Ascertain efficacy of anti-viral injection, FDA told

Published April 22, 2020, 12:00 AM

by manilabulletin_admin


By Genalyn Kabiling

The Food and Drug Administration (FDA) should finally study if the Fabunan antiviral injection is safe and effective for use in the treatment of COVID-19, according to Presidential Spokesperson Harry Roque.

Presidential spokesperson Harry Roque speaks during a press briefing at the New Executive Building in Malacanang, Friday. (CAMILLE ANTE / MANILA BULLETIN)
Presidential spokesperson Harry Roque Jr.(CAMILLE ANTE / MANILA BULLETIN FILE PHOTO)

He urged the regulatory agency to help protect public health by ascertaining the efficacy of such antiviral drug. He expressed concern that more people might believe such drug can treat the coronavirus until FDA makes a decision.

“Kinausap ko, kakausap ko lang po kay Dr. (Eric) Domingo ngayon, ang sabi ko nga, ‘Bakit ba hindi napag-aralan iyong sinasabing anti-viral injection ni Fabunan at once and for all, magdeklara ang FDA – ito ba ay safe to use or hindi (I just talked to Dr. Domingo today and I said, Why not study the antiviral injection of Fabunan and once and for all, the FDA can declare whether or not it is safe to use),” Roque said over government radio.

(Kasi habang hindi ginagawa at hindi nagdedeklara ng ganiyan ang FDA, palaging madaming maniniwala na baka ito na nga ang lunas (Because until it is not done, it is not declared by the FDA, more people may believe that this is the cure),” he added.

Roque recognized that health authorities must undertake clinical tests to verify if the antiviral drug will treat or harm patients.

“Sabi ko pag-aralan na nga kung ano iyan at magkaroon na ng pronouncement ang FDA dahil sa panahon na ito, maraming nais maniwala bagama’t kinakailangan ay siyensiya pa rin ang umiral nang malaman natin kung iyan ba ay banta o mabuti sa kalusugan ng ating mga kababayan (I said it should be studied so the FDA can finally make a pronouncement because at this time, many people may want to believe (its efficacy). Science must determine if this is a threat or, if it can help promote public health),” he said.

Early this month, the FDA has cautioned the public against using drugs and vaccines with unproven claims for treatment of COVID-19. The agency said there are no registered drugs or vaccines licensed for COVID-19 treatment or prevention so far.

It said the PRODEX B and the Fabunan antiviral Injections remain unregistered and cannot be sold to the public.

“Manufacturers and vendors of unlicensed products such as PRODEX B and the Fabunan Antiviral Injections have been informed regarding the process and requirements to register their products with the FDA Center for Drug Regulation and Research (CDRR),” the FDA said in a April 8 statement posted on its website.

“No applications for product registration have been filed to date. Until such products are proven safe and effective for use in the treatment of COVID-19 they cannot be dispensed to the public nor can therapeutic claims be made,” it added.

The President recently offered incentives for the search for the vaccine to the coronavirus disease that infected more than 6,000 people and left 437 dead.

Any Filipino who can find a vaccine to COVID-19 will receive P10 million from the President.

Duterte also pledged a “substantial grant” to the University of the Philippines and Philippine General Hospital to boost their the vaccine research and development efforts.

The President recently said once the country gets access to such antibody treatment to the coronavirus, he will readily lift the enhanced community quarantine in Luzon. A vaccine to the new coronavirus treatment may take a year to develop, according to Duterte.