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Author : Dr K Aggarwal , President CMAAO, HCFI
With input from Dr Monica Vasudev
India
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New Delhi, January 02, 2020 ;
The Oxford COVID-19 vaccine manufactured by the Serum Institute of India was sent for approval to the regulator Drugs Controller General of India (DCGI) by a government-appointed panel of experts. The centre is looking to start giving vaccine shots from this month, once the vaccine is cleared for a final time by the DCGI.
Covishield, which is similar to the ‘Oxford vaccine’ developed by the Oxford University vaccine group and marketed by AstraZeneca, was approved by the health regulator in the UK under emergency use conditions on Thursday. Under this the company can deploy its vaccines to priority groups and then the larger public, even though a full safety assessment hasn’t been completed.
For Covishield appraisal, the nod by the UK regulator and data from a phase 2 trial on 100 volunteers in India, antibody levels generated in the volunteers in response to the vaccine, and safety data from phase-1 studies were also relied onto accord emergency use approval.
In the UK, the vaccine has been recommended to be given in two doses 4-12 weeks apart. There is no clarity on how long the protective effect of a single first dose lasts. The UK regulator allowed this after a spike in cases in recent weeks and decided to ensure that maximum people get at least one dose of a vaccine. A longer dosage interval means that potentially more Indians could get at least a single jab of the vaccine. Covishield is currently being tested in 1,600 volunteers as part of its phase 2/3 trial. However, the results from these trials have not been published in scientific journals.
Other than the case from Chennai of a reported severe adverse event from the vaccine, no other safety events have been reported [said reaction was not directly linked to the vaccine].
Pfizer India, m-RNA vaccine has already been approved, under emergency use conditions, in the United States, United Kingdom and pre-qualified by the World Health Organisation. (Excerpts from The Hindu)
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