INDIA. Mumbai: The Pune-based Serum Institute of India (SII) is likely to start phase III trials of its second COVID-19 vaccine “Covovax”, which it is making in partnership with American company “Novavax Inc”, a biotechnology company, by May 15.
“Covovax” is the second vaccine candidate after “Covishield” that SII is manufacturing. The
Drugs Controller General of India has given its approval to go for the next phase trials after the Data Safety Monitoring Board reviewed the initial safety data of 200 participants of the phase-II clinical trial of “Covovax”. The ICMR and SII are jointly performing a phase-II/III observer-blind, randomized, controlled study to determine the safety and efficacy of the “Covovax” vaccine.
SII has partnered with “Novavax” to develop “Covovax”. It has signed a pact with SII, wherein the latter would produce about 1 billion doses of “Covovax” for supply to India and other countries. The Novavax vaccine, which uses different technology from the doses already widely licensed around the world, is a protein-based vaccine engineered from the genetic sequence of the first strain of the coronavirus. It can be stored at a temperature between 2 and 8 degrees Celsius (35 – 46.4 degrees Fahrenheit).
Earlier, SII CEO Adar Poonawalla had said that the firm plans to launch the vaccine by September. “Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and SII. It has been tested against African and UK variants of COVID-19 and has overall efficacy of 89 percent. Hope to launch by September 2021,” Poonawalla had said in a tweet in March.
Dr. Abhijit Kadam, Scientist C, coordinating principal investigator from ICMR-National AIDS Research Institute of the trial, said that tentatively Phase-III should start by mid-May.
“There are 19 sites across the country, four of them in Pune. Researchers across these sites said the process of recruiting volunteers for the larger phase-III trial will begin soon,” he said, as quoted by the newspaper.
Meanwhile, SII has said that it will invest 240 million pounds in the UK to expand its vaccine business and set up a new sales office. The move is part of a 1-billion pound India-UK Enhanced Trade Partnership creating around 6,500 jobs in Britain. SII’s investment will support clinical trials, research & development, and possibly the manufacturing of vaccines. This will help the UK and the world to defeat the coronavirus pandemic and other deadly diseases. SII has already started phase one trials in the UK of a one-dose nasal vaccine for coronavirus, in partnership with Codagenix INC.