India's premier medical research agency the Indian Council of Medical Research (ICMR) wants to launch its COVID-19 vaccine 'Covaxin' by August 15.
ICMR has written to select medical institutions and hospitals (about 12 of them where the trials are going to happen) to fast-track clinical trial approvals for the vaccine candidate being developed in collaboration with Hyderabad-based Bharat Biotech, news agency PTI said today. ICMR director general Balram Bhargava strictly advised all stakeholders to ensure human volunteer enrollment is initiated no later than July 7, 'in view of public health emergency' and the 'urgency to launch the vaccine'. "It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials," the report quoted the ICMR Chief.
Industry experts say this could be only an aspirational target and directive to speed up the trials, than a realistic move to get the vaccine launched within one and a half months. "Nowhere in the world has a vaccine or drug launched within two months of approval for clinical trials and it is impossible even if the vaccine is successful," said a top level R&D scientist with a Mumbai-based drug company.
The candidate vaccine, developed by Bharat Biotech in association with ICMR's Pune-based National Institute of Virology, was cleared for Phase-I and Phase-II trials together in India by the Drug Controller General of India (DCGI) only a couple of days ago.
In case of the ICMR vaccine, Bharat Biotech is yet to clarify when it will start trials and what the targeted timelines are. Apart from the ICMR vaccine, Bharat Biotech is developing two more vaccines for COVID-19 with international alliances. One is with the Thomas Jefferson Institute in the USA using an inactivated rabies virus platform and another named CoroFlu with the University of Wisconsin-Madison and biotech firm FluGen.
Zydus Cadila, one of the first companies globally to initiate research on a COVID-19 vaccine, has also got approval for Phase-I and Phase-II trials for its candidate vaccine ZyCoV-D in India. Zydus today said it has already manufactured clinical batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects.
Globally about 17 vaccine candidates are undergoing clinical trials for COVID-19 and only one has moved to the final Phase III trials. The Ad5-nCoV vaccine now in Phase III, developed in February by Beijing's CanSino Biologics during the early phase of the virus attack in Wuhan, is one of China's eight vaccine candidates approved for human trials at home and abroad. Though China's Central Military Commission approved use of that vaccine by the military for a period of one year, final phase trial data is yet to come out. Experts do not expect any vaccine to be commercialised before the end of the year.
Two other most promising vaccines are from AstraZeneca-Oxford University combine and US biotech Moderna. These companies are yet to publish even Phase I and II trials. Some media reports this week said the US government is pressurising the regulatory agencies to give faster approvals so that the vaccine reaches the market before the US elections.
Normally, journey of a new drug or vaccine from lab to market takes about 10-12 years and development costs are over $ 2.6 billion. It takes about three to six years to identify the target and do pre-clinical studies. Even after getting permissions to do the trials, it takes about six-seven years to test it on humans in three phases. In the case of COVID-19, regulatory agencies are fast-tracking approvals, but still the vaccines under trials are not expected to reach the market before next year.
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