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

Robie de Guzman   •   May 4, 2021   •   54

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)

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.

Pfizer, AstraZeneca doses from COVAX facility to arrive in May – Galvez

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – The Philippines is expecting to receive millions of COVID-19 vaccine doses this month from Pfizer and AstraZeneca under the World Health Organization (WHO)-led COVAX Facility, vaccine czar Carlito Galvez said Wednesday.

In his report to President Rodrigo Duterte during a Cabinet briefing, Galvez said the COVAX Facility may deliver more or less two million doses of AstraZeneca this May.

“Maganda po ang magiging volumes natin this coming May dahil may positive na nangyari na yung COVAX baka makapagdeliver ng Pfizer at saka ng Astrazeneca,” he said.

“Yung second dose wala na po tayong problema. Meron tayong makukuha ngayong May more or less na two million na AstraZeneca,” he added.

For Pfizer vaccines, Galvez said around 1.3 million doses will be delivered in May.

“Maganda po yung negotiation namin kanina ng Pfizer at dadaloy na nga po iyong Pfizer [under] COVAX [facility]. May assurance na po na 1.3 million ang darating sa May,” he said.

He said an initial batch of 193,000 doses of Pfizer COVID-19 vaccines will “most likely” arrive on May 11.

Galvez said this shipment will serve as a logistical run to prepare for the arrival of additional Pfizer vaccine doses, which require storage temperature conditions of -70°C.

“Parang yun po ang tinatawag nating mini rollout ng Pfizer para magamay po naming yung -70 [temperature requirement],” he said.

Galvez said local government units in the National Capital Region, as well as in Davao and Cebu are preparing for the delivery and storage of Pfizer vaccines.

“Prepared na po ang mga LGU ng NCR, at titingnan din po natin ang Davao at Cebu, ipiprepare din po natin kasi ang sabi po ng Pfizer, diretso po doon ang delivery doon sa Davao at Cebu kasi napaka-critical po. So hindi na po dadaan ng Manila,” he said.

“Kaya paplanuhin po naming yung delivery ng Pfizer,” he added.

With the possible delivery of vaccines from COVAX Facility, Galvez said the country may expect the delivery of around 7 million vaccine doses from the initial four million

“Ang maganda po dito, ‘yung delivery natin ng May, baka from 4 million ay madaragdagan tayo ng 7 million. Malaki po yun kasi ang nadagdag po dito yung COVAX,” he said.

Galvez previously said the government will start the vaccination of individuals in the A4 and A5 priority sectors by June, and the general population by August or September once the bulk of vaccine supply arrives.

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