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Announced within a year of the discovery of SARS-CoV-2, the news of several efficacious COVID-19 vaccines was met with great hope of some return to pre-COVID normality and set a new bar for the speed of knowledge generation and the production of life-saving vaccine technologies ([46]). However, the logistical and scientific challenges of developing an effective vaccine were not the end of the difficulties many would face in accessing a vaccine. As with previous novel technologies, inequities in vaccine access rapidly became a major obstacle, reminding the world of the divisions between the haves and the have-nots ([28]). This concern was captured by a comment from UN Secretary-General António Guterres at the UN General Assembly in July 2021: "We passed the science test. But we are getting an F in Ethics" ([61]).

Under enormous pressure, science delivered highly effective COVID-19 vaccines in record time. This unprecedented effort in science required global collaboration. For example, the first clinical trial to show that a COVID-19 vaccine was effective in preventing clinically evident infection was conducted by Pfizer-BioNTech—in the United States, Turkey, Germany, South Africa, Brazil, and Argentina ([46]).

The COVID-19 Vaccine The COVID-19 Messenger-RNA (mRNA) vaccine represents a new approach to vaccines. Although other vaccines rely on inactivated pathogens to trigger an immune response, the COVID-19 mRNA vaccine gives cells the instructions to make a small piece of the ‘spike’ protein found on the surface of the virus. As the protein has been made, the body’s cells break down the instructions and remove them from the body (Centers for Disease Control and Prevention [CDC], 2020). The body’s cells display the protein fragment on its surface, thereby prompting the immune system that recognizes the protein as foreign and thereby building an immune response and making antibodies (CDC, 2020). It is noteworthy that conspiracy theorists and anti-vaccination groups claim that vaccines alter the body’s DNA. In fact, the COVID-19 mRNA never enters the nucleus of the cell; therefore, it does not encounter the cellular DNA (CDC, 2020). It has been established that children’s rates of hospitalization and death due to COVID-19 are significantly lower than adults (World Health Organization [WHO], 2020a). However, a rare disease named multi system inflammatory syndrome that causes critical illness in children has been linked to COVID19 (WHO, 2020a). Al though the priority is to target high-risk groups in the adult population, vaccination against COVID-19 for children may be required. It has been recommended that older children and adolescents who are more at risk of severe and fatal disease than younger children be vaccinated first, and then extend the vaccination to younger children (Wong et al., 2021). The CDC (2021) recommends everyone 12 years and older should get a COVID-19 vaccination. Currently there are three major vaccines available. The U.S. Food and Drug Administration (FDA) has given the Pfizer-BioNTech COVID-19 vaccine emergency use authorization for children ages 12 through 15 years. The FDA has also approved this vaccine, now called Comirnaty, to prevent COVID-19 in people age 16 years and older. The PfizerBioNTech vaccine has been authorized for young people aged 16 and above, and trials for those 12 to 15 have been announced by Pfizer (Jenco & Korioth, 2021). Pfizer and Moderna have been given permission to increase the size of their clinical trials for children ages 5 to 11 years. Moderna’s vaccine has re - ceived emergency use authorization (EUA) for those aged 18, and Moderna has started trials on children from 6 months to 12 years (Jenco 2021). The KidCOVE Study conducted by Moderna is researching a COVID-19 vaccine that may protect children who are ages 6 months to 11 years (Kaiser Perma - nente Research, 2021). Johnson and Johnson/Janssen has also received EUA for individuals 18 years and older (Verdict, 2021) to test its vac cine on newborns, pregnant women and those with a compromised immune system. The Rise of the ‘Anti-Vaxxer’ The anti-vaxxer movement is almost as old as the history of vaccination itself. Edward Jenner, the originator of the smallpox vaccine, faced opposition from both physicians and clergy, and called these people ‘anti-vaxx’ in the early 19th century (Howard, 2003). The medical men were a powerful opposing force, using the developing power of the ‘press’ to spread their arguments against the procedure, arguing that the safety of vaccination could not be proven (Howard, 2003). As smallpox case numbers dropped significantly, the efficacy of the vaccine became clear, and this first wave of opposition waned. People eagerly took up vaccination against this disease. However, the poorer classes were unable to afford treatment, and unhygienic procedures often led to secondary infections leading to a drop in vaccination rates among the working class. To counteract this, the United Kingdom government passed an Act in 1853 making smallpox vaccination mandatory for infants, with parents facing a fine or imprisonment for disobeying the law. Similar laws were also passed in the United States to mandate vaccination (Howard, 2003), resulting in an organized and formal anti-vaccination movement on both sides of the Atlantic. Both middle- and working-class people fought against what they saw as increasing coercion by the elite forces of government and medicine, threatening their rights and liberties (Durbach, 2005). In the United Kingdom, the Leicester Anti-Vaccination League formed in 1869, and mass demonstrations of up to 100,000 people protested in the streets of Britain (Wolfe & Sharp, 2002). This League and its American counterpart, the Anti-Vaccination League of Ameri - ca, claimed that improved hygiene was the cause of decrease in disease, rather than the vaccinations them- selves. To address these fears, the British Vaccination Act 1898 introduced the concept of ‘conscientious objection’ to mandatory vaccination, which was picked up rapidly by the antivaccination activists (Howard, 2003). In the early years of the 20th century, a series of devastating epidemics, namely, smallpox, diphtheria, cholera, measles, and polio, prompted a greater uptake of vaccines despite the antivaccination lobby. Vaccination programs for an increasing number of diseases led to what became known as ‘herd immunity.’ However, several tragic events involving contaminated and faulty vaccines eroded public trust and confidence (Flaherty, 2011; Wolfe & Sharp, 2002). These disasters added to the argument against vaccination. Public fear was also compounded by apathy, as vaccines became ‘victims of their own success’ (Camargo, 2020, p. 2). As herd immunity grew, once-common diseases became less visible in the community. The importance of vaccination began to wane, leading to rejection or at least, hesitancy (Smith, 2017). This situation deteriorated further with what has been described as “the most damaging medical hoax of the last 100 years” – Andrew Wakefield’s infamous study (Wakefield et al., 1998) linking the measles-mumps-rubella (MMR) vaccine to autism (Flaherty, 2011), later proven to be completely unsubstantiated. Moreover, autism is a condition with no known etiology and no cure and affects children in the age range during which most vaccines are administered. Nonetheless, for parents grief-stricken to discover their child had developed autism and searching for something to blame, this study provided them with a reason they could understand (Flaherty, 2011). Parents began to refuse the MMR vaccine, and it seemed the proven benefits of vaccination against these common childhood diseases were outweighed by the tiny possibility they might cause another condition that would be life-changing. Vaccination rates consequently plummeted (Smith, 2017). Today’s antivaccination move ment may seem to fly in the face of science, but it may simply be due to hysteria, a response that depends not only on what is happening now, but also on what happened in the past. Many of the issues prompting antivaccination sentiment today can be seen in the history of the antivax movement – mistrust of a new and unproven treatment, fear of curtailment of liberties, class