PSG hospital, may diskresyon sa Sinopharm vaccine doses na may compassionate special permit – FDA

Robie de Guzman   •   May 4, 2021   •   48

MANILA, Philippines – Binigyang-diin ng Food and Drug Administration ngayong Martes na responsibilidad ng Presidential Security Group (PSG) Hospital ang paggamit ng Sinopharm COVID-19 vaccines na sakop ng inilabas nitong compassionate special permit (CSP).

Ginawa ng FDA ang pahayag kasunod ng pagpapabakuna ni Pangulong Rodrigo Duterte noong Lunes ng gabi gamit ang Sinopharm vaccine na wala pang emergency use authorization (EUA) sa Pilipinas.

Paliwanag ni FDA director-general Eric Domingo, ang Sinopharm dose na itinurok sa Pangulo ay sakop ng CSP na ibinigay sa PSG Hospital.

Noong Pebrero inilabas ng FDA ang CSP para sa 10,000 doses ng Sinopharm vaccines na ibibigay sa mga miyembro ng PSG at kanilang close contacts gaya ng asawa at iba pang miyembro ng pamilya.

Kung ginamit man ang bakunang ito para kay Pangulong Duterte ay nasa diskresyon na umano ito ng pamunuan ng ospital.

“Para maprotektahan ang kalusugan ng pangulo, sila ang magbibigay ng bakuna kung kailangan. Of course, primarily it was given to PSG members na close contact security ni Presidente,kung nag-decide sila ibigay sa ibang malapit kay Presidente, they have to report to us and they have to see muna kung ano ang kanilang report,” ang wika ni Domingo.

Ipinagtaggol rin ni Health Secretary Francisco Duque III ang ginawang pagbabakuna sa pangulo gamit ang COVID-19 vaccine na hindi pa rehistrado sa bansa.

“Ito ay pinahintulutang gamitin by virtue of the compassionate special permit. ‘Yung CSP ang siyang authority na pwedeng gamitin ito na galing ang authorization sa FDA,” ani Duque.

“Ang pangalawa naman, ang desisyon ni Pangulo na gamitin ito ay batay na rin sa prescription ng kanyang doctor,” dagdag pa niya.

Hanggang ngayon ay wala pa ring isinusumiteng pormal na aplikasyon para sa EUA ang Sinopharm liban sa tatlong letter of intent na una nitong ipinadala.

Ngunit batay sa inisyal na impormasyon ng ahensya, halos magkapareho lang umano ang bisa ng bakunang gawa ng Sinovac at Sinopharm.

“Hindi pa naman siya dumaan din sa evaluation sa sa ’min pero with what I’ve read sa ibang evaluation nya like sa WHO, similar din naman ang efficacy niya sa Sinovac, especially sa mga 18-59 years old at saka sa mga walang co-morbidity. Mataas din naman, 70-80% nakita ko na kaniyang efficacy,” ang pahayag ni Domingo.

Muli naming paalala ng FDA sa publiko na huwag tangkilikin ang umano’y COVID-19 vaccines na iniaalok online o sa merkado dahil sa ngayon ay tanging ang pamahalaan ang may karapatang mamahagi at magbigay ng bakunang nakatanggap ng EUA sa Pilipinas. – RRD (mula sa ulat ni Correspondent Aiko Miguel)

Show-cause order issued to FDA drug center for alleged inaction on over 600 applications

Marje Pelayo   •   May 12, 2021

MANILA, Philippines – The Anti-Red Tape Authority (ARTA) has issued a show-cause order to the Food and Drug Administration (FDA) Center for Drug Regulation and Research (CDRR) for allegedly not acting on over 600 drug applications despite having complete requirements.

The order, sent on Tuesday (May 11) by ARTA Investigation Enforcement and Litigation Director Jedrek Ng, directs FDA-CDRR Director IV Jesusa Cirunay  to “explain why no administrative or criminal case should be filed” against her over delays in applications of various pharmaceutical companies filed as far back as 2014 or so.

“Pag titingnan po ito ang mga applications na ‘to di ito kumplikado. Ito yung mga aplikasyong for automatic renewal. Ito ay mga produkto na dati nang ginagamit at ngayon ay gusto lang i-register o yung iba naman ay low to no risk sa taumbayan,” ARTA director general Jeremiah Belgica said.

“Di namin maintidihan kung bakit ito ay naiipit at ito ay palagi na nangyayari diyan sa FDA particularly sa Center for Drugs. Ito ay mga aplikasyon na pwedeng aprubahan ng center director,” he added.

Cirunay is given seven working days from receipt of the order to conduct an inventory of all pending permit, license, clearance or application; immediately release all said applications which have been pending beyond the prescribed processing time.

