1 min read.Updated: 27 Oct 2020, 07:50 PM ISTLeroy Leo
Prequalification makes a Covid-19 vaccine eligible for global access if they meet unified standards of quality, safety and efficacy
In India, RDIF has partnered with Dr Reddy’s Laboratories Ltd for conducting clinical trials and distribution of the vaccines
New Delhi: The Russian Direct Investment Fund, (RDIF), has submitted applications to the World Health Organization (WHO) for emergency use listing (EUL) and prequalification of Sputnik V vaccine, the Russian sovereign wealth fund said in a statement.
While an EUL procedure streamlines the process by which new or unlicensed products can be used during public health emergencies, the Prequalification of Medicines Programme is a United Nations programme, managed by WHO, which is the only global medicines quality assurance programme.
Prequalification makes the vaccine eligible for global access if they meet unified standards of quality, safety and efficacy.
"We express our gratitude to WHO for its active cooperation and look forward to the successful completion of the prequalification process at all major stages," RDIF chief executive officer Kirill Dmitriev said in the statement.
In India, RDIF has partnered with Dr Reddy’s Laboratories Ltd for conducting clinical trials and distribution of the vaccines. Dr Reddy’s has received an approval from the Drug Controller General of India (DCGI) VG Somani to conduct an adaptive phase 2 and 3 clinical trial for the Sputnik V vaccine in India.
The DCGI had asked the company to conduct proper monitoring for humoral and cell mediated immune response during the trial. While humoral immune response includes immunity provided by antibodies, cell-mediated response refers to that provided by T-cells.
Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology, which has developed the vaccine, had conducted phase 1 and 2 trials in Russia of only 76 patients, wherein the vaccine was shown to induce strong immune response among the participants. The study was published in The Lancet, a peer-reviewed journal, last month.
The Sputnik V vaccine is the world’s first registered vaccine against covid-19 based on the human adenoviral vector platform. It is currently undergoing phase 3 clinical trial in Russia, with the developers planning to enrol 40,000 participants. Phase 3 trial for the vaccine was also started in the UAE last week.