DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
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ONLINE SEMINAR ON DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION BACKGROUND MATERIAL 6TH FEBRUARY, 2021 4.00 PM - 6.00 PM Organised by WATERFALLS INSTITUTE OF TECHNOLOGY TRANSFER In Association with THE MADRAS CHAMBER OF COMMERCE & INDUSTRY 1
ONLINE SEMINAR ON DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION BACKGROUND MATERIAL 6TH FEBRUARY, 2021 4.00 PM - 6.00 PM Organised by WATERFALLS INSTITUTE OF TECHNOLOGY TRANSFER In Association with THE MADRAS CHAMBER OF COMMERCE & INDUSTRY CONTENTS 2
INVITATION … … … 1 PREFACE … … … 2 1. INTRODUCTION: COVID-19 & VACCINES 4 1.1 About COVID-19 4 1.2 Executive Summary (Covid 19 Vaccine – Operational Guidelines) 5 1.3 Introduction to Vaccines for Covid-19 8 1.4 Development of COVID-19 Vaccine 9 1.5 COVID-19 vaccine development in India 11 1.6 Communication Strategy 11 1.7 Contents of COVID-19 Vaccine(s) – Operations Guidelines 13 1.8 Contents COVID-19 Vaccine(s) – Communication Strategy 15 1.9 List of Awareness Material (Ministry of Health) 17 2. DEMYSTIFYING THE CONCEPTS ABOUT COVID-19 AND 20 VACCINATION 2.1 India’s Vaccination Drive 20 2.2 US COVID-19 Vaccination Program 21 2.3 FAQ and Answers on Vaccines for Covid-19 22 2.4 Myths on Vaccines 27 2.5 WHO Conversation in Science 39 3. VACCINE MANUFACTURING 40 3.1 Types of Covid-19 Vaccines 40 3.2 Vaccine Manufacturing 44 3.3 Indian Vaccine Development & Manufacturers 47 3.4 Emergency use Authorisation : Covid-19 Vaccine 50 3.5 Indian Vaccines: How the Globe Views It 52 4. INTELLECTUAL PROPERTY RIGHTS AND COVID 19 VACCINES 54 4.1 Patent Ownership of Covid-19 Vaccines 54 4.2 COVID-19 Patent Ban (South Africa/Indian) 56 4.3 Looking into Future of Patent Ban /Waiver 58 Annexure 4.1 : A note on International development regarding Access 61 to Medicine to address the COVID-19 ( A note from Dr. K.S. Kardam) 5. ABOUT THE SPEAKERS 63 3
P R E F A C E This background material is prepared for the online Seminar being planned for 6th February, 2021, jointly organised by Waterfalls Institute of Technology Transfer and Madras Chamber of Commerce and Industry. The subject of the Seminar is “Demystifying and Enhancing Awareness on Covid-19 Vaccination”. No doubt at all, the subject is rapidly evolving and this material assembled in later part of January 2021 would be impacted by newer information that would become available by the time the seminar takes place in the first week of February 2021. No originality whatsoever is implied by the Institute for the material assembled here; all credit is in fact due to several agencies and organisations for publishing very valuable information from time to time. Material put out by only a few organisations are included here after being abridged and edited in this backgrounder such as; the Ministry of Health and Family Welfare of the Govt. of India, World Health Organisation, Geneva Switzerland, leading Vaccine Manufactures, some medical centres and few others; the reader is urged to refer to the original material of such organisations to form a firm view on an issue, this backgrounder serving only as an indication for further study and examination. Chapter I. Introduction to Covid 19 and Vaccine is mainly from the Website of the Ministry of Health and Family Welfare of the Govt. of India under the “Resources” section, “Training Material” lists several links. Two of them dealing with vaccines is picked up; they are (i) Covid 19 Vaccines: operational guidelines uploaded on 28-12-2020. The Contents page and Executive Summary is given in this Chapter; and (ii) Covid 19 Vaccines: Communication strategy uploaded on 30-12-2020. The introduction and Contents page is also extracted for presentation in this Chapter. This chapter also gives a list of Awareness material on a wide range of topics by the Ministry of Health and Family Welfare. Chapter 2. contains material which will help to Demystify the concept about Covid-19 and vaccination. Section 2.1 give a brief overview of India’s vaccination drive, perhaps the largest in the history of the world. Section 2.2 similarly gives the US program on vaccination. In fact the largest impact of Covid-19 in terms of persons infected are USA and India and as such their vaccination program have many similar features with 2 vaccines in each country. Section 2.3 provides answers to the frequently asked questions on Vaccines for Covid-19. Section 2.4 provides explanations and clarifications on many myths relating to Covid-19 vaccines and vaccination. It will be seen that many items of myths relates to perception and misinformation in USA; similar myths exists in India too, but here the correct information has not yet been collected and clarified. Perhaps this could be done as India’s’ vaccination drive advances and the items reported in Phase I of the Vaccination could be brought out; this would be of use in enhancing awareness in the later phases of the vaccination program. Section 2.5 gives a list of subject items (Episodes) covered in the WHO series in “conversation in science”, which incidentally have cleared some myths and provided clarification relating to covid-19. 4
The third Chapter is focussed on Vaccine Manufacture, which will be of special interest to industry, showing how the recent advances in science is impacting this segment of the Industry particularly to meet the demands in the pandemic period. Section 3.1 provides an introduction to the different types of Covid-19 vaccines, and Section 3.2 points out the problem in the manufacturing vaccine to provide the large number of doses in an affordable manner. Section 3.3 provides insights to the Indian Vaccine development. Section 3.4 explains the process to obtain an Emergency use approval (EUA). Section 3.5 points out the praise showered on India in raising to the occasion in combating the pandemic and the success of the “vaccine diplomacy”. The Chapter 4 deals with the Intellectual property rights relating to vaccine manufacture and it impacts on the availability and accessibility issues and eventually leading to affordability. Section 4.1 points out the ownership issues relating to Patents rights, reorganising the large investments made by the pharmaceutical industrial giants and risks associated with such investment. However, the large investments provided by the public (the Government) is often ignored or forgotten. Section 4.2 deals with a proposal moved at the WTO by India and South Africa to temporarily ban the IPR on inventions relating to Covid-19 medicines and vaccines. Section 4.3 after an analysis of the proposal peeps into the future as to what may happen. An Annexure (4.1) to this Chapter is a note by Dr K S Kardam titled “A note on International development regarding Access to Medicine to address the COVID-19” Chapter 5 is a short two page note giving a brief thumb nail sketch of the speakers taking part in this Seminar. In the Seminar ahead, our experts will throw more information to clarify the issues and they will answer questions lingering in the minds of the audience. I wish to thank several of our experts in providing me information relating to this backgrounder. Special thanks are also due to the Staff of Waterfalls Institute of Technology Transfer and the Madras Chamber of Commerce and Industry for their efforts in planning the Seminar. Chennai Dr.K.V. Swaminathan 03- February, 2021 (Founder Chairman) 5
