The Serum Institute of India (SII) can apply for emergency use authorisation (EUA) of the AstraZeneca and Oxford University’s COVID-19 vaccine in India once it is approved in the UK,since it is a partner developer, Dr Randeep Guleria, Director of AIIMS, has said.
A member of the Centre’s taskforce on vaccines, Dr Guleria said if the vaccine candidate was approved by UK authorities, SII could also apply for emergency use in India based on the same data.
“The SII will have to wait for data to be authorised in the UK; based on that SII can approach Indian authorities for EUA. We can’t do that unless UK regulatory approves,” Dr Guleria told News18.
AstraZeneca announced that its vaccine proved to be 70 percent effective in large-scale trials, giving the world's fight against the pandemic a new weapon, cheaper to make, easier to distribute and faster to scale up than rivals.
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.
SII’s Covidshield is in its third phase trials and data will only be generated after the phase concludes, Dr VK Paul, member of the Expert Group on Vaccines, told News18.
SII CEO Adar Poonawalla said India could approve the emergency use of Covidshield by December 2020. “Once cleared, the vaccine will be used to protect priority beneficiaries identified by the Centre, including frontline healthcare workers and elderly,” he said.
"SII is hoping the data released earlier, along with preliminary data from the ongoing trial of the vaccine in India, will allow it to seek EUA for the vaccine by year-end, before gaining approval for a full rollout by February or March next year," said Poonawalla.
Prime Minister Narendra Modi is holding a high-level meeting with all stakeholders, including members of the Task Force on Vaccines, on November 24, sources in the government said.
The Centre, they added, was dialling manufacturers for early completion of trials and data so that the doors to emergency use open up, News18 reported.Follow our full COVID-19 coverage here