Sinopharm vaccine used on Duterte covered by FDA compassionate use permit — Palace

Robie de Guzman   •   May 4, 2021   •   97

MANILA, Philippines — The Sinopharm COVID-19 vaccine dose that President Rodrigo Duterte received on Monday night was covered by the compassionate special permit (CSP) issued by the Food and Drug Administration (FDA), Malacañang said Tuesday.

Presidential Spokesperson Harry Roque said the dose given to Duterte was part of the 1,000 doses of Sinopharm donated by the Chinese government, which are covered by the FDA’s CSP for the legal administration of the 10,000 doses of Sinopharm in the country.

The FDA issued the CSP in February this year for the use of Presidential Security Group members.

Roque issued the statement in response to queries on why the President was injected with a vaccine that has yet to secure an emergency use authorization from the FDA.

“Covered po yan ng compassionate special permit so wala pong nalabag ang ating president. Yung supply naman po ay nanggaling sa additional 1,000 donation ng Chinese government to the Philippine government,” he said during an online briefing.

Roque also said that the president took the Sinopharm vaccine based on his doctor’s advice.

Echoing Roque’s statement, vaccine czar Carlito Galvez Jr. said that the president’s physician recommended the Sinopharm vaccine adding that leaders in other countries have also used the vaccine.

“Yung Sinopharm ang ginagamit ng leaders sa China at tsaka nakita natin mahal yan, yan din po ang ginamit ng mga leaders dun sa area ng Middle East, with that nakita ng rekomendasyon ng kaniyang doktor, talagang Sinopharm, mas ano sa kaniya,” Galvez said.

Roque said Duterte did not experience any adverse reaction after getting inoculated on Monday night.

The president is expected to receive his second dose after a month, he added. – RRD (with details from Correspondent Rosalie Coz)

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)

Duterte: I asked Chinese Pres. Xi Jinping for help on COVID-19 vaccines but no talks on WPS

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – President Rodrigo Duterte on Monday disclosed that he asked help from his Chinese counterpart Xi Jinping in obtaining COVID-19 vaccines but insisted that they did not discuss issues on the West Philippine Sea.

During his Talk to the People public address on Monday night, Duterte recalled how he called Xi when the Philippines had yet to get any supply of COVID-19 vaccines.

“Let me just also say na itong history na… for public consumption na ito. Tumawag ako kay President Xi Jinping, sinabi ko kasi noong kasagsagan ng walang dumating talaga, walang makapkap si Secretary (Carlito) Galvez (Jr.), tumawag ako, sabi ko, ‘Mr. President (Xi), I would like to ask for your help until now Philippines is at a loss on how to get vaccines,’” he said.

“Sabi niya, ‘it’s okay we will help you.’ Ganoon lang. Hindi naman sinabi na kalimutan mo yung Scarborough Shoal, bigyan kita… Sinabi niya lang as simple as that,” he added.

The Philippines first received 600,000 doses of Sinovac COVID-19 vaccines that were donated by the Chinese government on February 28. The national government used this supply to roll out its vaccination program on March 1.

In total, the Philippines has received 1 million donated Sinovac vaccine doses from China, including the 400,000 doses that were delivered in March.

Duterte stood by his earlier statement that the Philippines owes a debt of gratitude to China for all its help but emphasized that there would be no compromise on the West Philippine Sea issue.

“It’s never, never wrong to say that I owe you a debt of gratitude. Totoo eh, binigyan tayo, tinanggap natin, ginamit natin,” he said.

“But it does not mean na tanggapin ko ang bakuna tapos sabihin ko kalimutan ko na yung claim diyan sa West Philippine sea, okay na yun dahil sa bakuna… It was never like that, the world does not operate like that,” he added.

He said there would be no compromise on the issue and that China knows it.

“Maski bahain tayo dito ng vaccine, gagamitin ko pa rin pero sabihin ko ‘hindi ito kabayaran’. Iba ito. This is a Philippine national interest, this is not a health issue that nagpasalamat ako,” he said.

Correction:
An earlier version of this article misstated that “they did discuss issues.” 

DOH: NCR Plus to get most of newly-delivered AstraZeneca COVID-19 vaccine doses

Robie de Guzman   •   May 10, 2021

MANILA, Philippines — The National Capital Region (NCR) and nearby provinces of Cavite, Bulacan, Rizal, and Laguna – collectively called NCR Plus – will get the highest allocation of AstraZeneca COVID-19 vaccine doses that were delivered to the country over the weekend.

In an online briefing, Health Undersecretary Maria Rosario Vergeire said a quarter of the additional two million doses of AstraZeneca vaccines will be distributed in Metro Manila followed by areas in the Central Luzon and Calabarzon regions.

“Nasa NCR Plus bubble po yung pinakamataas na alokasyon dahil alam naman po natin yung focus natin so we can be able to have herd containment here in this epicenter of this disease,” she said.

The health official said the allocations have been prepared and the vaccines will be distributed starting Monday.

“Nagawa na yung allocation list and ready to deploy na tayo starting today,” she said.

Other regions will also receive AstraZeneca vaccines but Vergeire did not specify the allocation breakdown.

The additional doses of AstraZeneca vaccines from the World Health Organization (WHO)-led COVAX Facility arrived in the country on Saturday.

The fresh vaccine supply was delivered after Philippine health authorities announced last Friday the official resumption of AstraZeneca vaccine administration for eligible populations.

The DOH previously suspended the use of AstraZeneca vaccines following the recommendation of the local Food and Drug Administration (FDA) to temporarily halt its use on persons below 60 years old after reports of “very rare” cases of Vaccine-Induced Thrombosis and Thrombocytopenia (VIIT).

VITT is a very rare condition of blood clots associated with low platelet counts that can occur 4 to 28 days after receiving a viral vector vaccine such as AstraZeneca, the DOH said.

“After discussions with the DOH All Experts Group and the Philippine College of Hematology and Transfusion Medicine (PCHTM), it was concluded that there are currently no known risk factors for VITT and that the benefits of receiving the vaccine against COVID-19 still outweighs the risk,” the department said in an earlier statement.

The DOH, however, said that specific guidelines and measures will still be enforced to mitigate the risks of vaccination.

Healthcare workers (HCWs) in vaccination sites will also be trained to detect and manage possible symptoms of VITT and refer them accordingly to the appropriate health facility for definitive workup and management.

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