Russia to begin vaccine trials on 40,000 people

The Philippine Star, 20.08.2020

MANILA, Philippines — Amid concerns over the safety of the vaccine Russia has developed against coronavirus disease 2019, authorities in Moscow said they would start next week large-scale clinical trials involving 40,000 people.

The Russian Direct Investment Fund (RDIF), which supports the development of the Sputnik V vaccine, said a “randomized, double-blind, placebo-controlled” clinical study on the efficacy and safety of the vaccine will begin in Russia next week.

More than 40,000 people would participate in a study that will be conducted in at least 45 medical centers.

The upcoming study would be the equivalent of Phase 3 clinical trials that other vaccines are currently undergoing.

It is unclear if the number of participants in the upcoming study already includes subjects from other countries that have expressed interest to host clinical trials of the vaccine.

But in an online briefing with international journalists on Thursday, RDIF chief executive officer Kirill Dmitriev confirmed that clinical trials will be conducted in other countries including the Philippines.

“We will conduct clinical trials, as you know, not only in Russia, but also in the United Arab Emirates, Saudi Arabia, the Philippines, possibly either in Brazil or in India,” he said.

“Russia is open for international cooperation. We plan to produce the vaccine in more than five countries. And there is a very high demand from Asia, Latin America for the delivery of the vaccine,” he added.

Dmitriev said that there is constant communication with countries that have expressed interest in the Russian vaccine.

“Information on Phase 1, Phase 2 clinical trials has been sent to our embassies in various countries. This information is accordingly forwarded to ministries of health in various countries,” he said.

“A very active work is underway and of course, we are prioritizing those countries that show the greatest interest in our vaccine, that are interested in developing partnerships. And we remain very focused on international cooperation,” he added.

Philippine officials earlier said that clinical trials of the Russian vaccine may start in the country in October and could run for six months.

President Duterte even offered to have himself vaccinated first, although Malacañang later clarified that he will receive the vaccine once it has been approved for the general public.

A panel headed by the Department of Science and Technology was created to discuss details of the possible clinical trials with Russian authorities, particularly the Gamaleya Institute that developed Sputnik V.

Participation in the clinical trials will be voluntary.

International experts earlier raised safety concerns after Moscow approved and registered the vaccine even before the conduct of large-scale trials.

Specific details of the initial trials conducted for the Russian vaccine, such as the number of participants, have yet to be released.

Dmitriev said the outcome of these clinical trials will be published in leading medical magazines this month.

During Thursday’s briefing, Gamaleya director Alexander Gintsburg explained the technology and process that they have used in developing the vaccine, maintaining that it is proven to be effective and safe for humans.

Denis Logunov, the institute’s deputy director for scientific work, added that the “conditioned registration” of Sputnik V is in line with existing Russian rules on vaccine development.

“That is the decree that enables us to issue vaccine to civilians in the risk groups, so those are the people who have a high probability to get a severe form of disease, or are likely even to die,” he said.

“All administration of the vaccine will be strictly controlled. Also that so-called conditioned registration means that we are obliged to conduct additional expanded clinical trials,” he added.