Topics Covered: Indigenization of technology and developing new technology.
Serum Institute`s Covishield vs Bharat Biotech`s Covaxin:
Context:
In a significant development, the Drug Controller General of India (DCGI) has formally approved Serum Institute and Bharat Biotech vaccines for restricted emergency use against COVID-19 in India.
Background:
Neither Covishield nor Covaxin has completed the crucial Phase-3 trial, under which a vaccine candidate is administered to volunteers at multiple locations across the country.
- The approval was based on a recommendation by a Subject Expert Committee which deliberated for two days on granting approvals to the vaccines.
About Covishield:
- Covishield has been developed by Oxford University in collaboration with Astrazeneca.
- Pune-based Serum Institute of India is their manufacturing and trial partner.
- It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus.
- This virus causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
About Covaxin:
- Covaxin is developed by Bharat Biotech and it is India’s first indigenous vaccine against Covid-19.
- Bharat Biotech has developed this vaccine in collaboration with the Indian Council of Medical Research and National Institute of Virology.
- It is an inactivated vaccine which is developed by inactivating (killing) the live microorganisims that cause the disease.
- This destroys the ability of the pathogen to replicate, but keeps it intact so that the immune system can still recognise it and produce an immune response.
Is it safe?
WHO has welcomed the authorisation but there are many who fear the vaccine and the safety of it all. Surveys have found that many Indians are in no rush to get vaccinated. Experts also believe that more information about the vaccine trials should be published.
What is the process of getting an emergency use authorisation in India?
Experts and activists say India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.
- Despite this, CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs during this pandemic for remdesivir and favipiravir.
Is there a risk in using a product that has only been granted an emergency use authorisation?
According to the US FDA, the public has to be informed that a product has only been granted an EUA and not full approval.
- In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks, and the “extent to which such benefits or risks are unknown”, and that they have a right to refuse the vaccine.
InstaLinks:
Prelims Link:
- Antigens vs Antibodies.
- How a vaccine works?
- Types of vaccines.
- About DGCI.
- Procedure to be followed for vaccine approval in India.
Sources: the Hindu.
