Bharat Biotech’s Covaxin
Bharat Biotech’s Covaxin, a coronavirus vaccine is being developed by the firm in partnership with the Indian Council of Medical Research (ICMR). Clearance for the third phase of clinical trials has been approved for Covaxin on October 22 which is planned to be launched in June 2021.
Drugs Controller General of India (DCGI)
The Hyderabad-based firm sought permission to conduct Phase three of the clinical trial for the COVID-19 vaccine, to the Drugs Controller General of India (DCGI) on October 2.
According to the Indian Express, over 20,000 volunteers across 12-14 states are to be tested by Bharat Biotech. The firm would cover 28,500 volunteers above 18 years of age for clinical trials across 19 cities such as Delhi, Mumbai, Patna, and Lucknow.
Sai Prasad, executive director of Bharat Biotech International added, “If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our phase 3 clinical trial. That is for the full efficacy results,”.
Serum Institute of India (SII)
Serum Institute of India (SII), a Pune-based firm is in the process of vaccinating participants for the third phase of the clinical trial which placed Bharat Biotech behind in the trials.
Serum Institute of India (SII) has also patterned with AstraZeneca for manufacturing the Oxford COVID-19.
On October 23, Bharat Biotech announced its completion of the interim analysis of phase one and phase 2. The approval for phase three has been initiated on 26,000 participants.
In a recent report, Bharat Biotech said that an animal study has shown the development of a strong immunity in its vaccine candidate against the virus.
Bharat Biotech was asked to submit complete safety data of the phase two trials before proceeding to phase three and the permission to conduct Phase 1 and Phase 2 clinical trials were given in July by DCGI.
Bharat biotech has recently posted on its website, “the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus”.
The initial release of Covaxin in the market was August 15 but the government officials later stated the impossibility of the drug release up until next year. On a wide scale, 100 vaccines are being prepared to fight the COVID-19 pandemic which has globally affected thousands of people.
The Covaxin vaccine
The Covaxin vaccine is being developed by BBIL partnering with the National Institute of Virology (NIV). Covaxin perpetrated pre-clinical testing on animals to check its safety before the firm needed the approval to conduct human trials.
The first phase was conducted on a small group to find out the dosage of the vaccine and its safety, the immunity development, and to find any side effects. The second phase was conducted on hundreds and it tested the potency of the vaccine.
Covaxin has been more advanced than the other vaccine candidates through global collaboration.
A vaccine has to go through three phases of human trials and Covaxin has reached its last stage. According to BBIL, the estimated time for phase I and phase II is a year and three months.
Even though the vaccine trials are fast-tracked, it will take over a year to launch the product. But Covaxin can be approved for emergency use provided the data from the first two trial phases are compelling enough to be used.