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Open accessJournal ArticleDOI: 10.1111/1468-0009.12503

International Collaboration to Ensure Equitable Access to Vaccines for COVID-19: The ACT-Accelerator and the COVAX Facility.

02 Mar 2021-Milbank Quarterly (John Wiley & Sons, Ltd)-Vol. 99, Iss: 2, pp 426-449
Abstract: Policy Points Equitable access to a COVID-19 vaccine in all countries remains a key policy objective, but experience of previous pandemics suggests access will be limited in developing countries, despite the rapid development of three successful vaccine candidates. The COVAX Facility seeks to address this important issue, but the prevalence of vaccine nationalism threatens to limit the ability of the facility to meet both its funding targets and its ambitious goals for vaccine procurement. A failure to adequately address the underlying lack of infrastructure in developing countries threatens to further limit the success of the COVAX Facility. Context Significant effort has been directed toward developing a COVID-19 vaccine, which is viewed as the route out of the pandemic. Much of this effort has coalesced around COVAX, the multilateral initiative aimed at accelerating the development of COVID-19 vaccines, and ensuring they are equitably available in low- and middle-income countries (LMICs). This paper represents the first significant analysis of COVAX, and the extent to which it can be said to have successfully met these aims. Methods This paper draws on the publicly available policy documents made available by the COVAX initiatives, as well as position papers and public statements from governments around the world with respect to COVID-19 vaccines and equitable access. We analyze the academic literature regarding access to vaccines during the H1N1 pandemic. Finally, we consider the WHO Global Allocation System, and its principles, which are intended to guide COVAX vaccine deployment. Findings We argue that the funding mechanism deployed by the COVAX Pillar appears to be effective at fostering at-risk investments in research and development and the production of doses in advance of confirmation of clinical efficacy, but caution that this represents a win-win situation for vaccine manufacturers, providing them with opportunity to benefit regardless of whether their vaccine candidate ever goes on to gain regulatory approval. We also argue that the success of the COVAX Facility with respect to equitable access to vaccine is likely to be limited, primarily as a result of the prevalence of vaccine nationalism, whereby countries adopt policies which heavily prioritize their own public health needs at the expense of others. Conclusions Current efforts through COVAX have greatly accelerated the development of vaccines against COVID-19, but these benefits are unlikely to flow to LMICs, largely due to the threat of vaccine nationalism.

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21 results found


Open accessJournal ArticleDOI: 10.3390/VACCINES9060538
21 May 2021-Vaccine
Abstract: The COVID-19 pandemic has evidenced the chronic inequality that exists between populations and communities as regards global healthcare. Vaccination, an appropriate tool for the prevention of infection, should be guaranteed by means of proportionate interventions to defeat such inequality in populations and communities affected by a higher risk of infection. Equitable criteria of justice should be identified and applied with respect to access to vaccination and to the order in which it should be administered. This article analyzes, as regards the worldwide distribution of anti-COVID-19 vaccines, the various ways the principle of equity has been construed and applied or even overlooked. The main obstacle to equal access to vaccines is vaccine nationalism. The perception of equity varies with the differing reference values adopted. Adequate response to needs appears to be the principal rule for achieving the criterion of equity in line with distributive justice. Priorities must be set equitably based on rational parameters in accordance with current needs. The entire process must be governed by transparency, from parameter identification to implementation. The issue of equal access to vaccination affects the entire world population, necessitating specific protective interventions. In light of this, the World Health Organization (WHO) has devised the COVAX plan to ensure that even the poorest nations of the world receive the vaccine; certain initiatives are also supported by the European Union (EU). This pandemic has brought to the fore the need to build a culture of equitable relationships both in each country's own domain and with the rest of the world.

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Topics: European union (54%), Equity (economics) (54%), Economic Justice (52%) ... show more

8 Citations


Open accessJournal ArticleDOI: 10.1007/S00253-021-11281-3
Jungsoon Lee1, Zhuyun Liu1, Wen-Hsiang Chen1, Junfei Wei1  +8 moreInstitutions (1)
Abstract: A SARS-CoV-2 RBD219-N1C1 (RBD219-N1C1) recombinant protein antigen formulated on Alhydrogel® has recently been shown to elicit a robust neutralizing antibody response against SARS-CoV-2 pseudovirus in mice. The antigen has been produced under current good manufacturing practices (cGMPs) and is now in clinical testing. Here, we report on process development and scale-up optimization for upstream fermentation and downstream purification of the antigen. This includes production at the 1-L and 5-L scales in the yeast, Pichia pastoris, and the comparison of three different chromatographic purification methods. This culminated in the selection of a process to produce RBD219-N1C1 with a yield of >400 mg per liter of fermentation with >92% purity and >39% target product recovery after purification. In addition, we show the results from analytical studies, including SEC-HPLC, DLS, and an ACE2 receptor binding assay that were performed to characterize the purified proteins to select the best purification process. Finally, we propose an optimized upstream fermentation and downstream purification process that generates quality RBD219-N1C1 protein antigen and is fully scalable at a low cost. KEY POINTS: • Yeast fermentation conditions for a recombinant COVID-19 vaccine were determined. • Three purification protocols for a COVID-19 vaccine antigen were compared. • Reproducibility of a scalable, low-cost process for a COVID-19 vaccine was shown. Graphical abstract.

