Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment

Abstract

The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities. In this Health Policy paper, we review potential challenges to success in each of these dimensions and discuss policy implications. To guide our review, we developed a dashboard to highlight key characteristics of 26 leading vaccine candidates, including efficacy levels, dosing regimens, storage requirements, prices, production capacities in 2021, and stocks reserved for low-income and middle-income countries. We use a traffic-light system to signal the potential contributions of each candidate to achieving global vaccine immunity, highlighting important trade-offs that policy makers need to consider when developing and implementing vaccination programmes. Although specific datapoints are subject to change as the pandemic response progresses, the dashboard will continue to provide a useful lens through which to analyse the key issues affecting the use of COVID-19 vaccines. We also present original data from a 32-country survey (n=26 758) on potential acceptance of COVID-19 vaccines, conducted from October to December, 2020. Vaccine acceptance was highest in Vietnam (98%), India (91%), China (91%), Denmark (87%), and South Korea (87%), and lowest in Serbia (38%), Croatia (41%), France (44%), Lebanon (44%), and Paraguay (51%).

Figure 1

Four dimensions of an effective global immunisation strategy against COVID-19 *Stringent regulatory bodies can approve vaccines or authorise their use in emergencies (eg, emergency use authorisation during public health crises, such as pandemics); WHO can grant emergency use listing (comparable to emergency use authorisation by a stringent body) or prequalification (comparable to approval by a stringent body). WHO publishes a list of stringent regulatory authorities.

Figure 2

Key characteristics of leading vaccine candidates with traffic-light system signalling potential for achieving global vaccine immunity The sources and methodology are documented in appendix 1, including the criteria for assigning a green, amber, or red light for each characteristic. Candidates shown in this figure have been approved or authorised on an emergency basis for human use in one or more countries, are in phase 3 clinical testing, or are under contract with CEPI or the COVAX Facility, as of Feb 3, 2021. Where there are no entries, either the data are unavailable or it is too early to know (eg, for vaccines in the early stages of development). Both Institut Pasteur (in collaboration with Merck) and the University of Queensland were developing COVID-19 vaccine candidates with funding from CEPI, but these clinical trials have been discontinued. CAMS=Chinese Academy of Medical Sciences. CEPI=Coalition for Epidemic Preparedness Innovations. HIC=high-income country. IMB=Institute of Medical Biology (China). RIBSP=Research Institute for Biological Safety Problems (Kazakhstan). SII=Serum Institute of India. *Only for vaccines that have been approved or granted emergency authorisation by at least one regulatory body; WHO publishes a list of stringent regulatory authorities, and can itself grant emergency use listing or prequalification for vaccines. †Clinical trial designs, including efficacy endpoints, differed for the various vaccine candidates; the efficacy figures might therefore not be perfectly comparable. Some of these results are interim analyses from phase 3 studies. Due to the emergence of new variants of the virus, the conditions under which trials take place vary, and not all vaccines are tested against the same variants. ‡These prices are the lowest the developers offered to any country or purchasing bloc; median prices for a range of countries are presented in figure 3. §The COVAX Facility has first right of refusal for a potential combined total of more than 1 billion doses in 2021 of vaccine candidates being developed by CEPI-funded companies: Biological E, Clover Pharmaceuticals, CureVac, Inovio, Moderna, Novavax, Oxford University/AstraZeneca, SK Biosciences, and the University of Hong Kong. ¶This was the result in the main efficacy analysis for participants receiving two standard doses, as specified in the protocol. The result in the out-of-protocol arm (a half dose followed by a standard dose) was 90%. This first-generation vaccine might offer less protection against a strain of SARS-CoV-2 first identified in South Africa. ||For the assignment of risk levels, we treated a single dose of a one-dose vaccine as equivalent to two doses of a two-dose vaccine. **One HIC (Hungary) has purchased 2 million doses, corresponding to 0·4% of all purchased doses; due to rounding, the figure presented in the dashboard is 0%. ††These interim phase 3 results have not been published in peer-reviewed journals; the figures were sourced from press releases by companies or researchers running the clinical trials. ‡‡The developer is also testing a two-dose version. §§This was the efficacy reported from a phase 3 trial in the UK; Novavax reported a lower efficacy level in a smaller phase 2b clinical trial in South Africa (49%). These results have not yet been published in peer-reviewed journals. ¶¶Sinovac and its research partners have reported a range of efficacy levels on the basis of phase 3 trials in Brazil (50%), Indonesia (65%), Turkey (91%), and the United Arab Emirates (86%), but none of these results have been published in peer-reviewed journals.

Figure 3

Median price per dose for existing vaccines and for leading COVID-19 vaccine candidates by procurement or country income group Data obtained from the WHO Global Vaccine Market Report. Data for non-COVID-19 vaccines are as of 2018; data for COVID-19 vaccines are as of Feb 3, 2021. Prices were not available for all procurement or income groups for all vaccines. Appendix 1 outlines the sources for all COVID-19 vaccine prices, which were obtained from press releases, investor documents, and media reports. The prices reported for COVID-19 vaccines are median prices for each country group; these prices might therefore not match those reported in figure 2, which show the lowest price offered. DTap–HepB–Hib–IPV=diphtheria, tetanus, acellular pertussis–hepatitis B–Haemophilus influenza type b–inactivated polio vaccine. DTap–Hib–IPV=diphtheria, tetanus, acellular pertussis–H influenza type b–inactivated polio vaccine. DTap–IPV=diptheria, tetanus, acellular pertussis–inactivated polio vaccine. DTwP–HepB–Hib=diphtheria, tetanus, whole-cell pertussis–hepatitis B–H influenza type b vaccine. HIC=high-income country. MIC=middle-income country. PAHO=Pan American Health Organization. *Sinopharm is charging the same price for both of its vaccine candidates.

Figure 4

Survey of potential acceptance of COVID-19 vaccines Data were jointly collected by the polling company ORB International and the Vaccine Confidence Project (London School of Hygiene & Tropical Medicine) between Oct 21 and Dec 16, 2020. Samples were random and nationally representative of the adult population in 30 of the 32 countries. Each respondent was asked, in the local language: “When a vaccine for the coronavirus becomes available, will you get vaccinated?” The possible responses were “definitely will”, “unsure but probably will”, “unsure but probably will not”, or “definitely will not”. In this figure, the category “will not get vaccinated” included respondents who said they “definitely will not” or “probably will not” get vaccinated, and the category “will get vaccinated” included respondents who said they “definitely will” or “probably will” get vaccinated. Appendix 3 describes the survey methodology.