The Hindu Editorial December 2nd Week

 Transparency is vital: On authorisation of coronavirus vaccines

Safety and efficacy data must be known before emergency-use authorisation for vaccines

A day after Pfizer sought the Indian regulator’s nod for emergency-use authorisation for its mRNA vaccine, the Pune-based Serum Institute of India has approached the regulator for a similar nod for its vaccine, Covishield, developed by Oxford University. Unlike Pfizer, AstraZeneca, which is carrying out the phase-3 trials of the Oxford vaccine in four countries, is yet to secure a nod from any of the regulatory agencies. AstraZeneca recently gave details of the interim safety and efficacy data involving 131 COVID-19 cases in the phase-3 trials in the U.K. and Brazil. But details of the trials in India are not out yet. The unprecedented speed in taking the vaccine from the development stage to approval process in less than a year is remarkable, and perhaps necessitated by the toll the virus has taken on lives and livelihoods. But this is not without cause for concern at a time when governments are putting pressure on regulatory bodies to fast-track the entire process. Lack of transparency about vaccine safety and efficacy does no good in gaining people’s confidence and willingness to get vaccinated. While Moderna, Pfizer and AstraZeneca took the extraordinary step of publicly sharing the trial protocol, the time points at which interim analysis of phase-3 trial in India will be carried out for safety and efficacy is unclear. While the U.S. FDA has clearly spelt out at least 50% efficacy and stipulated a median follow-up duration of at least two months after completion of the full vaccination regimen to assess a vaccine’s benefit-risk profile for emergency-use approval, no such conditions have been mentioned by the Indian regulatory agency. The phase-3 trial of Covishield began on September 21 and completed the enrolment on November 12.

Prime Minister Narendra Modi announced a few days ago that a vaccine would be available in the next few weeks bringing some cheer in an otherwise desolate scenario. The sooner a vaccine is available, the better it is for everyone, but pushing through an ineffective or unsafe vaccine is worse than not having one. A survey by the London-based Vaccine Confidence Project revealed that though the intent to get vaccinated was 87% in India, 34% respondents were worried about side-effects while 16% were concerned about fast-moving trials. While the Indian government is aware of vaccine hesitancy among a certain section of people, the concerns are best addressed when all stakeholders are transparent at every stage and not by merely sharing guidelines regarding vaccine safety with the States. It is important that those seeking emergency-use authorisation share the safety and efficacy data immediately.

vital--महत्वपूर्ण---Important,significant
efficacy--प्रभाव,प्रभावोत्पादकता--Effectiveness
must be--होना चाहिए--Should be
Unlike--भिन्न--Different
yet--अभी तक
unprecedented--अभूतपूर्व
necessitated--आवश्यक हो,Is necessary
livelihoods--आजीविका
stipulated--निर्धारित,Determined
assess--आकलन,Assessment
desolate--उजाड़
sooner--पहले,Before
worse--और भी बुरा,Even Worse
hesitancy--संदेह,Doubt

Rebuilding from debris: On Joe Biden securing certified results

Biden will have to heal the wounds of a nation that seems to be at war with itself

U.S. President-elect Joe Biden has officially secured enough certified results across States to cross the critical threshold of 270 electors in the Electoral College. That all but guarantees that he will be the 46th President. While there is lingering but near-zero chance of incumbent President Donald Trump overturning the results through legal challenges targeting mail-in ballots, it may be safe to assume that the Electoral College will carry out, on December 14, an uncontroversial confirmation that the Biden-Harris ticket won the 2020 presidential election, and that the Biden administration will take charge after Inauguration Day next month. However, there is little doubt that seeing the bitter 2020 election campaign through to victory is but the start of what is sure to be an arduous journey for Mr. Biden, who, at 78, will have to work tirelessly toward two goals: first, to undo the damage done over four years to domestic and international institutions, alliances, and strategic goals; and second, to heal the bitter polarisation of American politics along partisan lines, a phenomenon that appeared to peak through the harsh Trump years. At the top of the domestic policy agenda will be combating the catastrophic effect of the COVID-19 pandemic in the U.S., which has recorded the most infection cases globally and the highest fatalities too. The science-driven policy that Mr. Biden has promised to follow must be expediently put into action, for everything from mask-wearing mandates to an effective vaccine distribution plan. The economy will be a close second, requiring even more stimulus packages, backed by Congress, that kick-start the flagging job market and incentivise businesses to start humming with activity again.