struggle, public apathy, and the spread of misinformation through a new and rapid form of communication (Wolfe & Sharp, 2002). Vaccine Hesitancy An important consideration in the immunization debate is vaccine hesitancy, defined as “the reluctance or refusal to vaccinate despite the availability of vaccines” (WHO, 2019). Vaccine hesitancy has been described as the main contributor to the reduction to herd immunity globally (Haroune & King, 2020) and contributed to outbreaks of preventable diseases in some countries (Gordon, 2020). It is, therefore, an important issue that needs to be addressed early before it becomes vaccine refusal, which is an increasing problem (McGee & Suh, 2019). Vaccine-hesitant people have not yet decided about whether they will vaccinate or not; they instead are merely questioning whether they should vaccinate and therefore can be persuaded to immunize. In comparison, those who are ‘anti-vaxx’ have already made up their minds to not vaccinate, hence why it is important to address hesitancy before this situation arises. Vaccine hesitancy is complex and not just about parents agreeing or disagreeing to vaccinate their child or themselves (McGee & Suh, 2019). Factors that contribute to vaccine hesitancy have been explored in a study that identified three main themes: vaccine safety, effectiveness, and health care issues (Haroune & King, 2020). Vaccine safety referred to a concern about the ingredients in the vaccine as well as toxicity and potential side effects from the vaccine, with autism being the main concern (Haroune & King, 2020). This theme also included pain/discomfort from the vaccination and that vaccinating weakens the immune system. The effectiveness of the vaccine included the belief that some diseases had been eradicated, questioning the need for the vaccine. There was also a desire to fight off disease with natural immunity rather than by vaccinating, including breastfeeding, in the belief that this was more effective. The third contributing factor arose because of previous negative experience with health care, including delayed immunizations due to the child being unwell or difficulty getting appointments due to either the carer or general practitioner being too busy (Haroune & King, 2020). These parents may be motivated to vaccinate but have logistical difficulties, including not being able to take time off work or lack of public transport to access services. Conflicting or confusing vaccine information may also inhibit the decision to vaccinate. Vaccine-hesitant parents are also more likely to access social media for information to help them make the decision to vaccinate or not (McGee & Suh, 2019). A substantial amount of information is available through these platforms, and it is easy to find. Although it may lead to parents making the right decision for their child, it can also be detrimental because much information is inaccurate, and in some cases, deceptive (Grant et al., 2015). Generally, these platforms focus on creating communities of vaccine affected families, including resourc - es about vaccinations allegedly presenting an unbiased opinion. However, these sites are found to be strongly biased against vaccinations (Grant et al., 2015). Social media vaccine sceptical information is, therefore, considered to be troublesome, discouraging parents from vaccinating through several strategies. These include portraying themselves as authorities on vaccination, listing adverse effects, presenting themselves as unbiased, and appealing to the user’s emotions through personal testimonies of adverse effects (Grant et al., 2015). The problem is compounded by the fact that vaccine critics are more successful at using social media then vaccine promoters. Further more, the information disseminated is more difficult to dismiss by trying to educate the public to the contrary (Grant et al., 2015). Other issues that social media may present in the context of the vaccination debate will be further discussed below. Conspiracy Theories Conspiracy theories explain the origins of world events or situations as plots, led by powerful groups of people, usually malevolent, who hide the truth and disseminate misinformation (Douglas et al., 2019; Sutton & Douglas, 2020; Wood, 2017). They are also associated with medical conditions such as COVID19 (Andrade, 2020; Chen et al., 2020; Duplaga, 2020; Romer & Jamieson, 2020) and HIV/AIDS (Brotherton et al., 2013; Friedman, 2020), vaccination use (Brotherton et al., 2013; Douglas et al., 2019; Romer & Jamieson, 2020), and can be detrimental to health promotion and illness prevention. Under - pinning conspiracy theories is a distrust of people in power (Sutton & Douglas, 2020; Romer & Jamieson, 2020), an alleged conspiracy (Douglas et al., 2019), and belief in the conspiracy despite evidence of more probable causes (Brother ton et al., 2013; Freeman & Bentall, 2017; Wood, 2017). Confirmation bias, the acceptance of evidence that confirms a person’s existing beliefs and rejection or failure to consider contradictory evidence (American Psychological Associa - tion [APA], 2020), and the backfire effect, whereby a person’s beliefs are strengthened in the face of contradictory evidence (Noor, 2020), can perpetuate conspiracy beliefs. A range of psychosocial and demographic factors are associated with holding conspiratory beliefs. A tendency to accept weak beliefs (Sutton & Douglas, 2020) and attempts to make sense of life during uncertainty and when faced with complex and threatening phenomena can contribute to a belief in conspiracy theories (Douglas et al., 2019; Freeman & Bentall, 2017). Younger people; males; those with lower levels of education, income, and health literacy; those from an ethnic minority; the socially disconnected; and the politically disenfranchised are more likely to believe in conspiracy theories (Duplaga, 2020; Freeman & Bentall, 2017; Romer & Jamieson, 2020). Support of conspiracy theories is also associated with traits of individual and collective narcissism and exaggerated feelings of self-importance (Cichocka et al. 2016; Golec de Zavala & Federico, 2018). Subscribing to conspiracy theories can have adverse impacts on an individual’s health and wellbeing, including their mental wellbeing. Freeman and Bentall (2017) demonstrated in a general population that those who held a conspiratory world view had lower levels of physical and mental wellbeing, were more likely to have had adverse childhood experiences, had fewer current social connections, and experienced more negative emotions. Chen and colleagues (2020) found that health care workers who believed COVID-19 conspiracy theories were more likely to report psychological distress, anxiety, and lower satisfaction with their work and life as compared to those who did not. Conspiracy beliefs may also be associated with some mental health conditions. People who experience paranoia, a mistrust and fear of harm from others, and who meet the diagnostic criteria for a paranoid personality disorder are likely to accept the beliefs of malevolence espoused in conspiracy theories (Andrade, 2020). Even after controlling for paranoia, those who adopt conspiratory beliefs were more likely to meet the diagnostic criteria for a mental health disorder and to consider attempting suicide, as compared to those who did not hold such beliefs (Freeman & Bentall, 2017). To counteract vulnerability to the misinformation of conspiracy theories, health professionals have a role in the promotion of critical thinking skills and development of coping strategies in health care consumers (Andrade, 2020; Friedman, 2020). There are significant numbers of people worldwide who espouse conspiracy theories, which are explanations for important events that involve secret plots by powerful and malevolent groups (Douglas et al., 2017; Douglas et al., 2019), when other explanations are more plausible (Brotherton et al., 2017). For example, significant numbers of people around the world believe COVID-19 was created deliberately, is a hoax, and has killed far fewer people than reported, and the vaccine will have untenable side effects (Henley & McIntyre, 2020). Con - spiracy theories are dangerous and even more so in a pandemic when they encourage people to ignore the official advice (Henley & McIntyre, 2020).

