The worldwide spread of the coronavirus has led to a disaster for public health. The uncontrolled pandemic has put forth a challenge before the healthcare scientists and researchers all over the world. The number of coronavirus cases in India is more than 635,000 and the country’s death toll is above 19,000. The countries economical as well as political system has been affected a lot in the pandemic.
Everyone today is waiting for a vaccine that can fight with the virus. Many countries are in the race of vaccine launch.
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All you need to know about corona vaccine
Vaccination is one of the most effective ways to prevent spread of communicable diseases. A vaccine helps the body’s immune system to recognize specific agents and fight pathogens like viruses or bacteria. Polio vaccine is the one of the examples of vaccination that helped to complete elimination of the disease.
- On June 29, 2020, a Hyderabad based company Bharat Biotech International Ltd. has got an approval for human clinical trials.
- This has been approved by the Drugs Controller General of India (DCGI). This vaccine has been developed jointly by the Indian Council of Medical Research (ICMR), National Institute of Virology, Pune, and Hyderabad-based pharmaceutical company Bharat Biotech International Limited (BBIL) located in Genome Valley in Hyderabad.
- The vaccine is claimed to be made in India.
- Further the vaccine is an inactivated virus vaccine i.e. developed from the dead coronavirus. Thus in this case, vaccines have no potential to infect or replicate since it is a killed virus.
- This vaccine is named as BBV512 corona vaccine also COVAXIN. The human trials may begin from the 7th of July.
- Bharat Biotech is among seven Indian firms working on COVID-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials. Bharat biotech has also developed many other vaccines earlier like the h1n1 vaccine or rotavirus vaccine.
ICMR has written in a letter to Bharat Biotech that indigenous corona vaccine trials should be done in fast track mode, so that the clinical trial report can be launched by 15 August. The trial of this vaccine is planned to start on July 7.
Further, the Indian Council of Medical Research (ICMR) said that it is attempting to launch the world’s first COVID-19 vaccine on August 15. That is it may be possible that India can be the first country to launch vaccine against coronavirus if clinical human trials go well as planned.
What are the intermediate targets to be completed?
- According to reports, the ICMR has selected twelve medical institutes from different states for clinical trials of the vaccine.
- These include New Delhi, Goa, Visakhapatnam (Andhra Pradesh), Rohtak (Haryana), Patna (Bihar), Belgaum (Karnataka), Nagpur (Maharashtra), Kattankulathur (Tamil Nadu), Hyderabad (Telangana) and Gorakhpur, Arya Nagar and Kanpur (Uttar Pradesh). The institutes are included.
- According to ICMR, it is one of the “top priority projects which is being monitored at the top-most level of the government”.
- BBIL is working very hard to meet the target.
- The vaccine has to go through various phases before the launch.
- Preclinical tests – These involve tests on animals like rats, monkeys etc. Bharat Biotech completed comprehensive pre-clinical studies in two months after receiving regulatory approvals. It said results from these studies have been promising and show extensive safety and effective immune responses. In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, guinea pigs, rats, and rabbits. The vaccine produced antibodies that were able to completely neutralize the wild type virus in virus neutralization assay.
- Phase 1 trial – Phase 1 is planned to start on July 7 according to ICMR. The vaccine tests will be done on healthy patients to check if the body can produce sufficient immunoglobins to fight against the disease. This will further help to decide the appropriate dose as well as side effects if any. Over the course, researchers check how each volunteer metabolizes the given treatment and what common side effects emerge in response to various doses.
- Phase 2 and phase 3 trials – These will be on a large scale and involve large scale trials on patients. This will let to know about its short term and long term effects as well as effects on different age groups.
- However, vaccine can be considered safe to be commercially available only after Phase 3 – a much larger efficacy trial involving thousands of participants.
ICMR has advised to fast track all approvals related to the initiation of the clinical trial and ensure that the human enrollment is initiated no later than July 7, 2020. If the trial is successful, the Corona vaccine will be among us soon.
Further, the institutes are geared up for the clinical trials. Human trials also involve volunteer participation which is a major challenge.
Will COVAXIN will be the first?
- Well, another potential coronavirus vaccine is indigenously developed by Ahmedabad based company called Zydus Cadila Healthcare. Zydus Cadila have got an approval from the Drugs Controller General of India (DCGI) for human clinical trials for their indigenously developed vaccine ZyCoV-D. Hence this vaccine is also a candidate in the race.
- Serum Institute of India is another Indian firm engaged in the production of the corona vaccine.
- According to WHO, the company which is ahead in the race is AstraZeneca, Moderna. The company has collaborated with Oxford University. The company’s experimental corona vaccine named AZD1222 is one of the leading candidates and most advanced in terms of development. The vaccine has already completed phase 2 and has entered phase 3.
Meanwhile, everyone is waiting for a vaccine, and curious about the country will be the first to launch.
Let’s hope for a vaccine that can be available to all and can save the world from this pandemic. It will be a milestone if India happens to be the first country to launch such a vaccine.
Writing Credits: Lovepreet Arora