Udayavni Special

Ph 1 trial results show Covaxin has tolerable safety, enhanced immunity: Lancet study


PTI, Jan 22, 2021, 5:06 PM IST

New Delhi: India’s first indigenous vaccine against COVID-19, Covaxin, showed enhanced immune response without any serious side effects in the participants enrolled for the phase 1 trials, according to the results published in The Lancet Infectious Disease journal.

Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, the vaccine has been granted emergency use authorisation in clinical trial mode’ by the Indian government.

Covaxin, which is now undergoing phase-3 trials, had raised concerns among experts over its emergency approval earlier this month by India’s drug regulator.

The vaccine, codenamed BBV152, was well tolerated in all dose groups with no vaccine-related serious adverse events, noted the authors of the study funded by Bharat Biotech.

The same results were earlier published in the preprint server medRxiv in December.

However, there has been no new data released in the public domain which could demonstrate further safety and efficacy of the preventive.

The authors said that all adverse events were mild and moderate, and were more frequent after the first dose, adding that one adverse event was reported but was unrelated to the vaccine.

The randomised phase 1 trial to assess the safety and immunogenicity of BBV152 was carried at 11 hospitals across India.

Adults aged 18-55 years who were deemed healthy by the investigator were eligible.

Between July 13 and 30, last year, 827 participants were screened, of whom 375 were enrolled.

Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group.

Two intramuscular doses of vaccines were administered 14 days apart.

“BBV152 led to tolerable safety outcomes and enhanced immune responses. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events,” the authors of the study said.

The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever.

Covaxin is an inactivated vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction.

This process leaves the viral proteins, including the spike protein of the novel coronavirus which it uses to enter the human cells, intact.

Given as two doses, three weeks apart, the viral proteins in the vaccine activate the immune system and prepare people for future infections with the actual infectious virus.

According to Bharat Biotech, the therapeutic can be stored at room temperature for at least a week.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Can’t use language like ‘Tom, Dick, Harry’ in petition: HC

BJP to unleash high-voltage campaign to wrest power in Puducherry: Nirmal Kumar Surana

World’s first space hotel with rooms for 400 people to be operational from 2027

Saddening to see leaders like Azad being ‘castigated’ by Congress: BJP

Reopening of school for classes 1-5 unlikely says Min Suresh

Karnataka launches Engineering Research & Development policy; aims to create 50,000 new jobs

Rifts within Congress ahead of West Bengal elections



Related Articles More

Can’t use language like ‘Tom, Dick, Harry’ in petition: HC

TMC poll slogan in sync with party’s vision: Bengal minister

Saddening to see leaders like Azad being ‘castigated’ by Congress: BJP

Rifts within Congress ahead of West Bengal elections

BJP surges ahead of Congress in Gujarat civic polls

MUST WATCH

Udayavani 02-March-2021 News Bulletin | Udayavani

Mangalore: Prioritizing the city’s holistic development: New mayor Premananda Shetty

VenkiPalimar​ | Chhatrapati Shivaji Maharaj Magazine Collage Video

Interview with Shree Harsha | Harshadhwani | Udayavani

Why is drinking Cold Water Bad for Health?

Latest Additions

Can’t use language like ‘Tom, Dick, Harry’ in petition: HC

Minister BC Patil takes Covid-19 vaccine jab at home; ‘not allowed’, says Centre

BJP to unleash high-voltage campaign to wrest power in Puducherry: Nirmal Kumar Surana

Tiger Shroff’s ”Heropanti 2” to release in December

World’s first space hotel with rooms for 400 people to be operational from 2027

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.