Coronavirus vaccine likely to be approved by the Indian government, three companies in the race
A big decision on coronavirus vaccine is likely to be taken on the first day of the new year. On January 1, today, the Subject Expert Committee of the Central Drug Standards Control Organization will hold a meeting on vaccination of coronavirus vaccine. The meeting will review data from three companies that have sought permission from the Emergency Use Authorization. The DCGI will decide on the recommendation of this committee. Serum Institute of India, Bharat Biotech International Limited and Pfizer have sought approval for emergency use.
The first meeting of the Subject Expert Committee on Coronavirus Vaccine was held on December 9. In this meeting
– We need more time to provide more information about our data, a written request was made by Pfizer. Pfizer was later granted an extension by the Subject Expert Committee.
– The safety data collected by the Serum Institute was till November 14th. After lengthy discussions, the committee asked the Serum Institute of India for some information for review. This information is as follows
1- Updated data of the second and third phase of the clinical trial.
2 – Immunogenicity data from clinical trials in the UK and India.
3 – Emergency Use Authorization Information to UK Regulator.
– Bharat Biotech has also requested all the information. Bharat Biotech has been asked to submit information on the efficiency and safety of the ongoing clinical trials to the committee.
This was followed by another meeting of the Subject Expert Committee on 17th December in which further information was sought from the Serum Institute of India and Bharat Biotech International Limited, which was submitted.
Then on December 30, the SEC, the Subject Expert Committee, met again to discuss a coronavirus vaccine. According to the Ministry of Health, the emergency use of Pfizer, Serum Institute of India and Bharat Biotech vaccine was discussed.
– The meeting discussed additional information received by the SEC from Serum Institute and Bharat Biotech.
– Pfizer also asked for some more time in this meeting.
– Additional data assigned by companies is being reviewed. There will be another meeting on January 1, today.
The Subject Expert Committee may meet again today to review the data and make a recommendation. This recommendation will be made by DCGI i.e. Drug Controller General of India. On that basis, DCGI will announce its decision.
Meanwhile, the Serum Institute of India, which is developing the Oxford and Estrogen vaccines and testing them in India, has received approval for emergency use in the UK. At the first meeting of the Subject Expert Committee, it was stated that if permission is obtained from the UK regulator, this information should be provided along with the data. The second and third phases of the vaccine were also tested in India. Therefore, the Subject Expert Committee is expected to respond positively to this vaccine, with the permission of DCGI.
Government is prepared for vaccination
Which coronavirus vaccine gets approved first is still not known. But the Indian government has made preparations for this. Training of vaccinators and information of those who want to be trained to the cold storage everything is ready. In the first phase, the vaccine will be given to 30 crore citizens, for which priority has been fixed.
The vaccine will be given first to health workers, then to frontline workers and then to people over 50 years of age and those below 50 years of age who have a serious illness. In this regard, a two-day dry run has also been conducted in four states. From tomorrow, January 2, a one-day dry run will be held in all the states.