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      Urgent needs of low-income and middle-income countries for COVID-19 vaccines and therapeutics

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      Lancet Commission on COVID-19 Vaccines and Therapeutics Task Force Members *
      Lancet (London, England)
      Elsevier Ltd.

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          Abstract

          WHO and partners have learnt from the mis-steps in the response to the 2009 H1N1 influenza pandemic 1 and established the Access to COVID-19 Tools (ACT) Accelerator to promote equitable access to vaccines, therapeutics, and diagnostics. 2 However, many high-income countries already have bilateral agreements with manufacturers of COVID-19 vaccines. 3 The COVAX Facility of the ACT Accelerator has agreements to access 2 billion doses of WHO pre-qualified vaccines during 2021, but this represents only 20% of the vaccine needs of participating countries. 4 Most low-income and middle-income countries (LMICs) face difficulties in accessing and delivering vaccines and therapeutics for COVID-19 to their populations. 5 COVAX will require decisive action by Gavi, the Vaccine Alliance, WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI), supported by the countries they serve and with financing for vaccine purchasing, to ensure people worldwide have equitable access to COVID-19 vaccines.6, 7, 8 For 80% of the populations in LMICs that will not benefit from COVAX-provided COVID-19 vaccines, finances for purchase or donations are needed. Government measures in response to COVID-19 and the broader global financial situation have led to increasing fiscal imbalances of heavily indebted countries. 9 Multinational agencies, financial institutions, and wealthier countries should consider measures that could provide relief to indebted LMICs. The World Bank, the International Monetary Fund, and others need to lead an international initiative to mobilise support for LMICs in need. Many LMICs do not have an established platform for vaccinating their adult populations. 10 Although it is feasible to deliver COVID-19 vaccines to health-care and other front-line essential workers, in some LMICs it will be difficult to effectively reach and vaccinate with two doses all elderly populations and individuals with co-morbidities, given insufficient mechanisms to identify such groups. Governments and technical leaders will need to use transparent, accountable, and unbiased processes when they make and explain evidence-based vaccine prioritisation decisions, while also building confidence in COVID-19 vaccines and engaging with all the stakeholders. The ultracold chain requirements of mRNA COVID-19 vaccines are likely to be an insurmountable hurdle in LMICs, outside of major cities. COVID-19 vaccine delivery will require considerable investment of resources, health-care staff, and careful planning to avoid opportunity costs, including a disruption of routine health services and a decline in essential childhood vaccination coverage, which could result in outbreaks of measles and other vaccine-preventable diseases. There were more deaths from measles than Ebola virus disease in 2019 in the aftermath of the Ebola outbreak in the Democratic Republic of the Congo, due to failure to maintain adequate childhood vaccinations. 11 The infrastructure for vaccination in many LMICs is already inadequate, as shown by the 19·7 million under-vaccinated infants globally, most of whom are in these countries. 12 Thus, preparation for all aspects of COVID-19 vaccine delivery in LMICs must begin now with the support of international partners. Strengthening the capacity of LMICs to do clinical trials and promoting LMIC participation in research are also crucial. 13 More LMICs need to participate in future vaccine trials and in testing the clinical effectiveness of different therapeutic agents to ensure that interventions and implementation are suitable for local contexts. © 2021 Rassin Vannier/Getty Images 2021 Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. Tracking the safety and effectiveness of different COVID-19 vaccines over time in various populations and settings will necessitate improvements in pharmacovigilance. 14 Regulatory authorities in many LMICs need to be strengthened and could benefit from a programme of national and international support, as well as regional cooperation and reliance mechanisms. 15 As part of internationally coordinated actions, COVID-19 technologies should be transferred to LMIC-based manufacturers, accompanied by regulatory guidance. Efforts to boost local manufacturing capacity in LMICs will contribute to equity, global solidarity, and global health security. India and South Africa have called for the suspension of intellectual property rights related to COVID-19 vaccines to improve access for LMICs, a move now supported by many other countries, but opposed by the pharmaceutical industry, which cites the disincentive to innovation. 16 There are further challenges. Governments in LMICs with strong private health sectors, as those in high-income countries, will need to manage the inherent potential for inequity, whereby the rich could access COVID-19 vaccines before individuals with less access to private care who may be at increased risk of severe disease and death, such as older people and those with comorbidities. LMICs affected by war, civil conflict, economic crises, or natural disasters, or with large refugee populations or populations with special needs or vulnerabilities need additional support for vaccines and vaccination under extremely difficult operational conditions. Re-examining global governance structures, including the UN and its Security Council, is much needed so that the voices and interests of billions of people in LMICs are better represented and recognised. Global support to multilateral institutions is essential to sustain their support to LMICs to facilitate vaccinations globally. The COVID-19 pandemic shows that no nation can stand alone. We are all part of a common humanity that requires us to respect our diverse experiences, cultures, and countries and forge partnerships that better serve the interests of all.

