Categories: Uncategorized

Country’s first mRNA COVID-19 vaccine to shortly be approved for emergency use

The Subject Expert Committee (SEC) approved Emergency Use Authorisation (EUA) for India’s first mRNA COVID-19 vaccine during a meeting on Friday, sources informed ANI on Tuesday. The Drugs Controller General of India (DCGI) is anticipated to grant Gennova’s mRNA vaccine Emergency Use Authorization soon.

In the Friday meeting, the SEC, India’s drug regulator, judged Gennova Biopharmaceuticals’ evidence sufficient, according to sources.

The corporation supplied data in April and updated it in May.

Also Read: Hospitalisation being monitored as COVID cases increasing, but no new variant but severity: NDMC

Earlier in May, Gennova provided an update to ANI on the status of phase 3 data submission.

“Gennova is in discussion with the regulatory authorities and has submitted the relevant data and information for product approval,” stated a spokesman for the company.

“During pandemic times, product development employing novel technologies like mRNA, a fourth-generation vaccine platform stable at 2 to 8 degrees Celsius, is a tough path,” the representative added.

On 4000 people, the business performed phase 2 and phase 3 data trials to assess vaccination safety, immunogenicity, and tolerability.

The vaccine, GEMCOVAC-19, is the country’s first indigenous mRNA COVID-19 vaccine and is widely regarded as a game changer in the healthcare business.

Follow Medically Speaking on Instagram
Medically Speaking

Recent Posts

Harness the Power of Rice Water

Rice water, rich in inositol, antioxidants, vitamins, and minerals, protects hair from sunlight damage and…

3 hours ago

“8 Powerful Herbs and Supplements to Beat Bloating and Boost Your Gut Health Naturally”

Natural Remedies for Bloating: 8 Herbs and Supplements That Work Wonders for Your Gut Health…

3 hours ago

“Unlock the Power of Oil Pulling: Discover How This Simple Practice Improves Oral Health and Freshens Your Breath”

Benefits of Oil Pulling: Stops Bad Breath, Keeps Gums Healthy, But Can't Replace Brushing Oil…

3 hours ago

WHY DO YOU EXPERIENCE RUNNY NOSE AFTER EATING SPICY FOOD?

Spicy food – whether it’s a dash of chili in your curry, a spoonful of…

3 hours ago

“4 Simple Tests to Spot Adulterated Wheat Flour: Protect Your Health with These Easy Checks”

How To Identify Adulterated Wheat Flour? Try These 4 Easy Tests Wheat flour is a…

4 hours ago

“Unlock the Power of Jaggery: 10 Surprising Health Benefits of Eating It After Every Meal”

Reasons That Will Make You Eat Jaggery After Every Meal (Potential Health Benefits Inside) Jaggery,…

4 hours ago