Gennova mrna-based vaccine: India's first mRNA vaccine GEMCOVAC-19 has got emergency use authorization. The Drugs Controller General of India (DCGI) gave its go ahead to the two-dose mrna-based covid vaccine in India developed by Pune-based Gennova Biopharmaceuticals on June 28, 2022 for restricted use in emergency situations for all adults aged above 18 years.
The Subject Expert Committee (SEC) had recommended emergency use approval for India's first mRNA vaccine during a meeting on June 24. The committee made the recommendation after finding the data submitted by Gennova Biopharmaceuticals as "satisfactory". Gennova had submitted the trial data of its COVID-19 vaccine in April and then submitted additional data in May.
It is the first mRNA vaccine that remains stable during storage even at 2-8 degrees Celsius. Other mRNA vaccines require to be stored at sub-zero temperatures.
DCGI has approved 2 dose mRNA vaccine of Gennova Biopharmaceuticals for #COVID19 for restricted use in emergency situations for 18 & above age group. It is the first time ever that this vaccine is stable for storage at 2-8°C: Sources
— ANI (@ANI) June 28, 2022
Gennova mRNA-based Vaccine: 5 Key Facts
1. The Gennova mRNA-based vaccine, GEMCOVAC-19, is India's first homegrown mRNA COVID- 19 vaccine.
2. Gennova has conducted phase two and three trials of the vaccine involving 4,000 participants to evaluate the vaccine’s safety, immunogenicity and tolerability.
3. Gennova had submitted interim data on the indegenously-developed mrna-based vaccine to DGCA in April.
4. The Central Drugs Standard Control Organisation had sent some more queries to the company and additional data was submitted in May.
5. The Indian version of mRNA COVID-19 vaccine aims to made mRNA-based vaccine affordable and accessible.
India's first mRNA vaccine GEMCOVAC-19 gets Emergency Use Authorization pic.twitter.com/sBOm76os1V
— ANI (@ANI) June 28, 2022
Why is Gennova mRNA vaccine being called a game changer?
Most other mRNA vaccines have to be stored at sub-zero temperatures, while this mRNA vaccine can be stored between 2 and 8 degree celsius. This means that the mrna-based vaccine can be stored in a standard medical refrigerator as well. This will enable rollout of the vaccine easy in India and hence is being seen as a as a game-changer for the healthcare industry in the country.
What is mRNA vaccine?
mRNA is short for messenger RNA, a type of RNA found in cells that is used for the production of proteins. The mRNA vaccine teach our cells how to make a protein that will trigger an immune response inside our bodies.
The mRNA vaccines protect us from infectious diseases by activating cells to fight against invading virus. The immune response leads to the creation of antibodies that are required to fight the foreign virus by targeting that particular piece of protein.
How do mrna-based vaccines work?
The mRNA-based Covid-19 vaccines send instructions to the cells to create a piece of protein known as spike protein, the same as the one found studded on the surface of the novel coronavirus. These proteins have been engineered to stop them from replicating.
Which are other mRNA COVID vaccines?
The Pfizer-BioNTech and Moderna COVID-19 vaccines are both mRNA vaccines.
Background
The Indian government had started its nationwide COVID-19 vaccination programme on January 16, 2021. The centre was providing the COVID-19 vaccines free of cost to the states and UTs to enable vaccination of all.
The Covid-19 vaccination for children between 12-14 years of age began on March 16, 2022. The children are being administered Corbevax COVID-19 vaccine manufactured by Hyderabad-based Biological E.
The centre also began administering the COVID-19 precautionary dose to all those aged above 60 years from the same day. Now, the COVID-19 precautionary dose is available for all age groups, nine months after the second dose.
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