The data generated underlines impressive safety and immunogenicity profile.
According to the Lancet, all adverse events were mild and moderate and were more frequent after the first dose.
It said that one adverse event was reported but was unrelated to the vaccine.
Between July 13 and 30, 2020, 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.
"The most common solicited adverse events were injection site pain, headache, fatigue, fever and nausea or vomiting."
“After both doses, solicited local and systemic adverse reactions were reported by 17 participants in the 3 μg with Algel-IMDG group, 21 in the 6 μg with Algel-IMDG group, 14 in the 6 μg, and ten in the Algel-only group,” said the Lancet.
It further said that the most common solicited adverse events were injection site pain, headache, fatigue, fever and nausea or vomiting.
“All solicited adverse events were mild or moderate and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 μg with Algel group, unrelated to the vaccine,” it further said.
Covaxin is being developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology, is now undergoing phase-3 trials.
Experts have raised concerns over the emergency approval to Covaxin given earlier this month by India’s drug regulator.
ICMR DG Balram Bhargava had earlier said that approval to Bharat Biotech has been given on the basis of efficacy from phase 2 studies, which is a provision under Drugs and Cosmetics Act that allows companies to apply for an approval with Phase 2 data.
Download The Economic Times News App to get Daily Market Updates & Live Business News.
18 Comments on this Story
Yaj44 days ago
People here are really foolish. Phase 1 is done for safety and non toxicity and the no of participants are kept in between 20-100 only.
Phase 2 is done for efficacy and the no of participants are kept in between 100-300.
Phase 3 no in thousands and so on. It's not like they are testing a drug and in the 1st phase drug will be given 1000's of patients.
Aaaa Bbbb44 days ago
Good to see Lancet commend th vaccine as a positive one. Whilst super scientists in India with PhD s from whatsapp University will keep trolling even Lancet, but that can't be helped. I await rakingbthis jab for self and so do my family. My inky recco - can this govt guvebut on priority to the Taxpayers free and fast ? That will be a nice gesture as one recognising India s truest minority.....even though it's a privilege to be in this group. A privilege most prosperous politicos cutting across political lines don't have . Or willing to take :-)
LEOVSN45 days ago
We wholeheartedly congratulate Bharat Bio tech for developing World class Vaccine for preventing Deadly Carona Virus.
We are proud that World class Vaccine was developed by Bharat Bio tech,Hyderabad, India which saves lives of several people & which can prevent Corona Virus developed&spread by Wuhan ,China.