Speaking at the Lok Sabha in the monsoon session of the Parliament, Minister of State for Health Ashwini Choubey stated that if the advanced clinical trials of the current COVID-19 vaccine candidates continued successfully, an effective vaccination is likely to be available by the end of first quarter of 2021. He was responding to a question about the time by which an effective COVID-19 vaccine is likely to be commercially launched.

The Central Drugs Standard Control Organisation (CDSCO) has granted test license permission for manufacture of COVID-19 vaccine to seven manufacturers in India. They include the Serum Institute of India (SII) in Pune, Zydus Cadila Healthcare Ltd in Ahmedabad, Bharat Biotech International Ltd in Hyderabad, Biological E Ltd in Hyderabad, Reliance Life Sciences Pvt Ltd, Aurbindo Pharma Limited and Gennova Biopharmaceuticals Limited.

Other companies in India involved in COVID-19 vaccine development are Premas Biotech, Gennova, Mynvax, Epygen Biotech, Luxmatra Innovations and Biological Evans. In India, more than 30 vaccine candidates are in different stages of development, and three of them are in advanced stage of Phase I/II/III trials and more than four are in advanced pre-clinical development stage. Globally, 35 vaccine candidates are under clinical evaluation and 145 candidates are in pre-clinical evaluation stage as on September 9.

In addition, the government of India has formed a National Expert Group on Vaccine Administration for COVID-19, which is creating a strategy on the procurement mechanisms for vaccine, including both indigenous and international manufacturing, along with guiding principles for prioritisation of population groups for vaccination. Also, the ICMR has allocated Rs 25 crore for various studies and other research activities pertaining to vaccine development. The Science and Engineering Research Board (SERB), a statutory body under the Department of Science and Technology, has supported three projects under COVID-19 on vaccine research under Intensified Research in High Priority Areas (IRHPA). 

Which are the most watched vaccine candidates in India currently?

Oxford-AstraZeneca vaccine candidateSerum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates. ChAdOx1-S, a non-replicating viral vector vaccine developed by University of Oxford and pharma giant AstraZeneca, is the first. This vaccine is undergoing Phase III clinical trials in Brazil. Phase II and III bridging studies have been initiated by ICMR at 14 clinical trial sites. The DCGI had, on September 11, directed SII to suspend any new recruitment in the clinical trials after AstraZeneca paused the trials in other countries because of ''an unexplained illness'' in a participant in the study. The order has since been revoked, with certain conditions like extra care during screening, additional information in informed consent and close monitoring for adverse events.

Russian Sputnik vaccine candidate: The Centre is in consultations with the Russian government, exploring the possibility of cooperation between the two countries for advancing their COVID-19 vaccine in India, Choubey said. The Russian Sputnik coronavirus vaccine, from the day it was first announced to huge fanfare, has split opinion. While experts have questioned the rapidness with which the vaccine tests were done, and the lack of transparency in the results, Russian president Vladimir Putin had assured that it had passed the required checks, adding that one of his daughters was administered the vaccine. The two-part vaccine, with a primary shot and a booster dose, includes recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S), which have been modified to express the signature SARS-CoV-2 spike protein.

Novavax: The second global vaccine candidate under production in India. ICMR and SII have partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from the US. The trial will be initiated in the second half of October after the vaccine is manufactured by SII. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune.

Bharat Biotech candidate: One of the indigenous candidates. It is an inactivated whole virion candidate vaccine, developed by Bharat Biotech International Ltd using virus isolate provided by ICMR. Characterisation of the vaccine candidate has been undertaken at ICMR-NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits. Phase I clinical trials along with parallel studies in large animals have been completed. "The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing," Choubey stated at the Lok Sabha.

Cadila candidate: Another indigenous candidate. Cadila Healthcare Ltd has developed a DNA vaccine, the pre-clincial toxicity studies of which were conducted in small animals like mice, rats, rabbits and guinea pigs. "The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for conduct of parallel pre-clinical studies in rhesus macaques. Phase I clinical trials have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing," Choubey said.

-Inputs from PTI



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