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11th November 2020
Pfizer's Covid-19 m-RNA Vaccine
Recently, American pharma company Pfizer has claimed that its vaccine candidate BNT162b2 is more than 90% effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection.
The premise of any vaccine is to induce a long-lived immune “memory” in the form of B and T cells. Upon any encounter with a pathogen (which can be bacteria or viruses), these cells will recognise the danger and fight it off by destroying the pathogen and pathogen-infected cells. The danger signal takes the form of an antigen, a molecule that notifies the immune system of a pathogen. For SARS-CoV-2, the antigen targeted by B and T cells is usually a protruding spike protein on the surface of the virus.
The challenge in vaccination is inducing this response, which requires a handshake between an antigen-presenting cell and a specific type of T cell, without getting people sick. It’s the antigen peptide (smaller sections of antigen molecule) presented in this interaction that determines the target of the immune response.
Common vaccines are weakened or inactivated versions of the virus, like the yearly flu or the polio vaccine children receive 2 months after birth. A huge variety of antigens, some useful and some not, can be presented since cells are receiving the entirety of the virus. Newer vaccines utilise other engineered, well-studied doses containing specific regions of the target pathogen to create specific immune reactions.
- BNT162b2:
- It is a single nucleoside-modified messenger RNA (modRNA) vaccine, which is made of a short segment of genetic material (the messenger RNA/mRNA) which provides instructions for a human cell to make a harmless version of a target protein, in this case the spike protein of SARS-CoV-2, in order to activate an immune response.
- The mRNA vaccine is a new approach to protecting against viral infection.
- Unlike traditional vaccines, which work by training the body to recognise and kill proteins produced by pathogens, mRNA tricks the patient's immune system to produce viral proteins itself.
- The proteins are harmless, but sufficient to provoke a robust immune response.
- Its phase 3 clinical trial began in July with 43,538 participants, 38,955 of whom had received a second dose by November. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose.
- It means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
- Pfizer has become the first firm to release promising late-stage trial data of a potential vaccine for Covid-19, even though the announcement does not have scientifically conclusive evidence on the safety and efficacy of the vaccine candidate.
- However, the analysis of the vaccine candidate by an external independent Data Monitoring Committee (DMC) has not reported any serious safety concerns.
- The announcement comes days before the company plans to submit safety and efficacy data from the trial to the American regulator, the United States Food and Drug Administration (USFDA) seeking emergency use authorisation.
- It is a single nucleoside-modified messenger RNA (modRNA) vaccine, which is made of a short segment of genetic material (the messenger RNA/mRNA) which provides instructions for a human cell to make a harmless version of a target protein, in this case the spike protein of SARS-CoV-2, in order to activate an immune response.
- Vaccines Worldwide:
- As of mid-October 2020, the World Health Organization (WHO) has identified 42 candidate vaccines at the stage of clinical trials, up from 11 in mid-June.
- Ten of them were at the most advanced phase 3 stage, in which a vaccine's effectiveness is tested on a large scale, generally tens of thousands of people across several continents.
- The USA biotech firm Moderna, several state-run Chinese labs, and a European project led by the University of Oxford and AstraZeneca are also closing in on potentially viable vaccines.
- Two Russian Covid-19 vaccines have been registered for use even before clinical trials were completed, but have not been widely accepted outside of Russia.
- India is preparing to administer a vaccine against Covid-19 to its population early in 2021 and for that, it is working with neighbouring countries on possible collaborative clinical trials of vaccine candidates in the future.
- A specialist team of scientists and researchers from the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) under the Union Ministry of Science and Technology, has imparted training to doctors and regulators in Sri Lanka, Myanmar, Bangladesh, Bhutan, Nepal, and Afghanistan.
- The Indian team has focused its training on conducting crucial phase II and III human clinical trials of the potential vaccine candidate along lines of India’s regulatory mechanism.
- In phases II/III, reactogenicity (ability to produce common, adverse reactions), immunogenicity (ability to provoke an immune response), and safety of the vaccine candidate are assessed in a larger population.
- The current aim is to facilitate a future collaborative clinical trial but in future, it will allow India to explore the option of buying the potential Covid-19 vaccine from these neighbouring countries.
- Indigenously Developed Vaccines:
- ZyCoV-D: Designed and developed by Zydus (a pharmaceutical company) with support from the DBT.
- Covaxin: Developed by Bharat Biotech in collaboration with the ICMR.
- Assistance in Global Trails:
- Covishield: Name given to an Oxford-AstraZeneca Covid-19 vaccine candidate which is technically referred to as AZD1222 or ChAdOx 1 nCoV-19.
- Sputnik V: The first vaccine to be officially registered and has been developed by Moscow’s Gamaleya Institute in collaboration with the Russia’s defence ministry.
- The PBR is the third in Madhya Pradesh to be included in the list after Pachmarhi and Amarkantak.
- Along with PBR, the Fuvahmulahand Addu Atoll in the Maldives has also been included in the WNBR.Panna
- Established in 1981, PBR is located in the Panna and Chhatarpur districts of Madhya Pradesh with an area of around 540 km. sq.
