Covaxin – India’s First Vaccine To Go For Human Trials – Free PDF

The News

• India’s drug regulator, the Central Drugs Standard Control Organisation, has allowed to conduct human clinical trials for ‘Covaxin
• It the first indigenousCovid-19 vaccine candidate to receive this approval.
• These trials are scheduled to start across India in July.

Who has developed the vaccine?

1. Bharat Biotech India (BBIL)
2. National Institute of Virology (NIV),Pune

• NIV (under ICMR) isolated a strain of the virus from an asymptomatic Covid-19 patient and transferred it to BBIL.

Live-attenuated vaccines

• Weakened (or attenuated) form of the germ that causes a disease.
• Because these vaccines are so similar to the natural infection that they help prevent, they create a strong and long-lasting immune response.
• Just 1 or 2 doses of most live vaccines can give you a lifetime of protection against a germ and the disease it causes.
• Live vaccines are used to protect against:

1. Measles, mumps, rubella (MMR combined vaccine)
2. Rotavirus
3. Smallpox
4. Chickenpox
5. Yellow fever

Inactivated vaccines

• Inactivated vaccines use the killed version of the germ that causes a disease.
• Inactivated vaccines usually don’t provide immunity (protection) that’s as strong as live vaccines – booster shots.
• Inactivated vaccines usually have a better safety record.
• Inactivated vaccines are used to protect against:

1. Hepatitis A
2. Flu (shot only)
3. Polio (shot only)
4. Rabies

• Other Indian firms engaged in the development of Covid-19 vaccines

1. Zydus Cadila
2. Serum Institute of India
3. Panacea Biotec

• The AZD1222 (formerly known as ChAdOx1 nCoV-19) vaccination, developed by researchers at the University’s Jenner Institute, and manufactured by AstraZeneca, has already begun Phase III human trials.

• WHO list

Vaccine Development

• The general stages of the development cycle of a vaccine are

1. Exploratory stage
2. Pre-clinical stage
3. Clinical development
4. Regulatory review and approval
5. Manufacturing
6. Quality control

Clinical development

• Clinical development is a three-phase process.
• New drugs must pass through these three phases of clinical trials before being deemed safe and effective for widespread use.
• Assuming the initial tests go well, it may be 12 to 18 months before this Coronavirus vaccine is ready for public use.

Phase 1

• Phase 1 trials examine a small group of people, typically between 20 and 80 individuals, who receive different doses of an experimental treatment.
• Over the course of several months, researchers monitor how each volunteer metabolizes the given treatment and what common side effects emerge in response to different doses.

Phase 2

• Phase 2 trials typically examine several hundred people and monitor participants for periods of from several months to two years.
• Primarily, Phase 2 trials serve as a secondary measure of safety and help researchers to refine the dosing of a particular medication.
• At this stage, researchers select participants with characteristics, such as age and physical health, that match those of the people who the vaccine is being developed for.
• For example, although anyone can contract COVID-19, those of advanced age and those with chronic conditions are more likely to develop severe symptoms, so this could be a consideration in Phase 2 trials.

Phase 3

• Phase 3 trials typically follow 300 to 3,000 volunteers over the course of one to four years.
• With a larger group of people, researchers can take note of unusual side effects of the drug, and by lengthening the study period, they can catch long-term side effects as they emerge.
• Phase 3 trials must demonstrate that a given drug provides the medical benefits it’s intended to.

Phase 4

• After approval from the regulator, the firm has to continue monitoring the use of its vaccine on patients and submit post-marketing surveillance details, which checks for any long-term unintended adverse effects of the product.

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