Covaxin COVID-19 Vaccine Trial Commences in India (with Questionable Completion Targets) While New mRNA Vaccine Announced

Covaxin COVID-19 Vaccine Trial Commences in India (with Questionable Completion Targets) While New mRNA Vaccine Announced

Sponsors of the “Covaxin” COVID-19 vaccine trial in India report robust volunteer numbers as 3,500 volunteers have signed up for the clinical trial at the All India Institute of Medical Sciences (AIIMS) over the last week. Covaxin is the first vaccine developed in India. The study is being conducted at AIIMS-Delhi and 11 other research sites and hospitals selected by the Indian Council for Medical Research (ICMR). TrialSite has seriously questioned an August 15 target date established by at least one prominent individual in the ICMR. In other news, India-based Gennova announced India’s first mRNA-based vaccine that they are preparing for clinical trials by the end of the year.

The Study

With the launch of the Phase 1/2 randomized, double-blind, placebo-controlled study, the first phase centers on 275 volunteers with up to 100 signed up at AIIMS. These volunteers must be between the ages of 18 and 55 and no co-morbidities or pregnant women. Other site locations in India include Hyderabad, Patna, Kancheepuram, Rohtak, and now Delhi. Other centers targeted are locate din Nagpur, Bhubaneshwar, Belgaum, Gorakhpur, Kanpur, Goa and Visakhapatnam.

As the study just commenced it’s too early to say how this vaccine will work out in India. Already 22 volunteers were screened at AIIMS. The first dose was administered to male resident of Delhi in his 30s. Thus far, no immediate side effects are observed after the vaccine administration. 

The Second phase of this study involves 750 volunteers from the 12 participating sites. Already the Sunday Guardian reports 1,800 volunteers have registered for the trial via AIMMS.

The Vaccine

Covaxin is the first vaccine developed in India for that country’s consumption should it be approved. Sponsored by the developer, Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), the Drugs Controller General of India (DCGI), gave the greenlight to commence.

Questionable Covaxin Timelines

TrialSite reported that due to the political, social, health and economic pressures in India an artificially compressed timeline was superimposed over this study as ICMR, or at least a representative in that institution, declared that the vaccine could be ready by August 15, 2020. Given the Phase 1 segment of a Phase 1/2  study just commenced in July it seems highly improbable that a fully safe and effective vaccine against the novel coronavirus could be accomplished in what would essentially equal one month of clinical trials. This just doesn’t seem to add up.

Now Another mRNA-based Vaccine out of India

India’s Department of Biotechnology along with the Biotechnology Industry Research Assistance Council (BIRAC) reports the “First-of-its-kind” messenger RNA (mRNA) based vaccine platform out of India research and development enterprise.

Developed by Gennova, the press there describes it as a “novel self-amplifying mRNA-based vaccine candidate for COVID-19. Called HGC019, the Indian company reports the investigational vaccine has been developed in collaboration with Seattle-based HDT Biotech Corporation. They report that HCG019 already evidences safety, immunogenicity, neutralization antibody activity in rodent and non-human primate models.

The company (Gennova) commences toxicity studies in India to help pave the way for clinical trials. Their goal: first patient first dose by the end of 2020 or earlier, subject to Indian regulatory approvals.

HCG019 Overview

This novel mRNA vaccine candidate, reports the company, is programmed to direct the host cells to produce the “Spike protein” of the virus which interacts with the host cells receptor, and supported by ‘lipid inorganic nanoparticle (LION)’ as a delivery model. The company reports that the neutralizing antibody response of the vaccine as applied in preclinical mice and non-human primate models were comparable to the sera from the convalescent patients of COVID-19—higher than the recommended titer of 1:160 for neutralizing antibodies as established by the U.S. FDA reports the company.

About the India Council of Medical Research (ICMR)

The India Council of Medical Research (ICMR) represents the apex body in India for the formulation, coordination and promotion of biomedical research and is actually one of the oldest and largest medical research bodies in the world.

About All India Institute of Medical Sciences (AIIMS)

AIIMS is a New Delhi-based medical school, hospital and public medical research university. The institute is ranked No. 1 in India by the National institutional Ranking Framework and ranked first in South Asia and 231st in the world in the category of Life Sciences and medicine by QS WUR, as reported in Wikipedia

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