- It is situated in the Vindhya mountain range in the northern part of Madhya Pradesh.
- Ken River (one of the least polluted tributaries of the Yamuna River) flows through the reserve and the Ken-Betwa river interlinking project will also be located in it.
- The region is also famous for Panna diamond mining.
- Conservation and Recognition:
- 1994: The Panna National Park got the status of Project Tiger Reserve as India’s 22nd tiger reserve.
- 2011: It was notified as a Biosphere Reserve by the Union Ministry of Environment, Forest and Climate Change (MoEFCC).
- 2018: By 2018, it witnessed a remarkable turnaround in tiger population by increasing their numbers remarkably from zero estimated a decade ago.
- Madhya Pradesh has the highest number of tigers in the country followed by Karnataka and Uttarakhand.
- 2020: UNESCO included it in the Man and Biosphere Programme (MAB).
- Biosphere Reserves (BRs) are representative parts of natural and cultural landscapes extending over large areas of terrestrial or coastal/marine ecosystems or a combination thereof and representative examples of biogeographic zones/provinces.
- The idea of the biosphere reserve was initiated by UNESCO in 1974 under the MAB with the objective of obtaining international cooperation for the conservation of the biospheres.
- The first biosphere reserve of the world was established in 1979 and since then the network has increased to more than 600 in 119 countries across the world.
- A scheme called Biosphere Reserve has been implemented by the Government of India since 1986.
- Under it, financial assistance is given in a 90:10 ratio to the North Eastern Region States and three Himalayan states and in the ratio of 60:40 to other states for maintenance, improvement and development.
- The State Governments prepare the Management Action Plan which is approved and monitored by the Central MAB Committee.
- India has a total of 18 Biosphere Reserves and with the inclusion of PBR, the number of internationally designated WNBR has become 12.
- In 2012, the Nilgiri Biosphere Reserve became the 1st BR from India to be included in the WNBR.
- In 2018, the Khangchendzonga Biosphere Reserve became the 11th BR to be included in the list.
- It has sought a direction to the government to not implement the Madhav Gadgil and Kasturirangan committees’ reports on the conservation of the Western Ghats.
- The Western Ghats Ecology Expert Panel (WGEEP), also known as Gadgil Committee, and the Kasturirangan Committee, a High-Level Working Group, were constituted to conserve and protect the biodiversity of Western Ghats while allowing for sustainable and inclusive development of the region.
- They recommended that identified geographical areas falling in the six States of Kerala, Karnataka, Goa, Maharashtra, Gujarat and Tamil Nadu should be declared as ESA.
- A draft notification related to the same was issued in 2018 mentioning the areas to be notified in the ESA.
- Issues Highlighted by the Petition:
- The draft notification would declare 123 agricultural villages in Kerala as ESA converting the semi-urban villages in the region into forests with no facilities and roads. It will affect 22 lakh people and cripple the economy of Kerala.
- The Centre had wrongly branded people who had been residing in the Western Ghats area, as the “destroyers of the biodiversity and agents of ecological damage.”
- Apart from that, it suggested that ESA in Kerala should be restricted to reserved forests and protected areas.
- Gadgil Committee:
- It recommended that all of the Western Ghats should be declared as the ESA with only limited development allowed in graded zones.
- It classified the Western Ghats into ESA 1, 2 and 3 of which ESA-1 is a high priority zone where almost all of the developmental activities (mining, thermal power plants, etc) should be restricted.
- It also recommended the constitution of Western Ghats Ecology Authority (WGEA), as a statutory authority under the Ministry of Environment, Forests and Climate Change (MoEFCC) with the powers under Section 3 of the Environment (Protection) Act, 1986.
- It was criticised for being more environment-friendly and not in tune with the ground realities.
- Kasturirangan Committee:
- It sought to balance the development and environment protection in contrast to the system proposed by the Gadgil report.
- The committee’s major recommendations were:
- Instead of the total area of Western Ghats, only 37% of the total area to be brought under ESA.
- A complete ban on mining, quarrying and sand mining in ESA.
- No thermal power projects to be allowed and hydropower projects to be allowed only after detailed study.
- Red industries (highly polluting industries) to be strictly banned.
- Exclusion of inhabited regions and plantations from the purview of ESAs making it a pro-farmer approach.
- Eco-Sensitive Zones or Ecologically Fragile Areas are located within 10 km of Protected Areas, National Parks and Wildlife Sanctuaries.
- ESAs are notified by the MoEFCC under Environment (Protection) Act 1986.
- Aim: To regulate certain activities around National Parks and Wildlife Sanctuaries so as to minimise the negative impacts on the fragile ecosystem encompassing the protected areas.
- The matter pertains to the debate of ‘Development versus Conservation’, which highlights that destruction in the name of development should not be encouraged and sustainable development should be given priority.
- A proper analysis based on scientific study followed by consensus among various stakeholders by addressing respective concerns is required to solve the differences in a timely manner.
- Delays in implementation will only accentuate degrading of the prized natural resources of the country hence, with a holistic view of threats and demands on the forest land, products and services, devising strategies must be developed to address them.
