COVAXIN
- The Central Drugs Standard Control Organisation (CDSCO) has approved India’s indigenously developed COVID vaccine- COVAXIN to go for human/clinical trials.
- COVAXIN has been developed by Bharat Biotech India (BBIL) in collaboration with National Institute of Virology (NIV).
- Indian Council of Medical Research (ICMR) has directed trial sites of COVAXIN to finish the human trials within August 15th 2020.
- But, many BioEthics experts have pointed out that rushing to clear the vaccine within a month can be harmful.
Stages from research to market
- The stages can be divided into 6 stages:
| Stage 1 | It is where R&D is done. It usually takes 2 to 4 years. But for COVID-19 it has been fast-forwarded due to the presence of technology and available genetic sequence of the virus. |
| Stage 2 | It is called pre-clinical stage. It is where a vaccine is tested on non-humans such as cell-cultures, chimpanzees, guinea pigs, etc. It is to judge the possible immune response. |
| Stage 3 | In this stage human trials are started. It can be divided into 3 phases based on the magnitude of the human trials. It usually takes 90 months to complete the process.
Phase I: The vaccine is tested on a group of people and scientists measure antibodies in their blood. Phase II: Then the vaccine is tried on a few hundred people. In this stage 3 things are determined
Phase III: Here the vaccine is tried on thousands of people and here it is checked on various populations. |
| Stage 4 | Here the regulatory of the country is provided with details and then the vaccine receives the license. This process too takes longer. In the US, normally it takes 10 months to get a license. |
| Stage 5 | It is the manufacturing stage. Manufacturing of vaccines requires a lot of investment and raw materials, even if a company gets a license it is hard to acquire the required equipment and scientific expertise. Big companies like Pfizer, Johnson & Johnson etc have a greater advantage. |
| Stage 6 | Once the vaccine is in market its quality is monitored by both regulator and manufacturer |
- All above steps take several years of hard work and precision to make a vaccine successful.
- COVAXIN is now allowed to enter stage 3, but rushing in the upcoming stages can be harmful of the public.
What type of medicine is COVAXIN?
- It is an INACTIVATED vaccine, made using the killed COVID-19 vaccine.
- When they are injected into the persons, they cannot replicate.
- If injected into our body, our body can create antibodies against these dead viruses and the body shall remember these virus. If once again the alive viruses attack, these antibodies get activated and they will fight with them.
Central Drugs Standard Control Organisation (CDSCO)
- It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
- New Delhi is its headquarters .
- The major functions of this body are:
- Regulatory control over the import of drugs
- Approval of new drugs and clinical trials
- Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB)
- Approval of certain licenses as Central License Approving Authority.
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