Saturday, July 10, 2021

India’s Covaxin led to tolerable safety outcomes and enhanced immune responses: Lancet – ET HealthWorld


India’s indigenous vaccine against Covid-19, Covaxin led to tolerable safety outcomes and enhanced immune responses, British medical journal, the Lancet has said.

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.





Source link

Stay Connected

1,605FansLike
11,000FollowersFollow
342FollowersFollow
775FollowersFollow

Latest Articles

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...

Telangana caps Covid treatment charges in private hospitals

Hyderabad: The government of Telangana on Wednesday issued orders fixing treatment and investigation charges for Covid-19 in private hospitals.The state government, which had capped...