COVID-19 vaccine may be ready by December. Trials to safety — a look at India’s vaccine journey

The whole world is waiting with bated breath for a 'safe and effective' vaccine against novel coronavirus. The central government expects that a COVID-19 vaccine will be ready for sale in India as early as December if clinical trials are successful, according to Mint report.

At present, three vaccine candidates are at different phases of trial in India. Two homegrown vaccine candidates — Covaxin by Bharat Biotech and ZyCoV-D by Zydus Cadila have already started the phase II clinical trial. Another vaccine candidate, Covishield, developed by the University of Oxford has recently commenced the phase III clinical trial in India. Vaccine maker AstraZeneca has signed a deal with Serum Institute of India to manufacture Oxford's COVID-19 vaccine candidate for India and low-income countries.

"We're expecting that early next year we should have vaccine in the country from maybe more than one source. Our expert groups are formulating strategies to plan on how to roll out the distribution of the vaccine in the country," health minister Harsh Vardhan said earlier.

Oxford COVID-19 vaccine trial by Serum Institute of India

Pune based drugmaker Serum Institute of India recently commenced the final stage of the clinical trial of vaccine made by the University of Oxford.

Dubbed as AZD1222 or ChAdOx1 nCoV-19, the vaccine is arecombinant viral vector vaccine. It uses a weakened version of a chimpanzee common coldvirus that encodes instructions for making proteins from the novel coronavirus to generate an immune response and prevent infection. The vaccine is likely to provide protection for about a year, AstraZeneca CEO Pascal Soriot said in June.

The vaccine maker will be ready with 60-70 million dosages of vaccines by December 2020 but that will come in the market in 2021 after the clearance of licensing, Dr Suresh Jadhav, executive director, Serum Institute of India said.

Covaxin phase II/III trial update

Covaxin, India's first coronavirus vaccine has been developed by Bharat Biotech developed by Bharat BioTech, Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

"The vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus," the drugmaker said.

In the early stage of human trials, Covaxin has been tested in 12 hospitals across the country. Volunteers between the ages of 18 and 55 with no co-morbidity conditions have participated in the trial. The vaccine trial took place in Hyderabad, Rohtak, Patna, Kancheepuram, Delhi, Goa, Bhubaneswar and Lucknow among other places.

The drugmaker has sought the drug regulator's approval to start the large scale phase III clinical trial in the country. The Drugs Controller General of India asked the vaccine maker Bharat Biotech to submit "complete safety and immunogenicity data of the phase II trial" and some clarifications before proceeding for the next stage.

Zydus Cadila phase II trial update

ZyCoV-D, developed by Zydus Cadila began its phase II clinical trials in August. "The company reports that the doses of the vaccine administered to healthy volunteers in the phase I clinical trial, which began on July 15, 2020, has been well tolerated," Cadila Healthcare said.

"All the subjects in phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and the vaccine was found to be very safe," Zydus Cadila Chairman Pankaj R Patel said.

Sputnik V trial update in India

Central Drugs Standard Control Organisation (CDSCO) granted permission to Dr Reddy's Laboratories for conducting phase II clinical trials of the Russian COVID-19 vaccine Sputnik V in India. Russia was the first country in the world to register a COVID-19 vaccine after less than two months of human testing. Developed by Gamaleya Research Institute and the Russian defence ministry, the vaccine is currently under the phase III trial of the vaccine, which involved more than 40,000 people at more than 45 medical centres around Russia, the TASS news agency reported

Dr Reddy's said that phase II trial would include 100 subjects, while the phase III would involve 1,400 volunteers. Upon regulatory approval in India, Russian Direct Investment Fund shall supply to drug maker Dr Reddy's 100 million doses of the vaccine, the firm had said last month.