Two vaccines for coronavirus, Oxford Institute’s Covishield, that has been developed by the Pune-based Serum Institute, and Bharat Biotech’s Covaxin, received emergency approval from India’s drug regulator.
Drugs Controller General of India Dr VG Somani briefed the media on 3rd January 2021 saying that,
“the Subject Expert Committee of the Central Drugs Standard Organisation consisting of domain knowledge experts of pulmonology, microbiology, immunology, Pharmacology, Pediatrics, internal medicine etc. recommends permission to Serum Institute India vaccine named “Covishield” and Bharat BioTech vaccine named “Covaxin” for restricted Emergency Approval”Dr VG Somani
The DCGI farther stated that the Serum Institute India provided us with the data of 23745 participants aged over 18 or older from abroad clinical studies. Based on the data, general vaccine efficacy for Serum Institute Of India was 70.42 per cent. Further Serum Institute India was granted consent for conducting Phase2/Phase3 on 1600 individuals within the country.
Regarding Bharat Biotech “Covaxin” the DGCI told that it is inactivated vaccine and has an established track record within the country and globally. Bharat Biotech ran Phase 1, and Phase 2 clinical trials of covaxin on 800 subjects, and the results revealed that the vaccine is safe and gives a robust immune reaction.
The Phase 3 efficacy trials had been conducted in India on 25800 volunteers and until today 22500 vaccinated, and the vaccine has found to be safe until date. He also added that Bharat Biotech will continue within the country. Both the vaccine has to be taken in 2 doses and should be stored at 2 to 8 degree centigrade.
Some Facts About Covishield
- Covishield is co-developed by Oxford University and pharma giant AstraZeneca.
- The vaccine uses a replication-deficient chimpanzee viral vector based on a weakened form of a common cold virus (adenovirus) and comprises the SARS-CoV-2 virus spike protein’s genetic material. After vaccination, the surface spike protein is generated from the human body with no effects of the genuine COVID-19 disease, allowing the immune system to attack the SARS-CoV-2 virus if it infects the entire body in the future.
- The SII(Serum Institute India) has already manufactured five crore dosages of the vaccine and is progressively building its inventory under the at-risk production and stockpiling licence from the DCGI. It intends to produce around 30 crore doses by July 2021. The SII has an agreement with AstraZeneca to create 100 crore doses, chiefly because of supply to developing countries.
- The UK government has already issued an emergency use authorisation for the Oxford-AstraZeneca COVID-19 vaccine on December 30. Even the UK, which is now fighting the sudden spike in the number of cases due to the spread of a new mutated variant of coronavirus, has ordered ten crore shots of this vaccine, sufficient to vaccinate five crore people.
- The vaccine would be priced at around 500 to 600 rupees in India.
Some Facts About Covaxin
- COVAXIN, India’s native COVID-19 vaccine by Bharat Biotech is manufactured in cooperation with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
- The vaccine obtained DCGI approval for Stage I & II Human Clinical Trials and the trials Started across India in July 2020.
- After completing the interim analysis from the Phase 1 & 2 clinical trials of COVAXIN, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
The central government plans to vaccinate nearly 30 crore people in the very first phase of the driveway. It’ll be offered to a single crore health care employees, in addition to two crore frontline and essential employees and 27 crores older, mainly over age 50 years with comorbidities.
India now has eight COVID-19 vaccine candidates, including three native vaccines, under distinct clinical trials phases, which might be prepared for authorisation from the forthcoming months. A nationally dry run to estimate the readiness for vaccination was initiated on Saturday, January 2.
Globally, 64 COVID-19 vaccines are under clinical trials on humans, with 19 vaccines reaching the trials’ final phase. Most countries with large populations, including China, USA, UK and Russia, have initiated vaccination in December.
Russian Direct Investment Fund (RDIF) and Indian pharma firm Hetero, have consented to make over 100 million doses annually of Sputnik V covid vaccine in India. The creation of this Russian covid vaccine is anticipated to begin at the start of 2021.