2 January: After the first general public administering of COVID-19 jab in the UK, the vaccine race in India is approaching the end. The Serum Institute of India (SII) is all set to receive an emergency use authorisation for its vaccine ‘Covishield’, co-developed by Oxford University and pharma giant AstraZeneca. On Friday, January 1, 2021, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) reviewed the application from the front-runner vaccine developers and recommended the grant of emergency use authorisation (EUA) for SII’s Covishield.
The Drugs Controller General of India (DCGI) is likely to issue the final authorisation this weekend. According to government sources, the vaccination process will begin from January 6.
The first vaccine to be approved for public use as the other two applications—by Pfizer and Bharat Biotech—are still under review. Along with Covishield, the expert committee reviewed the applications of India’s indigenous shot Covaxin on Friday. The committee has reportedly asked for more data as well as the interim efficacy analysis for Covaxin, which has been co-developed by Bharat Bharat Biotech and Indian Council of Medical Research (ICMR). UK government has already issued an emergency use authorisation for the Oxford-AstraZeneca COVID-19 vaccine on December 30. The UK, which is currently fighting with the sudden spike in the number of cases due to the spread of a new mutated variant of coronavirus, has already ordered 10 crore shots of the vaccine, sufficient to vaccinate 5 crore people.
The Oxford-AstraZeneca COVID-19 vaccine is proven to be safe with no major side-effects reported throughout the human trials. It is shown to generate strong antibody and T-cells response for long-term immunity against the novel coronavirus SARS-CoV-2. The pausing of the trials to address safety concerns in the second week of September received a lot of publicity, but a review by the Medicines Health Regulatory Authority (MHRA) in UK reinforced the proof of vaccine safety, allowing the trials to resume after a week.
However, among a limited number of participants, who received a lower first dose followed by a full second dose, the efficacy went up to 90%. The overall efficacy, combining different dosage groups, was shown to be 70%. However, the half-dosage method was a result of a dosage error, as admitted by AstraZeneca. Moreover, the relatively lower number of volunteers of more than 55 years has also raised some eyebrows.
Oxford-AstraZeneca vaccine may seem less compared to the extraordinary efficacy of around 95% showcased by Pfizer and Moderna’s vaccines in the US, the easy storage and transportation benefits of Covishield trumps these two vaccines that must be stored need to be stored at ultracool temperatures of -20 t0 -70°C. The Oxford-AstraZeneca vaccine can be stored at regular fridge temperatures.
The SII has already manufactured 5 crore doses of the vaccine and is progressively building its stock under the at-risk manufacturing and stockpiling licence from the DCGI, and aims to produce around 30 crore doses by July 2021. The SII has an agreement with AstraZeneca to produce 100 crore doses, mainly for supply to developing countries.
The central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crores elderly, mostly above the age of 50 years with comorbidities. India currently has eight COVID-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorisation in coming months. A nationwide dry run to assess the preparedness for vaccination has been initiated on Saturday, January 2.
Globally, a whopping 64 COVID-19 vaccines are under clinical trials on humans, with 19 vaccines reaching the final phase of the trials, as per the New York Times. Most countries with large populations, including China, USA, UK and Russia, have initiated vaccination in December.