People hold different anti-vaccination attitudes. Having an understanding of how these attitudes have changed prior to and during the COVID-19 pandemic is critical for combatting anti-vaccination attitudes and increasing vaccine intention and uptake. Data was collected from different samples in the United States at three time points prior to (n = 840) and four time points during (n = 1543) the pandemic. All participants completed a multi-dimensional measure of anti-vaccination attitudes (VAX Scale) through an online platform. Results showed that, when it comes to vaccines, worries about unforeseen side effects, concerns about commercial profiteering, and preference for natural immunity were higher during the COVID-19 pandemic than they were prior to it. However, mistrust of vaccine benefit was lower during the COVID-19 pandemic than prior to it. These differences were found even after controlling for the potential effects of participant sex, education, socioeconomic status, age, and race/ethnicity. Additionally, worries about unforeseen side effects, concerns about commercial profiteering, and preference for natural immunity increased linearly alongside the persistence of COVID-19; whereas, mistrust of vaccine benefit showed no change. Although it might be intuitive to emphasize vaccines' effectiveness to increase uptake, the public's trust in vaccine effectiveness did not appear to be the major concern. Thus, public health efforts to increase uptake of vaccines should also focus on reducing concerns about potential side effects from the vaccine, tempering the attention on financial benefits to pharmaceutical companies, and rebuffing the overreliance on natural immunity.

