COVID-19 vaccines in India: quick facts



The year 2021 has brought new developments on the vaccine front. On January 3, India approved the emergency use of two coronavirus vaccines, namely Covishield and Covaxin. When this article was taking shape, nationwide drills were being held to train more than 90,000 health care workers to administer these vaccines. The dry runs were also intended to avoid logistical loopholes during the actual vaccination drive that will cover crores of people across the country. Health Minister Harsh Vardhan said the government expected the first phase of vaccination - targeting around 30 crore people on priority - to be completed by August 2021. While preparations are in full swing, some scientists expressed concern over the rushed approval given to the indigenous vaccine, Covaxin.



Who has developed Covishield and Covaxin?



Covishield is the Indian variant of AZD1222, the vaccine developed by AstraZeneca and University of Oxford. Pune-based Serum Institute of India developed and manufactured Covishield through a licence from Astrazeneca and Oxford.



The overall efficacy of the AstraZeneca/Oxford vaccine has been found to be 70.42%. Serum Institute of India has said it would price the vaccine at Rs. 440 for the government and around Rs. 700-800 for the private market.



Covaxin has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The vaccine is yet to complete late-stage human clinical trials and its efficacy rate has not been released. The price of Covaxin has not been made public



What does "restricted use approval in an emergency situation" mean?



During an emergency such as a pandemic drug regulators may allow vaccines to be given to certain people even when the studies of safety and effectiveness are ongoing. This form of approval is called Emergency Use Authorisation. Normally, the process to approve a new vaccine can take years, sometimes more than a decade. But the COVID-19 pandemic has urged governments around the world to relax certain rules and to not only speed up the process of vaccine development, but also go ahead with emergency use.



Instead of the usual requirement of "substantial evidence of safety and effectiveness, they allow products into the market as long as their benefits are "likely" to outweigh their risks.



In the case of Covishield and Covaxin, Indian pharmaceutical regulator, the Central Drugs Standard Control Organisation (CDSCO), has imposed certain conditions on the vaccines developers. The developers have to continuously submit safety, efficacy and immunogenicity data from their ongoing trials until these are complete.



They also have to submit safety data every 15 days for the next two months, and after that monthly for the duration of their trials.



Who will get vaccinated first?



Covishield will be given in the first phase of the vaccine drive. Union Health Minister Harsh Vardhan said that Covaxin will be used only in 'clinical trial mode, where consent will be taken and side effects monitored.



The Covishield vaccine will first be given to around one crore healthcare workers in both government and private hospitals. It will also be given to two crore frontline workers associated with the state and central Police department, armed forces, home guard, disaster management and civil defence organisation, prison staff municipal workers and revenue officials engaged in COVID-19 containment, surveillance and associated activities. People above the age of 50 years and those with comorbidities are next in line to get the vaccine.



How will the vaccines be given?



Both Covishield and Covaxin are meant to be administered in two doses and stored at temperatures of 2 degrees C to 8 degrees C. While Covishield will be given between four and 12 weeks apart, the DCGI has not clarified the intervals between the shots of Covaxin. (The vaccines do not need the ultra-cold storage facilities that some others do. They can be stored in refrigerators. This makes them feasible candidates.)



The remaining population will be inoculated after the people on the priority list are covered. Once it is open to the public, beneficiaries will have to register on the COWIN app and submit ID proof for vaccination.



The Union Health Ministry has said that getting vaccinated for COVID-19 will be voluntary. However, it has 'advised' all to get vaccinated.



What is CoWIN app?



For a smooth implementation of the COVID-19 vaccination programme, the government has developed the COWIN app, which stands for Covid Vaccine Intelligence Network. Registration on the app is mandatory to receive a vaccine.



Why are some experts concerned about the vaccines' approval?



Some doctors have criticised a lack of transparency in the approval process.



The main concern is that developers of both the vaccines have not presented to the CDSCO the results of their respective phase 3 efficacy trials conducted on Indian participants, Covishield is backed by phase 3 data from studies in Brazil and the United Kingdom, The data from the "bridging study" showing its vaccine can elicit an immune response in the Indian population comparable with the original AstraZeneca vaccine has not been analysed fully. Further, out of a pool of 1,600 Indian participants, the Serum Institute submitted data pertaining to only 100 volunteers to the CDSCO's subject expert committee.



In the case of Covaxin, there is no efficacy data. While Bharat Biotech has said that phase 1 and phase 2 trials have shown good results, the drug regulator has simply said the vaccine is safe and effective. Covaxin is expected to be a "backup," to be deployed only if India faces a surge because of the new coronavirus variant that has been recently identified in the U.K.