1. INTRODUCTION: COVID-19 & VACCINES 1.1 About COVID-19 Coronavirus disease (COVID-19) is an infectious disease that has spread rapidly throughout the world. In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. The pandemic has severely impacted health systems, economic and social progress throughout the world. From a few thousand confirmed COVID-19 cases in January 2020, cases continue to grow globally; as of 26 January 2021, there have been 100,280,252 confirmed cases of COVID-19, including 21,49,387 deaths. (www.worldmeters.info/coronovirus) COVID-19 is caused by a newly discovered coronavirus now named as the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Coronaviruses (CoV) are zoonotic, and are transmitted between animals and humans. Coronaviruses cause diseases such as the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) and more mild illnesses including the common cold. The most common signs of infection with COVID-19 include fever, dry cough, shortness of breath or difficulty in breathing, and tiredness or fatigue. Most people (~80%) experience mild disease and recover without requiring hospitalization. However, globally, around 20% of people who contract COVID-19 become more seriously ill and have trouble in breathing. In more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even lead to death. In India, 1,06,77,710 confirmed COVID-19 cases and over 1,53,624 deaths have been reported as of 26th January 2021. While strong measures were adopted and some progress was made in containing the spread through better public health interventions, diagnostics and treatments, scientists across the world have accelerated the process to develop a safe and effective vaccine that will break the chain of transmission. The Ministry of Health and Family Welfare in their Website has provided very valuable information concerning the theme of the Seminar planned for 6 February 2021. In particular two recent documents contains information about vaccines and vaccination; (i) Loaded on 28- December 2020 is titled “Covid-19 Vaccines – Operational Guidelines; (ii) Loaded on 30 December 2020 is titled “Covid-19: Communication Strategy”. Section 1.2 of this Backgrounder is the Executive Summary of the first publication covering operational guidelines. Section 1.7 and Section 1.8 gives the contents of these to publications. Table 1.4 gives details about the impact of Covid-19 on the world and 10 countries who had felt the impact severely, of which India ranks 2. The Ministry have also provided valuable awareness material in the website. Section 1.9 gives a list of such awareness Material. 6
1.2 Executive Summary (Covid 19 Vaccine – Operational Guidelines) Coronavirus disease (COVID-19), is an infectious disease caused by a newly discovered coronavirus (SARS-CoV-2), which has spread rapidly throughout the world. In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. The pandemic has severely ravaged health systems, and economic and social progress globally. In India, 96,06,810 confirmed COVID-19 cases and over 1,39,700 deaths have been reported as of 4 December 2020. COVID-19 most commonly manifests as fever, dry cough, shortness of breath and tiredness. Most people (~80%) experience mild disease and recover without hospitalization, while around 20% may become more seriously ill. While countries, including India, have taken strong measures to contain the spread of COVID-19 through better diagnostics and treatment, vaccines will provide a lasting solution by enhancing immunity and containing the disease spread. In response to the pandemic, the vaccine development process has been fast-tracked. Globally, over 274 candidate vaccines are in different stages of development as of 4 December 2020. The majority of vaccines in clinical evaluation as of 4 December 2020 will require a two dose schedule to be administered two, three or four weeks apart, and is need to be administered through the intramuscular route. Anticipating that the COVID-19 vaccine may soon be available, the Government of India (GoI) is preparing for its it to be introduced in the country so that it can be expeditiously rolled out when available. One of the milestones in this direction has been the constitution of a National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). The NEGVAC will guide all aspects of the COVID-19 vaccine introduction in India. High-level coordination at the national, state and district levels must be established for effective cooperation and collaboration among the key departments. 19 ministries at national level, 23 departments at state/ district and numerous developmental partners are involved in planning the COVID-19 vaccine introduction; their roles have been described in these operational guidelines. 7
The Successful introduction of the COVID-19 vaccine will largely depend upon the quality of training conducted for enumerators for beneficiary listing, health functionaries for vaccination activities, social mobilizers for all mobilization activities and communication training for all workers involved in the process of vaccination. As demonstrated during recent experiences with pneumococcal conjugate vaccine (PCV) introduction and polio supplementary immunization activities (SIAs) conducted during the COVID-19 pandemic, national and state training of trainers (ToT) may be successfully conducted on virtual platforms and cascaded to district and sub-district levels using a mix of virtual and face-to-face training. The COVID-19 vaccine will be introduced once all training is completed in the district/block/planning unit. COVID-19 vaccine will be offered first to healthcare workers, frontline workers and population above 50 years of age, followed by population below 50 years of age with associated comorbidities based on the evolving pandemic situation, and finally to the remaining population based on the disease epidemiology and vaccine availability. The priority group of above 50 years may be further subdivided into those above 60 years of age and those between 50 to 60 years of age for the phasing of roll out based on pandemic situation and vaccine availability. The latest electoral roll for the Lok Sabha and Legislative Assembly election will be used to identify the population aged 50 years or more. The COVID-19 Vaccine Intelligence Network (Co-WIN) system, a digital platform will be used to track the enlisted beneficiaries for vaccination and COVID-19 vaccines on a real-time basis. At the vaccination site, only pre-registered beneficiaries will be vaccinated per the prioritization, and there will be no provision for on-the-spot registrations. Based on the numbers of registered beneficiaries and the priority accorded, vaccination sessions will be planned with the following considerations: • One session for 100 beneficiaries; • While most of the healthcare and frontline workers would be vaccinated at fixed session sites that may be government health facilities above PHCs or private health facilities identified by district administration, vaccination of other high-risk populations may require outreach session sites, and mobile sites/teams; and State/UT can identify specific days for vaccination; The entire vaccination process will be broadly similar to the election process. The vaccination team will consist of five members as follows: Vaccinator Officer–Doctors (MBBS/BDS), staff nurse, pharmacist, auxiliary nurse midwife (ANM), lady health visitor (LHV); anyone authorized to administer an injection may be considered as a potential vaccinator; Vaccination Officer 1: At least one person (Police, home guard, civil defense, national cadet corps (NCC), national service scheme (NSS), endr yuva kendra sangathan (NYKS) who will check the registration 8