On the international front, Mr. Biden is likely to use his first 100 days in office to explore what options there are to re-join WHO and the Paris climate change agreement. This could signal the end of the era of Trumpist isolationism on the global stage. He is also likely to train his guns on immigration reform, an area in which the Trump administration ripped a gash through the earlier paradigm of gradual adjustment to new realities. That could well include lifting Mr. Trump’s executive orders restricting the issuance of new skilled worker visas and green cards, as well as limits on entry for students at universities offering mainly online courses. Family separations at the U.S.’s southern border may halt, perhaps substituted by the Obama-years policy of “catch and release”, and the border wall that Mexico was supposed to pay for will be indefinitely shelved. Yet none of these reversals of Mr. Trump’s policies will matter if Mr. Biden does not proactively seek to build bipartisan consensus in Congress and across the country. The fact that the U.S. was riven by hateful discourse from both sides of the political spectrum throughout the 2020 campaign suggests that Mr. Biden will have to work overtime to heal the wounds inflicted on a nation that at times appears to be at war with itself.

debris--मलबा, अवशेष, टूटे हुए-Remnants,Broken
heal--धाव भरना, ठीक होना--recover
wounds --घाव, ज़ख्म
lingering--सुस्त,dormant, Idle
incumbent--निर्भर,Dependent
overturning--उथलनेवाला--Upside down
bitter--कड़वा
arduous--कठिन--Tough
tirelessly--अथक
partisan--पक्षपातपूर्ण--Biased
phenomenon-घटना---incident
harsh--कठोर--Hard
catastrophic--आपत्तिजनक--Offensive
fatalities--मौत--Death
expediently--जल्दी से--Quickly
stimulus--प्रोत्साहन--Incentives,spur
likely---उपयुक्त,संभावित--Suitable
explore--छान-बीन करना--Scrutinize
isolationism--अलगाववाद--Separatism
paradigm--मिसाल--उदाहरण--Example,instance
issuance--जारी करने, निर्गमन--To issue
gradual--क्रमिक--serial
shelved--हटाया--Removed
proactively--पूरी सक्रियता--Full activism
reversals--बदलाव--Change
consensus--आम सहमति--
Riven--फूट पैदा हो जाना--Split
discourse--प्रवचन--lecture, preachning

The road taken: On Chennai-Salem greenfield highway

Salem greenfield highway may now be a fait accompli after SC verdict

By upholding notifications intending to acquire agricultural land for the proposed Chennai-Salem greenfield highway, the Supreme Court has both paved the way for completing the land acquisition process and sought to ensure that environmental clearances are obtained before its construction. It has ruled that it will be premature to expect the authorities to obtain environmental approvals at the stage of identifying the land linked to the proposed alignment of a highway, but, once the land was notified for acquisition and surveyed for feasibility, they would have to apply for all statutory clearances. It would be at the stage of entertaining objections that questions such as whether the project was truly a ‘public purpose’ could be dealt with. However, the land could be taken over and construction begun only after the competent authto such a stage that there is irreversible commitment of resources.

The three-judge Bench has now ruled that the High Court was wrong in holding that clearances under environmental and forest laws were required even before the initial land acquisition notice. It goes on to uphold the Centre’s power to notify any stretch of land, including greenfield land, and not merely a pre-existing road, as a national highway. As part of a growing body of jurisprudence on sustainable development, the top court had laid down in Karnataka Industrial Areas Development Board (2006) a general principle that in future, before acquiring land for development, the possible adverse environmental impact should be “properly comprehended” and the acquisition done in a way that did not impair it. In a departure from this dictum, it now says the statutory framework governing highways and the process laid down for acquiring land for highway projects did not provide for a prior clearance requirement. The Court’s line of reasoning based mostly on development-centric statutes is something of a disappointment when it could have taken, even at this stage, a holistic view of the need for sustainable development. True, it has left open the question whether the clearances obtained after the lands were notified for acquisition are valid; and the principle that construction of the highways cannot begin without such clearances also stays. But it is not inconceivable that the Court’s position may have rendered the project a fait accompli.

orities give their clearances, along with measures for mitigating and remedying possible environmental damage. The judgment of the Madras High Court, which had taken a nuanced position in favour of environmental protection, agriculture and preservation of rural livelihoods over the economic benefits of a new highway on virgin land, has been set aside in the process. The High Court had shown greater sensitivity to possible livelihood and ecological concerns. It had favoured early judicial intervention, relying on judgments from the U.S. that spoke out against letting projects advance 

verdict--निर्णय-decision, judgment,
may now be a --अब हो सकता है--
upholding--कायम रखने
feasibility--होने की संभावना--Likely to happen
statutory--वैधानिक--constitutional,legal

truly--सही मायने में---

in true sense

dealt--निपटा---get over
competent--सक्षम---capable
clearances--मंजूरी,निकासी--evacuation,sanction
mitigating--कम करने--

To reduce

nuanced--सूक्ष्म--Subtle
preservation--
intervention--हस्तक्षेप--Interference
stretch --खिंचाव--strain, tension
existing --मौजूदा-- current, present
laid--रखी--keep
acquiring--प्राप्त--received, Derived, earned,get
impair--ख़राब--defective
dictum--कथन--Statement
holistic--समग्र--Overall
inconceivable--समझ से बाहर--Delphic

