Hindi English Translation || Editorial || Jabbing children: On a COVID-19 vaccine for kids

Jabbing children: On a COVID-19 vaccine for kids

As Covaxin gets closer to approval for children, data transparency is vital (महत्वपूर्ण, आवश्यक)

As a milestone (major achievement, historic event, significant stage, turning point), the Subject Expert Committee’s (SEC) (विषय विशेषज्ञ समिति) recommendation to the Drugs Controller to grant emergency use authorisation (EUA) (आपातकालीन उपयोग प्राधिकरण) for Covaxin among children aged 2-18 years, is huge. If the Drugs Controller General of India (DCGI) goes ahead and grants approval, it will be the first vaccine (टीका) to be administered (प्रशासन करना, प्रदान करना) to children in India. While one other vaccine, ZyCoV-D, has been granted EUA, it is still to be administered. Trials (परीक्षण, अध्ययन, प्रयोग) have started with the Serum Institute’s Covovax (The US-based Novavax, the maker of Covovax, as the vaccine has been named in India, developed in collaboration with the Serum Institute of India. The Novavax candidate, which is also known as NVX-CoV2373, is a “recombinant nanoparticle” vaccine with the company saying it is the “first protein-based option”) for children, extending the timeline of any other COVID-19 vaccine for actual use in children. On the front of it, it seems like a tremendous achievement within a short period. While the data seem to have convinced the SEC that there is cause (वजह, कारण, आधार) to make its considered recommendation, none of that is yet in the public domain (if something (e.g. information) is in the public domain, people generally know about it since it is no secret), at the time of SEC’s announcement. Bharat Biotech presented interim (अंतरिम, अल्पकालीन) data from the phase II/III trials to the DCGI, as the safety follow-up (any systematic collection and collation of data that is designed in a way that enables learning about the safety of a medicinal product. It may include passive or active surveillance, observational studies, or clinical trials) is longer in this case. One month after the two doses, an immunogenicity (प्रतिरक्षाजनकता) check and safety follow up are done, according to reports. The company claimed the data indicated that the vaccine used — the same product and presentation as the adult vaccine — was safe. The two-dose Covaxin (India’s first indigenous COVID-19 vaccine candidate (COVAXIN) developed by a Hyderabad-based company (Bharat Biotech) in collaboration with the ICMR (The Indian Council of Medical Research)) was administered to 525 children 28 days apart, after it received the nod to conduct trials on children in May this year. A possibly unintended (अनपेक्षित, अनियोजित, अप्रत्याशित) but welcome outcome of the pandemic (वैश्विक महामारी) is the stress (तनाव, महत्व, आग्रह) on being transparent (पारदर्शी, स्पष्ट, खुला) about scientific data generated in trials. Data from other vaccine trials have routinely been posted in the public realm (क्षेत्र, अधिकार), not just with state regulators.

Working on vaccine or drug regimens (plan, course of action, procedure (of medical treatment) with children is challenging (demanding, testing, difficult, tough) on many fronts; to start with (at first, to begin with, at the outset, at the beginning), it is not merely a case of sizing down adult dosage for children. Children have distinct (discrete, separate, individual, different) developmental and physiological differences, and WHO recommends that clinical trials in children are essential to develop age-specific, empirically (actually, really, practically) verified therapies (treatment) and interventions to determine the best possible treatments for them. Their bodies work in very different ways and they undergo (be subjected to, go through, experience) many changes as they grow from infancy (beginnings, early days/stages) towards adolescence (youth, teenage years, early life) and adulthood (the condition of being fully grown/mature), calling for age de-escalation (it means that phase I and II trials are conducted first in adults, then in older children, and finally, if relevant, in small children. Epidemiology of the disease, the risks/benefits of the vaccine for each age group, and the safety profile are all factors to be taken into account in de-escalation) studies in trials, beginning with an older age group, and working towards the youngest group. Another question experts are raising is whether the cohort of 525 children is large enough to wing (to do something without preparation/guidelines; improvise) an EUA, or if incremental (gradual, step-by-step, staggered, phased) numbers should be added, given (considering, taking into account, bearing in mind) the size of the target paediatric/teen population. Many of these questions are easily addressed (tackle, deal with, attend to, try to sort out) with publication of the data. While a recommendation is only that, it has indeed (in fact, actually, undeniably) raised extraordinary expectations in the community. The DCGI, as it considers the SEC’s advice, should address the concerns raised, and reinstate (restore, bring back, re-establish) the issue of transparency to its rightful place as the cornerstone (mainstay, linchpin, backbone, central component) of scientific temper, besides (apart from, in addition to) infusing (inject, impart, add) confidence in the public.

