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

Robie de Guzman   •   May 4, 2021   •   35

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)

Duterte may take second dose from Sinovac if Sinopharm fails to secure EUA – vaccine expert

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – President Rodrigo Duterte may still get his second dose of COVID-19 vaccine using a different brand should Sinopharm fail to secure approval from the country’s Food and Drug Administration (FDA), a member of the Philippine vaccine expert panel said Thursday.

Infectious disease expert and vaccine expert panel member Dr. Rontgene Solante said Duterte may be inoculated with the Sinovac vaccine as this brand is similar to Sinopharm.

Duterte was vaccinated on Monday using Sinopharm COVID-19 vaccine, which has yet to be granted an emergency use authorization from the FDA.

“As long as hindi pa yan [aprubado para sa] emergency use authorization, dapat hindi ibabakuna,” Solante said.

“Iyong second dose pwede niyang (Duterte) ipahabol ang Sinopharm but Sinopharm has to produce the data and submit it to VEP and FDA,” he added.

“Kung halimbawa hindi na pwede ang Sinopharm, meron naman isang bakuna na magkahawig sa Sinopharm, na nabigyan na rin ng approval natin – yung Sinovac… It is possible because they have the same platform,” he further stated.

COVID-19 vaccines made by Sinovac and Sinopharm are both whole virus vaccines that use weakened or deactivated form of the pathogen that causes COVID-19 to trigger protective immunity to it. Inactivated pathogens cannot infect cells and replicate but can trigger an immune response.

Solante said these vaccines can be stored in a standard refrigerator and are administered in two doses.

The FDA earlier said that Sinopharm’s application for EUA remains pending as firms that have filed for its emergency use in the Philippines have yet to submit requirements.

“We also stand by our policy na as long as hindi pa iyan EUA, dapat hindi ibabakuna, that is one. Pangalawa, yung Sinopharm, walang sinu-submit na mga documents sa VEP para ma-assess namin. Kung meron lang sana noon, bago nagpabakuna yung presidente, pwede naman namin i-review tapos we can also give our recommendation to the FDA,” Solante said.

Duterte earlier defended his decision to be inoculated with a COVID-19 vaccine that has yet to undergo further evaluation and secure EUA from the FDA.

He apologized for using a vaccine that has not been vetted by Philippine authorities then said that he had asked China to withdraw the Sinopharm doses it donated to the Philippines.

Presidential Spokesperson Harry Roque said Duterte’s second Sinopharm COVID-19 vaccine dose will not be returned to China so he can complete his immunization process. – RRD (with details from Correspondent Aiko Miguel)

DOH studying possibility of mixing vaccine brands – FDA

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – The Department of Health (DOH) is currently looking into the possibility of mixing different brands of vaccines against novel coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Thursday.

FDA director general Eric Domingo said the DOH is already drafting a set of guidelines that will allow a person to receive different brands of COVID-19 vaccines for first and second dose in case of severe allergic reaction and other adverse effects.

Aaralin po ngayon yan ng Department of Health, in fact, meron naman po talagang ongoing meetings ang Department of Health on that dahil meron po talagang instances na for example naturukan ka ng bakuna ng first dose tapos nagka-severe allergy ka so hindi ka na puwede sa second dose nun at kailangang isipin ngayon yung magiging alternative,” Domingo said during the Laging Handa briefing.

“Gumagawa na ng guidelines ngayon ang DOH kung paano ‘yung interchangeability or mixing ng vaccines in case the second dose cannot be given na identical doon sa first dose,” he added.

Domingo said this after President Rodrigo Duterte said he has requested China to recall the 1,000 doses of Sinopharm vaccines it donated following criticisms over his decision to receive a jab that has yet to secure an emergency use authorization from the FDA.

Duterte received his first dose of Sinopharm vaccine on Monday night.

Malacañang earlier said that the vaccine dose used on the president was covered by the compassionate special permit issued by the FDA for the Presidential Security Group.

DND’s Lorenzana backs Duterte remark on arbitral ruling on WPS vs China

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – Department of National Defense (DND) Secretary Delfin Lorenzana on Thursday expressed agreement with President Rodrigo Duterte’s recent remark on the 2016 ruling of the Permanent Court of Arbitration (PCA) favoring the Philippines in its case against China’s activities in the West Philippine Sea.

“What President Duterte said last night regarding the PCA ruling is correct,” Lorenzana said in a statement, referring to Duterte’s statement that nothing happened when he tried to assert the arbitral ruling on the Philippines’ rights in the resource-rich West Philippine Sea.

In a pre-taped public address on Wednesday night, Duterte said he tried to pursue the arbitral ruling when he came to power in 2016 but “nothing happened,” adding that the ruling was “just a piece of paper” that can be tossed into a waste basket.

Lorenzana said he agrees with the President when he said that there is no international law enforcement body that can enforce the ruling.

He, however, stressed that even without the PCA ruling, the Philippine government will still continue to defend “what is rightfully ours.”

“As I said in my previous statement, the President’s orders have been firm and straightforward: we defend what is rightfully ours without going to war and maintain the peace in the seas,” he said.

Lorenzana also said that Philippine Coast Guard and the Bureau of Fisheries and Aquatic Resources will continue conducting maritime exercises in the West Philippine Sea and the Kalayaan Island Group.

The National Task Force on the West Philippine Sea earlier said that it has intensified maritime patrols in the West Philippine Sea after Chinese vessels were spotted lingering in areas within the Philippine exclusive economic zone.

The Department of Foreign Affairs have repeatedly filed diplomatic protests over Chinese incursions in the West Philippine Sea.

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