certain basic requirements to fulfill.
He cited the need for the FDA’s post-marketing surveillance (PMS), which he said: “is an important part of the science of pharmacovigilance and is a mandatory requirement” of the agency.
“The FDA permanently revoked the dengue vaccine from the market because of safety issues and the lack of compliance of the pharmaceutical company to post-marketing safety requirements,” said Leachon.
Citing Sanofi’s study leading to the label change in November 2017 and NEJM (The New England Journal of Medicine) study of June 2018, he said Dengvaxia was risky in seronegative patients.
“The vaccine is fine as long as it is given to seropositive children,” said Leachon.
“That’s what we’ve been saying all along. Instead, for commercial reasons, it was given to everyone,” he added.
Then, for political reasons, he said, the anti-dengue vaccine was given to no one.
“Science always loses to commerce and politics. The ultimate victim is a patient. That’s sad,” also said Leachon.
Furthermore, Leachon said Sanofi should seek FDA approval through proper channels, not through media blitz or political links before distribution in the local market.
Leachon and former DoH Undersecretary Ted Herbosa believe that still, the eradication of mosquito breeding grounds is so far, the most effective” way to prevent dengue.
“Eradication of the breeding places of mosquitoes and massive clean-up of schools, workplaces, and community are the most effective measures than vaccination with a potentially dangerous vaccine,” said Leachon.
Herbosa, on the other hand, asked: Can a vaccine that is useful only if you had been infected with dengue before be of any help during a dengue outbreak?
“Can someone explain that to these dumb people who are suggesting the lifting of the ban on Dengvaxia?” stressed Herbosa.
He pointed out that the Case Fatality Rate of dengue fever in the Philippines is 0.44 percent based on the DoH.
Or if one was afflicted with dengue, he emphasized that 99.56 percent would get better and recover.
Since there is no full protection against dengue, Health Sec. Francisco Duque III has encouraged everyone to implement the 4S Kontra Dengue strategy.
Senate President Vicente Sotto III said questions on the efficacy of Dengvaxia—manufactured and tested in the Philippines—had remained unresolved.
“If it was not effective before, how can it be effective now?” he asked.
“It’s not that I’m not amenable, we all want protection from or cure for dengue, but there is uncertainty in the product,” stressed Sotto.
Before making any decision, he said the government must await the recommendations on the use of Dengvaxia.
Senator Richard Gordon described as a “catastrophic step in the wrong direction” releasing the anti-dengue vaccine to the market.
Gordon, chairman of the Blue Ribbon committee that investigated the Dengvaxia controversy in the previous Congress, said that when his committee probed the P3.5-billion procurement of the vaccines in 2016, the senators found “a lot of ethical things happening,” including meetings between then-president Benigno Aquino III and former health secretary Janet Garin with Sanofi-Pasteur executives.
Gordon disclosed he wrote a letter to Duque two weeks ago requesting him to check on whether those inoculated with the vaccine got sick again with dengue.
Dengue is a disease that forms part of the daily lives of Filipinos because of the existence of the Aedes aegyptimosquitoes that carry the dengue virus.
“However, there are measures that we can do as individuals and communities to prevent dengue infections,” said Duque.
Every year, there are about 200,00 dengue cases registered in DoH.
Although the case fatality rate remains below 1 percent, Duque said “we acknowledge the fear brought by this disease. Let us work together as one nation to ensure the health and safety of our children against dengue and other illnesses, whether vaccinated with Dengvaxia or not.”
As a result of the Dengvaxia snafu, Aquino, Garin and several other Aquino administration officials are still facing charges before the courts and prosecution offices.
Garin is now a congressman representing Iloilo City.
Atienza said: “Let us not allow ourselves to be stampeded into embarking on another round of Dengvaxia vaccinations due to the rising number of dengue cases all over the country, estimated at over 100,000. In fact, now is the best time to find out whether the forced vaccinations done in the past is the cause of this upsurge, or if it is safe and effective, as claimed by those who implemented the program. Today, the Food and Drug Administration has banned its use, while Sanofi says the vaccine was misused. Now we have a national problem.”
According to Atienza, the government should first determine if many of those infected with dengue now had been vaccinated with Dengvaxia in the past.
“If they had indeed been vaccinated before, then this clearly shows that the vaccine is not safe and is in fact causing this problem now. On the other hand, if it is determined that most of the victims today have not been vaccinated, then it is time to also clear those falsely suspected of causing the problem,” Atienza said.
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