MANILA, Philippines – Presidential Spokesperson Harry Roque confirmed on Thursday, August 13, that the Philippine government agreed to conduct local Phase 3 clinical trials on Sputnik V, the Russian COVID-19 vaccine starting October 2020 to March 2021.
This will possibly be done simultaneously with the Phase 3 clinical trial in Russia. The Philippine trials will be funded by the Russian government.
Under the Phase 3 clinical trials, around 300 to 3,000 volunteers who have COVID-19 will have to take the vaccine to test its efficacy and safety.
SEE ALSO: Duterte thanks Russia for COVID-19 vaccine offer
Roque added that they are expecting the vaccine to be by the Philippines’ Food and Drug Administration (FDA) by April 2021.
“Sa Abril inaasahan pong marerehistro ang vaccine ng Russia sa Food and Drug Administration, at ibig sabihin po sa Maya a-uno 2021 pa lamang pwedeng magpasaksak ng bakuna galing sa Russia ang ating Pangulong Rodrigo Roa Duterte,” Roque said.
Officials assured the public that the Russian COVID-19 vaccine will have to undergo a thorough and strict regulatory screening before it is approved to be used.
Director General of the Food and Drug Administration (FDA) Eric Domingo said they will make sure that they government will be "very careful" in approving the said vaccine.
"We have to make sure before we roll out a vaccine that it's safe and effective," he said in a television interview.
Domingo also explained why the Philippines is a good venue for the Phase 3 clinical trials.
"The Philippines is a good site for clinical trial because we know there is community transmission in many of our communities so you can select that area," he said.
Meanwhile, the Department of Science and Technology (DOST) Usec. Rowena Cristina Guevara, Chair of the sub-Technical Working Group (TWG) on Vaccine Development, confirmed that a meeting of with the Vaccine Expert Panel of Gamelaya, the developers of Sputnik V already happened. She said the preparation "went well" and they are hoping to begin the process within the month.
“The process involves getting confidentiality agreement signed, review of phase 2 and phase 3 clinical trial results, apply for FDA permission to do the trial, and undertake the phase 3 clinical trial,” Guevara said.
— Sally, The Summit Express
This will possibly be done simultaneously with the Phase 3 clinical trial in Russia. The Philippine trials will be funded by the Russian government.
Under the Phase 3 clinical trials, around 300 to 3,000 volunteers who have COVID-19 will have to take the vaccine to test its efficacy and safety.
SEE ALSO: Duterte thanks Russia for COVID-19 vaccine offer
Roque added that they are expecting the vaccine to be by the Philippines’ Food and Drug Administration (FDA) by April 2021.
“Sa Abril inaasahan pong marerehistro ang vaccine ng Russia sa Food and Drug Administration, at ibig sabihin po sa Maya a-uno 2021 pa lamang pwedeng magpasaksak ng bakuna galing sa Russia ang ating Pangulong Rodrigo Roa Duterte,” Roque said.
Officials assured the public that the Russian COVID-19 vaccine will have to undergo a thorough and strict regulatory screening before it is approved to be used.
Director General of the Food and Drug Administration (FDA) Eric Domingo said they will make sure that they government will be "very careful" in approving the said vaccine.
"We have to make sure before we roll out a vaccine that it's safe and effective," he said in a television interview.
Domingo also explained why the Philippines is a good venue for the Phase 3 clinical trials.
"The Philippines is a good site for clinical trial because we know there is community transmission in many of our communities so you can select that area," he said.
Meanwhile, the Department of Science and Technology (DOST) Usec. Rowena Cristina Guevara, Chair of the sub-Technical Working Group (TWG) on Vaccine Development, confirmed that a meeting of with the Vaccine Expert Panel of Gamelaya, the developers of Sputnik V already happened. She said the preparation "went well" and they are hoping to begin the process within the month.
“The process involves getting confidentiality agreement signed, review of phase 2 and phase 3 clinical trial results, apply for FDA permission to do the trial, and undertake the phase 3 clinical trial,” Guevara said.
— Sally, The Summit Express