status of a beneficiary at the entry point and ensure the regulated entry to the vaccination session; Vaccination Officer 2: Is the verifier who will authenticate/verify the identification documents; and Vaccination Officer 3 & 4 are the two-support staff who will be responsible for crowd management and ensure 30 minutes of waiting time by beneficiary post-vaccination. Support staff will provide information, education and communication (IEC) messages and support to vaccinator as well as the vaccination team. Essential health services including existing routine immunization sessions should not be impacted or interrupted. Vaccine safety need to be ensured during storage, transportation and delivery of vaccine with sufficient police arrangements so that there are no leakages in the delivery system. Safety precautions, including infection prevention and control practices, safe injection practices and waste disposal, will be followed during vaccination sessions. As large population groups will be vaccinated over a short period with a new vaccine, monitoring the safety of these vaccines will be critical. The existing adverse events following immunization (AEFI) surveillance system will be utilized to monitor adverse events and understand the safety profile of the vaccines. To ensure confidence in the vaccine and the immunization programme during COVID-19 vaccine introduction, states/UTs must rapidly detect and promptly respond to all AEFIs. The reporting of AEFI through surveillance and action for events following vaccination (SAFEVAC) has been integrated with Co-WIN software and every AEFI to be reported at the district level and facilitate the referral mechanisms in case any AEFI needs to be put in place. Requirements for management of the cold chain for COVID-19 vaccination will vary depending on the type of COVID-19 vaccine, as different vaccines have different storage temperature ranges. Cold chain assessments and gap analysis have been completed, and there are plans in place for supplying additional cold chain equipment where required. States/UTs must ensure adequate cold chain storage capacity for the COVID-19 vaccine campaign. Cold chain handlers, and vaccinators at all levels will be trained on procedures for vaccine and logistics management as well as infection prevention and control precautions. Every effort is being made to ensure that everyone in the country has access to timely, accurate and transparent information about the COVID-19 vaccine(s). This requires a meticulous, structured, informative and clear communication strategy to create adequate awareness, ensure accurate knowledge, generate and manage adequate demand, facilitate eagerness and address vaccine hesitancy and confidence, and mitigate for unintended situations (e.g. AEFI clusters, delay in vaccine roll-out for certain population categories) to ensure the smooth introduction and roll-out of COVID-19 vaccine(s). Key communication and demand generation strategies include advocacy at national, state, district and sub-district levels; capacity building, media engagement, social mobilization and partnership, community engagement and empowerment is included at family and community levels. Key 9
areas to be addressed in the communication plan includes information on COVID-19 vaccine, vaccine eagerness, vaccine hesitancy and COVID-19 appropriate behavior. A vaccination programme of this scale will require close monitoring and supportive supervision at all levels to identify bottlenecks and challenges faced at the ground level. Each step-in the vaccine introduction will be monitored. This includes: • Tracking the progress of introduction activities – beneficiary registration training, vaccine logistics availability, and task forces. This will be supported by partners through tracking mechanisms; • Readiness assessment before vaccine introduction – field visits and desk review of data at national and state levels; • Concurrent monitoring of vaccination activities – daily evening meetings, standardized monitoring tools, mobile-based apps, real-time data from the planning unit to the national level; and • Knowledge management – the best practices and innovations at all levels would be shared to improve the implementation in the next phase of scale-up. 1.3 Introduction to Vaccines for Covid-19 The overarching goal is for COVID-19 vaccines to contribute significantly to the equitable protection and promotion of human well-being among people globally. Global equitable access to a vaccine, particularly protecting health care workers and those most-at-risk is the only way to mitigate the public health and economic impact of the pandemic and is the current priority. The vaccine is to be used in conjunction with other control measures. In the longer term, the vaccine is intended to be used for active immunization of people at-risk to prevent COVID-19. While countries, including India, have taken strong measures to contain the spread of COVID-19 through better diagnostics and treatment, vaccines will provide a solution by enhancing immunity and containing the disease spread. Scientists throughout the world have accelerated the process to develop safe and effective COVID-19 vaccines. Vaccines aim to expose the body to an antigen and provoke an immune response that can block or kill the virus if a person becomes subsequently infected, without causing the disease. As part of the global efforts for rapid development of a safe and effective COVID-19 vaccine, various scientific techniques like the use of different viruses or viral parts10 are being developed. The COVID-19 vaccines under development use one of the following techniques: 10
