PHL, one of 5 countries outside Russia to join Sputnik V Phase 3 clinical trials starting October
(Eagle News) – The Philippine government said it already has a “confidentiality data agreement” with the Russian government so details regarding the results of the Russian clinical trials on its vaccine against COVID-19, Sputnik V, would be given to the Philippines.
“The Department of Science and Technology said that this is important so Philippine experts can analyze the clinical trial results in Russia on Sputnik V, which is needed for the approval of the Food and Drug Administration of the Russian-made and registered vaccine.
Phase 3 of the clinical trials on Sputnik V is set to start in October, and will last for six months, or until March 2021.
The Philippines is one of five countries outside Russia participating in the final clinical trials of Sputnik V. The other countries also participating in the trial are UAE, Saudi Arabia and possibly India and Brazil, according to the Russian government.
-Confidential data agreement-
“Iyon pong sa Russia, iyong sa Sputnik na iyon, nagkaroon na po kami ng dokumento at ito po ay tungkol sa confidentiality data agreement kasi kung anuman ang resulta ng trials nila sa Russia ay kailangan mai-disclose sa atin para ma-analyze ng ating mga eksperto iyong resulta ng kanilang trials sa Russia,” said DOST Secretary Fortunato dela Peña in a Laging Handa virtual presser Saturday, Aug. 29.
“Kung ano ang kalalabasan ng ating pagsusuri ng ating panel, isa-submit iyan sa FDA kasi ang ating FDA po ang magbibigay ng go signal sa pag-conduct ng clinical trials,” he said.
Russia is set to start Phase 3 of the clinical trials of Sputnik V, the first registered vaccine against COVID-19.
Russian President Vladimir Putin has earlier said that he is confident about the efficacy of Sputnik V, and to prove this, one of his daughters had been inoculated with the virus.
-Post registration clinical trial starts in Moscow-
The Russian government on Aug. 24 announced the “start of a post-registration clinical trial” of the vaccine in Moscow. It said 40,000 people will take part in the program.
“They will have an opportunity to be vaccinated against coronavirus with a vaccine developed by the Gamaleya National Research Center of the Ministry of Health,” said a release from the Russian government through its Russian Direct Investment Fund (RDIF).
The RDIF is Russia’s sovereign wealth fund established by the Russian government in 2011 to make investments in leading companies of high-growth sectors of the Russian economy.
Similar post-registration clinical trials of the coronavirus vaccine will also be carried out in five other countries, including the Philippines.
Aside from the Philippines, the other countries which will participate in the post-registration clinical trials are UAE, Saudi Arabia, and possibly India or Brazil, according to the website of the Sputnik V vaccine.
-Sputnik V clinical trials in PHL to be funded by Russian gov’t-
DOST Secretary Dela Pena said that the clinical trials in the Philippines on Sputnik V will be funded by the Russian government.
Earlier, the Philippine government said around 1,000 volunteers will participate in the Phase 3 clinical trials for Sputnik V in the country.
Dela Pena said that they are also preparing for the World Health Organization (WHO) clinical trials for COVID-19 vaccines. But unlike the clinical trials on Sputnik V, which is considered an independent trial, the expenses on the WHO Solidarity Trial will be shouldered by the Philippine government.
“Nabanggit ko kanina, iyong sa WHO solidarity trial for vaccine ay ang DOST po ang magsu-shoulder ng gastos sa clinical trial. Iyong mga independent trials na hindi kasama sa WHO, kung sino po ang producer noon or developer, sila po ang magsu-shoulder ng trials dito sa Pilipinas, ng clinical trials,” the DOST chief said.
“So pinaghahandaan natin iyong ating WHO solidarity trials, at kung iyan po, iyang Sputnik ay mapupunta doon sa category ng independent trials, sila naman po ang gagastos doon,” he said.
Russia said that the Sputnik V has successfully passed two stages of clinical trials.
“Vaccinated people have developed antibodies and formed immunity, and, importantly, the vaccine is tolerated by the body in the same way as a regular vaccination,” it said in the website specially made to provide information on the Russian-made vaccine.
Sputnik V was developed by the Gamaleya National Center of Epidemiology and Microbiology, Russia’s leading research institution.
President Rodrigo Duterte has earlier thanked the Russian government for the vaccine offer to the Philippines.
The Philippine leader had repeatedly said before that the COVID-19 crisis can only be remedied with the development of a vaccine.
He had expressed hope that by December, the country would already have a vaccine against the virus.
(Eagle News Service)