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.Adverse Effects
“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.