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          Most cited references9

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          Reserving coronavirus disease 2019 vaccines for global access: cross sectional analysis

          Abstract Objective To analyze the premarket purchase commitments for coronavirus disease 2019 (covid-19) vaccines from leading manufacturers to recipient countries. Design Cross sectional analysis. Data sources World Health Organization’s draft landscape of covid-19 candidate vaccines, along with company disclosures to the US Securities and Exchange Commission, company and foundation press releases, government press releases, and media reports. Eligibility criteria and data analysis Premarket purchase commitments for covid-19 vaccines, publicly announced by 15 November 2020. Main outcome measures Premarket purchase commitments for covid-19 vaccine candidates and price per course, vaccine platform, and stage of research and development, as well as procurement agent and recipient country. Results As of 15 November 2020, several countries have made premarket purchase commitments totaling 7.48 billion doses, or 3.76 billion courses, of covid-19 vaccines from 13 vaccine manufacturers. Just over half (51%) of these doses will go to high income countries, which represent 14% of the world’s population. The US has reserved 800 million doses but accounts for a fifth of all covid-19 cases globally (11.02 million cases), whereas Japan, Australia, and Canada have collectively reserved more than one billion doses but do not account for even 1% of current global covid-19 cases globally (0.45 million cases). If these vaccine candidates were all successfully scaled, the total projected manufacturing capacity would be 5.96 billion courses by the end of 2021. Up to 40% (or 2.34 billion) of vaccine courses from these manufacturers might potentially remain for low and middle income countries–less if high income countries exercise scale-up options and more if high income countries share what they have procured. Prices for these vaccines vary by more than 10-fold, from $6.00 (£4.50; €4.90) per course to as high as $74 per course. With broad country participation apart from the US and Russia, the COVAX Facility—the vaccines pillar of the World Health Organization’s Access to COVID-19 Tools (ACT) Accelerator—has secured at least 500 million doses, or 250 million courses, and financing for half of the targeted two billion doses by the end of 2021 in efforts to support globally coordinated access to covid-19 vaccines. Conclusions This study provides an overview of how high income countries have secured future supplies of covid-19 vaccines but that access for the rest of the world is uncertain. Governments and manufacturers might provide much needed assurances for equitable allocation of covid-19 vaccines through greater transparency and accountability over these arrangements.
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            Potential effects of vaccinations on the prevention of COVID-19: rationale, clinical evidence, risks, and public health considerations

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              Report on WHO meeting on immunization in older adults: Geneva, Switzerland, 22–23 March 2017

              Many industrialized countries have implemented routine immunization policies for older adults, but similar strategies have not been widely implemented in low- and middle-income countries (LMICs). In March 2017, the World Health Organization (WHO) convened a meeting to identify policies and activities to promote access to vaccination of older adults, specifically in LMICs. Participants included academic and industry researchers, funders, civil society organizations, implementers of global health interventions, and stakeholders from developing countries with adult immunization needs. These experts reviewed vaccine performance in older adults, the anticipated impact of adult vaccination programs, and the challenges and opportunities of building or strengthening an adult and older adult immunization platforms. Key conclusions of the meeting were that there is a need for discussion of new opportunities for vaccination of all adults as well as for vaccination of older adults, as reflected in the recent shift by WHO to a life-course approach to immunization; that immunization in adults should be viewed in the context of a much broader model based on an individual’s abilities rather than chronological age; and that immunization beyond infancy is a global priority that can be successfully integrated with other interventions to promote healthy ageing. As WHO is looking ahead to a global Decade of Healthy Ageing starting in 2020, it will seek to define a roadmap for interdisciplinary collaborations to integrate immunization with improving access to preventive and other healthcare interventions for adults worldwide.
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                Author and article information

                Journal
                Lancet
                Lancet
                Lancet (London, England)
                Elsevier Ltd.
                0140-6736
                1474-547X
                28 January 2021
                13-19 February 2021
                28 January 2021
                : 397
                : 10274
                : 562-564
                Author notes
                [†]

                The members of the Lancet Commission on COVID-19 Vaccines and Therapeutics Task Force are: *J Peter Figueroa, Maria Elena Bottazzi (Co-Chair), Peter Hotez (Co-Chair), Carolina Batista, Onder Ergonul, Sarah Gilbert, Mayda Gursel, Mazen Hassanain, Jerome H Kim, Bhavna Lall, Heidi Larson, Denise Naniche, Timothy Sheahan, Shmuel Shoham, Annelies Wilder-Smith, Natalie Strub-Wourgaft, Prashant Yadav, and Gagandeep Kang.

                Article
                S0140-6736(21)00242-7
                10.1016/S0140-6736(21)00242-7
                7906712
                33516284
                6c3b547f-33a5-4fce-ba05-d2ea700bc2ba
                © 2021 Elsevier Ltd. All rights reserved.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

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