New Delhi: In what it could be called as a major breakthrough in combating the fast spread of coronavirus pandemic, Drug regulator Indian Council of Medical Research (ICMR) has partnered with Hyderabad-based Bharat Biotech International Limited (BBIL) for clinical trials of home-grown vaccine which could be launched by August 15 for public use.
BBIL is using the virus strain isolated at ICMR’s National Institute of Virology (NIV) in Pune to develop the vaccine.
The clinical trials will be held in 12 institutes across the country.
The ICMR has asked these institutes to fast-track clinical trials of the vaccine as it is being considered as one of the “top priority projects” which are being “monitored at the topmost level of the government”.
In a letter to these institutes, the ICMR said that it is envisaged to launch the vaccine for public health use latest by August 15, after completion of all clinical trials.
“BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” it further said in the letter.
It has also asked the institutes to ensure that the subject enrolment is initiated during the first week of July.
Apart from IMS and SUM Hospital here, the other institutes selected for the clinical trial are located in Visakhapatnam, Rohtak, New Delhi, Patna, Belgaum (Karnataka), Nagpur, Gorakhpur, Kattankulathur (Tamil Nadu), Hyderabad, Arya Nagar, Kanpur (Uttar Pradesh) and Goa.
Meanwhile, the Drug Controller General of India (DCGI) on Thursday granted permission to pharma giant Zydus Cadila to conduct phase I and phase II human clinical trials for Covid-19 vaccine.
The potential vaccine showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement to Indian stock exchanges.
Zydus will begin human trials this month in over 1,000 subjects in multiple sites in India, it said.
Lets have a look at the status of Vaccines being developed worldwide
Oxford University-AstraZeneca coronavirus vaccine status
A leading scientist behind the Oxford University’s potential Covid-19 vaccine, which is undergoing phase III trails, has said the jab has been considered safe even for people with a weak immune system.
Meanwhile, the AZD1222 vaccine is already being used on about 5,000 volunteers in Brazil’s first clinical trial of the Oxford candidate.
Simultaneously, it is also undergoing trials in the UK and South Africa.
The Oxford vaccine technology is based on an adenovirus, a virus that causes mild upper respiratory tract infections.
Inovio Pharmaceuticals coronavirus vaccine status
US biotech firm Inovio Pharmaceuticals, part of the Donald Trump administration’s Operation Warp Speed program, recently reported that its experimental Covid-19 vaccine had shown encouraging results in preliminary clinical trials.
The firm claimed that its INO-4800, a DNA vaccine, triggered an immune response in 94 per cent of volunteers who completed the phase 1 clinical trial. Inovio now plans to start a combined Phase 2/3 trial to assess the efficacy of the vaccine.
In the phase 1 trial, Inovio administered the vaccine to 40 healthy adult volunteers between 18 to 50 years of age.
Results showed that the vaccine was generally safe and well-tolerated in all participants.
The company plans to have 1 million doses of the vaccine by the end of 2020.
The vaccine is designed to precisely match the DNA sequence of the SARS-CoV-2 virus. The vaccine is patterned to inject DNA into a person so as to set off a specific immune system response against the novel coronavirus.
Currently, about 140 vaccines are in different stages of trials around the world
BioNTech-Pfizer coronavirus vaccine status
The vaccine candidate developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer has been found to be well tolerated in early-stage human trials, Reuters reported.
BioNTech said testing of two dosages of its BNT162b1 drug on 24 healthy volunteers showed that after 28 days they had developed higher levels of Covid-19 antibodies than seen in infected people.
“These first trial results show that the vaccine yields immune activity and causes a strong immune response,” Reuters quoted BioNTech’s co-founder and Chief Executive Officer Ugur Sahin as saying.
The next stage will see the vaccine undergoing trials on 30,000 healthy participants, which is likely to begin in the United States and Europe in late July.
BioNTech-Pfizer are gearing up to make up to 100 million doses by the end of 2020 and another 1.2 billion doses by the end of 2021 in Germany and the United States.
CanSino Biologics coronavirus vaccine status
The vaccine candidate developed by CanSino Biologics has been approved for use by China’s military after clinical trials proved it was safe and somewhat efficient.
The Ad5-nCoV vaccine, one of the eight vaccine candidates being developed by China, has won approval for human testing in Canada.
China’s Central Military Commission approved the use of the vaccine by the military on June 25 for a period of one year, CanSino said in a filing. The Phase 1 and Phase 2 clinical trials showed the vaccine candidate has potential to prevent diseases caused by the coronavirus.