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

Marje Pelayo   •   September 13, 2021   •   413

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.

 

PH FDA approves COVID-19 vaccine booster jabs for general adult population

Robie de Guzman   •   December 1, 2021

MANILA, Philippines – The Food and Drug Administration (FDA) on Wednesday announced it has approved the administration of COVID-19 vaccine booster shots for the general adult population.

FDA director general Eric Domingo said the booster shots will be administered to all adults aged 18 years old and above, based on the assessment of benefit and risks

Domingo said the same brands and combinations like those recommended for health workers, senior citizens, and immunocompromised individuals will be applied to booster doses for the general adult population.

The FDA earlier said that vaccine brands Pfizer, AstraZeneca, SInovac, Moderna, and Sputnik V will be used as booster shots.

The guidelines on the distribution and use of booster shots will be released by the Department of Health.

“Sisimulan na rin natin, lumabas na yung EUA Amendment mula sa FDA. Nilagdaan na po ni director general Eric Domingo yung advisory na ito… Anytime this week,” said Health Secretary Francisco Duque III.

The government has started giving booster shots to health workers, senior citizens, and select immunocompromised individuals in November.

Pagbabakuna sa mga edad 11 pababa posibleng simulan bago matapos ang 2021 – FDA

Robie de Guzman   •   November 23, 2021

MANILA, Philippines – Naniniwala ang Food and Drug Administration (FDA) na malaki ang tiyansang masimulan na rin ngayong taon ang pagbabakuna laban sa COVID-19 para sa mga batang may edad 11 at pababa.

Ayon kay FDA director general Eric Domingo, dalawang vaccine manufacturers na ang nag-aasikaso sa ngayon ng requirements para maaprubahan ang aplikasyon para sa emergency use authorization (EUA) ng kanilang mga bakuna para sa nakababatang populasyon.

“I would think before end of the year. I am pretty sure Pfizer is going to be ready. The Sinovac also told us that their data is being collated and it will be submitted soon,” ani Domingo.

“I believe before the end of the year, we are going to have vaccines for children below 12,” dagdag pa niya.

Sakaling makumpleto ng vaccine manufacturers ang requirements para ma-amyendahan ang dosing regimen ng kanilang mga bakuna ay maaaring mabigyan na ng bakuna ang mga batang may edad lima hanggang 11 bago pa pumasok ang 2022.

“By Pfizer, I hope that they will be sending in their application for an EUA very soon. Nagtanong na sila eh, they have already asked for the list of requirements and they told us that they will be completing the requirements,” ani Domingo.

“It is like a new EUA kasi may bagong innovation doon sa product,” dagdag pa niya.

“Ang Sinovac rin hinihintay pa ulit namin na mag-submit ng EUA nila for children below 18 years old. They just want to complete some more data to give to our vaccine experts and we hope to get that soon,” ang wika ni Domingo.

Ang pagbabakuna sa 5-11 age group ay sinimulan na sa mga bansang Amerika at Israel upang upang mabigyan ng proteksyon kontra COVID-19 ang mga bata dahil sa banta ng mababagsik na coronavirus variants gaya ng Delta.

Lumabas din sa mga pag- aaral ng mga eksperto na sampung beses na mas may tiyansang mahawa sa COVID-19 ang mga batang 12 taong gulang at pababa.

Sa ngayon, ang mga batang may edad 12 hanggang 17 pa lamang ang binabakunahan kontra COVID-19 sa Pilipinas. (mula sa ulat ni Correspondent Aiko Miguel)

COVID-19 pill molnupiravir, maaaring ireseta basta’t may compassionate special permit – FDA

Robie de Guzman   •   November 23, 2021

MANILA, Philippines – Maaari nang mag-reseta ng COVID-19 pill na molnupiravir ang mga ospital at doktor na nabigyan ng compassionate special permit.

Ginawa ni Food and Drug Administration (FDA) director general Eric Domingo ang pahayag matapos sabihin ni Vice President Leni Robredo na may supply na sila ng molnupiravir na maaaring ireseta sa mga kokonsulta sa Bayanihan E-Konsulta program ng kanyang tanggapan.

Ang gamot na molnupiravir ay isang oral pill para sa treatment ng mild to moderate cases ng COVID-19.

Ani Domingo, ang mga doktor at ospital na nabigyan ng compassionate special permit ang may obligasyong mag-monitor sa mga pasyenteng bibigyan ng oral antiviral pill.

Sa isang Facebook post noong Lunes, sinabi ni Robredo na may kasunduan na ang Office of the Vice President (OVP) sa Qualimed Health Network na siyang magus-supply at magre-reseta ng molnupiravir sa mga pasyenteng dudulog sa kanilang teleconsultation program.

“In the agreement, the OVP will issue a guarantee letter under our special medical assistance program to any qualified patient referred by our volunteer doctors at Bayanihan E-Konsulta. QualiMed facilties will then further assess and prescribe the medicine to the patient,” ani Robredo.

Inihayag rin ni Robredo na ang unang shipment ng nasabing gamot ay dumating sa bansa noong Nobyembre 17.

Sa isang Twitter post naman ni Manila Mayor Francisco “Isko Moreno” Domagoso, sinabi niyang may 40,000 capsules ng molnupirarvir ang nasa anim na district hospitals at COVID-19 field hospitals ng Maynila.

Sa datos ng mga ekspertong nagsagawa ng clinical trials sa iba’t ibang bansa, kabilang ang dalawang ospital sa Pilipinas, sinasabing mabisa ang molnunpiravir para maiwasang maopsital at masawi ang isang pasyenteng may COVID-19.

Kumpara sa ibang COVID-19 investigational drugs, ang molnupiravir ay idinesenyo para sa early treatment ng mga pasyente.

Ngunit paalala ng FDA, hindi pa maaaring ibenta sa merkado ang naturang gamot dahil wala pa itong certificate of product registration.

Una nang sinabi ng ahensiya na hindi maaaring ipagbili ang mga gamot o bakuna na wala pang emergency use authorization at hindi pa rehistrado sa bansa. (Mula sa ulat ni Correspondent Aiko Miguel)

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