Will India's homegrown Covaxin be able to prevent COVID-19?
As the race around vaccine development kicks up a notch globally, Indian scientists are leaving no step behind to present a homegrown prototype of a novel COVID-19 vaccine to battle the surge. Amongst the strongest competitors is COVAXIN, which has been developed by Bharat Biotech International Limited (BBIL) in collaboration with ICMR (Indian Council of Medical Research) and NIV (National Institute of Virology), Pune.
Covaxin clinical trials are going on across India
The one of a kind vaccine was one of the first to be granted authorisation to start clinical trials phase in early July. Ever since researchers have been reporting steady advancements regarding the development. Volunteers and research labs have been shortlisted for conducting the trials pan India and AIIMS, Delhi just recently dosed a 30-year-old participant as part of the trial.
What do the latest findings suggest?
Now, newer reports have emerged which say that Covaxin trials, which were started at a medical facility in Rohtak, Haryana have shown good results, which may prove to be a gamechanger in the critical stage of vaccine development.
Covaxin shows "encouraging" results
An agency report quoted that Rohtak PGIMS, which had commenced the first part of Phase-1 trials of Covaxin on July 17 on 50 volunteers, reported “encouraging” result.
Dr Savita Verma, who is spearheading the phase I study in the Rohtak facility added that as many as six volunteers have been dosed with the experimental vaccine and they are hopeful of showing good results going forward.
“First part of Phase-1 of vaccine trial (Covaxin) has been completed. 50 people across India were administered the vaccine and the results were encouraging. Six people were administered the vaccine on Saturday under the second part of phase-1,” said the official report by the research group.
AIIMS Delhi and Patna also start dosing patients in phase I
A report by AIIMS, Delhi also mentioned that the first volunteer who was administered the dose will be continued to be monitored for two weeks going forward. Post injection, he was observed for two hours and no specific or threatening side-effects were seen in the patient.
Apart from this, the Patna wing of the frontier medical institution has also started dosing patients. In the first round, nine people have been dosed so far and the hospital plans on testing the vaccine on 18-20 more people in the coming weeks.
How does Covaxin work in fighting COVID-19?
Covaxin has been modelled using an inactive version of the virus after isolating a strain of the deadly pathogen from an asymptomatic individual in a containment facility in Hyderabad in May.Pre-clinical trials showed extremely effectively safe and effective results, which led ICMR to issue the authorisation to start trials on humans.
What to expect in the first phase of trials
Authorities have received applications from more than 3500 people for the vaccine trials. While phase I usually involves 30-40 participants, COVAXIN's trials are being advanced and involve a larger pool of candidates.
The current stage involves 375 people, who will be given the dose to measure its safety response. Experts say that the first phase will take a month's time to complete, while they are hoping to start the second phase, on 700-750 recruits in the next month or so.
Participants will be dosed twice in phase I
In the first phase of the trial, they will be conducting randomized double-blind clinical trials, wherein some of the volunteers will be administrated a vaccine dose while others will be given a placebo, to see how the vaccine works. The participants will be vaccinated twice in phase I, after a gap of two weeks.
The results from phase I will be monitored by a Data and Safety Monitoring Board and if found to be effective, the vaccine will be given the go-ahead for the next phase of trials.
How long will it take for COVAXIN trials?
Even though Covaxin was one of the first approved vaccines developed and tested in India, one of the firsts for the country, there still is a long road ahead for the vaccine candidate to be approved for mass usage. Experts at the top-level are hoping that Covaxin trials, in phase I and II will take up to a year's time or more.
On the other hand, global contenders, such as Moderna Inc., CanSino Biologics, Oxford University are in their late phase III testing, with promises of having a vaccine ready before 2020 made possible. Till date, all top vaccine prototypes have shown "safe" and "promising" results in early phases of testing.
What other vaccines are being made in India?
Apart from Covaxin, Ahmedabad based Zydus Cadila has also started clinical trials of its novel COVID-19 prototype, ZyCOV-D. The company is hopeful of getting necessary approvals by March 2021 and has also said that it can produce a vaccine for emergent use if the need arises.
A total ofseven Indian vaccine companies are working on developing a COVID-19 vaccine in the country and are in different phases of testing.
Serum Institute of India (SII) has also sought approvals to start phase III of the Oxford-AstraZeneca vaccine in the country in the coming weeks.