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Indian Express Explained-04/07/2020

1) Explained: ICMR claims it wants to launch Covaxin by August 15

Central Theme- ICMR has targeted August 15 launch for Covid-19 vaccine. How much remains in the trial process? How have other vaccine candidates progressed?

What is Covaxin?

It has been developed by the company Bharat Biotech India (BBIL) in collaboration with ICMR’s National Institute of Virology (NIV). It is an “inactivated” vaccine — one made by using particles of the Covid-19 virus that were killed, making them unable to infect or replicate.

When does ICMR aim to launch it?

Aiming to make it available for public use by August 15, Bhargava wrote to the 12 trial sites to ensure “all” clinical trials were conducted by then. While BBIL’s application with the Clinical Trials Registry of India (CTRI) shows it plans to complete enrolment of trial participants by July 13.

Is this achievable?

  • A vaccine usually goes through three phases of human trials. The Central Drugs Standard Control Organisation has given approvals for phase I and II trials so far. According to details from CTRI, BBIL in its application estimated phase I and II trials to take a year and three months, including at least a month for phase I alone.
  • While vaccine trials can be fast-tracked, it still takes over a year to launch the product, experts said.
  • In a pandemic, emergency-use approval can be given if data from the first two trial phases is compelling enough,
  • This would allow the launch without the third phase being conducted, but this approval would likely be given with riders to submit additional data and adverse event reports.

What other types of vaccine candidates are being studied?

Over 100 vaccines are being tested globally, including inactivated and various other types. Some of the frontrunners include:

Non-replicating viral vector

  • The SARS-CoV-2 virus uses the spike on its surface, the ‘spike protein’, to enter and infect cells and multiply. A non-replicating viral vector vaccine uses a weakened version of a different virus to carry this Covid-19 spike protein into the body, but it is modified not to replicate.
  • FRONTRUNNERS: The University of Oxford, in collaboration with AstraZeneca.

RNA vaccine

  • These use messenger RNA (mRNA) molecules that tell cells what protein to build. In this case, the mRNA is coded to tell cells to build the molecular structure on the surface of SARS-Cov-2 — which the immune system will recognise and build antibodies against.
  • FRONTRUNNERS: Moderna, in collaboration with the US National Institute of Allergy and Infectious Diseases

DNA vaccine

  • These vaccines use genetically engineered DNA molecules that, again, are coded with the antigen against which the immune response is to be built.
  • FRONTRUNNER: Inovio Pharmaceuticals, in collaboration with the International Vaccine Institute.

2) What (and how long) does it take to make a vaccine; what’s the Covid timeline?

Central Theme- In general, a vaccine is developed and tested over a number of stages. For Covid-19, this has been fast-tracked in various ways.

Introduction

  • The August 15 target for launching Covaxin, India’s Covid-19 vaccine, is being described as a fast-track effort. This is because the development of a vaccine is usually a long, uncertain process. It is also expensive, with funding playing an important role.
  • One of the fastest developed vaccines is the one used for mumps, which received approval in four years after trials began in 1963.

Stages

In general, a vaccine is developed and tested over a number of stages.

Stage I: R&D

This typically takes two to four years. For Covid-19, this stage has been progressing fast for two reasons. First, a large number of candidates are based on the virus’s genetic code instead of its protein and second is technology.

Stage II: Pre-clinical

This is when scientists test the vaccine on cell cultures and animals. They first inactivate the virus, pull out parts of the genetic sequence, and test if it triggers an immune response.

Stage III: Clinical trials

On the basis of data submitted from the pre-clinical phase, regulators allow testing in humans. Very few candidates enter this stage. This phase consists of three phases and usually takes more than 90 months.

  • PHASE I: The vaccine is given to a small group of people — this takes about three months — and scientists measure antibodies in their blood.
  • PHASE II: If found safe, it moves to the next phase (6-8 months). The vaccine is given to several hundred people. This stage has been shortened in Covid-19 vaccine development.
  • PHASE III: Thousands of people are enrolled. This takes 6-8 months. This assesses how the vaccine works in larger populations.

Stage IV: Regulatory review

The manufacturer submits the data to receive a licence. In the US, approval typically comes after 10 months. However, this is fast-tracked during emergencies.

Stage V: Manufacturing

This requires immense resources — funds running into millions of dollars, infrastructure, raw material, and scientific expertise.

Stage VI: Quality control

The safety of the vaccine is monitored by both the regulator and the manufacturer.

3) New research: Testing on throat secretions reduces false negatives

Central Theme- Researchers have reported that testing of oropharyngeal secretions — secretions from the part of the throat at the back of the mouth — may reduce the number of false negative results.

What are False Negatives?

When a person carrying a pathogen tests negative — have been reported several times during the Covid-19 pandemic. These results have come up during nasal swab testing of patients who have seemingly recovered from the disease — but have later been found to be still carrying the virus.

Oropharyngeal secretions

  • Now, researchers have reported that testing of oropharyngeal secretions — secretions from the part of the throat at the back of the mouth — may reduce the number of false negative results.
  • Sampling of oropharyngeal secretions is a simple procedure that can be performed in any quarantine setting. It minimises contact between healthcare workers and patients, thereby reducing the risk of virus transmission, the researchers said.

4) Explained: Standoff in week 9, what are India’s options on China border now?

Central Theme- The Article talks about What options are available to India to restore status quo ante on the Line of Actual Control (LAC) in the region?