 



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What is Prosthesis?



Prosthetics is the evaluation, fabrication, and custom fitting of artificial limbs, known as "prostheses." Prostheses enhance the function and lifestyle of persons with limb loss. The prosthesis must be a unique combination of appropriate materials, alignment, design, and construction.



Lower-limb prostheses might address stability in standing and walking, shock absorption, energy storage and return, cosmetic appearance, and even running, jumping, and other athletic activities. Upper-limb prostheses might address reaching and grasping, occupational challenges including hammering, painting, or weight lifting, and activities of daily living like eating, writing, and dressing.



A person's prosthesis should be designed and assembled according to the person's appearance and functional needs. For instance, a person may need a transradial prosthesis, but need to choose between an aesthetic functional device, a myoelectric device, a body-powered device, or an activity specific device. The person's future goals and economical capabilities may help them choose between one or more devices.



Craniofacial prostheses include intra-oral and extra-oral prostheses. Extra-oral prostheses are further divided into hemifacial, auricular (ear), nasal, orbital and ocular. Intra-oral prostheses include dental prostheses such as dentures, obturators, and dental implants.



Prostheses of the neck include larynx substitutes, trachea and upper esophageal replacements,



Somato prostheses of the torso include breast prostheses which may be either single or bilateral, full breast devices or nipple prostheses.



Penile prostheses are used to treat erectile dysfunction, correct penile deformity, perform phalloplasty and metoidioplasty procedures in biological men, and to build a new penis in female-to-male gender reassignment surgeries.



 



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What is the difference between blindness and visual impairment?



The definition of visual impairment is “a decrease in the ability to see to a certain degree that causes problems not fixable by usual means, such as glasses.” Blindness is “the state of being unable to see due to injury, disease or genetic condition.”



There are four terms used to describe different levels of vision impairment and blindness—partially sighted, low vision, legally blind and totally blind. Partially sighted means a person has partial vision, either in one or both eyes. Low vision refers to a severe visual impairment in which visual acuity is 20/70 or poorer in the better-seeing eye and cannot improve with glasses or contacts. Legally blind means a person has a corrected vision of 20/200 in their best-seeing eye. Totally blind refers to a complete loss of sight.



Effective interventions are available for health promotion, prevention, treatment and rehabilitation to address the entire range of needs associated with eye conditions and vision impairment across the life course. Some are among the most feasible and cost-effective to implement. For example, uncorrected refractive error can be corrected with glasses while cataract surgery can restore vision. Vision rehabilitation is also effective in improving functioning for people with an irreversible vision impairment.



 



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Which language is used commonly by people with hearing – and speech-impairment?



Sign languages (also known as signed languages) are languages that use the visual-manual modality to convey meaning. Sign languages are expressed through manual articulations in combination with non-manual elements. Sign languages are full-fledged natural languages with their own grammar and lexicon. Sign languages are not universal and they are not mutually intelligible with each other, although there are also striking similarities among sign languages.



Wherever communities of deaf people exist, sign languages have developed as useful means of communication, and they form the core of local Deaf cultures. Although signing is used primarily by the deaf and hard of hearing, it is also used by hearing individuals, such as those unable to physically speak, those who have trouble with spoken language due to a disability or condition (augmentative and alternative communication), or those with deaf family members, such as children of deaf adults.



 



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According to the World Health Organisation, what per cent of the world population has some form of disability?



Over 1 billion people are estimated to live with some form of disability. This corresponds to about 15% of the world's population, with up to 190 million (3.8%) people aged 15 years and older having significant difficulties in functioning, often requiring healthcare services. 



Disability is extremely diverse. While some health conditions associated with disability result in poor health and extensive healthcare needs, others do not. However, all people with disability have the same general healthcare needs as everyone else, and therefore need access to mainstream healthcare services. Article 25 of the UN Convention on the Rights of Persons with Disabilities (CRPD) reinforces the right of persons with disability to attain the highest standard of healthcare, without discrimination. However, the reality is that few countries provide adequate quality services for people with disability.



Also, very few countries collect data to enable disaggregation by disability in the health sector.  This became very apparent during the COVID-19 pandemic where countries failed to include disability consistently in their response to control the pandemic. This left people with disability exposed to three increased risks with devastating consequences: the risks of contracting COVID-19, developing severe symptoms from COVID-19 or dying from the disease, as well as having poorer health during and after the pandemic, whether or not they are infected with COVID-19.



 



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