True to its name: On drugs regulator and COVID-19 vaccines

The DCGI did well to seek more data before clearing emergency use of vaccines

With a stroke of a pen, the Drugs Controller General of India has put to rest any doubts and concerns that it would rush to grant emergency use approval to COVID-19 vaccines tested and manufactured in India or elsewhere in the absence of sufficient data. The greatly reassuring decision to seek additional safety and immunogenicity data from the Pune-based Serum Institute of India and Hyderabad’s Bharat Biotech underlines the regulator’s priorities even for emergency use approval rather than an early roll-out of vaccines that have not been sufficiently studied. The decision to seek more evidence would mean a slight delay in locally manufactured vaccines becoming available. But it clearly demonstrates that the committee did not misread the announcement by Prime Minister Narendra Modi that a vaccine will be available in the next few weeks as a signal to grant approval in haste. By keeping the approval on hold pending more evidence, the expert committee has done much to generate trust in the regulator’s uncompromising approval process even for emergency use in the midst of the pandemic. However, these manufacturers have unfortunately come out as being in a hurry to seek approval without sufficient data to support their case.

Bharat Biotech’s rush to seek approval is of concern as the company had not submitted any data from its phase-3 trial but relied entirely on the interim safety and immunogenicity data of the phase-1 and phase-2 trials; the company had begun phase-3 trials only in mid-November. While Serum had submitted interim safety and efficacy data of the Oxford vaccine from the phase-2/3 clinical trials carried out in India and other countries, the safety data of the Indian trial submitted was only till mid-November. The phase-3 trials by Serum began on September 21, and since the second dose is administered 28 days after the first, the median follow-up after the second dose would have been for just a few weeks, far less than at least two months that the U.S. FDA had stipulated. With the published data of the interim phase-3 trial of the Oxford vaccine raising some concerns, the committee has rightly sought immunogenicity data from the U.K. trial. While the U.K. has approved the mRNA vaccine from the U.S.-based Pfizer, no country including the U.K. has approved the Oxford vaccine manufactured by London-based AstraZeneca. In September, nine global vaccine manufacturers had signed a joint pledge that they would not seek premature approval from regulatory authorities and would test COVID-19 vaccines to the highest standards and keep “the safety of vaccinated individuals our top priority”. So Indian manufacturers should strive to carry out the trials to the highest ethical standards and submit comprehensive data such that emergency use approval is a sure shot. Any further haste shown in seeking approval for emergency use may turn detrimental and the companies may even run the risk of losing public trust.

grant--स्वीकार करना---give, provide, allow/permit.

elsewhere--किसी दुसरे स्थान में

greatly--बहुत--very much considerably

slight--थोड़ा--

misread--पढ़ने में भूलना--get wrong,interpret incorrectly.

haste--जल्दी--quickly, rapidly, fast, speedily

uncompromising --सीधा-- inflexible, unbending

midst --मध्यस्थिति--in the middle of.

strive--प्रयास करते हैं--try, attempt, make every effort.

detrimental--हानिकारक--harmful, unfavourable, counterproductive.

Grain and chaff: On farmer protests

The Centre must first implement its proposals before continuing talks with the farmers

Both sides unrelenting in their contradictory positions, an agreement between the Narendra Modi government and the agitating farmers on the question of three controversial Farm Bills appears elusive. With the farmers’ organisations calling for a blockade of Delhi’s highways to Jaipur and Agra by December 12, tensions may escalate further. A large number of these farmers from the neighbouring States of the national capital are camping at locations around it for two weeks now. After several rounds of talks, the Centre has now offered a written assurance that government procurement at minimum support price would remain, along with proposals to amend the laws to deal with farmers’ concerns regarding parity between State-run and private mandis, registration of traders, and dispute resolution mechanisms. These assurances are in response to the concerns being raised by the farmers, but they find them inadequate and half-hearted. They have decided to intensify the strike, demanding complete repeal of the controversial laws. The government has ruled out their repeal, setting the stage for a showdown.