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Virus vaccines These vaccines use the virus itself in a weakened or inactivated form. Vaccines against measles and polio (oral) are made in this manner. There are two types of virus vaccines under development against coronavirus, weakened virus and inactivated virus vaccines. Viral-vector vaccines In the development of these vaccines, a virus (such as adenovirus or measles), is genetically engineered to produce coronavirus proteins in the body, but the virus is weakened and cannot cause disease. The two types of viral-vector vaccines under development are replicating viral vector (can replicate within cells) and non-replicating viral vector (cannot replicate within cells). Nucleic-acid vaccines In these vaccines, nucleic acid (DNA or RNA) is inserted into human cells. These human cells then produce copies of the virus protein which produces an immune response. The two types of nucleic-acid vaccines under development are DNA vaccine and RNA vaccine. Protein-based vaccines These vaccines use virus protein fragments or protein shells which are injected directly into the body. The two types of protein-based vaccines being developed against the coronavirus are the protein subunit vaccines and virus-like particle vaccines. 1.4 Development of COVID-19 Vaccine The Development of a vaccine is a time-consuming process that includes the following phases: Table.1.1. Phases of vaccine development Phases of vaccine development/trial Purpose Pre-clinical Vaccine development in laboratory Phase 1 Clinical trial (8-10 participants) For testing vaccine safety Phase 2 Clinical trial (50-100 participants) For testing vaccine immunogenicity i.e. production of antibodies against virus Phase 3 Clinical trial (30,000-50,000 For testing actual protection offered by the participants) vaccine The vaccine development process has been fast-tracked and multiple platforms are under development. Among those with the greatest potential for speed are DNA and RNA-based platforms, followed by those for developing recombinant- subunit vaccines. RNA and DNA vaccines can be made quickly because they require no culture or fermentation, instead use synthetic processes. 12
Per the tracker developed by the Vaccine Centre at the London School of Hygiene and Tropical Medicine, a total of 274 candidate vaccines are in different stages of development as of 4 December 2020, preclinical (215), phase I (25), phase I/II (17), phase II (5), phase II/III (1), phase III (10) and licensed (1). Table 1.2: Progress on COVID-19 Vaccine Development (Source: Vaccine Centre of London School of hygiene and Tropical Medicine, accessed 4 December 2020). Types of COVID-19 vaccines Pre- Phase Phase Phase Phase Phase Licensed clinical I I/II II II/III III Live-attenuated 3 1 Virus Vaccine Inactivated 11 1 2 1 4 Replicating viral vector 18 1 2 1 Viral vector Vaccine Non-replicating viral 26 6 4 vector DNA vaccine 16 2 5 Nucleic acid vaccines RNA vaccine 29 2 2 1 1 1 Protein subunit 64 9 5 2 1 Protein based vaccine Virus like particle 17 1 1 Unknown - 31 3 Total 215 25 17 5 1 10 1 With multiple COVID-19 vaccines under development, key characteristics regarding dosage, storage requirements, efficacy, route of administration, etc., currently remain unknown. However, a recent landscape document by WHO details 51 vaccines in clinical evaluation. The landscape document, as of 2 December 2020, indicates that most vaccines will require a two-dose schedule to be administered two, three or four weeks apart, and will be administered through-the intramuscular IM route. Vaccine specifications In June 2020, the United Nations Children’s Fund (UNICEF) gathered information on vaccine specifications from 26 vaccine developers and manufacturers (10 manufacturing in China, 6 in India, 3 in the United States of America, 2 each in Belgium, Russia and Japan, 1 each in France, South Korea, Switzerland and the United Kingdom). From the results, which were made public on 31 August 2020, characteristics of the COVID-19 vaccines under development from these 26 developers are: 13
Of the four vaccines with preliminary efficacy data available as of 4 December 2020, all are intramuscular (IM) injections with 2-dose courses. • The University of Oxford/AstraZeneca vaccine can be stored, transported and handled at +2o to 8oC. • BioNTech/Fosun Pharma/Pfizer vaccine has a recommended temperature condition of -80oC and can be stored for five days at +2o to 8oC. • The Moderna/NIAID vaccine remains stable at -20oC for up to six months and remains stable at +2o to 8oC for 30 days and the Gamaleya institute, Sputnik-V vaccine can be stored at +2o to 8 oC. 1.5 COVID-19 vaccine development in India There are 9 COVID-19 vaccine candidates in different phases of development in India, of these 3 are in pre-clinical phase whereas 6 are under clinical trials. Table.1.3. Indian landscape of COVID-19 vaccines under development 1.6 Communication Strategy The communication strategy that supports the COVID-19 vaccines rollout in India seeks to disseminate timely, accurate and transparent information about the vaccine(s) to alleviate apprehensions about the vaccine, ensure its acceptance and encourage uptake. The strategy will also serve to guide national, state and district level communication activities, so that the information on the COVID-19 vaccines and vaccination process reaches all people, across all states in the country. 14
To support and encourage appropriate uptake of the vaccines by: Managing and mitigating any potential disappointment expressed by unmet demand for the vaccine or ‘eagerness’ amongst people. Addressing vaccine ‘hesitancy’ that could arise because of apprehensions around vaccine safety, efficacy; and any other myths and misconceptions. Provide information on potential risks and mitigate unintended crisis (e.g. AEFI clusters, delay in vaccine rollout for certain population categories) during the introduction and rollout. The strategy also seeks to build trust and enable greater confidence in the COVID-19 vaccine amongst all people by employing transparency in communication, while also managing any mis/disinformation and rumours around it. Table 1.4 TOP 10 COUNTIRES IMPACTED BY COVID-19 (Numbers as of 01, February 2021) No. Country Total Cases Total deaths Recovered Active Per million Cases Population Cases Deaths 1. USA 26,767,229 452,279 16,403,843 9,911,107 80,590 1,362 2. India 10,758,619 154,428 10,434,983 169,208 7,752 111 3. Brazil 9,204,731 224,534 8,027,042 953,155 43,125 1,052 4. Russia 3,868,087 73,619 3,318,173 476,295 26,499 504 5. UK 3,817,176 106,158 1,673,936 2,037,082 56,057 1,559 6. France 3,197,114 76,057 224,406 2,896,651 48,917 1,164 7. Spain 2,830,478 58,319 N/A N/A 60,525 1,247 8. Italy 2,553,032 88,516 2,010,548 453,968 42,262 1,465 9. Turkey 2,477,463 25,993 2,362,415 89,055 29,191 306 10. Germany 2,225,659 57,777 1,935,600 232,282 26,514 688 Total World 103,569,867 2,238,898 75,193,856 26,132,615 13,287.0 287.2 15
(Source: https://www.worldometers.info/coronavirus/) 1.7 Contents of COVID-19 Vaccine(s) – Operations Guidelines CONTENTS 16
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1.8 Contents COVID-19 Vaccine(s) – Communication Strategy 18
