Duterte ‘puzzled’ over FDA advice on Sinovac use for health workers – Palace

Robie de Guzman   •   February 24, 2021   •   450

MANILA, Philippines – President Rodrigo Duterte was perplexed by the recommendation of the Food and Drug Administration (FDA) not to use the Sinovac COVID-19 vaccine on health workers who are frequently exposed to patients with coronavirus disease (COVID-19), Malacañang said Wednesday.

Presidential Spokesperson Harry Roque said the president has asked FDA Director-General Eric Domingo to explain such recommendation after the agency’s issuance of an emergency use authorization (EUA) to Sinovac.

“Si president po mismo, nagtataka bakit nga ganuon nga ang naging EUA ng FDA at pinatawag po talaga si Dr. Domingo ng huling cabinet meeting… Naiparating ng president ang pagtataka kung bakit may ganitong colatilla,” Roque said.

Domingo explained that the vaccine’s efficacy rate on healthcare workers is 50.4% based on Sinovac’s clinical trials conducted in Brazil, making it not the best vaccine suited for healthcare workers treating coronavirus patients.

The FDA chief, however, stressed that this is only a recommendation and healthcare workers are not prohibited from receiving Sinovac if they chose to.

“Nirerespeto po ni president ang mga opinion ng mga experts kaya let the colatilla remain,” Roque said. – RRD (with details from Correspondent Rosalie Coz)

DICT vaccine information system aims to expedite COVID-19 vaccine rollout

Aileen Cerrudo   •   April 21, 2021

MANILA, Philippines — The Department of Information and Communications Technology (DICT) has underscored the importance of the Vaccine Information and Management System (VIMS) in the government’s vaccination rollout for COVID-19.

On Wednesday (April 21), DICT Usec. Manny Caintic said VIMS aims to expedite the monitoring and tracking of the supply and distribution of vaccines throughout the country.

Caintic said health professionals can also use VIMS in monitoring vaccination centers during rollout.

Ang VIMS ay magiging single source of truth para sa lahat ng impormasyon patungkol sa pagbabakuna kontra COVID-19 (VIMS will serve as the single source of truth for all information on vaccination against COVID-19),” he said.

He also assured data privacy will be implemented and any personal information of a vaccinated individual will not be leaked.

The DICT official also said the data from LGUs is vital in VIMS.  He urged LGUs to submit requirements for VIMS to track its vaccine distribution for the vaccination information system.

The deadline given to the DICT for VIMS rollout in the National Capital Region LGUs is set until end-April, while the deadline for the VIMS in LGUs outside NCR was set until the end of May. AAC

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.

FDA open to probe into alleged delays in EUA, CPR issuances to local drug manufacturers

Marje Pelayo   •   April 21, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) welcomes the intention of the members of the House of Representatives (HOR) to investigate the process on the issuance of permits for drugs specifically the ones that show potential in combatting coronavirus disease (COVID-19).

During the Laging Handa briefing on Tuesday (April 20) FDA Director-General Eric Domingo stated that the agency has a set of standards on issuing approval on applications for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA).

“Mayroon naman tayong set ng policies at mga standard na sinusunod bago mag-approve po ng isang gamot kasama na ang safety, quality, and evidence on efficacy,” Domingo said.

Domingo said the investigation will help the FDA explain the measures it applies in expediting the country’s access to medicines, diagnostic kits, and other medical needs.

This,  after House Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera-Dy filed House Resolution (HR) 1711 that calls on the Committee on Good Government and Public Accountability to look into the policies and guidelines for the registration, utilization, [manufacturing], distribution, and sale of drug products “which appear to be detrimental to public interest”.

Earlier, Velasco also urged the FDA to speed up the process of acquiring permits for local drug manufacturers after the government opened opportunities for the local pharmaceutical industry to boost the country’s response against COVID-19 in addressing the need for vaccines and medicines crisis.

During the briefing, Deputy Speaker Dy pointed out that there seems to be a problem with the process.

“Nakita natin na parang arbitrary kung paano nila pinapakinggan ang WHO or ‘yung iba mabilis ang approval, ‘yung iba matagal,” she said.

“Noong nakausap ko ang mga local pharmaceutical companies natin, they can make the tocilizumab, the remdesivir, pero it seems na nahihirapan silang magpa-register dito mismo sa ating bansa,” she added.

“Marami naman tayo mga foreign clinical trials na pwede nating gamiting basis. Iba kase yung available na siya sa market. Tandaan mo pag sinabi mong compassionate special permit these are for those na malubha na sa ospital. Papaano yung pang prophylactic niya? Paano yung pang prevention niya? Yun yung gusto nating patingnan sa FDA. Baka pwede nilang tingnan sa portion na ito and to make it available,” Dy further said.

For the part of the FDA, Domingo said any investigation would give the agency an avenue to explain their side on the matter.

“We welcome this para pa-explain natin sa ating mga mambabatas kung ano ang ating mga proseso at saka kung ano na ang nagawa natin sa FDA simula ng pandemic,” he said.

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