Clinical trials on the Sputnik V vaccine against the coronavirus disease 2019 (Covid-19) involving 40,000 volunteers start next week in Russia as development health authorities in the Philippines, which hopes to be one of the first beneficiaries of the serum, will be closely monitoring.
Kirill Dmitriev, chief executive officer of the Russia Direct Investment Fund, said the trials would be a “randomized, double-blind, placebo-controlled” type.
“That will be a very important trial, that will be parallel with the vaccination of risk groups,” Dmitriev told an international press briefing that included The Manila Times.
In an earlier interview, Dmitriev told The Manila Times that Moscow was willing to send 1,000 doses of Sputnik V to the country as long as the Department of Science and Technology (DoST) and the Food and Drug Administration (FDA) approve the results of the phases one and two trials that they have submitted to the Russian embassy.
DoST-Philippine Council for Health Research and Development Executive Director Dr. Jaime Montoya and FDA Director General Dr. Rolando Enrique Domingo agreed that Russia should present the results of its trials to Philippine authorities before the vaccine could be tested here.
“We will not accept a phase three trial here in the country if [the manufacturer] cannot prove in the phase one and phase two trials the safety and some level of efficacy of a vaccine,” Domingo said.
Prof. Alexander Gintsburg, director of the Gamaleya Research Institute of Epidemiology, said the vaccine was developed using human adenovirus vectors, which were highly effective in the tests for the Middle East respiratory syndrome, or MERS, coronavirus.
Gintsburg is hopeful that the use of the human adenovirus vectors would lead to the production of future flu vaccines, saying the current flu vaccines need to be changed every one or two years because of changes in their antigen composition.
Denis Logunov, the deputy director of scientific work at Gamaleya, said trial participants would be tracked using Quick Response (QR) codes and a mobile app to check on their conditions during the trial.
“The purpose of this protocol is not that much to study the immunogenicity and safety of the vaccine, and goes without saying will happen as always, but additionally we will have to assess the epidemic efficacy of this vaccine,” Logunov said.
Dmitriev said Gamaleya is working with four partners in India in developing Sputnik V.
“And it is very important to say that these partnerships allow us to cover the demand that we have,” he said.
The global demand for the vaccine is a billion doses but their current capacity is only 500 million doses per year, he said.
Meanwhile, the DoH said the recommendation to waive the requirement of a phase four clinical trial in the Bayanihan to Recover As One measure allows a faster national response to Covid-19 in terms of vaccine distribution.
The recommendation, which DoH made together with the Health Technology Assessment Council, FDA and the Philippine Medical Association, has a historical precedent, as accelerated clinical trials enabled mitigation of the spread of the Ebola virus disease and the decline of meningitis spread in Africa.
The Philippines is expected to carry out clinical trials on four or five vaccines that have passed the World Health Organization’s (WHO) pre-qualification process.
President Rodrigo Duterte had accepted Russia’s offer to supply the Philippines with Sputnik V.
The third phase of the clinical trials for Sputnik V will be held simultaneously in the Philippines and Russia from October 2020 to March 2021.
The vaccine is expected to be registered with the FDA by April 2021.
The government is also working on the standardization of compensation of individuals who will take part both in the WHO Solidarity Trial and independent clinical trials for Covid-19.
This developed after the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) approved on Thursday the recommendations of the sub-technical working group on Covid-19 vaccine development.
“The Philippine Health Research Ethics Board should review the Ethical Guidelines for the Covid-19 clinical trials and standardize compensation of trial participants both for WHO Solidarity Trial and independent clinical trials,” IATF-EID’s Resolution 64 read.
All applications for clinical trials must first be submitted to the Vaccine Expert Panel, reviewed by designated Ethics Boards, and submitted to the FDA for approval.
Zoning guidelines on vaccine clinical trials must be issued by the Subtechnical Working Group on Vaccine Development to avoid competition for sites.
Local government units should prioritize the WHO Solidarity Trial over independent trials.