Courtesy: The Hindu

Important Word List With Meaning

1.vaccine (noun)

Hindi Meaning - टीका
English Meaning - a biological preparation that improves immunity to a particular disease.

2.transparency (noun)

Hindi Meaning - पारदर्शिता, स्पष्टता
English Meaning - clarity, straightforwardness, openness, honesty, unambiguity.

3.vital (adjective)

Hindi Meaning - महत्वपूर्ण, आवश्यक
English Meaning - key, essential, important.

4.Subject Expert Committee’s (SEC) (noun)

Hindi Meaning - विषय विशेषज्ञ समिति
English Meaning - The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding public health by ensuring efficacy, safety, and quality of drugs used in India. One of the important decision-making factors in the entire regulatory review process is Subject Expert Committees (SECs). In March 2011, the CDSCO constituted 12 New Drug Advisory Committees (NDACs), consisting of experts from government medical colleges and eminent institutions within India for review of regulatory applications including new drugs, fixed‑dose combinations, additional indications, and clinical trials (CTs). These 12 NDAC committees were re-named as “SECs” since July 2014. It was stated in this order that the members for these committees will be drawn randomly from a large pool of experts. Later in January 2015, a number of SEC panels were expanded to 25 in various therapeutic areas.

5.Emergency Use Authorisation (EUA) (noun)

Hindi Meaning - आपातकालीन उपयोग प्राधिकरण
English Meaning - a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.

6.administer (verb)

Hindi Meaning - प्रशासन करना, प्रदान करना
English Meaning - dispense, provide, give, apply (a drug/vaccine).

7.trial (noun)

Hindi Meaning - परीक्षण, अध्ययन, प्रयोग
English Meaning - test, pilot study, experiment (phase 1, 2,3, and or human/clinical trial).

8.cause (noun)

Hindi Meaning - वजह, कारण, आधार
English Meaning - reason, grounds, justification, basis.

9.interim (adverb)

Hindi Meaning - अंतरिम, अल्पकालीन
English Meaning - provisional, temporary, transitional.

10.immunogenicity (noun)

Hindi Meaning - प्रतिरक्षाजनकता
English Meaning - the ability of cells/tissues to provoke an immune response in the body of a human.

11.unintended (adjective)

Hindi Meaning - अनपेक्षित, अनियोजित, अप्रत्याशित
English Meaning - unplanned, unexpected, inadvertent, incidental/accidental.

12.pandemic (noun)

Hindi Meaning - वैश्विक महामारी
English Meaning - the worldwide spread of a new disease; The illness spreads around the world and typically affects a large number of people across a wide area.

13.stress (noun)

Hindi Meaning - तनाव, महत्व, आग्रह
English Meaning - emphasis, importance, insistence.

14.transparent (adjective)

Hindi Meaning - पारदर्शी, स्पष्ट, खुला
English Meaning - clear, open, straightforward, honest, unambiguous.

15.realm (noun)

Hindi Meaning - क्षेत्र, अधिकार
English Meaning - area, field, domain (of activity).

16.Covaxin (noun)

English Meaning - India’s first indigenous COVID-19 vaccine candidate (COVAXIN) developed by a Hyderabad-based company (Bharat Biotech) in collaboration with the ICMR (The Indian Council of Medical Research).

17.jab (noun)

English Meaning - vaccination, injection, inoculation, immunization.

18.jab (verb)

English Meaning - vaccinate, inoculate, immunize, inject (a vaccine).

19.data transparency (noun)

English Meaning - it means utilizing data with integrity (honesty) so that individuals know what data is being collected, who has access to it, and how they’re able to interact with it.

20.milestone (noun)

English Meaning - major achievement, historic event, significant stage, turning point.

21.Drug Controller General of India (DCGI) (noun)

English Meaning - Drugs Controller General of India (DCGI) is a department of the Central Drugs Standard Control Organization (CDSCO) of the Government of India responsible for approval of licences of specified categories of drugs such as vaccines, and etc. in India. Drugs Controller General of India, comes under the Ministry of Health & Family Welfare. DCGI also sets standards for the manufacturing, sales, import, and distribution of drugs in India.

