EUA application for Sinopharm vax now being processed — DOH

Robie de Guzman   •   May 10, 2021   •   222

MANILA, Philippines — The Department of Health (DOH) on Monday said it has started the process of the filing of the application for emergency use authorization (EUA) of the coronavirus disease (COVID-19) vaccine developed by Chinese drug maker Sinopharm.

In an online briefing, Health Undersecretary Maria Rosario said they are just waiting for the dossier of Sinopharm to complete the application process.

“We were already instructed to process and facilitate the application for the EUA of Sinopharm,” she said.

“Ito po ay inaayos na natin ngayon, kailangan lang natin makuha yung mga dokumento, the dossier of Sinopharm so we can complete the process of applying for this EUA,” she added.

Health Secretary Francisco Duque III earlier said that the EUA application will be filed after the World Health Organization (WHO) approved the Sinopharm vaccine for emergency use.

A WHO emergency listing means that a product’s safety and efficacy have been rigorously evaluated. It will also allow the product to be included in the COVAX facility – a global program that seeks to provide vaccine supply mainly for poor countries.

The emergency use listing will also allow countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

The DOH, however, stressed that the vaccine will still undergo a thorough evaluation and strict regulatory process by the country’s vaccine experts panel and the Food and Drug Administration (FDA) even if it has been granted WHO emergency use listing.

Vergeire also emphasized that this is not the first time that the DOH will be applying EUA for a certain vaccine product and that it has existing policies supporting the process.

“Hindi lang ito ang unang pagkakataon na mag-a-apply ng EUA ang DOH para sa mga new technologies like these vaccines. We have done this for the COVAX facility, ginawa rin po natin ito para sa mga donasyon na bakuna from China, yung Sinovac,” she said.

“This is actually something that we do so that we can facilitate the process of receiving vaccines but of course, everything undergoes the strict regulatory process,” she added.

The FDA earlier said that three firms have expressed intent to seek EUA for the Sinopharm but they have yet to submit the required documents.

With the EUA application through the DOH, Vergeire said the agency will not be representing any manufacturer.

“We are not going to represent any manufacturer for that matter. The reason why we are doing this is merong posibilidad na magiging government to government ang transaksyon o negotiations for Sinopharm,” she said.

“When you say it’s government to government, it is like the donations, pag sa donasyon, sasabihin ng isang gobyerno sa abroad ‘magdo-donate ako sa inyo,’ kami na ang mag-a-apply para doon. Walang manufacturer na kasama dito, gobyerno sa ibang bansa ang kausap namin,” she explained.

“This is the pathway na tinitingnan namin ngayon for Sinopharm baka pwedeng dito na rin kami dadaan, mas magiging mabilis ang proseso. But of course, as I’ve said, we’ll still go through the usual regulatory process, it’s just that instead of the manufacturers applying for this EUA, it’s the government through the DOH who’s going to apply for this emergency use authority,” she further stated.

The Philippines has so far granted EUA to COVID-19 vaccines manufactured by Pfizer/BioNTech, Sinovac, AstraZeneca, Bharat Biotech, Gamaleya Institute, and Johnson&Johnson.

Dahan-dahang phase out ng COVID-19 quarantine protocols, isinusulong

Robie de Guzman   •   January 21, 2022

MANILA, Philippines – Isinusulong ng isang opisyal ng pamahalaan ang graduwal na pag-aalis ng quarantine protocols sa bansa sa oras na bumaba na ang mga kaso ng COVID-19 sa bansa, partikular na ang pagkalat ng Omicron variant.

Ayon kay Presidential Adviser for Entrepreneurship Joey Concepcion, layon nitong mapabilis ang pagbangon ng ekonomiya at matulungan ang mga negosyanteng makabawi sa pagkalugi lalo na ngayong limitado na naman ang galaw ng publiko at mahigpit mula ang restrictions.

“As we see Omicron start to subside then maybe we can move towards a gradual phase-out of our quarantine in the country,” ani Concepcion.

Naniniwala ang opisyal na malaking dagok para sa ekonomiya ng bansa ang ipaiiiral na restrictions gaya ng mandatory quarantine period dahil apektado rin nito ang lokal na turismo.

Karamihan aniya sa mga negosyong malaki ang lugi ay ang airline companies, hotel at restaurants na dalawang taon na ring limitado ang operasyon dahil sa pandemya.

Ang iba namang maliliit na negosyo ay tuluyan nang nagsara.

Ang mga pasahero namang pumapasok sa bansa gaya ng returning Filipinos ay apektado rin ng mandatory quarantine protocols.

Kaya ang mungkahi ni Concepcion, sa halip na facility-based quarantine na kasalukuyang requirement ng pamahalaan ay gawin na lamang itong home quarantine.

“We are not suggesting to remove quarantine immediately. What I’m proposing to IATF members is that a gradual move towards the removal of quarantine in the Philippines and moving towards home quarantine, rather than facility based quarantine. In my own view is that it does not actually help us from preventing Delta of Omicron from entering the country,” ang pahayag ng opisyal.