- Biden’s running mate Kamala Devi Harris has become the first woman and first Indian- and African- American Vice President of the country. Biden and Harris will be sworn into office on 20th January 2021.
- The US has a Presidential System, whereas India has the Parliamentary System of Government.
- There are several ways in which the US economy, its health and the policy choices of its government affect India. Both the countries recently had 2+2 dialogue.
- The US President is both the head of the State and head of the Government.
- The law making is done by the legislature (called the Congress in the US), but the President can veto any law.
- S/he has a fixed tenure of four years and completes it even if her/his party does not have a majority in the Congress.
- The President and the Vice President are chosen by ‘electors’ through a process called the Electoral College.
- The presidential candidate of each of the political parties, chooses a vice presidential running mate. Voters vote on the two—presidential and vice presidential candidates—as a team.
- The President can be removed for conviction of treason, bribery, or other high crimes or misdemeanor.
- There is a President who is the formal Head of the state of India and the Prime Minister and the Council of Ministers, which run the government at the national level.
- The Constitution of India vests the executive power of the Union formally in the President. In reality, the President exercises these powers through the Council of Ministers headed by the Prime Minister.
- The Prime Minister has the support of majority in the Lok Sabha.
- The President is elected for a period of five years. S/he is elected indirectly. This means that the President is elected not by the ordinary citizens but by the elected MLAs and MPs.
- The President can be removed only for ‘violation of the Constitution’ (impeachment procedure).
- Economic Relations: Under Biden administration, India’s trade with the US could recover from the dip since 2017-18.
- Trade Surplus: A recent analysis by experts of CARE Ratings (a credit rating agency) shows that over the past 20 years, India has always had a trade surplus (exports exceeding imports) with the US.
- The trade surplus has widened from USD 5.2 billion in 2001-02 to USD 17.3 billion in 2019-20. Trade surplus had peaked at USD 21.2 billion in 2017-18 and has moderated to some extent.
- In 2019-20, India exported goods worth USD 53 billion to the US - that’s roughly 17% of all Indian exports that year and imported goods worth USD 35.7 billion in return - that’s roughly 7.5% of all Indian imports.
- Trade in Services: India accounts for nearly 5% of USA’s services imports from the World.
- Investment:
- The US is the fifth-biggest source for Foreign Direct Investment (FDI - investment in the physical assets inside India) into India. Only Mauritius, Singapore, Netherlands, and Japan have invested more FDI since 2000.
- The US also accounts for one-third of all Foreign Portfolio Investments (that is, investment in financial assets) into India.
- Trade Surplus: A recent analysis by experts of CARE Ratings (a credit rating agency) shows that over the past 20 years, India has always had a trade surplus (exports exceeding imports) with the US.
- H1-B Visa Issue: How a US President looks at the H1-B visa issue, affects the prospects of Indian youth far more than the youth of any other country.
- Under President Trump, who severely curtailed the visa regime, owing to his policy of “America First”, India had suffered the most.
- H-1B visa is a non-immigrant visa that allows American companies to employ foreign workers in speciality occupations that require theoretical or technical expertise.
- US’ Generalized System of Preference: India’s exclusion from the US’ Generalized System of Preference (GSP) could come up for reconsideration under Biden.
- In 2019, President Donald Trump had terminated India's designation as a beneficiary developing nation under the GSP trade programme after determining that it has not assured the US that it will provide "equitable and reasonable access" to its markets.
- India was the largest beneficiary of the programme in 2017 with USD 5.7 billion in imports to the US given duty-free status.
- GSP is designed to promote economic development by allowing duty-free entry for thousands of products from designated beneficiary countries.
- Other Issues: Other points of contention between India and US - such as the tricky issue of data localisation or capping prices of medicines and medical devices - have a chance of getting towards a resolution.
- Further, under the Trump administration, the US sanctions on Iran severely limited India’s sourcing of cheap crude oil.
- On China, it is more likely that a Biden administration will help India against China, instead of clubbing the two together.
- Paris Climate Accord: Biden has promised to rejoin the Paris Climate Accord, and this may help countries such as India in dealing with the massive challenges - both technical and financial - on this front.
- Civil Liberties and Democratic Rights in India:
- Although some US Congressmen and women had raised red flags on the human rights situation following the revoking of J&K’s special status under Article 370 and passage of the Citizenship (Amendment) Act alongside the proposed nationwide National Register of Citizens (NRC), the Trump administration had not taken any actions beyond making some perfunctory statements.
- According to the Biden campaign’s policy paper, Biden has been “disappointed by the measures that the Government of India has taken with the implementation and aftermath of the National Register of Citizens (NRC) in Assam and the passage of the Citizenship (Amendment) Act into law”.
- India should be prepared to hold its own in tough conversations on sensitive issues. A Biden presidency may see a renewed push towards a rules-based trading system across the world - instead of outright ad-hocism as was the case under Trump - as well as a move away from the protectionist approach that has been getting strong across the world.
- Combined with the control of Covid infections and the economic recovery, the US could yet again provide a growth impulse to the global economy that countries such as India need to boost their exports and grow.
POSTED ON 11-11-2020 BY ADMIN
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Some Reference Essays
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