Coronavirus vaccine update: Serum Institute of India says will resume trials after DCGI nod

4 | Chinese President Xi Jinping offers to cooperate with India, BRICS countries to develop COVID-19 vaccine: Chinese President Xi Jinping on November 17 offered to cooperate with India and other BRICS nations in the development of vaccines against the coronavirus and called for holding a symposium by the five-member bloc on traditional medicine to explore its role in the COVID-19 prevention and treatment.

Serum Institute of India (SII) will resume clinical trials of AstraZeneca's COVID-19 vaccine candidate after getting the permission from the Drugs Controller General of India (DCGI), the Pune-based vaccine maker said on September 12.

Pharma giant AstraZeneca on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe.

"Once DCGI will give us the permission to restart the trials in India, we will resume the trials," SII said in a statement.

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In a tweet, SII CEO Adar Poonawalla said: "As I'd mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford."

As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford. https://t.co/ThIU2ELkO3

COVID-19 Vaccine

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How does a vaccine work?

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.

How many types of vaccines are there?

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.

What does it take to develop a vaccine of this kind?

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.

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— Adar Poonawalla (@adarpoonawalla) September 12, 2020

The human trials resumed days after a pause had been announced in the trials after an adverse reaction in one of the participants.

Following the suspension, the DCGI directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the vaccine candidate.

AstraZeneca and the University of Oxford, as the trial sponsor, on Saturday said that they cannot disclose further medical information but confirmed that independent investigations concluded that the trials were safe to restart.

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