Ang panukala ay batay aniya sa ginagawa sa ibang bansa gaya ng Thailand, Switzerland, at Estados Unidos na hindi na nagpapatupad ng mandatory quarantine lalo na sa mga fully vaccinated individuals.

“We should think about it, I believe that eventually as you have seen in the news Thailand, Switzerland started to open up… And some of them are removing their quarantine,” ani Concepcion.

“Seeing how people are coping with COVID-19 in America specifically in Dubai area, I’ve noticed that basically everybody is wearing mask, they are  definitely conscious about you know the need to prevent themselves from getting sick but they live a normal life, there’s a lot of movement and people have accepted that,” dagdag pa nito.

Para kay Concepcion, hindi na kakayanin ng bansa kung patuloy pang hihigpitan ang galaw ng publiko kaya’t kailangang pag-aralan ng mga kinauukulan ang pagluluwag sa restrictions para makabawi ang ekonomiya ng Pilipinas.

“We will really try to engage with the IATF on starting to study this whole gradual move towards the removal of quarantine,” pahayag ng opisyal.

“We can’t continue to lock ourselves out, we can’t continue to restrict movement we definitely have to open up the economy,” dagdag pa niya.

Samantala, ayon naman kay acting Presidential Spokesperson at Cabinet Secretary Karlo Nograles, kailangang pag-aralan ng mabuti ang pag-phase out ng quarantine protocols dahil hindi naman lahat ng polisiya sa ibang bansa ay aplikable rin sa Pilipinas.

Kailangan rin aniyang may rekomendasyon ng health experts at siyentipikong batayan ang pagpapatupad ng protocols.

“Lahat naman ng mga suggestions naman po ay pinagaaralan natin sa IATF, then of course tinitignan din natin yung ginagawang practices ng other countries, we benchmark also with the practices ng other countries,” ani Nograles.

“But we are also mindful that it’s not a one size fits-all for all countries, kailangang mong tingnan ang konteksto ng bawat bansa… Siyempre base rin po sa suggestions recommendations sa mga health experts natin so lahat is based on science and data,” dagdag pa niya. (mula sa ulat ni Correspondent Janice Ingente)

 

COVID-19 cases sa NCR, bumababa na pero hawaan sa mga probinsiya, tumataas – DOH

Robie de Guzman   •   January 21, 2022

MANILA, Philippines – Bumababa na ang kaso ng COVID-19 cases sa National Capital Region (NCR), batay sa obserbasyon ng Department of Health (DOH).

Ayon kay DOH Undersecretary Maria Rosario Vergeire, kapansin-pansin ang bumabagal na ngayong hawaan ng COVID-19 sa NCR kahit may umiiral na transmission o hawaan ng Omicron variant, kumpara sa nakalipas na linggo.

“Base naman sa obserbasyon na ito, atin namang sinasabi na, oo bumabagal po ang pagtaas ng mga kaso, mayroon po tayong nakikita na parang nagpa-plateau dito sa National Capital Region,” ani Vergeire.

“But we do not look only sa number of cases kapag tayo ay nag-aanalisa ng ating sitwasyon. Tinitignan pa po natin ang ibang mga metrics na gingamit gaya ng positivity rate,” dagdag pa niya.

Ayon sa DOH, nakatulong ang mataas na vaccination coverage sa NCR kaya naman kahit tumaas ang kaso ay hindi ganoon kadami ang na-ospital at nakaranas ng severe infection.

Ngunit sa labas ng NCR, napansin rin ng DOH na tumataas naman ang kaso ng COVID-19 sa mga lalawigan, dahilan upang ilagay sa COVID-19 Alert Level 4 ang ilang lugar.

Kabilang sa mga lugar na nasa ilalim ng Alert Level 4 hanggang Enero 31 ay ang Kalinga, Ifugao, Mountain Province, at Northern Samar.

Sa ilalim ng Alert Level 4, hanggang 10% indoor capacity lang ang papayagan sa operasyon ng mga establisiymento para sa fully vaccinated individual habang 30% naman ang outdoor capacity.

Bawal namang mag-operate ang amusement parks, casinos, mga sinehan, pati na ang pagsasagawa ng contact sports at face-to-face classes.

“Bagamat mataas na po talaga ang kanilang mga kaso ang kanilang healthcare utilization ay pumalo na po more than 70%. Now there are areas in the country na pumalo na rin po sa more than 70% ang kanilang healthcare utilization pero hindi po natin inescalate so bakit po? Dahil tinitihgnan din po natin kung magkano po ba or how much they have allocated for their ICUs and wards,” ang paliwanag ni Vergeire.

“Nakikita po natin na medyo nahihirapan na po ang mga lugar na ito that’s why the decision to escalate them compared to other areas,” dagdag pa niya.

Ganito rin ang obserbasyon ng OCTA Research group sa sitwasyon ng COVID-19 sa bansa.