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Table 1.9 Awareness Material (Ministry of Health & Family Welfare - GOI) 04.01.2021 Audio visual on Dr Guleria, Director, AIIMS sharing FAQs on COVID 19 vaccine rollout Episode 1/3 Episode 2/3 Episode 3/3 17.12.2020 FAQs on COVID 19 Vaccine for Healthcare providers and Frontline workers – English - Hindi 17.12.2020 FAQs on COVID 19 Vaccine for General Public - English - Hindi 12.10.2020 Encouraging youth to advocate against stigma and discrimination during COVID-19 - English 12.10.2020 Encouraging youth to advocate against stigma and discrimination during COVID-19 - Hindi 15.07.2020 Patients, their families and health care providers stand together to counter stigma and discrimination associated with COVID19 15.07.2020 A/V on 15 COVID Appropriate Behaviours - English 15.07.2020 A/V on 15 COVID Appropriate Behaviours - Hindi 03.07.2020 Hindi Video on supporting COVID recovered patients 03.07.2020 Hindi Video on COVID Appropriate Behaviours during COVID-19 03.07.2020 Hindi Video on extending support towards persons returning home during COVID-19 03.07.2020 Hindi Video on showing respect to healthcare workers 03.07.2020 Hindi Video on showing respect to sanitation workers 03.07.2020 Video on health care workers’ helping us fight the battle against COVID-19 03.07.2020 Heartfelt thanks to Corona Warriors 03.07.2020 Video on showing support for persons in quarantine / isolation 02.07.2020 A/V on thanking Corona Warriors 02.07.2020 Video on Home Isolation for very mild/ pre-symptomatic COVID-19 patients 22.06.2020 A/V on COVID Appropriate Behaviours (1/5), (2/5), (3/5), (4/5) & (5/5) 18.06.2020 An Illustrative Guide on COVID Appropriate Behaviours -English, Hindi 18.06.2020 A/V on "Quit using spit as it can increase the risk of spread of COVID-19" - (English) 18.06.2020 A/V on "Quit using spit as it can increase the risk of spread of COVID-19" - (Hindi) 16.06.2020 Guide to address stigma associated with COVID-19 - English 16.06.2020 Guide to address stigma associated with COVID-19 - Hindi 12.06.2020 Guidelines for Hotels on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Offices on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Religious Places on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Restaurants on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Shopping Malls on preventive measures to contain spread of COVID-19 08.06.2020 A/V on the need to address Stigma and Discrimination associated with COVID-19 08.06.2020 A/V on COVID Appropriate Behaviours - (English) 08.06.2020 A/V on COVID Appropriate Behaviours - (Hindi) 28.05.2020 RAP video to advocate no spitting 20
27.05.2020 Video on Caring and Sharing, the new normal 16.05.2020 NO Spitting in public places (Video) 15.05.2020 Guidelines for Home Isolation of very mild / pre-symptomatic COVID-19 cases (Video) 05.05.2020 Thematic Bank of COVID19 Creatives 1. What is Corona Virus and how does it transmits 2. Handwashing 3. COVID Appropriate Behaviours Pack 1.0 4. COVID Appropriate Behaviours Pack 2.0 5. Home Quarantine 6. Myth Busters 7. All India National Helpline 1075 8. No Spitting 9. Stigma and Discrimination 10. Thank you COVID Warriors 29.04.2020 Awareness Material for front line workers of COVID-19 – Hindi 29.04.2020 Awareness Material for front line workers of COVID-19 – Punjabi 29.04.2020 Awareness Material for front line workers of COVID-19 - Bengali 29.04.2020 Awareness Material for front line workers of COVID-19 - Marathi 29.04.2020 Awareness Material for front line workers of COVID-19 - Telgu (Telangana) 29.04.2020 Awareness Material for front line workers of COVID-19 - Telgu (Andra Pradesh) 29.04.2020 Awareness Material for front line workers of COVID-19 - Malayalam 29.04.2020 Awareness Material for front line workers of COVID-19 - Kannada 29.04.2020 Awareness Material for front line workers of COVID-19 - Tripura 29.04.2020 Awareness Material for front line workers of COVID-19 - Tamil 29.04.2020 Awareness Material for front line workers of COVID-19 - Gujrati 29.04.2020 Awareness Material for front line workers of COVID-19 - Odia 20.04.2020 Audio Visual on Addressing Stigma Related to COVID-19 18.04.2020 Information for general public on use of necessary medicines for COVID19 (Poster) 18.04.2020 Information for general public on use of necessary medicines for COVID19 - Audio Visual 11.04.2020 Video on use of reusable face cover (English) - Part 1 11.04.2020 Video on use of reusable face cover (English) - Part 2 08.04.2020 Video on Salutations to Coronavirus Warriors - I 08.04.2020 Video on Salutations to Coronavirus Warriors - II 08.04.2020 Know how to use your own Homemade Reusable Face Cover 07.04.2020 Know how to use your own Homemade Reusable Face Cover 04.04.2020 Video on Lockdown - Staying Active at Home 02.04.2020 Aarogya Setu App for staying informed and alert against COVID19. Government initiative to develop a digital Bridge to fight against COVID_19. Download Today! Play Store APPIOS APP 31.03.2020 Handling Public Grievances pertaining to COVID-19 in M/o Health & Family Welfare 29.03.2020 Video from experts from AIIMS, New Delhi sharing basic steps on hand washing to fight against COVID-19 – English 21
29.03.2020 Video from experts from AIIMS, New Delhi sharing basic steps on hand washing to fight against COVID-19 - Hindi 29.03.2020 Video from experts from AIIMS Advising Stay Home Stay Safe – English 29.03.2020 Video from experts from AIIMS Advising “Stay Home Stay Safe” – Hindi 29.03.2020 Poster on Social distancing in a market place during COVID-19 English 29.03.2020 Poster on Social distancing in a market place during COVID-19 Hindi 28.03.2020 COVID-19 Health Service Providers Toolkit: General Health Facilities 1. A letter from HFM to the Health Administrators 2. Community leaflet 3. What is Novel Coronavirus? 4. Is your Healthcare facility ready to manage patients with COVID-19? 5. How to use the handrub? 6. When and How to wear mask? 7. Guidelines on the use of materials 28.03.2020 COVID-19 Health Service Providers Toolkit: Designated Hospitals 1. A letter from HFM to the Health Administrators 2. Community leaflet 3. What is Novel Coronavirus? 4. Is your Healthcare facility ready to manage patients with COVID-19? 5. How to protect all health workers at designated hospital? 6. What are my moments of hand hygiene? 7. How to manage Suspected or confirmed COVID-19 patients at designated hospital? 8. Guidelines on the use of materials 28.03.2020 COVID-19 Frontline Worker Toolkit in Englsih 1. Facilitator Guide 2. PPT with seven sessions including for Urban 3. A digital pocket book for front line workers 4. Training Protocols and guidelines 5. Training Plan template 28.03.2020 When to get tested for COVID-19 English 28.03.2020 When to get tested for COVID-19 Hindi 25.03.2020 Role of Frontline Workers in Prevention and Management of CORONA VIRUS- English 25.03.2020 Role of Frontline Workers in Prevention and Management of CORONA VIRUS - Hindi 23.03.2020 Posters for Safety measures against COVID-19 - English 23.03.2020 Posters for Safety measures against COVID-19 - Hindi 22.03.2020 KIDS, VAAYU & CORONA : Comic book for children to provide correct information about COVID-19 - Part 2 19.03.2020 Posters for Indians traveling from abroad – English 19.03.2020 Posters for Indians traveling from abroad – Hindi 09.03.2020 KIDS, VAAYU & CORONA : Comic book for children to provide correct information about COVID-19 06.03.2020 Do's and Don't Poster in English 06.03.2020 Do's and Don't Poster in Hindi 06.03.2020 Watch all COVID-19 management videos here 06.03.2020 TV and Radio Spots (English & Hindi) for COVID-19 ------------------------------------------------------------------------------------------------------------------------------------- 22
