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Indigenous corona vaccine trials have come in the last phase of covaxine. Bharat Biotech, which is developing this vaccine, has announced Phase-III trials. Haryana Health Minister Anil Vij administered vaccine dose at Civil Hospital, Ambala Cantt. These trials will be on 25,800 volunteers in 23 institutions across the country. These are the final stage trials. If the vaccine proves to be effective in large-scale trials, the company will apply for regulatory approval early next year. Know, everything about Phase-III trials of Kovaxin of Bharat Biotech…
What is covaxin first? Who made it?
- Bharat Biotech has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune. NIV isolated a strain of novel coronavirus. With its help, Bharat Biotech developed the inactivated vaccine at the High-Containment Facility in Gnome Valley, Hyderabad.
- The vaccine is injected into a person’s body. This virus does not survive, due to which it neither infects nor can flourish in the body. It comes as a dead virus in front of the body’s immune system, which develops antibody response to the virus.
What have been the results of covaxin so far?
- The clinical trials of covaxin began around July 15. In the first and second phases, around 1,000 volunteers were vaccinated in 12 cities including Hyderabad, Rohtak, Patna, Kanchipuram, Delhi, Goa, Bhubaneswar and Lucknow. The company claims that the vaccine strengthened the immune response of volunteers.
Have there been any disturbances in the trials so far?
- No. By the way, a media report claimed that a volunteer had to be admitted to the hospital after applying the vaccine. The Data and Safety Monitoring Board (DSMB) analyzed the data and also shared it with the Drug Regulatory Authority, but it was believed that what happened had nothing to do with the vaccine. Due to this, neither the trials stopped nor the news could come out.
- The first dose was given to 402 volunteers and 73 of the volunteers showed side effects. A second dose was given to 394 volunteers, with 18 of them having side effects. Most of the cases were of Mild Nature and were soon resolved. But a case was serious.
- Krishna Alla, chairman and managing director of Bharat Biotech, said in a webinar on Friday that the company was following the international guidelines. International protocol states that information will be given to the Ethical Committee of the hospital. We had to inform DSMB. We then also reported to the Drug Controller (DCGI). The Subject Expert Committee reviews and the procedure followed. Everyone is doubtful about the manufacturers of India. Trust us, we are following international guidelines.
- Trials of covaxin will be completed before December; Indian government will give first order of 50 lakh doses
What will be the condition of becoming a Volunteer?
If you also want to become a Volunteer in the Phase-3 trials of Covaxin These conditions must be met:
1. Age between 18 and 99 years.
2. There was no serious illness till three months before enrollment.
3. It may not have been corona positive before.
4. Women should avoid pregnancy for at least three months after enrollment. The woman should not be pregnant.
5. Do not enroll in any other clinical trial.
6. There is no Kovid-19 positive patient in the house.
7. Do not have HIV, Hepatitis B, or Hepatitis C infection.
How many injections will be done during the trials?
- Volunteers involved in the trial will be administered two intramuscular injections at a difference of 28 days. Half the volunteers will get covaxin and the rest will be placebo. Placebo is a kind of saline water, which is applied only to see how effective the vaccine is. Volunteers will be assigned covaxin or placebo on a random basis.
- The trial is double blind. This means that even investigators, volunteers and the company will not know who is engaged in covaxin and who has been given a placebo.
What will happen after injection?
- Volunteers will be monitored after both injections. They must agree not to go out of the city. Also, periodic checks will be done to find out if they have an infection. Also, side-effects will also be seen through this investigation.
What is the status of other trials going on in India?
- There are currently four human vaccine trials in India involving covaxin. Zydus Cadila vaccine is currently in Phase-2. At the same time, Trials Serum Institute of India (SII) is doing the Kovyshield vaccine of Oxford / AstraZeneca. Its Phase-2 and Phase-3 trials have started simultaneously. Its initial results can be expected by the end of December.
- Biological E said last week that it has started Phase-1/2 trials of its Kovid-19 sub-unit vaccine. Biological E has tied up with American company Dynavax Technology Corporation and the Vaccine Candidate Adjuvant CpG 1018 of Beller College of Medicine, Houston. Dr. Reddy’s Laboratory may soon apply for phase-2 and phase-3 trials of the Russian vaccine Sputnik.
Has Bharat Biotech made vaccines even before this?
- Yes India has an excellent track record of biotech. The company claims to have 140 global patents. The company has 16 vaccines, 4 bio-therapies, registrations in 116 countries and WHO pre-qualification. Bharat Biotech has previously delivered more than 4 billion vaccines worldwide. These include the world’s first tetanus-toxoid conjugated vaccine for influenza H1N1, rotavirus, Japanese encephalitis, rabies, chikungunya, zika and typhoid. The company has globally completed 75 multi-center clinical trials with over 3 lakh volunteers.