Also, she is directed to submit to ARTA a compliance report with a list of all permits, licenses, clearances or applications issued pursuant to the show cause order.

If Cirunay fails to comply, ARTA will resort to the filing of formal charges against her in accordance with Republic Act No. 11032 or the Ease of Doing Business and Efficient Government Service Delivery law before the Office of the Ombudsman.

Belgica also urged Health Secretary Francisco Duque III and FDA Director General Eric Domingo to remove, if necessary, their erring officials and personnel.

Philippine GDP declines by 4.2% in first quarter of 2021 – PSA

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – The Philippine economy shrank by more than expected in the first quarter of the year, according to government data released on Tuesday, as prolonged community quarantines due to the pandemic hamper reopening efforts.

The Philippine Statistics Authority (PSA) reported that the country’s gross domestic product (GDP) fell -4.2 percent in the first quarter from a year earlier.

This is the fifth consecutive quarter that the country has posted negative GDP growth due to the coronavirus pandemic.

The PSA said the main contributors to the decline were Construction (-24.2 percent), other Services, (-38.0 percent); and Real Estate and Ownership of Dwellings (-13.2 percent).

Among the major economic sectors, Agriculture, Forestry, and Fishing (AFF) declined by -1.2 percent in the first quarter of 2021. Likewise, Services and Industry contracted by -4.4 percent and -4.7 percent, respectively during the period, the PSA noted.

“On the demand side, Household Final Consumption Expenditure (HFCE) declined by -4.8 percent, along with the following items: Gross Capital Formation (GCF), -18.3 percent; Exports, -9.0 percent; and Imports, -8.3 percent,” the agency said.

The net primary income (NPI) from the rest of the world continued to decline by -75.8 percent, bringing the Gross National Income (GNI) to drop by -10.9 percent during the period, it added.

On the other hand, the PSA said that government final consumption expenditure (GFCE) grew by 16.1 percent in the first quarter of 2021.

Contributors to growth were led by financial and insurance activities (5.2 percent), public administration and defense, compulsory social activities (7.5 percent), and human health and social work activities (11.7 percent).

Other industries that managed to grow during the period were information and communication, 6.3 percent; manufacturing, 0.5 percent; and electricity, steam, water, and waste management, 1.9 percent, the PSA said.

The National Economic Development Authority (NEDA) said the aversion to risk for most of 2020 has placed the country in a long period of quarantine, and that this came at a huge cost to the economy and the people.

It, however, observed some improvements as the rate of contraction has slowed, and that the country has time to catch up with on its growth target of 6.5 to 7.5 percent despite the pandemic-induced quarantine restrictions.

Evaluation of EUA application for Sinopharm vax may be completed in less than 21 days – FDA

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – The evaluation process for the Sinopharm COVID-19 vaccine will not take long before it can be granted an emergency use authorization (EUA) in the Philippines, the Food and Drug Administration (FDA) said Tuesday.

FDA director-general Eric Domingo said the Sinopharm vaccine has already been included in the emergency use listing (EUL) of the World Health Organization (WHO) and access to its documents, including inspection reports from the WHO will be faster.

“Useful yung kanyang Emergency Use Listing sa WHO kasi before this, wala pa siyang EUA from a stringent regulatory authority katulad ng mga USFDA ganyan or Europe, Japan… hindi pa siya listed sa mga iyon. Pero yung WHO na emergency use listing that’s equivalent to a stringent regulatory authority,” he said.

“Ang maganda sa WHO kasi very transparent ang documents nyan. Available din siya sa FDA. Lahat ng ni-review nila, maaari naming ma-access kaya hindi tayo masyado mahihirapan sa paghingi ng information,” he added.

The Department of Health (DOH) earlier said it has started the process of applying for EUA, pending documents about the vaccine product.

The FDA said the process may take less than 21 days once the DOH completes the application process.

“Kapag ganyan na merong WHO EUL, mas mapapabilis iyan. Nakakaya natin iyan usually less than 21 days,” Domingo said.

The FDA also echoed the DOH’s earlier statement that there are no irregularities with the government’s move to file an EUA for a Chinese-made vaccine since they also applied for the EUA of other COVID-19 vaccine brands, such as Sinovac, AstraZeneca, and Pfizer, in order for these vaccines to be delivered to the country.

“Talagang nasa batas and it’s a worldwide practice,” he said. “Based on WHO guidelines, posible naman na gobyerno gusto bumili ng bakuna na walang local manufacturer or representative dito. In those cases, the government itself can get EUA.”

“Hindi naman conflict yun dahil ang EUA ay hindi naman product registration o marketing authorization lang, talagang for emergency use lang ang mga bakuna,” he added. – RRD (with details from Correspondent Aiko Miguel)

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