Question: recently mRNA based COVID-19 vaccine has been approved in India for human trial. Consider following statements regarding above vaccine-
i. Name of this vaccine is HGCO-19
ii. It is being manufactured by Hyderabad based Bharat Biotech Limited
iii. This vaccine has been approved by DCGI for face-1 and face-2 human trial
Which of the above statement/statements is/are incorrect-
Select the answer from following code-
a) i
b) i & ii
c) iii
d) ii
Answer: (d)
Related Facts:
- On 9 December 2020; Drug Controller of India (DCGI) has given its approval for the human trial of India’s indigenous mRNA based vaccine.
- The mRNA vaccine developed by the Pune-based Gennova Biopharmaceuticals, has received approval from DCGI to carry out Phase I/II clinical trials on humans.
- The subject expert committee of the DCGI, which met here on 09 December, 2020; had approved its clinical trials.
- Gennova’s vaccine candidate, HGCO19, uses the same platform technology as those used by Covid-19 vaccines developed by Pfizer-BioNTech and Moderna.
- Ministry of science and technology is a statement on 11 December 2020 informed that its seed grant came from the Ind-CEPI grant of the Department of Biotechnology (DBT).
- The mRNA vaccines do not use the conventional model to produce immune response.
- Instead, the mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus.
- The host body uses this to produce the viral protein that is recognised, thereby making the body mount an immune response against the disease.
- Vaccines-based on mRNA are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline.
- The mRNA vaccine is considered safe as it is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.
- They are expected to be highly efficacious because of their inherent capability to be translatable into the protein structure inside the cell cytoplasm.
- Additionally, mRNA vaccines are fully synthetic and do not require a host for growth.
- Therefore, they can be quickly manufactured in an inexpensive manner to ensure their availability.
- Due to above factors the have greater accessibility for mass vaccination on a sustainable basis.
- HGCO19 has been developed in collaboration with HDT Biotech Corporation of the US and it has already demonstrated safety, immunogenicity and neutralisation antibody activity in animals.
- The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from convalescent patients of Covid-19.
- HGCO19 is stable at 2-8 degree Celsius for two months. Gennova has completed all preliminary work and should initiate the Phase I/II human clinical trials soon.
By – Rajesh Tripathi