The first indigenous CORONAVIRUS vaccine COVAXIN has been given a target launched date of August 15th, 2020.
Covaxin in the limelight due to its expected early release. The government is actively involved, everyone is putting in all effort 24/7.
On July 2, Director General of the Indian Council of Medical Research (ICMR) Dr. Balram Bhargava sent out a letter asking officials at 12 hospitals across the country to expedite the vaccine testing process.
Covaxin coronavirus vaccine: Bharat Biotech plans to start its first and 2nd phase trials in July, but is unsure of the timeline for testing and approval of its vaccine. The Central Drug Standard Control Organization (CDSCO) has allowed Bharat Biotech India (BBIL) to conduct clinical trials of ‘Evaxin’, a non-invasive immunization agent for Covid-19. Trials are scheduled to start out across India in July.
The vaccine candidate was developed by BBIL together with the National Institute of Virology (NIV). NIV isolated the novel coronavirus patient in asymptomatic Covid-19 patients and transmitted it to BBIL in early May.
The firm then used it to figure on developing an “inactivated” vaccine — a vaccine that uses the dead virus — at its high-containment facility in Hyderabad. The trials are done on groups of people and meant to test if the vaccine is safe in humans and produces protective antibodies. The potential vaccine in question is a sars-Cov-2 strain sourced from the ICMR-National Institute of Virology. The aim is to test if the weakened form of the virus can stimulate enough immunity to protect healthy people from Sars cov-2 infection.
Once the vaccine is injected into a person’s, it’s no potential to infect or replicate, since it’s a killed virus. It just serves the system as a dead virus and mounts an antibody response towards the virus,” said the corporate, adding that inactivated vaccines usually have a proven safety record. Covaxin then tested, pre-test on animals such as gear pigs and mice to see if it was safe before the company went to CDSCO for permission to proceed.
Covaxin, having received the approval from the authorities are scheduled to start their trials in July. Bharat Biotech India (BBIL) will be helpful in two phases. Phase I will be conducted in small groups of individuals, where the dosage of the vaccine will be determined. The concerned personnel will study the effectiveness and side effects of the vaccine in accordance with the number of dosages. Phase II will comprise of a larger group of people where they will be organized and categorized according to certain characteristics such as age and sex.
To check for its safety and efficacy for the human trials, the Covaxin vaccine was first tested on mice and guinea pigs. It was only after its safety was evaluated on animals that the Central Drugs Standard Control Organisation (CDSCO) gave the go-ahead to conduct human trials for the COVID-19 vaccine candidate from India. “If an individual is vaccinated, the body will take 28 days to supply antibodies. Theoretically, it is possible to see if antibodies generate in participants by August 15.”
“But practically, it’s impossible to supply confirmed data by then. The approvals of the ethics committee take time, selection, and enrollment criteria take time.” “Making the vaccine feasible for public use will take a year or more.” – said Dr.Venkant Rao (EPIDEMIOLOGICAL, IMS AND SUM HOSPITAL).
Dr. Anant Bhan ( RESEARCHER, GLOBAL HEALTH BIOETHICS AND HEALTH POLICY ) said – ” I would find it very surprising if it is done. Even the most ambitious companies in the world.” The more advanced stages of development for their COVID-19 vaccines have a longer time-frame even having all the trial results, with safety and efficacy data, by Assumption is difficult. This raises several questions. “