The whole world is waiting with great anticipation for a ‘safe and effective’ vaccine against the new coronavirus. The central government expects a COVID-19 vaccine to be ready for sale in India from December if clinical trials are successful, according to mint report.
Currently, three candidate vaccines are in different phases of testing in India. Two homegrown candidate vaccines, Covaxin from Bharat Biotech and ZyCoV-D from Zydus Cadila, have already started the phase II clinical trial. Another vaccine candidate, Covishield, developed by the University of Oxford, has recently started the phase III clinical trial in India. Vaccine maker AstraZeneca signed an agreement with the Serum Institute of India to manufacture Oxford’s candidate COVID-19 vaccine for India and low-income countries.
“We hope that early next year we will have the vaccine in the country from perhaps more than one source. Our expert groups are formulating strategies to plan how to implement the distribution of the vaccine in the country,” said Health Minister Harsh Vardhan . said before.
Oxford COVID-19 Vaccine Testing by Serum Institute of India
The Pune-based drug maker Serum Institute of India recently began the final stage of the vaccine’s clinical trial conducted by the University of Oxford.
Named AZD1222 or ChAdOx1 nCoV-19, the vaccine is a combined viral vector vaccine. It uses a weakened version of a chimpanzee common cold virus that encodes instructions for making proteins from the new 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 doses of vaccines by December 2020, but that will hit the market in 2021 after the license is approved, said Dr. Suresh Jadhav, CEO of the Serum Institute of India.
Covaxin Phase II / III Trial Update
Covaxin, India’s first coronavirus vaccine, has been developed by Bharat Biotech developed by Bharat BioTech, the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV).
“The candidate vaccine was found to elicit strong immune responses. Therefore, it prevents infection and disease in primates after extensive exposure to the live SARS-CoV-2 virus,” the drug maker said.
In the initial stage of human trials, Covaxin has been tested in 12 hospitals across the country. Volunteers between the ages of 18 and 55 with no comorbid conditions participated in the trial. The vaccine trial took place in Hyderabad, Rohtak, Patna, Kancheepuram, Delhi, Goa, Bhubaneswar, and Lucknow, among other locations.
The pharmaceutical company has requested approval from the drug regulator to start the large-scale phase III clinical trial in the country. India’s Comptroller General of Medicines asked the vaccine manufacturer Bharat Biotech to submit “full safety and immunogenicity data from the phase II trial” and some clarification before moving on to 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, have been well tolerated,” said Cadila Healthcare.
“All subjects in the phase I clinical trial were closely monitored in a clinical drug unit for 24 hours after dosing for safety and for 7 days thereafter and the vaccine was found to be very safe,” said the President of Zydus Cadila, Pankaj R Patel.
Sputnik V test update in India
The Central Drug Control Organization (CDSCO) has granted permission to Dr. Reddy Laboratories to conduct phase II clinical trials of the Russian COVID-19 Sputnik V vaccine 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 the Gamaleya Research Institute and the Russian Defense Ministry, the vaccine is currently in the phase III trial of the vaccine, which involved more than 40,000 people in more than 45 medical centers in Russia, the agency reported. TASS news.
Dr. Reddy’s said the phase II trial would include 100 subjects, while phase III would involve 1,400 volunteers. Following regulatory approval in India, Russia’s Direct Investment Fund will supply drug maker Dr. Reddy with 100 million doses of the vaccine, the firm said last month.
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