Societies are diverse and it is impossible to implement the same international regulations everywhere. Besides, anthropogenic factors leading to disease emergence vary from one society to another. They vary depending on culture, history and geography but they can all lead to an accidental coincidence of events opening the way to the emergence of a disease. However, the chain of events might be different depending on the society. The only way to prevent future pandemics from happening is to properly organize each society to block the chain of events and prevent the accidental event of emergence to occur, based their respective traits. This endeavor must be coordinated at the international level but actions must be designed and implemented locally to match national and local specificities. WHO will open in September 2021 in Berlin, a Hub for Pandemic and Epidemic Intelligence which will, according to WHO, be in charge of “quickly analyze data to predict, prevent, detect, prepare for, and respond to risks worldwide” and “be able to detect pandemic signals earlier than current systems” (WHO, 2021). However, these early pandemic signals are, according to UNO and WHO, mostly climate changes, early case detection and fast communication (UNO, 2021). Diseases have always emerged in human populations, long before the current issue of climate change. Climate change is only marginally affecting the potential for disease emergence mostly by influencing animal species movements and geographic range. The influence of climate change is on the circulation of pathogens through host mobility and replacement not on the process of emergence itself. On the other hand, as previously said, the early detection of cases is particularly complicated since the pathogens involved are not known, the associated pathologies have not been identified yet and the rate of asymptomatic cases is usually high. Early detection of emerging pathogens could be envisioned at two levels: a search for the pathogen in i) animal species or ii) human populations. An exhaustive and permanent screening of every human or wild animal populations for viruses is non-realistic. It would not only be logistically impossible and economically extremely costly, but it does not yield any information since it is impossible to identify a potential threat before it has spread through the population and already went out of control. International regulations and measures against epidemics taken after Influenza, SARS, MERS or even Ebola did not help preventing the emergence of COVID-19. This hub might well be unable to prevent the next pandemic if relying only on the speed of relaying information and signs of epidemics because when these signs become visible it is already too late. Actions, i.e. proper organization, must be taken before these signs become visible. Furthermore, there is also a risk of deleterious effect as it will direct all efforts and attention on reactions instead of prevention, leaving thus the society totally vulnerable and unprepared for the next emerging virus.

