New Delhi: The National Expert Group on Vaccine Administration Monday met with five domestic Covid vaccine manufacturers, including two whose products are not yet in the clinical trial stages in India, to review the situation.
The two companies are Gennova Biopharmaceuticals, based in Pune, and Biological E in Hyderabad. The remaining three are Serum Institute of India, Bharat Biotech and Zydus Cadila, all of whose vaccine are in different stages of clinical trial.
According to a government statement on Monday’s expert group meeting: “It provided the National Expert Group with inputs about the present stage of various candidate vaccines being developed by the indigenous manufacturers as well as their expectations from the Union Government.”
Gennova Biopharmaceuticals, in collaboration with HDT Biotech Corporation in Seattle, USA, has developed an mRNA vaccine candidate (HGCO19) with “demonstrated safety, immunogenicity, neutralization antibody activity in the rodent and non-human primate models”.
“The company is working aggressively to ensure first human injection by the end of the year, subject to Indian regulatory approvals,” a PIB statement issued last month stated while announcing a tie-up of the Department of Biotechnology (DBT) with the company.
The DBT Biotechnology Industry Research Assistance Council (DBT-BIRAC) had facilitated the establishment of ‘first-of-its-kind’ mRNA-based vaccine manufacturing platform in India. DBT provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for Covid-19, the statement had said.
As for Biological E, the company just announced a tie-up with Johnson & Johnson. In its statement on 13 August, the company said: “Biological E. Limited (“BE”) has entered into an agreement with Janssen Pharmaceutica NV (“Janssen”), one of the Janssen Pharmaceutical companies of Johnson & Johnson, for the creation / enhancement of manufacturing capacities for drug substance and drug product for Johnson & Johnson’s COVID-19 vaccine candidate, Ad26.COV2.S. Johnson & Johnson’s COVID-19 vaccine candidate is currently in Phase 1/2a clinical trials.”
The three frontrunners
Prime Minister Narendra Modi, in his Independence Day speech Saturday, said India was ready to produce three vaccines once scientists gave the green-light. India currently has three vaccines in the clinical trial stage.
One is by Serum Institute of India, Pune, which is manufacturing the vaccine developed by Oxford University, currently in phase 3 human trials. Another is Bharat Biotech’s Covaxin, jointly developed with ICMR, which is in phases 1 and 2 in various sites across the country, and third vaccine candidate is by Zydus Cadila, called Zycov D, that is also in phases 1 and 2 trials. Zydus Cadila says it may be able to launch the vaccine by next year.
Of these, the Oxford vaccine, while not strictly indigenous, is in the most advanced stages of being developed, and government sources say is most likely to be rolled out in the next three months.
On Russia’s Sputnik V vaccine
The Russian vaccine that has caused a lot of excitement is not yet a part of the deliberations as the data for the trials in Russia are not yet available to the Indian government.
The government, according to sources, is trying to access this data. While the website of Sputnik V claims that phase 3 trials will be carried out in several countries including India, there is as yet no application submitted for such a trial, sources added.