Russian COVID-19 vaccine Sputnik V, is projected to be available for approval in the country by April 2021, an official from the Department of Science and Technology - Philippine Council for Health Research Development (DOST-PCHRD) said Thursday.

This handout picture taken on August 6, 2020 and provided by the Russian Direct Investment Fund shows the vaccine against the coronavirus disease, developed by the Gamaleya Research Institute of Epidemiology and Microbiology.
(Photo by Handout / Russian Direct Investment Fund / AFP / MANILA BULLETIN)

In a radio interview on DZBB, PCHRD Executive Director Jaime Montoya explained the availability of the vaccine will depend on the approval of the Food and Drug Administration (FDA).

"Best case scenario po, based on the projections of the Russian vaccine developers, they will have FDA approval in Russia after the phase end of Quarter 1, 2021. So in other countries, their respective FDAs may approve sometime in the second quarter of 2021," Montoya told Manila Bulletin.

Malacañang is expecting the Sputnik V to get registered with the FDA by April, 2021.

Presidential spokesman Harry Roque said Duterte may only receive the Sputnik V vaccine after it is registered with the FDA.

“Ibig sabihin po sa Mayo a-uno 2021 pa lamang puwedeng magpasaksak ng bakuna galing sa Russia ang ating Pangulo (It means the President may only get vaccinated as early as May 1, 2021),” he said.

“’Yung ating target date po na May 1, ito po ay sang-ayon nga pala sa (Our target date of May 1 is based on the) DOH (Department of Health) and DOST (Department of Science and Technology),” he added.

Roque, however, reiterated that the target date of May 1 for the President’s vaccination will only happen if the Presidential Security Group (PSG) gives Duterte the green light.

Montoya clarified the Russian government approved the vaccine after Phase 2 of its clinical trials due to the pandemic and applied for registration for its emergency use.

As such, the vaccine will be available for use only with "high risk" individuals. This includes health workers, and the elderly. It will not be used on a wide scale.

"Kasi hihintayin pa po nila ang Phase 3 pero considered na po siya as certified at this stage para magamit po ng ilang sektor ng kanilang population (The rest would have to wait for the Phase 3 to finish but it is now considered to be certified so it could be administered in certain sectors of the population,") Montoya said in the same interview.

On Wednesday, DOST Usec. Rowena Cristina Guevara, Chair of the sub-Technical Working Group (TWG) on Vaccine Development, said the Gamaleya will be conducting a local Phase 3 clinical trial, possibly simultaneous to the Phase 3 clinical trial in Russia.

Montoya said the Russian government will be shouldering all the expenses and that Gamaleya is willing to conduct the Phase 3 clinical trials and eventually the production of the vaccine. The only help that the country will be providing is as to where and who will conduct the trials.

In the meeting of DOST with representatives from the Gamaleya National Research Center for Epidemiology and Microbiology that developed the vaccine together with the Russian Foreign Direct Investment, the scientists from Russia presented details on their Phase 1 and Phase 2 trials.

"They presented even the animal studies they conducted and based on our study together with our vaccine experts it was proven there that it is effective, has a sufficient antibody level, which are the parameters that we are looking for and it is safe since there are no side effects except for slight fever," Montoya said.

"But we still have to see the details that is why we will execute a Confidentiality Data Agreement that the Russian government and the Philippines will both sign," he added.

Once this is signed, which Montoya said maybe next week, Gamaleya would then provide details on the result of the Phase 1 and Phase 2 of their clinical trials for our Vaccine Expert Panel to study. They will then ask permission from the Philippine FDA to conduct the Phase 3 of the clinical trials.

According to Montoya, the design and protocol on how the clinical trials will be conducted is up to the Russian vaccine developer as part of the Confidentiality Data Agreement.

"We will see if it will be accurate and can be conducted here in the Philippines," he said.

There will be an estimated 1,000 Filipinos who will be part of the Phase 3 clinical trials. This is the minimum that Russia needs from the country, said Montoya.

For the clinical trials, Roque said the public will not be forced to take the vaccine, saying it will only be open to volunteers.

“This is voluntary. We will not be forcing anybody. Those who want to volunteer for the trials can get the vaccine shot,” Roque said.

The Philippines is one of four other countries where the trials will be conducted. Others include Russia, the United Arab Emirates, and Brazil.

Meanwhile, Roque said a COVID-free Christmas, like what Duterte said in his late-night public address Monday, is still possible as there are other vaccines that are already in the third phase of clinical trials.

“It's still possible because from what I know the vaccines of China, Oxford , and the United States are already in the third phase of the clinical trial,” he said.

“There is a possibility. Maybe not by October, if not, by the end of the year,” said FDA Director General Rolando Enrique Domingo during a radio interview.

Domingo said several candidate vaccines are being developed across the world. (With a report from Analou de Vera)

DHEL NAZARIO and ARGYLL B. GEDUCOS

Russia’s Sputnik V vaccine may already be available by April or May next year