(Eagle News) – President Rodrigo Duterte will only be able get vaccinated with the Russian-made “Sputnik V” vaccine against COVID-19 in May next year after this has passed clinical trials and had been approved for distribution by the Food and Drug Administration (FDA), according to Malacanang.
But for the clinical trials that would start in October and will last until March next year, there will be about 1,000 Filipinos who will volunteer for this who could participate for the phase 3 testing of Sputnik-V vaccine against the virus. The phase 3 clinical trial for six months would be funded by Russia, but the Department of Science and Technology (DOST) would also be having its own study which the Philippine department would fund.
The Phase 3 clinical trial in the Philippines will be simultaneous with the Phase 3 clinical trial in Russia, according to Presidential Spokesperson Harry Roque.
Roque said that the President, while he had said before that he is willing to be “experimented” on as an expression of his trust on the safety and efficacy of the Russian-made vaccine against COVID-19, would only be allowed to have the vaccine in May after the clinical trials and if this gets the FDA seal of approval.
Roque said the Presidential Security Group (PSG) would not allow President Duterte to have a vaccine which has not yet passed the approval of the FDA.
“Well, the May 1 is when the PSG may allow him kapag natapos na po lahat ng mga tests na kinakailangang gawin dito sa Gamaleya Vaccine although ang sinasabi ko nga baka mayroon pang ibang mauna kasi marami na pong nasa third phase of clinical trials at matagal na po silang nasa third phase ‘no. So there is a possibility na mas mauna pa iyong iba,” he explained.
And since the FDA is still expected to approve the vaccine after six months of studies, which is expected to be in April, the President can only be injected with the vaccine in May next year.
-Roque stresses only those who will volunteer to be given vaccine for Phase 3 clinical trials-
Roque said that this September, there will be a vaccine expert panel review on the results of the clinical trials for phases 1 and 2.
“Mula Oktubre naman po hanggang Marso ng susunod na taon ay magkakaroon ng clinical trial phase 3, simultaneous po iyan sa Russia at sa Pilipinas,” Roque explained.
In the country, only about 1,000 volunteers are needed for phase 3 of the trials for Sputnik V.
Roque stresses the voluntary nature of the phase 3 trials to be done in the country.
“Lahat po iyan ay boluntaryo ‘no. So wala pong sapilitan iyan, kung sino lang gustong mag-volunteer, pupuwede pong magpasaksak,” he said.
The stage 3 clinical trials to be done in the country will be funded by the Russian government. The details of the clinical trial will have be agreed upon by Gamaleya, which developed the vaccine, and the Philippine Department of Health (DOH) and Department of Science and Technology (DOST).
But Roque said that the DOST would also fund a separate study on the vaccine.
“Definitely po at ang napagkasunduan naman po ng Gamaleya at ng ating DOST at DOH eh magko-conduct talaga sila ng stage 3 clinical trial dito funded by the Russians. Pero tayo po, mayroon din po tayong gagawin on our own, ito po ay separate study pa na gagawin ng DOST na pupondohan din po ng DOST,” he said.
Gamaleya Research Institute of Epidemiology and Microbiology in Moscow developed the vaccine called Sputnik V, which Russian President Vladimir Putin announced on television as having been as registered the world’s first vaccine against coronavirus due to be available to the general public by January.
President Duterte said in his public address on Aug. 11 said that he would want to be injected with the Russian-made vaccine as soon as it comes into the country.
“Ako, pagdating ng bakuna, in public, para walang satsat diyan, in public magpa-injection ako. Ako ‘yung maunang ma-eksperimentuhan. Okay para sa akin,” he said.
“Sabihin ko rin kay President Putin na tiwalang — malaki ang tiwala ko sa pag-aa(ral) — your studies in combatting COVID and I believe that the vaccine that you have produced is really good for humanity,” the President said.
Russian President Putin, in his announcement on Tuesday, about the registration of the vaccine attested to its safety, saying that one of his own daughters had received the inoculation, dubbed “Sputnik” after the pioneering 1950s Soviet satellite.
“I know that it is quite effective, that it gives sustainable immunity,” Putin said of the vaccine developed by the Gamaleya research institute in coordination with Moscow’s defence ministry.
(with an AFP report)