2. DEMYSTIFYING THE CONCEPTS ABOUT COVID-19 AND VACCINATION 2.1 India’s Vaccination Drive India started the world's largest Covid-19 vaccination drive, inoculating 3 crore people on priority. On 16 January, 2021- the first day of the drive - over 3 lakh healthcare workers were to be administered the vaccine against Covid-19. (Actual about 2.0 lakh were vaccinated). A total of 3,006 session sites across all states and union territories will be virtually connected during the launch at 10.30 am by Prime Minister Narendra Modi and around 100 beneficiaries will be vaccinated at each session site. As India begins its journey into what the Health Ministry has called 'the beginning of the end”. (i) What are the Vaccines approved by India, and their prices? The vaccines Covishield, developed by the Serum Institute of India, and Covaxin from Bharat Biotech have been approved by the Indian government. These have already been delivered to all states and union territories. A dose of Covishield and CoVaxin may cost in the range of ₹200 to 295 in India. Serum Institute chief has also said that the jab may cost Rs.1,000 in the private market. (ii) Are there any side-effects to the Vaccines? The Health Ministry has cautioned about mild side effects following vaccination for both the vaccines. In case of Covishied, some mild adverse effects may occur like injection site tenderness, injection site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia and nausea. Some mild adverse effects in case of Covaxin include injection site pain, headache, fatigue, fever, body ache, abdominal pain, nausea and vomiting, dizziness-giddiness, tremor, sweating, cold, cough and injection site swelling. Paracetamol may be used to provide symptomatic relief from post vaccination adverse reactions. (iii) Who is in the Priority Group ? Healthcare workers will receive the jab first because they are at high risk of contracting the infection. Next, come the frontline workers, the vaccination of whom will help in reducing the societal and economic impact by reducing COVID-19 mortalities. And lastly, persons over 50 years of age and persons under 50 years with comorbid conditions will be inoculated, due to there being high mortality in the category. (iv) What about the Co-win Application ? Co-WIN is an online platform designed by the Centre for monitoring COVID-19 vaccine delivery. The Health Ministry has said it will form the foundation for the anti-coronavirus inoculation drive. The App is also designed to enable citizens to self-register for the vaccination process. However, that will take some time as the vaccination drive will start for frontline workers and other vulnerable citizens. The government had explained that the Co-WIN app comes with five modules, namely - Administrator module, Registration module, Vaccination module, Beneficiary Acknowledgement module, and Report module - to ensure smooth tracking and registration for COVID-19 vaccine in the country. The mobile app is also an upgraded version of the eVIN (Electronic Vaccine Intelligence Network) and it will be available to download for free via the Google 23
Play Store and Apple App Store. The App may also launch on Jio phones that run on KaiOS. 2.2 US COVID-19 Vaccination Program (Information provided by the Centers for Disease Control and Prevention) Now that there are authorized and recommended vaccines to prevent COVID- 19 in the United States, here are 8 things one need to know about the new COVID- 19 Vaccination Program and COVID-19 vaccines. Vaccination started in US in December 2020. (i) The safety of COVID-19 vaccines is a top priority. The U.S. vaccine safety system ensures that all vaccines are as safe as possible. CDC has developed a new tool, v-safe, as an additional layer of safety monitoring to increase our ability to rapidly detect any safety issues with COVID-19 vaccines. V-safe is a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. (ii) COVID-19 vaccination will help protect one from getting COVID-19. Two doses are needed. Depending on the specific vaccine, a second shot 3-4 weeks after your first shot is needed to get the most protection the vaccine has to offer against this serious disease. (iii) CDC is making recommendations for who should be offered COVID-19 vaccine first when supplies are limited. To help guide decisions about how to distribute limited initial supplies of COVID-19 vaccine, CDC and the Advisory Committee on Immunization Practices have published recommendations for which groups should be vaccinated first. (iv) There is currently a limited supply of COVID-19 vaccine in the United States, but supply will increase in the weeks and months to come. The goal is for everyone to be able to easily get vaccinated against COVID-19 as soon as large enough quantities are available. Once vaccine is widely available, the plan is to have several thousand vaccination providers offering COVID-19 vaccines in doctors’ offices, retail pharmacies, hospitals, and federally qualified health centers. (v) After COVID-19 vaccination, one may have some side effects. This is a normal sign that the body is building protection. The side effects from COVID-19 vaccination may feel like flu and might even affect ability to do daily activities, but they should go away in a few days. (vi) Can a COVID-19 vaccine make one sick with COVID-19? 24
No. None of the COVID-19 vaccines contain the live virus that causes COVID- 19 so a COVID-19 vaccine cannot make one sick with COVID-19. (vii) The first COVID-19 vaccines are being used under Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA). Many other vaccines are still being developed and tested. If more COVID-19 vaccines are authorized or approved by FDA, the Advisory Committee on Immunization Practices (ACIP) will quickly hold public meetings to review all available data about each vaccine and make recommendations for their use in the United States. All ACIP-recommended vaccines will be included in the U.S. COVID-19 Vaccination Program. CDC continues to work at all levels with partners, including healthcare associations, on a flexible COVID-19 vaccination program that can accommodate different vaccines and adapt to different scenarios. State, tribal, local, and territorial health departments have developed distribution plans to make sure all recommended vaccines are available to their communities. (viii) COVID-19 vaccines are one of many important tools to help stop this pandemic. It’s important for everyone to continue using all the tools available to help stop this pandemic as we learn more about how COVID-19 vaccines work in real- world conditions. Cover your mouth and nose with a mask when around others, stay at least 6 feet away from others, avoid crowds, and wash your hands often. 