The UK government on December 30 approved the use of Oxford University-AstraZeneca COVID-19 vaccine after a "thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness".
The UK nod will strengthen the case for quick approval of the Serum Institute of India's emergency use authorisation application. SII is a partner of the Oxford University-AstraZeneca and is manufacturing the vaccine in India.
The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), India's drug regulator, is likely to meet later on December 30 to take a possible decision on SII's application.
AstraZeneca said it would continue to work with regulatory authorities around the world to support their rolling reviews for emergency supply or conditional marketing authorisation. AstraZeneca is also seeking emergency-use listing from the World Health Organization (WHO) for a quick vaccine availability in low- and middle-income countries.
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.
Along with data from local clinical trials, drug regulators of emerging world like India generally take cues from their counterparts in the US, the UK, Europe and Japan before deciding on approvals.
Government officials and ministers have hinted at the possibility of the vaccine rollout in India as early as January first week.
Earlier this week, SII CEO Adar Poonawalla said the company had been adding 40-50 million doses every month and will be reaching a production capacity of about 300 million doses by July 2021.
Poonawalla said 50 percent of the vaccine supplies will go to India, and the rest will go to COVAX, the WHO's programmed to deliver COVID-19 vaccine to poorer countries. However, during the initial months, India would prioritise supplies.
The government is planning to vaccinate 300 million, or 23 percent of the population, in the first wave of vaccination. The first phase will target 10 million frontline health workers by February. In the second phase, 20 million frontline and essential workers would be administered the jab by March and in the third phase, 270 million people aged over 50 and with co-morbidities would be vaccinated by August.
VK Paul, NITI Aayog member and the head of the national expert group on vaccine administration for COVID-19, told media that the government had formed a committee to come out with guidelines on ascertaining the high-risk groups that need to be vaccinated. The government has also been conducting dry runs in four states.The UK government said having studied evidence on both the Pfizer-BioNTech and Oxford University-AstraZeneca vaccines, the Joint Committee on Vaccination and Immunisation (JCVI) has advised the priority should be to give the vaccine as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible.