Covexin Phase-2 Trials Results Announced; Will keep safe from Corona for a year

 Covexin Phase-2 Trials Results Announced; Will keep safe from Corona for a year

Covin is equally effective on men and women as well as children

A decision on emergency approval of covexin may come next month

The company made the claim based on a study conducted on 380 volunteers

Bharat Biotech has announced the results of clinical trials of Phase-2 of Indigenous Vaccine-Covacin. According to which this vaccine is able to protect against corona for at least 12 months. Most notably, the vaccine has been shown to be equally effective on men and women of all ages. Phase-3 trials of the vaccine are currently underway. The company has also sought emergency approval from the drug regulator for its vaccine.

There are reports that AstraZeneca and Oxford University's Vaccine-Covishield could receive emergency recognition by the end of December. The data requested by the Subject Expert Committee of the Drug Regulator has been submitted by the Serum Institute of India (SII), which is conducting vaccine trials in India. The committee of subject experts has sought data from Bharat Biotech on the preliminary results of the ongoing Phase-3 trials of the vaccine across the country for their vaccine.

Meanwhile, Bharat Biotech Wednesday announced the results of Phase-2 of Covexin i.e. BBV152. It has long been shown to be the appropriate antibody and T-cell memory response in the body. The vaccine has been found to be effective even three months after the second dose of vaccination was given to Phase-1 volunteers. So the Phase-2 trials have shown increased humoral and cell-mediated human response to the vaccine.

This is how to understand the phase-2 results of convex...

Trials of Covexin of Bharat Biotech have been conducted on the basis of randomized on 380 healthy children and adults. Two formulas of 3 micrograms and 6 micrograms were determined. Two groups were formed and they were given two intramuscular doses within four weeks.

In the follow-up of the Phase-1 trial, Covexin produced high-level neutralizing antibodies. Even three months after the second vaccination, the number of antibodies in all volunteers has increased. Based on this result, the company claims that the antibodies produced in the body due to covexin last for 6-12 months.

The number of neutralizing antibodies was found to be higher in the Phase-2 study than in the Phase-1 study. The best part is the local and systemic side effects that have been reported since the vaccine was administered. He has also recovered within 24 hours. No serious side effects were found.

સંપૂર્ણ માહિતી ગુજરાતી માં વાંચવા અહી ક્લિક કરો

Why is Emergency Approval being delayed?

Bharat Biotech had sought emergency approval for covexin in the first week of December. On which a meeting of the Subject Expert Committee of the Drug Regulator was also held. The committee asked Bharat Biotech to submit additional data related to safety and efficiency. Emergency Use Approval (EUA) will then be issued. For that, the company will have to submit safety and efficiency data from the ongoing Phase-3 clinical trials in the country.