In the Independent Panel for Pandemic Preparedness and Response's 1-year progress report, Transforming or Tinkering?: Inaction Lays the Groundwork for Another Pandemic,7 published on May 18, 2022, we set out these grim tolls as reasons to make concerted efforts to end the harms of COVID-19 and transform systems through actions that are well within the collective capacity of governments and global agencies. Containing pandemic threats is a choice. Through fragmented and slow processes, the world is choosing to risk a repeat of the events that resulted in the current situation. To produce key evidence for the 1-year progress report,7 we consulted with civil society, received 50 responses to a survey from 24 countries, held two academic round tables, and did a systematic review of the literature. There was broad support for the recommendations of the Independent Panel for Pandemic Preparedness and Response, and after more than 2 years of learning, broader themes were also emphasised: the case for preventing pandemic threats upstream; the centrality of human rights, investing in communities, and maintaining trust; the need for regional self-sufficiency; the need to address inequalities and the social determinants of health; and the results of neglecting to invest in promoting healthy populations. Declining COVID-19 mortality globally,2 insufficient political focus, and relaxing of public health measures is leading to a premature perception in many countries that the pandemic is over, even as the number of COVID-19 cases remains high globally.2 Ongoing transmission of SARS-CoV-2 could lead to new, more virulent, or more transmissible variants.8 Although the omicron (B.1.1.529) variant may be less virulent than previous SARS-CoV-2 variants,9 its increased transmissibility combined with inadequately protected, vulnerable populations could lead to an additional 400 000 deaths between April and August, 2022.4 The prevalence and burden of long COVID is increasingly better understood in high-income countries, together with its social and economic costs.10 There are not enough data to understand the burden of long COVID in lower-income countries. Vaccination is essential to reduce severe disease and death. Yet the available COVID-19 vaccines seem to have limited effect on transmission, and boosters are required to continue to protect vulnerable populations. We need better, more accessible diagnostic tools, vaccines, and treatments and responsive public health strategies.11 Test and treat programmes must be implemented and accessible to prevent COVID-19 deaths. There are reasons for optimism, but the world remains dangerously unprepared for the next pandemic threat. This is despite the evidence-based roadmap provided by the Independent Panel for Pandemic Preparedness and Response,1 and overall convergence on these solutions by other review panels, including that of the G20 High Level Independent Panel and the Global Preparedness Monitoring Board.12, 13 Examples of the leadership required for pandemic preparedness and response include initiatives such as the US-initiated Global COVID Summit14 on May 12, 2022, co-sponsored with the chairs of the African Union, the Caribbean Community (CARICOM), the G7, and the G20, among others and efforts by the African Centres for Disease Control and Prevention (Africa CDC), the G7 100 days initiative,15 and the UN General Assembly High-Level Dialogue on Vaccine Access.16 The decision by the 74th World Health Assembly to establish an Intergovernmental Negotiation Body (INB) to agree a new legal instrument on pandemic prevention, preparedness, and response,17 together with current proposed amendments to the International Health Regulations (IHR) aimed at faster alert and response,18 are meaningful steps towards fixing the international legal framework. The announcement by the Government of Indonesia of G20 consensus to establish a financial intermediary fund is a step towards closing the US$10–15 billion annual funding gap that the report of the Independent Panel for Pandemic Preparedness and Response1 and the G20 High Level Independent Panel identified.12, 19 At WHO, the member state Working Group on Sustainable Financing also made progress towards improving WHO's fiscal autonomy by recommending non-earmarked funding, and an increase in assessed contributions to cover 50% of the WHO base budget, by contrast to the 16% in the previous programme budget.20 Work is also underway to develop improved tools for assessing preparedness, with more dynamic metrics being developed and piloted in a new universal periodic health review.21 The major issue remains a lack of sustained high-level political leadership that will bring the coherence and urgency required to fragmented reform processes. Much energy will be spent on developing a new pandemic instrument, a new financial intermediary fund, and reforms at WHO, but how will this all be linked together? WHO's health emergency preparedness, response, and resilience white paper22 suggests a framework anchored to the organisation, but effective pandemic preparedness and response extends well beyond WHO, and so should high-level monitoring and oversight. The issue of equitable access to COVID-19 vaccines, diagnostics, and treatments requires considerable work. By May 15, 2022, less than 15% of the population in low-income countries had received their primary COVID-19 vaccination series.23 Access to diagnostic tests in low-income countries is woefully inadequate, and COVID-19 therapies are hardly available. This failure has been catastrophic. It exposes the inability of a donor-driven charity model to deliver market-driven products, which should instead be inclusively and equitably produced and shared as global public goods. The failure to make vaccines available to vulnerable populations including health workers in low-income countries in 2021, when demand was high, is contributing to a closing window of demand this year. Poor surveillance and low testing capacity in low-income countries risks failure to detect the emergence of dangerous new SARS-CoV-2 variants. Steps to support vaccine manufacturing capacity in low-income and middle-income countries are also running into challenges—eg, one manufacturer had to stop production of COVID-19 vaccine due to insufficient orders.24 With no appreciable progress to create a platform that can equitably deliver global public goods, and the current sclerotic and insufficient progress to agree a Trade-Related Aspects of Intellectual Property (TRIPS) waiver, newer and more effective vaccines, diagnostics, and treatments will not be distributed equitably during this and future pandemic threats. Poorer countries will probably be expected to take excess doses of older and less effective vaccines, while wealthier countries will have preferential access to the most effective tools as they come on the market.