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Topics: Pichia pastoris (53%)

6 Citations


Open accessJournal ArticleDOI: 10.1016/J.CHOM.2021.06.007
Abstract: Global vaccine inequity is prolonging the COVID-19 pandemic. Here, we outline the scope and impact of inequitable vaccine distribution and identify challenges in vaccine development, manufacturing, and distribution as well as potential solutions to address this crisis.

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4 Citations


Open accessJournal ArticleDOI: 10.1016/J.VACCINE.2021.08.034
24 Sep 2021-Vaccine
Abstract: Background Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. Methods We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). Results We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. Conclusion This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

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Topics: Vaccination (52%)

4 Citations


Open accessJournal ArticleDOI: 10.1016/J.MATURITAS.2021.05.003
26 May 2021-Maturitas
Abstract: Concomitantly with the start of the pandemic, the pursuit of effective vaccines began and developed with great success, and mass vaccination campaigns commenced by the end of 2020. The first quarter of 2021 saw countries such as Israel, the United Kingdom and the United States advancing at great pace in the vaccination programs, while other countries, mainly in the southern hemisphere, were just starting. By the beginning of April, 30 countries had not received a single dose and only 0.57% of the African population was vaccinated [1]. The lag in the introduction of new immunization strategies between countries is not new. For example, in 2016, only 14% of the low- and middle-income countries (LMICs) had introduced the HPV vaccine in their national immunization plans, while 55% of high-income countries (HICs) had done so already [2]. Indeed, some vaccines have been introduced in LMICs years later than in HICs [3]. Despite the challenges posed by the unequal impact and the long duration of the pandemic, the introduction of a vaccine for the prevention of COVID-19 has awakened feelings of hope in the global population. In this context, the Vaccine Global Access (COVAX) agreement was born as an initiative to ensure equitable global distribution of vaccines [4]. But even with this mechanism, there are multiple risks for unequal administration of the vaccines, so the greatest challenge now will be closing the gaps and mitigating the inequities in access to healthcare that have arisen [3,5,6]. Here we describe some of the barriers that contribute to unequal distribution of vaccines in LMICs (see Fig. 1 ). Open in a separate window Fig. 1 Global challenges in the distribution of vaccines and implementation of vaccination plans against COVID-19.

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Topics: Global health (50%)

3 Citations


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Open accessJournal ArticleDOI: 10.1056/NEJMOA2022483
Abstract: Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vacci...

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1,543 Citations


Open accessJournal ArticleDOI: 10.1016/S0140-6736(20)32623-4
Maria Deloria Knoll1, Chizoba Wonodi1Institutions (1)
09 Jan 2021-The Lancet
Topics: Vaccine efficacy (63%), Viral Vaccine (59%)

231 Citations


Open accessJournal ArticleDOI: 10.1016/J.XPHS.2020.12.006
Abstract: As mRNA vaccines became the frontrunners in late-stage clinical trials to fight the COVID-19 pandemic, challenges surrounding their formulation and stability became readily apparent. In this commentary, we first describe company proposals, based on available public information, for the (frozen) storage of mRNA vaccine drug products across the vaccine supply chain. We then review the literature on the pharmaceutical stability of mRNA vaccine candidates, including attempts to improve their stability, analytical techniques to monitor their stability, and regulatory guidelines covering product characterization and storage stability. We conclude that systematic approaches to identify the key physicochemical degradation mechanism(s) of formulated mRNA vaccine candidates are currently lacking. Rational design of optimally stabilized mRNA vaccine formulations during storage, transport, and administration at refrigerated or ambient temperatures should thus have top priority in the pharmaceutical development community. In addition to evidence of human immunogenicity against multiple viral pathogens, including compelling efficacy results against COVID-19, another key strength of the mRNA vaccine approach is that it is readily adaptable to rapidly address future outbreaks of new emerging infectious diseases. Consequently, we should not wait for the next pandemic to address and solve the challenges associated with the stability and storage of formulated mRNA vaccines.

