The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), India's drug regulator, will be meeting on January 1 to further review the emergency use applications of Serum Institute of India (SII) and Bharat Biotech COVID-19 vaccines.
The SEC which met on December 30 couldn't take a decision on SII's COVID-19 vaccine, as it needed more data.
"The additional data and information presented by SII and Bharat Biotech was perused and analysed by the SEC. The analysis of the additional data and information is going on. SEC will convene again on 1 January 2021 (Friday)," the CDSCO said in a statement.
The CDSCO said Pfizer requested more time to make its presentation for its vaccine.
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".
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.
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.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 for quick vaccine availability in low- and middle-income countries.