FDA to visit Gamaleya’s manufacturing facility in Russia for Sputnik’s EUA application

Marje Pelayo   •   March 11, 2021   •   551

MANILA, Philippines — The Food and Drug Administration (FDA) is continuously coordinating with Russia’s Gamaleya Research Institute for the requirements needed for the pharma firm’s application for emergency use authorization (EUA) in the Philippines.

The Russian drug company still lacks one requirement which opted the FDA to visit its facility in Russia to verify for itself if Gamaleya is compliant with the standards in manufacturing the COVID-19 vaccine Sputnik.

Gamaleya submitted its application for EUA on January 7 which until today, has not been approved by the FDA.

One document that the firm needs to provide is the certificate of good manufacturing practice, according to FDA Director-General Eric Domingo.

“Sila naman din ang nag-offer na mag-inspect na lang ang Philippine FDA the same with what other countries have done with their manufacturing facility. Iyon na ang naging kasunduan,” Domingo said.

“Ang inspection kasi titingnan mo ang findings, sabihan mo sila kung meron silang kailangang i-correct or kailangang i-explain sa amin kung ano ang measures nila to be sure na iyong findings namin ay ma-address,” he added.

Regulatory inspectors are set to fly to Russia next week.

Once all requirements are complete, the FDA may approve Gamaleya’s EUA for the vaccine Sputnik.

“Ang gusto naman natin matapos na within the month of March kasi ang plano nmin pupunta sila ng March 15 to 18 and the gagawa pa ng report doon it may take a few days after that,” Domingo said.

“Hopefully ang gusto ko matapos na sya within the month of March,” he added.

To date, aside from Gamaleya, another pharmaceutical company with pending EUA application with FDA is India’s Bharat Biotech. – MNP (with reports from Aiko Miguel)

Pharma companies to develop drugs based on COVID-19 variant

Maris Federez   •   December 3, 2021

MANILA, Philippines — Pharmaceutical companies are looking into developing drugs specific to each COVID-19 variant.

Health experts involved in the clinical trial of molnupiravir in the country said the oral anti-viral pill can help  fight the Omicron variant.

The Philippine Food and Drug Administration (FDA), however, stressed the need for extensive studies to check on the efficacy of the anti-viral pill against COVID-19.

Based on data collected in the previous clinical trial results, molnupiravir is able to prevent the condition of patients with mild or moderate COVID-19 symptoms from getting worse.

The Philippines is one of the countries that participated in the global clinical trial of molnupiravir.

According to medical experts and clinical investigators in the country, molnupiravir can help destroy COVID-19 variants of concern like the heavily mutated Omicron.

“The game changer of this pandemic or any other pandemic or any other disease in the world will always be the treatment. Kasi kapag may gamot, mas madaling i-address iyong problemang iyon,” said Dr. Benjamin Co, clinical investigator from the Asian Hospital Medical Center.

“You’re able to diagnose patients early, you are able to treat them even if they are breakthrough infections, and you are able to see patients who are exposed to those index cases,” he added.

“The mutant strains would still respond kasi doon sa core or inner mechanism nagwo-work iyong molnupiravir and not sa surface or sa superficial na spike proteins niya,” said Dr. Joel Santiaguel, clinical investigator from the Quirino Memorial Medical Center.

“Kahit magka-variation na mutation, may changes doon sa spike protein. Active pa rin ang molnupirvir mo against the virus,” he added.

The FDA also said that even the investigational drugs against COVID-19 that are currently being used are able to give relief to patients.

Nevertheless, the FDA underscored the need for in-depth studies to prove the efficacy of the new anti-COVID-19 drugs.

“Iyong mga gamot for severe COVID katulad ng mga steroid, katulad ng tocilizumab, baricitinib kapag severe case, aandar pa rin iyan sa dito sa Omicron,” FDA director-general Usec. Eric Domingo said.

“Pero hindi pa natin sigurado ang ibang gamot, itong monoclonal antibodies at mga antiviral, iyong mga bago kung magwo- work sila, as well,” the FDA chief added.