22.go ahead (phrasal verb)

English Meaning - to proceed, to continue to do something, to start/begin to do something.

23.ZycoV-D Vaccine (noun)

English Meaning - a three-dose “plasmid DNA” candidate vaccine being developed by Ahmedabad-based Zydus Cadila. It is a vaccine that uses a genetically engineered, non-replicating version of a type of DNA molecule known as a ‘plasmid’. If approved by the regulator, ZyCov-D will be the world’s first DNA vaccine against infection with SARS-CoV-2.

24.Covovax (noun)

English Meaning - The US-based Novavax, the maker of Covovax, as the vaccine has been named in India, developed in collaboration with the Serum Institute of India. The Novavax candidate, which is also known as NVX-CoV2373, is a “recombinant nanoparticle” vaccine with the company saying it is the “first protein-based option”.

25.front (phrase)

English Meaning - a particular situation; a particular sphere of operation.

26.considered (adjective)

English Meaning - carefully thought about, investigated, well-advised.

27.in the public domain/realm (phrase)

English Meaning - if something (e.g. information) is in the public domain, people generally know about it since it is no secret.

28.phase-3 trial (noun)

English Meaning - In phase 3 trial, the vaccine is given to thousands of people to confirm its safetyHindi Meaning - English Meaning - including rare side effectsHindi Meaning - English Meaning - and effectiveness. These trials involve a control group which is given a placebo.

29.phase 2 trial (noun)

English Meaning - In phase 2 trial, the vaccine is given to hundreds of people so scientists can learn more about its safety and correct dosage.

30.safety follow-up (noun)

English Meaning - any systematic collection and collation of data that is designed in a way that enables learning about the safety of a medicinal product. It may include passive or active surveillance, observational studies, or clinical trials.

31.nod (noun)

English Meaning - a sign of approval.

32.regulator (noun)

English Meaning - an association that supervises a particular business activity.

33.regimen (noun)

English Meaning - plan, course of action, procedure (of medical treatment).

34.challenging (adjective)

English Meaning - demanding, testing, difficult, tough.

35.to start with (phrase)

English Meaning - at first, to begin with, at the outset, at the beginning.

36.merely (adverb)

English Meaning - only, simply, just.

37.size down (phrasal verb)H

English Meaning - cut down, bring down, decrease, reduce.

38.distinct (adjective)

English Meaning - discrete, separate, individual, different.

39.difference (noun)

English Meaning - dissimilarity, distinctness, unevenness, variation.

40.human trial/clinical trial (noun)

English Meaning - a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.

41.empirically (adverb)

English Meaning - actually, really, practically.

42.therapy (noun)

English Meaning - treatment.

43.intervention (noun)

English Meaning - an activity directed at or performed on an individual with the object of improving health, treating disease or injury, or making a diagnosis.

44.undergo (verb)

English Meaning - be subjected to, go through, experience.

45.infancy (noun)

English Meaning - beginnings, early days/stages.

46.adolescence (noun)

English Meaning - youth, teenage years, early life.

47.adulthood (noun)

English Meaning - the condition of being fully grown/mature.

48.call for (phrasal verb)

English Meaning - as for, request, appeal, demand.

49.age de-escalation (noun)

English Meaning - it means that phase I and II trials are conducted first in adults, then in older children, and finally, if relevant, in small children. Epidemiology of the disease, the risks/benefits of the vaccine for each age group, and the safety profile are all factors to be taken into account in de-escalation.

50.epidemiology (noun)

English Meaning - the study of the distribution and determinants of health-related states or events (including disease), and the application of this study to the control of diseases and other health problems (Courtesy: WHO).

51.de-escalation (noun)

English Meaning - reduction, lessening, decrease (the intensity of something).

52.wing (verb)

English Meaning - to do something without preparation/guidelines; improvise.

53.incremental (adjective)

English Meaning - gradual, step-by-step, staggered, phased.

54.given (preposition)

English Meaning - considering, taking into account, bearing in mind.

55.paediatric (adjective)

English Meaning - relating to the branch of medicine dealing with the health and medical care of infants & children.

56.address (verb)

English Meaning - tackle, deal with, attend to, try to sort out.