Health experts still question Dengvaxia-mass vaccination

UNTV News   •   February 7, 2018   •   3698


MANILA, Philippines – The Senate Blue Ribbon Committee once again questioned the process of procurement of the controversial Dengvaxia vaccines.

For Senate Blue Ribbon Committee chairman, Senator Richard Gordon, there seems to be a manipulation on the procurement of the said vaccines.

The Food and Drug Administration (FDA) and former Health Secretary Janette Garin refuted the allegations.

“I would say that it follows the process po,” FDA Deputy Dir. Gen. for Field regulatory Operations Office Ma. Lourdes Santiago said.

“Because if no CPR (Certificate of Product Registration) is forthcoming, then I will directly inform the president na imposible po ang dengue vaccine (that a dengue vaccine is impossible).” Garin said.

But for some health experts, the mass vaccination of more than 800,000 children is still questionable, as the conduct of such undertaking entails long and thorough preparation.

“I will not take any risk . . . especially on a massive scale,” UP-PGH Dr. Juliet Sio-Aguilar said.

“The patient has the right to know. Hindi nalaman ng tao ‘yan (The public did not know). Prescription based ka, bakit ka magma-mass vaccination (It’s prescription-based, why would you conduct a mass vaccination?),” said health reform advocate, Dr. Anthony Leachon.

On the other hand, health experts believe there is no need to worry for now regarding the effects of Dengavaxia.

“Sa daming kanilang na bakunahan ng Dengvaxia, talagang mayroon at mayroon doon na mga normal diseases that will happen with or without Dengvaxia,” Aguilar said.

( Translation: With the number of people vaccinated with Dengvaxia, there will inevitably be normal diseases that will happen with or without Dengvaxia.)

“Results from the clinical trials . . . in general safe ho,” infectious diseases specialist, Dr. Mary Ann Lansang said.

They said it is premature for them to come up with any conclusion until they have seen the result of the probe conducted by the Dengue Investigative Task Force.

Meanwhile, DOH Secretary Francisco Duque said, the Dengvaxia issue has greatly affected the other government’s Immunization Program.

“And to date, I think it’s down to 57% it’s substantial 30% reduction, that’s truly a cause of concern,” Duque said.

As the hearing rolled on, the Blue Ribbon Committee has issued subpoenas to Public Attorney Office (PAO) Chief Persida Acosta and PAO Forensic Laboratory Director Dr. Erwin Erfe who conducted a separate investigation on the issue.

Some senators are calling for unity on handling the issue to establish an airtight case against the persons involved in the controversy.

“Eh di ba dapat tayo ay magsama-sama, magtulong-tulong? Ang hindi ko maintindihan bakit ayaw nilang makipagtulungan, ano ba ang meron?” said Senate Committee on Health & Demography chairman, Sen. Joseph Victor Ejercito.

(Are we not supposed to work together? I don’t understand why they refuse to cooperate. What’s the reason?)

“Ang ayaw ko lang sa kanila, sinasabi nila Dengvaxia. Hihina ang kaso ng gobyerno kapag sinasabi niyo Dengvaxia tapos wala namang napapatunayan,” Gordon said.

(What I don’t like about them is they keep saying it’s Dengvaxia. The government’s case will weaken if you keep saying Dengvaxia without any proof.)

The Blue Ribbon Committee will set another hearing on the Dengvaxia controversy. – Nel Maribojoc | UNTV News & Rescue

FDA: 6 hospitals have secured special permit for ivermectin use vs COVID-19

Robie de Guzman   •   May 5, 2021

MANILA, Philippines — Another hospital has secured a compassionate special permit (CSP) for the use of ivermectin to treat patients with coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Wednesday.

FDA director-general Eric Domingo said there are now six hospitals within and outside Metro Manila that have been allowed limited use of the anti-parasitic drug on COVID-19 patients.

“That means the doctors in the hospitals can prescribe it [ivermectin],” he said in an online forum.

Domingo declined to identify these hospitals with CSP since the FDA doesn’t want to “violate the privacy of the patients.”

“Of course, the hospitals can freely identify themselves. We’re not stopping them,” he added.