Ayon kay OCTA Research fellow Guido David, inaasahang sa pagpasok ng Pebrero ay mas mababa pa ang maitatalang kaso ng COVID-19 kada araw sa NCR,

“Even by the end of the month we are projecting just a little over 2000 cases per day in the NCR it peaked at around 18,000,” ani David.

“By Valentine’s Day, it could be at less than 1,000 cases and by the end of February it could be at around less than 500 cases. Again these are very rough projections we hope that it could guide our friends in the business sector and in the government,” dagdag pa niya.

Sa obserbasyon ng OCTA, ang pagbaba ng kaso sa NCR ay gaya ng pattern na naobserbahan sa South Africa pagkatapos ng mabilis na pagkalat ng Omicron variant.

Pero babala ng grupo, hindi dapat maging kampante ang publiko dahil tumataas pa rin ang kaso ng COVID-19 sa ibang lugar gaya sa Central Luzon, CALABARZON at sa Cebu City.

Dapat rin umanong panatilihin muna ang alert level sa NCR dahil mahigit pa sa 1 ang reproduction number ng rehiyon at hindi pa rin naman napuputol ang hawaan ng Omicron at Delta variant.

“Downgrading to alert level at this time might not be advisable until the NCR reaches the moderate risk just to sustain the rapid decrease that we’re seeing so that we could see those good numbers later in the moths of February,” ani David.

“Last year we almost reach a baseline of about less than 100 cases per day in the NCR,” dagdag pa niya.

Samantala, muli namang nagpaalala ang mga otoridad sa publiko na sumunod sa health protocols at magpabakuna o booster upang magkaroon ng proteksyon laban sa COVID-19.

 

Concepcion wants Philippines’ COVID-19 quarantine rules revisited

Robie de Guzman   •   January 21, 2022

MANILA, Philippines – Presidential Adviser for Entrepreneurship Joey Concepcion on Friday suggested for the government’s task force on COVID-19 response to revisit its quarantine protocols for international travel in light of recent developments in the COVID-19 situation in the country.

In a statement, Concepcion said quarantine restrictions for international travel should be re-examined, noting that other countries, particularly Switzerland and Thailand, have started easing restrictions to allow entry of international visitors.

 “It is quite understandable that public health should be the primary concern of governments. But as COVID itself changes, policy should be also open to re-examination,” he said.

Specifically, Concepcion believes that facility-based quarantines and the use of RT-PCR tests need to be revisited.

“The entry requirements are so extensive and complicated that they put the country out of the reach of international visitors, and even our returning kababayans,” said Concepcion.

He added that when it comes to air travel, the focus should be on testing, and testing fast and accurately.

“The goal is to find out if a passenger is infected, and if not, to send him on his way as fast as possible and not create bottlenecks,” he said.

Thailand recently announced that it will resume its quarantine-free visa program for vaccinated visitors. Switzerland, meanwhile, will not require pre-arrival COVID-19 tests for vaccinated or recovered visitors.

Concepcion also noted that the United States does not require specifically the use of RT-PCR tests or facility quarantines for arriving passengers.

“Inbound passengers to the US only need a negative result from an antiviral test, not necessarily an RT-PCR, taken no more than 24 hours before departure. Rapid tests are acceptable as long as they meet the requirements of the Centers for Disease Control and Prevention (CDC),” he said.

“This remains true even following the emergence of the Omicron variant. The US does not require facility-based quarantines for international passengers arriving in the US,” he added.

Currently, the Philippines is implementing travel conditions depending on the passenger’s point of origin and vaccination status. All arriving passengers must test negative from an RT-PCR taken 48 hours before departure. Except for fully vaccinated travelers coming from the 32 countries in its Green list, all passengers get swabbed again after having spent at least five days in facility-based quarantine.

Concepcion believes that the Philippines “can do the job with only an antigen test taken 24 hours prior to departure,” saying that “testing closer to the time of departure using an antigen test is more practical than waiting for RT-PCR test results.”

He said RT-PCR test results take longer to deliver results and are more expensive.

As an additional safeguard, he suggested conducting second antigen tests upon arrival, and home-based quarantines instead of facility-based quarantines to allow returning Filipinos to spend more time with their family.

“Our OFWs can’t afford to spend their hard-earned money and precious time to spend days in facility quarantine,” he said.

“Other countries seem to have already accepted the fact that COVID is here to stay. Maybe it’s time we practice living with COVID or else the Philippine economy will suffer and along with it, its MSMEs,” he added.

Concepcion said that the survival of businesses and industries in the Philippines depends largely on government policy.

“This is also quite true of other industries that are downstream from air travel, not the least of which are the tourism and hotel and restaurant sectors. Many MSMEs depend on the trickle-down business generated by air travel,” he said.

“Our economy can’t shut itself from taking any more lockdowns as our country’s debts continue to mount. Time is not on our side,” he added.

Concepcion said the country should move on after taking the necessary steps by vaccinating and boosting the population.

“But these are baby steps. We need to take that leap of faith. While vaccines are the solution to keeping a healthy nation, learning to live with COVID will revive our economy and bring life back to our MSMEs,” he said.

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