2.3 FAQ and Answers on Vaccines for Covid-19 (i) How do vaccines work? Vaccines stimulate the human body’s own protective immune responses so that, if a person is infected with a pathogen, the immune system can quickly prevent the infection from spreading within the body and causing disease. In this way, vaccines mimic natural infection but without actually causing the person to become sick. For SARS-CoV-2, antibodies that bind to and block the spike protein on the virus’s surface are thought to be most important for protection from disease because the spike protein is what attaches to human cells, allowing the virus to enter the cells. Blocking this entrance prevents infection. Not all people who are infected with SARS-CoV-2 develop disease (Covid-19 is the disease caused by the virus SARS-CoV-2). These people have asymptomatic infection but can still transmit the virus to others. Most vaccines do not completely prevent infection but do prevent the infection from spreading within the body and from causing disease. Many vaccines can also prevent transmission, potentially leading to herd protection whereby unvaccinated people are protected from infection by the vaccinated people around them because they have less chance of exposure to the virus. 25
(ii) What are the different types of vaccines in use or in development and why are there so many? Several different types of vaccines against SARS-CoV-2, the virus that causes the disease Covid-19, are in use or in development. Some are based on traditional methods for producing vaccines and others on newer methods. One of the more traditional ways of making a viral vaccine is to inactivate (kill) the virus with chemicals, such as is done with the flu vaccine, inactivated polio or hepatitis A vaccines, so that the virus can no longer multiply. Several inactivated SARS-CoV-2 vaccines are in development. Other vaccines are based on just a part of the bacteria or virus, typically one or more proteins, such as the vaccines for whooping cough (pertussis) and hepatitis B virus. For SARS-CoV-2 vaccines that focus on a part of the virus. Newer vaccine types include what are called viral vector vaccines, in which the SARS-CoV-2 gene for the spike protein is inserted into another harmless virus to deliver the gene to human cells where the spike protein is produced. The spike protein then stimulates immune responses. The most common viral vectors are adenoviruses, which typically cause common cold-like symptoms in people but are further weakened for vaccines so they cannot cause any disease at all. Several adenovirus vector vaccine for SARS-CoV-2 are in advanced clinical testing (phase 3 clinical trials), such as the vaccine produced by Johnson & Johnson that may be protective following a single dose. Finally, instead of using a viral vector, the gene for the spike protein can be used directly as a vaccine in the form of DNA or messenger RNA (mRNA). These are the most novel SARS-CoV-2 vaccines. Several mRNA vaccines are in advanced clinical testing. Many manufactures around the world are working on this global problem. This means that there will likely be multiple different types of SARS-CoV-2 vaccines and they may work differently in different people. Hopefully, some will work well in older adults and in people with underlying conditions that impair their immune system, as these groups are more likely to get sick and die from Covid-19. (iii) How do we know if a vaccine is safe and effective? The safety and efficacy of a vaccine are determined through clinical trials. Clinical trials are studies that are typically conducted in three phases to assess the safety and efficacy of vaccines in increasingly larger numbers of volunteers. Phase 1 clinical trials assess the safety and dosage of a vaccine in a small number of people, typically a dozen to several dozen healthy volunteers. Whether a vaccine stimulates immune responses is often assessed in a phase 1 study but this is better assessed in phase 2 studies, which typically involve hundreds of people including some special groups such as children, people with pre-existing conditions such as heart disease, and older adults. Vaccine safety is also assessed in phase 2 studies, in which adverse events not detected in phase 1 trials may be identified because a larger and more diverse group of people receive the vaccine. However, only in much larger phase 3 clinical trials can it be demonstrated whether a vaccine is actually protective against disease and safety is more fully assessed. 26
Phase 3 clinical trials often include thousands of volunteers, and for Covid-19 vaccines involve tens of thousands (30,000 to 45,000 people in some of the phase 3 trials). In phase 3 trials, participants are randomized to receive either the viral vaccine or a placebo vaccine (sometimes a vaccine against another disease or a harmless substance like saline). Randomization is a process to determine who receives the vaccine and who receives the placebo without any bias, like flipping a coin. To further prevent any bias in interpreting the study data, participants and most of the investigators will not know if an individual received the vaccine or placebo. The participants are then followed to see how many in each group get the disease. If the vaccine is efficacious, many fewer people who received the viral vaccine will get the disease compared to those who received the placebo vaccine. It takes time for cases of disease to accumulate so that we can be confident there is a true difference between the two groups, and this is why these phase 3 trials often take a long time. Assessing safety is also a major goal of phase 3 trials, both short-term (e.g., fever, tenderness, muscle aches) and long-term safety (e.g., autoimmune conditions or enhanced disease following infection). After a vaccine is approved and in more widespread use, it is critically important to continue to monitor for both safety and effectiveness. Some very rare side effects may only be detectable when large numbers of people have been vaccinated. Safety concerns that are discovered at this late stage could lead a licensed vaccine to be withdrawn from use, although this is very rare. (iv) When will a vaccine be available ? Vaccines for SARS-CoV-2 will be available when they are demonstrated to be safe and efficacious in large phase 3 clinical trials, have been approved by regulatory authorities (the Food and Drug Administration in United States), and have been manufactured and distributed to places where people can be vaccinated. To demonstrate efficacy, sufficient differences in disease must be observed between those who received the viral vaccine and those who received the placebo or comparison vaccine in a phase 3 clinical trial. This depends on the likelihood of infection in places where the studies are conducted but can take from several months to years. Once sufficient data are available to be confident that the vaccine is efficacious, and no evidence of serious adverse events is identified, a rigorous and transparent approval process should take place. Manufacturing capacity has already been developed for some vaccines and vaccine distribution systems are being put in place. However, because of limited quantities of vaccine, some groups of people will be offered the vaccine first, likely health care workers, other essential personnel, and those most vulnerable to severe disease and death. (v) How is the process for approving a vaccine moving so quickly ? Traditionally, it has taken many years to develop a vaccine, confirm its safety and efficacy, and manufacture the vaccine in sufficient quantities for public use. This timeline has been substantially shortened for SARS-CoV-2 vaccines in development. There are several ways this has been made possible. First, some 27
