“Covaxin is safe and has no side effects:” says Lancet Study

In a new report, a leading medical journal The Lancet has revealed that the COVID-19 vaccine, Covaxin has no serious side effects. Read on to know more.

By: Arushi Bidhuri | | Updated: March 10, 2021 11:11 am

India started its biggest vaccination drive against the deadly disease, COVID-19 on January 16, and millions of people have been inoculated. So far, two COVID-19 vaccines, Covaxin and Covishield have been approved in India. Covaxin, the first indigenous vaccine developed by Hyderabad-based Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) was granted approval in January before data from its final stage testing, which was termed as a ‘hasty approval’ by many experts. Concerned over tche emergency approval of the vaccine, it was reported that it might not be safe for use. Also Read - COVID-19 Second Wave: Experts Suggest Strict Lockdown In India To Break Coronavirus Chain

An interim efficacy analysis published in the leading medical journal The Lancet has found that Covaxin is “safe, immunogenic with no serious side effects.” However, it was only the phase 2 results of the vaccine and the report suggested that further corroboration with phase 3 safety results. Also Read - Kumbh Mela Haridwar: Over 1000 Tests Positive For COVID-19 In 48 Hrs After Taking Holy Dip

The report says, “The results reported in this study do not permit efficacy assessments. The evaluation of safety outcomes requires extensive phase 3 clinical trials. We were unable to assess other immune responses (i.e., binding antibody and cell-mediated responses) in convalescent serum samples due to the low quantity. Furthermore, no additional data on the age of the participant or the severity of disease from symptomatic individuals were obtained.”
It was also reported that comparisons between phase 1 and 2 trails were not done. “Conclusions are to be considered as posthoc analyses. Even though direct comparisons between the phase 1 and 2 trials cannot be made, the reactogenicity assessments reported in this study were substantially better in the phase 2 trial than the phase 1 trial and other trials with a placebo group,” continued the report. In the phase 2 trial, the proportion of participants who reported adverse events were lower than the phase 1 trial. Also Read - Out of the tri-doshas, which are responsible for COVID-19 infection?

Researchers did a randomized, double-blind, multicenter, phase 2 clinical trial that helped evaluate the safety and immunogenicity of Covaxin in healthy adults and people between the ages of 12 and 65 at 9 hospitals in India. According to the researchers, the most common adverse event in the phase 2 trial was a pain in the injection site along with a headache, fatigue, and fever. No life-threatening adverse events were reported in the trial.

They administered two intramuscular doses of vaccine, four weeks apart, in 380 healthy children and adults. They observed higher neutralizing antibody litres (2-fold) in the second phase of the trial. After two doses, it was found that people experienced a side effect of 10-12 per cent, which is six times lower than other Emergency Use Authorized vaccines.

In the second phase of vaccination that started on March 1, Prime Minister Narendra Modi took the Covaxin shot to ensure people that it is safe. Also, the results of phase 3 released last week claimed that the vaccine showed 81 per cent efficacy in preventing the coronavirus, in those without prior infection, after the second dose.

(with inputs with IANS)

Published : March 9, 2021 4:32 pm | Updated:March 10, 2021 11:11 am

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