Serum Institute of India (SII) is likely to submit the findings of COVID-19 clinical trial before the end of December. If the data is found satisfactory, the government may approve the Oxford-AstraZeneca coronavirus vaccine by the first week of January.
SII is expected to submit the final set of data before the subject expert committee in the next 10 days or so, people in the know told Business Standard.
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Last week, the subject experts committee (SEC) constituted by the Drug Controller General of India (DCGI), sought more data from Serum Institute of India for further consideration of their emergency use authorisation applications for Covishield.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"After detailed deliberation, the committee recommended that the SII should submit the following data/information for updated safety data of Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK MHRA for grant of EUA," DCGI said.
Read: 100 people to be vaccinated per session, says Centre's new SOP on COVID-19 vaccine distribution
SII’s Chief Executive Officer (CEO) Adar Poonawalla has said that India can start its initial vaccine roll out by January 2021. However, the company expects a full-fledged approval to come by March 2021. The Pune-based firm has already manufactured 40 million doses of the AstraZeneca vaccine.
Meanwhile, the government on December 14 released guidelines for COVID-19 vaccination drive. Vaccinating 100-200 people in each session per day, monitoring them for 30 minutes after administering the shots for any adverse event and allowing only one beneficiary at a time are among the guidelines issued by the Centre for the COVID-19 inoculation drive.
Explained | Why DCGI set aside emergency approvals of Serum Institute, Bharat Biotech COVID-19 vaccines
COVID Vaccine Intelligence Network (Co-WIN) system--a digitalised platform--will be used to track enlisted beneficiaries for the vaccination and anti-coronavirus vaccines on a real-time basis.
So far, India has recorded 99,06,165 confirmed COVID- 19 cases, including 1,43,709 deaths. A total of 94,22,636 patients have recovered, as per the latest data from the Union Health Ministry. There are 3,39,820 active cases in the country.
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