The FDA earlier said that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

Only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

Doctors who will prescribe the drug to treat COVID-19 patients are required to report to the FDA on a monthly basis. They will also be held liable for possible side effects.

The FDA also reiterated that a compassionate use permit is different from a certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

Domingo likewise stressed that the drug is still an investigational product and is not yet approved as COVID-19 treatment in the country.

The clinical trial for ivermectin as possible COVID-19 treatment is expected to start in May or June.

FDA warns public vs use of silver jewelry cleaners containing cyanide

Robie de Guzman   •   May 3, 2021

 

MANILA, Philippines — The Food and Drug Administration (FDA) on Monday reminded the public that the sale and promotion of silver jewelry cleaners containing cyanide remain prohibited in the country.

The FDA issued the reminder following post-marketing surveillance activities and laboratory testing by its Common Services Laboratory, which showed that these cleaning solutions are still being sold in the market.

The agency further noted that cases of poisoning from silver jewelry cleaners with clinical features of changes of the sensorium, loss of consciousness, and hemodynamic instability as possible signs and symptoms of cyanide poisoning. These were documented by the National Poison and Management Control of the University of the Philippines – Philippine General Hospital (NPMCC, UP-PGH) up to the year  2020.

“In order to eliminate potential risks to human health brought about by cyanide exposure, the FDA hereby reiterates the ban of all silver jewelry cleaners containing cyanide that is manufactured, distributed, imported, sold, and offered for sale or promoted in the market/e-commerce marketplaces,” the FDA said in its advisory.

“Cyanide is a highly toxic chemical, which may be inhaled, absorbed through the skin, or ingested (accidental or deliberate) even at small doses/concentration,” the agency said.

“Exposure to cyanide may bring about any of the following signs and symptoms within minutes –dizziness, headache, nausea, and vomiting, rapid breathing, rapid heart rate, restlessness, and weakness or may lead to respiratory failure, loss of consciousness, and possibly death, among others,” it added.

It also advised the public to always check if a product is registered with the FDA by using its Verification Portal.

“All concerned establishments are warned not to distribute any banned household/urban hazardous substances,” it said.

“All FDA regional field offices and regulatory enforcement units, in coordination with law enforcement agencies and local government units, are requested to ensure that banned products are not sold or made available in the market or areas of their jurisdiction,” it added.

Duterte orders FDA to deal with illegal sale, distribution of ivermectin

Robie de Guzman   •   April 21, 2021

MANILA, Philippines – President Rodrigo Duterte has directed the Food and Drug Administration (FDA) to take the lead in dealing with illegal traders of anti-parasitic drug ivermectin amid push to use this to treat COVID-19, Malacañang said Wednesday.

“To ensure the safety and welfare of the public and at the same time avoid any unnecessary conflicts, the Food and Drug Administration (FDA) has been directed to take the lead in determining the course of action against the illegal trading/dispensing of Ivermectin,” Presidential Spokesperson Harry Roque said in a statement.

“The Philippine National Police (PNP) cannot arbitrarily determine on their own which drug/s should not be on the market. All operations to apprehend or seize goods must be done in coordination with the FDA,” he added.

Roque, however, clarified that the FDA is only ordered to stop the sale or trade of ivermectin for veterinary use that has been repackaged as human grade, including those that have no been determined by competent authorities as safe to be used in humans.

“Having said this, we advise the public to seek the advice of medical practitioners before taking medicines and/or supplements,” he said.

“The President is closely monitoring the developments concerning ivermectin here and abroad. He has even directed the Presidential Management Staff (PMS) to give him weekly updates on ivermectin studies and FDA-related clearance,” he added.

The FDA earlier granted two hospitals compassionate special permit for ivermectin.

The agency, however, reiterated that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

The agency also emphasized that a compassionate use permit is different from certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

The FDA likewise stressed that only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer. Doctors who will use ivermectin to treat COVID-19 patients are required to report to the FDA on a monthly basis.

The FDA also said that distribution and promotion of ivermectin as a COVID-19 treatment remains prohibited in the country.

Ivermectin is registered in the country for veterinary use to prevent heartworm disease and treat internal and external parasites in certain species.

Ivermectin products registered for human use in the country were in topical formulations under prescription use only.

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