Farmers, howsoever politically empowered they might be in some parts of the country, are at the mercy of market forces and government policy all the time. The Centre appears willing to brazen it out in the face of stiff opposition from the people most affected by the laws. In this battle of unequals, the government should look at a just settlement, not a political compromise. The underlying premise of the Centre that farmers will be better off in an open market needs to be qualified. No country serious about food security can leave farming and marketing of produce entirely to market forces. Even the most free market countries and the WTO acknowledge this. India’s agriculture marketing and its crop pattern both undoubtedly require reforms. And reforms do trigger resistance. The way forward is not by questioning democracy itself as senior government officials and functionaries of the ruling BJP have been doing. The Centre must be more cognisant of the fact that the farmers and the farm sector are both under its protection, and they cannot be free market actors. Thy do not have enough leverage to protect their own interest in negotiations with big corporations. There is no point in replacing existing distortions in the agriculture sector with reforms that do not inspire confidence among the farmers. As a start, the Centre must go ahead and fulfil all the promises it made to the agitating farmers, rather than use those as a negotiating position. It must legislate the guarantee of MSP and reassure farmers on procurement and subsidies.

chaff--भूसा--Straw
unrelenting--बेदर्द, बेरहम,कठोर--unmerciful, unrepentant
contradictory--परस्पर विरोधी,असंगत--at odds with,incompatible
elusive--टाल-मटोल वाला,मायावी
procurement--खरीद--Purchase
parity--समानता--equality, similarity
inadequate--अपर्याप्त--Insufficient
repeal--भंग--dissolution, Breach,
howsoever--कितना ही न
stiff-- कड़ा, कठोर--tough, hard
compromise--समझौता--a settlement,agreement
underlying--आधारभूत--basic, fundamental,
premise--आधार--base, foundation
undoubtedly--निश्चित रूप से,निस्संदेह--Of course,Certainly
cognisant--जानकार--Knowledgeable
Thy--तुम्हारा, तेरा--yours, your,
distortions--विकृतियों--deformation, perversion
As a--के तौर पर

Connecting more people: on PM WANI

Public wi-fi is a low-cost option to reach unserved citizens and grow the economy

The Central government’s move to enable public wi-fi data service through small retail data offices can get many more people connected, just as long-distance telephony was expanded through STD public call offices over three decades ago. Bringing broadband Internet to remote locations at minimum investment, and giving subscribers the option of making small, need-based payments to use it has remained a challenge thus far, but the Prime Minister Wi-Fi Access Network Interface (PM WANI) scheme approved by the Union Cabinet aims to bridge that divide using wireless technologies. Potentially, Internet access will connect a new wave of users not just to commercial and entertainment options, but also to education, telehealth and agriculture extension, and bring greater accountability to government by boosting transparency and interactivity. The government is hoping that by cutting through layers of bureaucracy and eliminating licences and fees, it can make it easy even for a tea shop owner to register online as a service provider, opening up new income avenues. Three years ago, when TRAI outlined the plan and initiated the first pilot of a public wi-fi system on the WANI architecture, it noted that a 10% rise in net penetration led to a 1.4% increase in GDP. Public wi-fi, however, suffered neglect because it was seen as a competitor to data services sold by mobile telecom firms, rather than as the complementary technology it is.

A rapid scale-up of Internet in rural India will be transformative, given the low level of penetration — 27.57 subscribers per 100 population in 2019 - and wi-fi linked to broadband fibre service is the fastest route to achieving that. Upcoming mobile technologies such as 5G may provide good quality data, but they involve high investment in new spectrum, connectivity equipment and regular subscriber fees. The WANI system offers an elegant way forward to connect low revenue consumers. It opens up opportunities for community organisations, libraries, educational institutions, panchayats and small entrepreneurs to tap into a whole new ecosystem, purchasing bandwidth from a public data office aggregator to serve local consumers. What the citizen expects is robust service, protection of data integrity, transparency on commercial use of data, and security against cyberattacks. The government must also ensure true unbundling of hardware, software, apps and payment gateways in the WANI system, as advocated by TRAI, to prevent monopolies. Existing public wi-fi options run on a limited scale by some entities compel consumers to pay through a single gateway app, underscoring the need for reform. Executed properly, the public data offices (PDOs) of PM WANI can do what the PCOs did for phone calls, going well beyond ‘ease of doing business’ to genuinely empower citizens.

sweeping--व्यापक--Comprehensive
tighten--कस--constrict
majority--बहुमत
remained--बने रहे--Remained as it is
bloc --गुट--Faction
turnout--उपस्थित होना-To be present
embroiled-घपला--Patchwork,Snafu
charismatic--करिश्माई
predecessor--पूर्ववर्ती--foregoing
override--अवहेलना--Disregard
convened--बुलाई--Called
mobilise--संगठित करना--To organise
semblance--दिखावा--show off
antipathy--घृणा--Hatred
unseat--तोड़ना--to break
grievances--शिकायतों--Complaints
may or may not--हो भी सकता है और नहीं भी


accountability--जवाबदेही--responsibility
boosting --बढ़ाने--To enhance
avenues---रास्ते--The way,Path
penetration-प्रवेश--Entry,Entrance
elegant--शिष्ट--Decent
compel--मजबूर--helpless
genuinely--सही मायने में--in true sense
empower--सशक्तिकरण--