Current approaches to pharmaceutical innovation mainly rely on market dynamics to drive product development, manufacturing, and distribution, even for epidemics that are threats of international concern and matters of public responsibility. Governments have used a range of push and pull mechanisms to attract R&D investment in areas of public health need and uncertain market return, including research subsidies, tax credits, regulatory incentives, and advance purchase agreements.10 Although these are designed to accelerate commercial product development, they often do not translate into products optimised for use by public health systems especially in low-resource environments, or to equitable access to products or technologies. As we saw again during the COVID-19 pandemic, even when receiving substantial public support, private companies retain ownership of new products and of decisions about which product to prioritise and trial, where and how to do so, where to seek market approval, at what price to sell, and to whom. Equity, when considered at all, has been left as optional, separate from the business model, and addressed only after innovation is complete and after the wealthiest countries have secured their supplies.

The COVID-19 pandemic is by no means the only epidemic for which the global response has been profoundly shaped by the interests of commercial producers and the purchasing power of the richest nations. Fear of pandemic influenza moved wealthier countries to buy virtually all available vaccines and prohibit their export at different points over the past two decades, leaving limited or no supply for poorer countries.11 Treatments and vaccines developed for US health security against smallpox and mobilised to contain mpox in Europe and North America in 2022 remain largely unavailable in countries of west and central Africa where mpox is endemic.12 Treatments for Ebola virus disease—successfully trialled in DR Congo—are now in US Government stockpiles, but remain unregistered and largely unavailable in DR Congo or other countries where they are most needed.13

This increase in the number of patent applications related to combating bioterrorism and biological warfare in the early 2000s coincides with the results found by Cardoso and Cardoso (2011). They reported exponential growth in scientific publications, especially after spreading anthrax spores through the US mail in 2001. This attack highlighted how the US health and safety system was illequipped to deal with high-lethal emergencies adequately. This has led to a substantial increase in Research, Development and Innovation (RD&I) funding and international cooperation programs to develop emergency plans to deal with future bioterrorist attacks in the country (GOSTIN; NUZZO, 2021). * It is not by chance that the United States has a consolidated market because, as of the 352 patent applications identified, it was responsible for 64.8% of them. Then come China with 18.5% and Australia with 6.5% of deposits. It is essential to highlight that 23.9% of patent applications were made via the Patent Cooperation Treaty (PCT), demonstrating a particular interest in obtaining a competitive advantage in international markets. * Concerning the profile of depositors, companies prevailed, with 147 patent deposits related to the investigated technology (41.76%), followed by universities, with 132 deposits (37.50%), and independent inventors, with 64 requests (18.18%). The strategy of technological cooperation between organizations is still incipient in this area, as only 2.56% of deposits were made due to partnerships between universities and companies (Figure 4). According to Menezes et al. (2020), technological cooperation is indispensable for technological innovation. In this process, combining resources, skills, and competencies can increase the countries' economic growth and ensure competitive advantages.

IP supported knowledge and technology creation for developing vaccines

When the Covid-19 pandemic began, background technology and knowledge were available to help address the crisis. Innovators drew on existing platforms for vaccines, monoclonal antibodies, manufacturing technologies, and related expertise, some of which included contributions from public sector researchers. These provided the foundation for a rapid response. As one industry representative remarked:

Many of the proposals listed above would be extremely deleterious to pandemic research and development incentives.

IP is the bedrock upon which almost all of today’s Covid-19 vaccines have been built. The technologies they are based on did not come out of thin air at the beginning of the pandemic, but had been under development for decades, with substantial basic research in academic and government labs followed by years of risky investment by commercial start-ups to develop applications for patients.

Innovation does not fall out of the sky. It is the product of intense networks of cooperation that bring together scientists and researchers, small and large companies, workforce training organizations and manufacturing centers, as well as marketing and distribution systems. Secure intellectual property ensures the cohesiveness of this system. Patents secure, to inventors, the exclusive rights to their inventions, making it possible for them to collaborate effectively in the knowledge that their invention will not be stolen. Strong intellectual property systems also incentivize entrepreneurs to bring new goods and services to the marketplace based on those inventions by using the time-limited exclusive rights to earn a sufficient return on their investment. 

Giving away intellectual property and waiving royalties—as the Pandemic Agreement proposes—breaks the very fabric of the innovation system. This is the same innovation system that the world will rely on to produce timely countermeasures for the next pandemic or health emergency. 