clinical trials have combined phases 1 and 2 to assess safety and immune responses. Second, because of the high number of new cases of Covid-19 in many places, differences in disease risk between those who received the viral vaccine and those who received the placebo or comparison vaccine can be measured more quickly than in the absence of a pandemic. Third, the United States government and others heavily invested in building the manufacturing capacity to produce large numbers of vaccine doses before the findings of the phase 3 trials were available. Typically, vaccine manufacturers wait until the phase 3 trial is completed and shows safety and efficacy before making such a large investment in manufacturing capacity. None of these factors that contribute to the accelerated development of a vaccine for SARS-CoV-2 imply that safety, scientific or ethical integrity are compromised, or that short-cuts were made. (vi) What is an emergency use authorization? Drugs and vaccines have to be approved by the Food and Drug Administration (FDA) to ensure that only safe and effective products are available to the American public. In situations when there is good scientific reason to believe that a drug is safe and is likely to treat or prevent disease, the FDA may authorize its use even if definitive proof of the efficacy of the drug is not known, especially for diseases that cause high mortality. Emergency use authorizations were granted by the FDA Commissioner for chloroquine and hydroxychloroquine (later revoked) and for the use of convalescent plasma to treat hospitalized patients with Covid-19. Many are concerned that Emergency Use Authorization for a vaccine could be issued prematurely, before sufficient safety and efficacy data have been generated through phase 3 clinical trails. It is important to emphasize that the bar for ensuring safety of a vaccine is higher than for a therapeutic to treat an ill person. Vaccines are given to potentially millions of healthy people, unlike drugs for sick people, and loss of trust in a vaccine for SARS-CoV-2 could spill over into loss of trust in other vaccines, seriously jeopardizing public health. (vii) How long will it take for the general public to be vaccinated after a vaccine is approved? It is not clear at this point in time when vaccines will be available, but a reasonable guess may be at least six months to one year after approval. The timeline depends on how rapidly vaccine doses can be produced and distributed. Importantly, the public will need to trust a vaccine and be willing to be vaccinated to have a public health impact. Building trust in a vaccine for SARS-CoV-2, particularly in communities with long-standing mistrust of the government and scientific experiments, is critical. (viii) Should children get the vaccine? Children will not be a priority group for a vaccine early in vaccine deployment but will likely be eligible as vaccine availability improves. The major vaccine clinical trails are currently focussed on enrolling adults, and as they expand, the inclusion of children in vaccine clinical trials will produce data on safety and 28
efficacy that can be applied to children. While children are less likely to develop severe disease and die from Covid-19, there are several reasons for ensuring that eventually there is a vaccine that is safe and effective for children. Although rare, some children may develop severe disease or die from Covid- 19. Children have also developed a severe inflammatory syndrome, called multisystem inflammatory syndrome in children. Children may be important transmitters of SARS-CoV-2 and vaccinating them with a vaccine that reduces transmission could be important in controlling the pandemic. Finally, having a safe vaccine for children will build confidence towards opening up schools and learning centers for in-person educational processes. (ix) How long will protection last following vaccination? We do not yet know how long protection lasts following vaccination but it will be critically important to measure long-term protection (at least two years) in the phase 3 trials and in other groups prioritized for early vaccination. We are still learning about the duration of protection following infection with SARS-CoV-2 and it is too early to tell how long protection will last. There have already been cases where individuals have been shown to be infected twice but most often the second illness was mild or without any symptoms. This is what we would expect with an immune response that protects against disease but not infection. There are ways to potentially make protection following vaccination more durable than following natural infection, such as with an adjuvant, an ingredient used in some vaccines that helps create a stronger immune response, or with booster doses of vaccine. These strategies to enhance vaccines may be particularly important for vulnerable populations, such as the elderly and those with underlying diseases, who are at particular risk of severe Covid-19 but are also less likely to develop a protective immune response to a vaccine. (x) If I already had Covid-19, should I still get a vaccine? When people recover from some viral infections, such as measles or mumps, they are protected against reinfection and would not need to be vaccinated. However, for other diseases, such as pneumococcal pneumonia or influenza, it is important to be vaccinated (or revaccinated) despite having disease because the vaccine protects against several strains or types of the pathogen and thus can still be valuable. There is no evidence that there are significant differences in SARS-CoV-2 to warrant vaccination for this reason, but we do not yet know how long people are protected after having Covid-19 and so do not yet know if these people should be vaccinated. If protection only lasts for several months, vaccination could be of benefit. (xi) Can someone get Covid-19 from the vaccine? No, it is not possible to get Covid-19 from vaccines. Vaccines against SARS- CoV-2 use inactivated virus, parts of the virus (e.g., the spike protein), or a gene from the virus. None of these can cause Covid-19. (xii) Should I get the vaccine for influenza (flu shot)? Yes, it is very important to get the influenza vaccine, particularly this season when both influenza viruses and SARS-CoV-2 can infect people. We still do not 29
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