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Topics: Vaccine Potency (56%)

57 Citations


Open accessJournal ArticleDOI: 10.1001/JAMA.2018.0345
10 Apr 2018-JAMA
Abstract: The availability of vaccines in response to newly emerging infections is impeded by the length of time it takes to design, manufacture, and evaluate vaccines for clinical use. Historically, the process of vaccine development through to licensure requires decades; however, clinicians and public health officials are often faced with outbreaks of viral diseases, sometimes of a pandemic nature that would require vaccines for adequate control. New viral diseases emerge from zoonotic and vectorborne sources, such as Middle East Respiratory Syndrome coronavirus and Chikungunya, and while these diseases are often detected in resource-rich countries, they usually begin in lowand mid-income countries.1 Therefore, part of the timeline for a vaccine involves surveillance and detection of new pathogens in remote areas and transfer of specimens to laboratories capable of vaccine development. Development of vaccines for viral infections has historically been an empirical and iterative process based on the use of attenuated or inactivated whole virus. This requires unique methods of cultivation for each virus, development of animal models for vaccine testing, and a prolonged process of fine-tuning product formulation and immunogenicity, and for live-attenuated vaccines, pathogenicity. Thus, preclinical vaccine development can take years, followed by several more years of early-phase clinical testing and defining of dose and schedule. Moreover, efficacy testing and registration with regulatory agencies often takes another 5 to 10 years. In total, 15 to 20 years would be a typical timeframe from virus discovery to vaccineavailability iftheprocessproceedssmoothlyandthere are no major biological or logistical challenges. Fortunately, during the last decade, there have been substantial technological advances for conceiving, developing, manufacturing, and delivering vaccines. Rapid genetic sequencing allows both early identification of new pathogens and the identity of the genes encoding structural proteins that can form the basis for vaccine immunogen development. Also, rapid isolation of human monoclonal antibodies has proven to be extremely helpful in defining epitopes that are the targets of protective immunity. Additional tools of modern vaccinology include (1) delineation of atomic-level structures of viral proteins that facilitates structure-enabled immunogen design and protein engineering; (2) cell sorting and sequencing technologies that allow single-cell analysis of immune responses; and (3) genetic knock-in technologies that allow construction of animal models with human antibody genes for vaccine testing. These tools have already provided the potential not only for solving longstanding problems in vaccinology, such as the development of a new candidate vaccine for respiratory syncytial virus, but they have facilitated rapid development of new candidate vaccines for emerging pathogens such as the Zika virus and pandemic strains of influenza virus. Synthetic vaccinology and platform manufacturing are important innovations that can speed the initial vaccine immunogen design and vaccine development process, and shorten the time needed for manufacturing and initial regulatory approval to begin phase 1 testing. Synthetic vaccinology is the process of using viral gene sequence information to accelerate vaccine development.2 For example, if a new influenza virus emerges anywhere in the world and is identified through genomic sequencing, the digitally transferred information can be used to synthesize nucleic acids encoding the viral surface proteins (hemagglutinin and neuraminidase). The process of gene synthesis is now extremely rapid and relatively inexpensive. Thus, within a few weeks, DNA plasmids encoding viral proteins can be available for preclinical testing. These genetic vectors (DNA and mRNA) can be used directly for immunization whereby intramuscular immunization leads to muscle cells producing the viral proteins. Alternatively, the genetic vectors can be used to express recombinant protein antigens, in vitro, that can be used for immunization. Similarly, if an outbreak of a new flavivirus becomes an epidemic or even a pandemic threat, as with Zika in 2015, the gene sequences that encode the viral surface proteins premembrane and envelope can be rapidly identified and form the basis for vaccine immunogen design strategies, based on prior knowledge of flavivirus structure and mechanisms of neutralization.3 Once a structurally authentic immunogen is available, the protein or genetic vectors encoding the protein can be used to immunize animals. In addition, the vaccine proteins can be used as probes to identify monoclonal antibodies secreted by B cells of convalescent humans. Such antibodies are valuable not only for refining vaccine immunogen designs, but also for development of diagnostic assays and potentially for use in passive transfer as therapeutic agents. Thus, development of reagents, diagnostics, candidate vaccines, and immune assessment assays can be done without having the actual virus in hand. This has particular value for viruses with extreme pathogenicity because it avoids the need for high-level containment in laboratory and manufacturing facilities. Platform manufacturing technologies allow more rapidproductionandclinicalimplementationoncethevaccine immunogen design is established. The term platform is used in many ways; however, in vaccine production, VIEWPOINT

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Topics: Viral Vaccine (62%)

57 Citations


Open accessJournal ArticleDOI: 10.1001/JAMA.2020.6641
23 Jun 2020-JAMA
Abstract: Scientists from across the globe are racing to develop effective vaccines and therapeutics for coronavirus disease 2019 (COVID-19). Plans are beginning to emerge for ensuring the equitable worldwide distribution of vaccines and therapeutics resulting from biomedical innovations. Absent broad agreement and buy-in on those plans, governments may prioritize their own populations, resulting in inequitable distribution of medical products both within and among countries. During the 2009 influenza A(H1N1) pandemic, wealthy nations bought virtually all vaccine supplies. Even after the WHO appealed for donations, supplies for low- and middle-income countries (LMICs) were limited. The White House may have already sought exclusive access to a COVID-19 vaccine candidate. European and Asian countries have imposed export controls on personal protective equipment and ventilators, with similar export controls likely to extend to COVID-19 vaccine and therapeutic stocks. The development and widespread distribution of COVID-19 medical treatments are a common global interest. Here we offer a proposal for global cooperation to ensure equitable distribution of vaccines and therapies for COViD-19.

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57 Citations


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