Phase 3 of Covaxin trials kick off at AIIMS, neurology chief gets first dose
By MYBRANDBOOK
Covaxin’s phase 3 trials kicked off at the All India Institute of Medical Sciences (AIIMS), with the vaccine being given to the head of the department of neurology Dr MV Padma Shrivastava.
Unlike the phase 1 and 2 trials, people from the general population - including the young, the old and the comorbid - will be given the vaccine in Phase 2 and not just healthy volunteers.
Over 26,000 volunteers from 25 trial sites across the country will be recruited for the large scale phase 3 trials. In Delhi, doctors from AIIMS will administer the two dose vaccine, developed by an Indian vaccine maker in collaboration with the Indian Council of Medical Research, to 3,000 persons in Delhi’s Dakshinpuri.
“The first person to be enrolled for the phase 3 trial has received the first shot today. Another shot will be given a month later. We hope to complete the enrolment of 3,000 persons within a month. Volunteers would be selected from among AIIMS employees and from a site we have in Dakshinpuri. That will ensure that we are able to do proper follow-ups,” said Dr Puneet Mishra, professor, department of community medicine, AIIMS. He is one of the investigators of the vaccine trial.
“It is my institute’s trial and my country’s product. It is an honour to participate in the trial. All medicines that come into the market have to go through the trial. I understand the science; it is a placebo controlled trial and no one will know who gets the vaccine and who does not, and I am happy to play my part,” said Dr MV Padma Srivastava. The doctor vouched that she is over the age of 60 years and has no comorbidities.
Vaccine candidates have to be tested on animal models first to check their safety and immune response. In humans, a small phase 1 trial is done to check the safety of the compound, while in phase 2; trials are done to see the immune response and the dose at which the vaccine should be administered.
Large scale phase 3 trials are done to see how many infections or severe disease the vaccine prevents in a given population.
“The recruitment should be complete within a month and we will start seeing some preliminary data by that time,” said Dr Mishra.
The people who administered the vaccine will be followed up for a period of 207 days by the researchers. The vaccine uses an inactivated Sars-Cov-2 virus to generate an immune response that can prevent COVID-19 disease. The preliminary data, which can be presented to the drug regulator for seeking emergency use authorisation, should be available within two months, the researcher said.
The doctor said so far, none of the participants in the phase 1 and 2 trials has had any adverse effects, although there have been news reports of a volunteer from Nagpur developing viral pneumonia or inflammation of the lungs.
“Some participants have just experienced redness and pain at the injection site, but that is common to many injectables,” said Dr Mishra.
Apart from Covaxin, ZyCovD developed by Indian pharmaceutical company Zydus is also in advanced stages of human trials.
Singapore to remove One-Time Passwords from Bank Accounts
According to the Monetary Authority of Singapore, clients who utilise secur...
Is 375 million Airtel subscribers database breached?
When a hacker claims to have accessed and put up for sale a customer databa...
The government of India intends to construct a single portal f
A single portal will be launched by the Indian government to list all of it...
OpenAI offers GPT-4o, a faster model available to all users at
GPT-4o, a faster and more sophisticated AI model, is made available to all...
Icons Of India : ASHISH KUMAR CHAUHAN
Ashish kumar Chauhan, an Indian business executive and administrator, ...
ICONS OF INDIA : RAJIV MEMANI
As Chair of the EY Global Emerging Markets Committee, Rajiv connects e...
Icons Of India : RAJENDRA SINGH PAWAR
Rajendra Singh Pawar is the Executive Chairman and Co-Founder of NIIT ...
LIC - Life Insurance Corporation of India
LIC is the largest state-owned life insurance company in India...
IOCL - Indian Oil Corporation Ltd.
IOCL is India’s largest oil refining and marketing company ...
STPI - Software Technology Parks of India
STPI promotes and facilitates the growth of the IT and ITES industry i...
Indian Tech Talent Excelling The Tech World - Thomas Kurian, CEO- Google Cloud
Thomas Kurian, the CEO of Google Cloud, has been instrumental in expan...
Indian Tech Talent Excelling The Tech World - REVATHI ADVAITHI, CEO- Flex
Revathi Advaithi, the CEO of Flex, is a dynamic leader driving growth ...
Indian Tech Talent Excelling The Tech World - ARVIND KRISHNA, CEO – IBM
Arvind Krishna, an Indian-American business executive, serves as the C...