FDA OKs clinical trial application for Janssen COVID-19 vaccine

Robie de Guzman   •   December 29, 2020   •   1128

MANILA, Philippines – The application for clinical trial of Janssen COVID-19 vaccine has been approved, the country’s Food and Drug Administration (FDA) announced Tuesday.

“We already approved one. Ito po ‘yung clinical trial ng Janssen. This has been given the go signal by the FDA,” FDA director general Eric Domingo said during a virtual forum with the Department of Health.

“Baka they will start the clinical trial after ng New Year,” he added.

Janssen COVID-19 vaccine was developed by Johnson & Johnson.

Domingo said the applications of two other vaccine developers are being evaluated by the FDA – Clover Biopharmaceuticals and Sinovac, which are both from China.

The FDA earlier expressed hopes to issue an emergency use authorization by January for Pfizer’s COVID-19 vaccine. – RRD (with details from Correspondent Aiko Miguel)

No nasal sprays yet against COVID-19, FDA says

Robie de Guzman   •   September 22, 2021

MANILA, Philippines — The Philippine Food and Drug Administration (FDA) on Wednesday said that nasal sprays have not been proven effective yet in preventing COVID-19 infection.

FDA director-general Eric Domingo said nasal sprays against COVID-19 are still being studied and undergoing clinical trials.

“Wala pa pong approved sa mga ito. Hinihintay pa nating matapos ang mga trial na ito para masabi talaga (na panggamot sa COVID-19),” he said in a televised briefing.

Domingo said the public would have to “wait for a little more” for the results of these trials before COVID-19 nasal spray vaccines become available in the market.

“Sa ngayon, ang available sa atin na nasal sprays, mga ano lang po ito, panlinis ng ilong, pambigay ng konting proteksyon pero sa panandaliang panahon lamang at hindi pa maaaring gamiting pamalit sa mga gamot at bakuna kontra COVID,” he said.

Domingo urged the public to immediately report to authorities anyone who is selling or offering products that claim to be COVID nasal spray.

“Wala pa pong COVID vaccine nasal spray na pinapayagan sa Pilipinas o kahit saang parte ng mundo,” he said.

“‘Pag merong nagbenta sa inyo ng spray na sinasabing COVID vaccine po ito, ito po ay either fake o hindi po natin alam kung ano ang laman nito. Huwag po ninyong gagamitin at paki-report po ninyo sa FDA para mahuli po namin,” he added.

The World Health Organization (WHO) earlier said that eight spray vaccines that aim to deliver immunity against COVID-19 through the nose are being evaluated.

FDA, may babala vs mga ospital na maniningil ng higit kaysa COVID-19 drug price cap

Robie de Guzman   •   September 17, 2021

MANILA, Philippines – Binalaan ng Philippine Food and Drug Administration (FDA) ang mga ospital na maniningil ng higit kaysa itinakdang price cap para sa mga gamot na ginagamit para sa mga pasyenteng may COVID-19.

Sa panayam sa programang Get it straight with Daniel Razon, sinabi ni FDA director general Eric Domingo na maaaring patawan ng parusang pagkakakulong at suspension ng lisensiya ang mga ospital gayundin ang mga botika na nagbebenta ng COVID-19 drugs na mas mahal kumpara sa price ceiling.

Ginawa ng FDA ang babala kasunod ng mga ulat ng overpricing sa mga gamot na ginagamit sa treatment ng COVID-19 patients tulad ng Remdesivir at Tocilizumab .

“Pag ospital po, kwestyonable ang presyo, at least yung quality sigurado tayo dahil yung ospital hindi naman yan bibili, bawal po silang bumili sa unlicensed distributor. Pero mayroon silang pananagutan dahil lumalagpas po sila sa retail price na pinapayagan po ng DOH,” ang paliwanag ni Domingo.

Alinsunod sa kautusan ng DOH, nasa P8,000 hanggang P28,000 ang suggested retail price ng Tocilizumab na ginagamit sa treatment ng critical hanggang severe COVID cases.

Nasa P1,500 hanggang P8,200 ang retail price ng bawat 100 milligram vial ng Remdesivir.

Samantala, kaugnay naman ng pagkakaloob ng compassionate special permit o CSP sa COVID-19 drugs, inihayag ni Domingo na halos lahat ng ospital sa bansa ay may special permit na para sa isa o dalawang gamot kontra COVID-19.

Dagdag pa nito, hindi masyadong istrikto ang FDA sa pagbibigay ng CSP basta lisensyado ang ospital at mga doktor na gagamit ng gamot para sa COVID-19 patients.

“Actually lahat ng ospital ngayon sa Pilipinas, may special permit na sila for one drug or another, para sa ating COVID dahil talagang puno ng COVID-19 cases. At tayo naman po, hindi tayo very strict,” ani Domingo.

Ayon sa FDA, nade-desisyunan naman agad sa loob ng 24 hanggang 48 oras ang aplikasyon para sa CSP ng isang ospital. Maaari ding mag-apply in advance ng CSP ang mga ospital para sa COVID-19 patients nito sa pamamagitan ng email address na odg@fda.gov.ph.

Kaugnay naman ng investigational drug na Leronlimab, sinabi ni Domingo na wala pang price ceiling na itinakda ang pamahalaan dito dahil kakaunti lamang ang nanghihingi ng special permit para sa suplay ng gamot na ito. – RRD (mula sa ulat ni Correspondent Rosalie Coz)

FDA warns: Nasal spray products are not substitutes for medicines, vaccines

Marje Pelayo   •   September 13, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) has cautioned the public on the claims of nasal spray products authorized in the Philippines.

In an advisory dated September 10, the agency noted that “these nasal spray products have been authorized as medical devices which are intended for short-term use in the nasal cavity and serves as mechanical barrier from particulates. These are sprays that coat the nasal mucosa with substances that have a non-specific effect against pathogens.”

The FDA explained that these nasal spray products “do not have active pharmaceutical ingredients that directly treat, eliminate or prevent diseases.”

Therefore, the agency reminded consumers that these products “should not be used as substitutes to medicines and vaccines to prevent or treat SARS-CoV-2 Infection or COVID-19.”

The FDA encourages the public to be vigilant in using these products claiming prevention or treatment of COVID-19.

 

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