Clinical investigators invite volunteers for the one-month Phase-3 of the clinical trial for molnupiravir in the Philippines.

They must be 18 years old or older, unvaccinated, and with exposure to a COVID-19 positive person or to an Index Case.

Index cases are mostly economic or medical frontliners who expose family members when they go home.

The clinical trials will check the efficacy of molnupiravir against the Omicron variant.

Blood specimens will be collected from the participants to check the variant that an individual possesses and the effect of molnupiravir on them.

“Genotyping is very important so that we know what the variant of the individual is. Remember when this clinical trial was rolled out, the variants of concern were already rolling out in the world – si Gamma, si Beta, si Alpha, si Delta,” Dr. Co said.

“And that’s the reason why you can see how successful this drug is in addressing the concern of whether it will work or it will not work with SARS- COV2 infection. So far, ang datos po shows that it is very good drug,” he added. —/mbmf (from the report of UNTV Correspondent Aiko Miguel)

October hits biggest supply of COVID-19 vaccines — Galvez

Maris Federez   •   October 20, 2021

MANILA, Philippines — The country has, so far, received the biggest supply of vaccines against coronavirus disease in October, having recorded 20 million vaccine doses delivered for this month alone.

“Sir, marami pong magandang balita po sa October, it’s the biggest supply delivery from Pfizer, Moderna, and COVAX, and Sputnik. As we have said earlier, almost 92 million doses already been delivered,” said NTF COVID-19 chief implementer and vaccine czar Secretary Carlito Galvez Jr. during Monday’s Talk to the Nation of President Rodrigo Duterte.

Galvez said the country received the biggest delivery from the COVAX facility for having delivered 7.3 million doses of the COVID-19 vaccines.

This is composed of 6.4 million doses of Pfizer vaccine as donations from the United States government and 844,800 from the German donation.

“The German ambassador told us that they will add more to make it 1.6 million AstraZeneca [as] donation,” Galvez added.

Another 2 million vaccine doses will be given by the US totaling approximately 18 million delivered though the COVAX facility.

The vaccine czar said that the arrival of 20 million vaccine doses this month is the biggest so far, surpassing September deliveries of 19 million doses.

“So, the achieving of 100 million doses delivery before the end of October is on track. And right now, the supply is not anymore an issue. We have more than 38 million doses in our warehouses,” he said.

The official noted the efforts contributed by the World Health Organization and the UNICEF for the significant deliveries made by the COVAX facility.

“It already accounted for 24.3 million doses and the majority of which are coming from the US donation. Total na po ng US natin ngayon 16 [million doses], plus iyong promise po na additional sa 18 [million] and other countries are expected to donate this October,” Galvez added. —/mbmf

900K more doses of COVID-19 vaccines arrive in PH

Aileen Cerrudo   •   October 18, 2021

MANILA, Philippines—Around 900,000 doses of COVID-19 vaccines arrived in the country over the weekend.

A total of 720,000 Sputnik V doses from Russia’s Gamaleya Research Institute were delivered on Saturday (October 16). The latest shipment is the largest delivery so far from the Russian-based vaccine maker.

To date, the country has received a total of 1,290,000 Sputnik V doses consisting of Components I and II.

An additional 207,090 doses of Pfizer’s COVID-19 vaccine also arrived on Saturday.

According to National Task Force Against COVID-19 special adviser Teodoro Herbosa said a portion of the vaccines will be delivered to Cebu and Davao, while the rest will be used for pediatric vaccination which began on Friday (October 15).

“We do hope that this will help a lot in our vaccination program. The other good news is we have reached about 92 million doses delivered to the Filipino people by the different brands. I think the promise of Secretary Carlito Galvez Jr. of 104 million by the end of October will be fulfilled,” he said.

More COVID-19 vaccine supplies are expected to arrive in the country. The national government estimated around 140 million to 160 million doses will be delivered to the Philippines before the end of 2021. AAC


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