Traditional avenues of regulation of dual-use technology are not adequate to address bioterrorism because of globalization and the unique qualities of dual-use technology. As a result, one may assume that the materials necessary to create a dual-use technology will reach the hands of malfeasors. For this reason, countermeasures to this type of technology are paramount. Past, current, and proposed legislation concerning dual-use technology, however, has been inadequate in incentivizing private industry to create countermeasures. The following suggests a patent-term extension for dual-use technologies in exchange for an accompanying countermeasure, arguing this incentive will be practical and effective.

III. ANALYSIS

The use of patent ownership and marketing exclusivity to encourage innovation in the pharmaceutical industry is reflected in existing law and government policy. Studies have shown that these efforts appear to have been successful in facilitating the development and commercialization of new technologies.114 As such, there appears to be congressional interest in utilizing and expanding this approach for the specific purpose of generating innovative bioterrorism countermeasures. While no legislation was enacted during the 109th Congress, three of the bills introduced, S. 3, S. 975, and S. 1873 established regimes under which patent terms would be restored and/or extended and market exclusivity periods increased to reward innovation in this arena. Although different in the specific provisions, these bills built upon incentives that have been used in the past. Encouraging the development of new counterterrorism technologies, on one hand, and ensuring affordable access to new drugs and medical devices, on the other, are both significant goals. These aspirations may potentially conflict, however. Introducing augmented patent- and exclusivity-based incentives may stimulate innovative firms to engage in the research and development of new countermeasures, as well as to shepherd these products through time-consuming and costly marketing approval procedures. Commentators have expressed concern, however, over whether such heightened protections for innovators will be in proportion with the risks and costs of developing new countermeasures. Detractors have also questioned the propriety of financing the development of antiterrorism technologies through increased prices upon distinct medical products via the wild card patent term extension. Striking a balance between encouraging the development of new countermeasures and maintaining the traditional goals of our public health system is a central concern of the current discussion with respect to homeland security.

Governments have created various types of developmental arrangements that have effectively tried to address the “three challenges” characterizing biotechnology: “first, accessing a science base that generates new knowledge and intellectual property; second, obtaining early funding for the timely development of a viable product; and third, navigating commercial and regulatory demands in taking the product to market” (Gilding et al, 2020). One typical policy instrument that potentially provides a – partial – solution to all three challenges is the creation of incubators and technology/science parks around universities or other types of research institutions. Such parks not only facilitate the diffusion of scientific knowledge and the creation of university spin-offs, but they also typically establish an administrative infrastructure that offers support to entrepreneurial researchers in, for example, finding seed funding for the commercialization of their research findings or in designing business plans and accessing management consultancy services to help them take their product to market (e.g. Casper, 2000; Chiaroni and Chiesa, 2006; Zhang, Cooke and Wu, 2011). Another widely used strategy to address the second challenge identified above has been to get states involved in venture capital either through direct state provision of venture capital funds or, increasingly, through the creation (state-owned) funds of (privately owned) venture capital funds (Klingler-Vidra 2018).

State support for biotechnology has also been shown to have been a key success factor in the rise of the national biotech industry that is widely considered as the leading one in the world, namely American biotech (Block, 2008, pp. 176-178; Mazzucato, 2015, chapter 3). A key role here has been played by the National Institutes of Health (NIH), a medical research agency of the Department of Health and Human Services (DHHS), that has not only massively funded – public and private – research on genetic engineering, but has also lobbied policymakers to eliminate any regulatory barriers that might prevent scientists from pursuing research in this area (Ibid.). Although Block’s and Mazzucato’s analyses would suggest that the US’s developmentalism in the biotech area has been driven by public health concerns, Linda Weiss (2014) – who characterizes the US as a “national security state” pursuing perpetual innovation for military preparedness instead of using Block’s concept of a “hidden developmental state” or Mazzucato’s notion of the “entrepreneurial state” – has suggested that a more important driver has been security considerations.

The landscape of pandemic threats continues to evolve, necessitating a dynamic and informed response that extends beyond our current knowledge base. The WHO blueprint list for pathogens with pandemic potential (revision in consultation) currently includes eight viral pathogens (COVID-19, Crimean-Congo haemorrhagic fever, Ebola virus disease and Marburg virus disease, Lassa fever, Middle East respiratory syndrome coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS), Nipah and henipaviral diseases, Rift Valley fever, Zika and ``Disease X'', representing a pathogen or pathogens that have not yet been shown to cause disease in humans.28).We know from genomic modelling that there are as many as 320,000 yet-to-be-characterized mammalian viruses, many of which possess zoonotic `Disease X' potential.29 This vast, unexplored virosphere represents a substantial challenge and underscores the need for continuous enhanced surveillance using for example, advanced next generation sequencing technologies.

