Bharat Biotech releases results of Phase-3 trials; 65% effective against Delta varaint
Hyderabad-based Bharat Biotech has released the final data of the Phase-3 clinical trial of its corona vaccine Covaxin. It has proved to be 77.8% effective against corona virus. The efficacy of Covaxin against the delta variant is reported to be 65%.
According to Bharat Biotech, the vaccine works 93.4% in cases with severe symptoms of corona. Apart from this, Covaxin is 63.6% effective in case of mild symptoms. Against the B.1.617.2 (Delta) variant, which is currently causing worldwide concern, it has a proven efficacy of 65%. The results of the Phase III trial of Covaxin have been published in the MedRxiv Preprint Server.
Trial on more than 25 thousand people in 25 hospitals
According to the data, the trial was done on 25,800 people in 25 hospitals. In this it was seen how much this vaccine protects against corona. Covaxin has been developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR). According to sources, Covaxin may get approval from the Drug Controller General of India (DCGI) today.
The SEC had approved the data
The company had submitted the data of the trial to the Drug Controller General of India (DCGI) a few days ago. After this, an important meeting of the Subject Expert Committee (SEC) was held and the data of the Phase 3 trial of the vaccine was approved.
WHO had approved the EOI
Earlier, the Expression of Interest (EOI) of Bharat Biotech was accepted by the WHO. The company submitted the EOI on April 19 to get approval for Covaxin.
What is the significance of WHO’s emergency use approval?
The WHO’s Emergency Use Listing examines the safety and effectiveness of a health product in a public health emergency such as a pandemic. The WHO gave emergency use approval to Pfizer’s vaccine on 31 December 2020, Oxford-AstraZeneca’s vaccine on 15 February 2021 and Johnson & Johnson’s vaccine on 12 March.
According to the WHO, in view of the emergency situation, it is necessary to develop and approve medicines, vaccines and diagnostic tools as soon as possible. That too while meeting the standards of safety, efficiency and quality. This assessment ensures the usefulness of these products to a wider range of people during the pandemic.
