India Coronavirus Dispatch: How emergency vaccine authorisation works

Queues at Ahmedabad's crematoriums get longer, doubts about AstraZeneca vaccine and bringing diagnostics closer to communities-news relevant to India's fight against Covid-19

What is the emergency use authorisation drugmakers are seeking for the Covid-19 vaccine?

Vaccines, like medicines, require the approval of a regulatory authority before these can be administered. In India, the top regulatory authority is the Central Drugs Standard Control Organisation, or CDSCO.

In the case of vaccines, and also medicines, the approval is granted after an assessment of its safety and effectiveness, based on data generated from trials on animals and human beings. In fact, approval from the regulator is required at every stage of these trials. This is a long process, designed to ensure that medicine or vaccine is absolutely safe and effective. 

But in emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals to medicines, vaccines, and other medical products, if there is sufficient evidence to suggest that these are safe and effective, and would help in dealing with the emergency. Read more here

From Covid-19 To AIDS, it is important to take diagnostics closer to communities

With the end of India’s fight against Covid-19 not yet in sight, the resilience of the country’s health systems is faced with a serious test, says S.Y. Quraishi, former chief election commissioner of India.

The limitations of the public health system in India are well-known. India lags behind not only among its BRICS peers but also some of its neighbours on the health and quality (HAQ) index.

Covid-19 has substantially disrupted healthcare services, especially due to overburdening at hospitals and clinics. In settings like ours, with a high burden of HIV, tuberculosis, and other infectious diseases, these disruptions have in turn driven up the number of deaths due to HIV by up to 10%, and due to tuberculosis by up to 20%. Read more here

A clinical trial participant falls Sick. What happens next?

No vaccine – or drug, from aspirin to zinc – is absolutely risk-free. But no vaccine is licensed wherein the benefits don’t hugely outweigh any risks. To know risk is rare is no consolation when adverse events following immunisation (AEFIs) occur, but it’s important as a society to understand that the risks exist and are measured, says Gagandeep Kang, a professor of microbiology at the Wellcome Trust Research Laboratory, division of gastrointestinal sciences at the Christian Medical College, Vellore.

But if a participant becomes ill – especially in a vaccine trial – all medical and psychological support possible has to be provided, as we do our best to assess relatedness. That is an individual as well as collective responsibility. Read more here

Queues at crematoriums get longer in Ahmedabad as Covid-19 cases surge

As Gujarat saw 20 deaths due to Covid-19 on Monday — the highest since August — of which 13 were from Ahmedabad city, there were long queues of relatives outside city hospitals to receive the bodies of their dear ones, as well as outside crematoriums. Ahmedabad does not have any designated crematorium for Covid-19 deaths. Read more here

Covid-19 reinfection cases spark panic in Delhi, debate over longevity of antibody

A hospital under the Delhi government which is also a designated Covid-19 facility recently reported that five of its doctors have gotten reinfected with the virus for a second time. Read more here

Why Serum Institute wants to sue vaccine participant for Rs 100 Cr

While the vaccine against Covid-19, being developed by AstraZeneca and the University of Oxford, remains plagued by global questions over its efficacy, trouble seems to be brewing for the much-talked-about vaccine at home as well. This time, over a series of side-effects, as alleged by a trial participant. 

Officially known as Covishield, the AstraZeneca vaccine has the capacity to produce 100 million doses by the end of December 2020. This vaccine could be India's best bet. So, read more here as to why the allegations raised by the trial participant may matter.  Read more here