OPTION 1: Evict the Chinese by force, destroy what they built

This, however, will almost certainly lead to military escalation and in a full-blown war. Even the limited attempt to evict the Chinese from the observation post near PP14 on June 15 led to the clash in which 20 Indian soldiers and an unspecified number of Chinese lost their lives.

OPTION 2: ‘Quid pro quo’ tactic

There are areas on the LAC that are not strongly defended by the Chinese, where Indian soldiers can move in and occupy a swathe of Chinese territory. At the negotiating table, the two sides can then exchange the occupied territories, and restore status quo ante.

But such proactive options have a certain window of opportunity, which may have been lost after eight weeks of tensions. Also, it carries the risk of military escalation, as the Chinese may misread it as a larger military attack, or see it as a provocation.

OPTION 3: Hold the line and negotiate

  • In this scenario, the Indian Army “holds the line” by deploying in strength along the LAC to ensure that the Chinese do not ingress deeper.
  • Talks are held simultaneously, including, if required, at the highest political level, to ensure the Chinese side returns to status quo ante.
  • It could allow for the formation of newer diplomatic, security, and trade partnerships to put China under pressure.
  • The downside is the prolongation of the standoff, possibly into winter, which would impose a heavy logistic and financial burden on the Indian Army.

OPTION 4: A limited war

It can be limited in terms of geography — say, only in Ladakh, or in time — for a few days before India unilaterally declares a cessation of hostilities. This would be a very bold move; it carries the greatest risk of a full-blown war against a well-prepared adversary.

5) Explained Ideas: Why sudden boycott of China would be counter-productive for India’s pharmaceutical industry?

Central Theme- boycotting trade with China amidst recent political tensions between the two countries. Such a possible move, however, is a major cause of concern for India’s pharmaceutical industry as well as for people in India

Impact on Industry and People

  • India is the third-largest producer of finished drugs in the world, it relies significantly on China for supplies of active pharmaceutical ingredients (APIs), the key components in making medicines.
  • An estimated 70 per cent of API requirements of India’s pharmaceutical industry are sourced from China. For some drugs, such as paracetamol and ibuprofen, this dependence is almost 100 per cent
  • A severe contraction of Indian pharmaceutical production would affect access to medicines both in India and globally.
  • In India, any decoupling from China must be strategic, with significant policy support, and it will take time for a paced indigenization

6) Ladakh through a bifocal lens: a short zoom-in, zoom-out history

A short primer on the region, its history, and some of the places where Indian soldiers are locked in conflict with the Chinese army.

Looking back at an ancient land

  • Lying between the Kunlun mountain range in the north and Himalayas to the south, Ladakh was originally inhabited by people of Indo-Aryan and Tibetan descent.
  • Historically the region included the valleys of Baltistan, Indus, and Nubra, besides Zanskar, Lahaul and Spiti, Aksai Chin, Ngari and Rudok.
  • In the beginning of the first century AD, Ladakh was part of the Kushan empire.
  • Later it changed hands multiple times, alternating between the kingdoms of Kashmir and Zhangzhung.
  • In 1834, Gen Zorawar Singh, a general of Raja Gulab Singh who ruled Jammu as part of the Sikh empire, extended the boundaries of Maharaja Ranjit Singh’s kingdom to Ladakh, which till the 15th century was part of Tibet and was ruled by dynasties of local Lamas.

Partition, Pakistan and Chinese occupations

  • Immediately after India’s Partition, tribal raiders from Pakistan attacked Ladakh. They captured Kargil, and were heading for Leh when they were confronted by the Indian Army, who got back Kargil.
  • China today claims Aksai Chin to be part of Hotan county of its Xinjiang province.
  • Pakistan ceded the Shaksgam Valley, which was part of the Baltistan region north of the Karakoram, to China following a Sino-Pakistani agreement signed on March 2, 1963

The strategic importance of Ladakh

The Tibetan revolt of 1959 and the Dalai Lama’s flight to India saw China further strengthening its military presence in Ladakh to ensure the security of NH 219. India reacted with its ‘forward policy’ as part of which it began setting up Army posts in the region to prevent Chinese expansion.

Pangong Tso, the contested lake

  • Lake which is one-third in India and two-thirds in China, is of great tactical significance to the Chinese who have built infrastructure along both its sides to ensure the speedy build-up of troops.
  • Chinese incursions in this region aim at shifting the LAC westward so that they are able to occupy important heights both on the north and the south of the lake, which will enable them to dominate the Chushul Bowl.

Strategic SSN, to the far north

  • The area spanning Galwan, Depsang plateau, and Daulat Beg Oldie (DBO), is called Sub-Sector North (SSN).
  • This enclave that lies to the east of the Siachen glacier is of immense significance given its proximity to the Karakoram Pass, close to China’s western highway or NH 219 going to Aksai Chin. It’s the SSN that provides land access to Central Asia through the Karakoram Pass.
  • Domination of this area is also crucial for the protection of the Siachen glacier, lying between the Saltoro ridge on the Pakistani side and the Saser ridge close to the Chinese claim line.
  • Occupation of Galwan will neutralise the tactical advantage India gained by building the all-weather Durbuk-DBO road over the last two decades
  • The Chinese have also intruded into the Depsang plains near a place called Bottleneck point, an area 7 km away from an ITBP base on the newly-built Darbu-Shyok-DBO road.
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