Coronavirus cases in India are not taking an abiding name. The total number of COVID-19 cases in India has so far reached 6,06,645. Apart from this, 2,26,950 are active cases, while 3,59,865 people have become infection-free. Meanwhile, so far, 17,836 people have died of this deadly virus. Worldwide, more than 5,00,000 people have died due to the coronavirus infection.
Recently, the “COVAXIN” India’s first autochthonous vaccine for the coronavirus treatment has been approved for human trials.
According to a letter issued by ICMR, enrollment for human trials will begin on July 7. If all trials are completed well, the indigenous vaccine for COVID-19 will be launched by August 15.
What does endorsement for the COVID-19 vaccine mean for India?
The Indian Drug Control Agency, CDSCO, has approved BBL for Phase I and II clinical trials. As cases continue to rise in the country, this brings India closer to finalizing the domestic Covid-19 vaccine. It will help in boosting the immune system.
The ICMR said in a letter to Bharat Biotech that the domestic coronavirus vaccine needs to be tested quickly so that we can publish the report of the clinical trial by August 15.
What is “COVAXIN” and how was it developed?
BBIL produced the Covaxin vaccine for COVID-19 in collaboration with the National Institute of Virology (NIV). The SARS-CoV-2 strain was secluded from NIV Pune and transferred to Bharat Biotech. Indigenous inactivated vaccines for coronavirus treatment are developed and manufactured in the BSL-3 (Biosafety Level 3) high-closed facility of Bharat Biotech in Hyderabad Genome Valley.
Dr. Krishna Ella, President and Managing Director of Bharat Biotech, stated: “We are proud to proclaim COVAXIN, India’s first indigenous vaccine against COVID-19. The alliance with ICMR and NIV was effective in the development of this vaccine.
On Thursday, the Indian Council of Medical Research (ICMR) partnered with Bharat Biotech International Limited (BBIL) told BBL to conduct a rapid clinical trial of the indigenous vaccine COVID-19 (COVID BBV152 vaccine). ICMR CEO Balram Bhargava stated in a formal statement that ICMR plans to launch the COVID-19 domestic vaccine by August 15.
“The public health vaccine for corona infection is considered to be released on August 15, after the success of all clinical trials. BBIL is working hard to achieve this goal, but the results will depend on the cooperation of all sites in clinical trials participating in the project “.
It is the prime autochthonous vaccine for COVID-19 developed in India and one of the topmost priorities monitored by the government at the most crucial level. The vaccine is procured from the SARS-CoV-2 strain isolated by ICMR-National Institute.
ICMR and BBIL are performing co-operatively for the preclinical and clinical development of this vaccine, the statement also stated.
“You have been selected as the clinical test site for the COVID BBV152 vaccine. Due to the COVID-19 pandemic, the vaccine headed to a public health emergency. Hence, we strongly recommend you to quickly track all endorsed clinical trials associated with launching tests of the BBV152 COVID vaccine and ensuring that enrollment of subjects commences no later than July 7, 2020,” the letter added.
How many stages of testing must the vaccine pass before being approved?
Like most new drugs, the vaccine must go through a four-stage testing process, starting with preclinical testing and ending with a phase III study of thousands of patients. After obtaining regulatory approval, the company must continue to monitor the use of its vaccines on patients and submit post-marketing monitoring details to verify any unexpected long-term adverse effects.
Bharat Biotech’s track record in developing Vero cell culture platform technology has been successfully confirmed in vaccines against rabies, rotavirus, polio, Japanese encephalitis, chikungunya, and Zika diseases.
We hope that COVAXIN, India’s first indigenous medicine, will also play an important role in the treatment of coronavirus and help to reduce the mortality rate and strengthen the immune system.