Scientific progress will be pivotal in shaping our preparedness for future pandemics, which are likely to differ significantly from previous outbreaks. The next response to a pandemic threat should leverage the latest advances in technology, including the expanding field of artificial intelligence (AI). AI's integration into pandemic preparedness and response strategies represents a paradigm shift in how we will approach future outbreaks, which are likely to differ significantly from those in the past. For example, the use of AI to predict protein structure and functionality from genomic data is currently being revolutionised by tools such as AlphaFold. In a pandemic scenario, rapid insights into the protein structure of a novel virus could significantly shorten the timeline for developing effective therapeutics and vaccines. AI algorithms are also adept at analysing vast amounts of data to model disease spread and predict future outbreaks, incorporating international travel patterns and climate change. AI tools can be used to enhance disease surveillance systems by analysing data from multiple sources, such as social media, news reports, and healthcare databases. AI-driven diagnostic tools also have the potential to provide rapid analysis of clinical data, such as imaging and laboratory results, to assist in the early detection of infectious diseases.31 During a pandemic, these tools could be pivotal in screening large populations quickly and efficiently.

First, mindful of the time, investments required and risks to develop safe and effective countermeasures, sustaining a thriving innovation ecosystem which fosters a continued drive of innovation ahead of the next pandemic, is of the utmost importance. We want to develop new pandemic countermeasures even faster, as proposed in the 100 Day Mission. Such aspirations require sustaining a thriving innovation ecosystem that can be counted on and guaranteeing fast, certain, and unencumbered access to pathogens and their genetic information.

Intellectual property incentives are critical to this kind of ecosystem on which global health security can depend. They provide the necessary framework that makes at risk investments possible in advance of the next pandemic, as well as facilitating voluntary partnerships, business-to-business agreements, technology transfer to scale up for high volume supply.

Globalisation and climate change have resulted in changing patterns of the emergence and global spread of infectious diseases. The majority of emerging infectious diseases are  or vector-borne with over 85 such diseases discovered since 1980 [1]. Notable cases, including highly pathogenic avian influenza (H5N1) and  (SARS) among others, have highlighted the difficulty in predicting zoonotic disease outbreaks. Vaccination is a crucial tool in combatting  and the spread of circulating pathogens, and is central to the One Health paradigm that acknowledges the interaction between human and animal health, as well as the influence of the environmental and social context [2]. Addressing infectious disease within this framework requires, above all, responsive protein production. The maturation of plant-based  has demonstrated that this technology is able to meet this requirement for both human and animal health [3,4].

Around the turn of the century, transient transformation of plant tissues emerged as an alternative mode of  [5] that has created new opportunities for  in biologics production [],  [6] and synthetic biology [7]. Introducing disarmed  strains carrying binary vectors into the leaves of whole plants, known as , results in T-DNA delivery to all cells in the area infiltrated with bacterial suspension. This approach has three considerable benefits for  production in infectious disease prevention and preparedness: (i) it enables easily scalable and rapid upstream processes, (ii) it allows straightforward multiplexing of gene constructs (gene stacking), and (iii) it decouples host cell engineering from plant viability and biomass accumulation (Figure 1). The implications of these advantages with regard to responsive vaccine production, and recent technological advances complementing these features, are the subject of this review.

A vastly improved global approach is within reach. By 2030, every country should enjoy the fundamental building blocks of pandemic preparedness, including the capacity to sequence emergent threats, the expertise and resources to rapidly build diagnostics, treatments, and vaccines, and the infrastructure to both surveil viral spread locally and share data in real time. Because viruses are so fast-moving, penetrating, and volatile, no country can be left behind if we are to successfully preempt another global pandemic. Pandemic preparedness and response require the full participation of every nation and must be undertaken with the precision and speed of military alliances such as NATO, the diplomatic tact of the World Health Organization (WHO), and the inclusive nature of the United Nations General Assembly.3 To achieve this vision, governance and coordination are key. Among the many recommendations outlined by the IPPPR and G-20 High Level Independent Panel, there emerges a common theme: strengthening global leadership and coordination at every level for pandemic preparedness—from building and improving surveillance systems to developing “pre-negotiated” platforms for production and distribution of tests and medical countermeasures—with financing as a key facilitator.4 Even before the next outbreak or pandemic strikes, immediate action to advance the recommendations of both panels are critical for a number of reasons. Most evidently, infectious disease has generated more personal and economic devastation than any war in modern history. Every year, the impacts of annual infections eclipse those of all major wars, but traditional defense budgets, including that of the United States, contribute very little to combating the bioterror threat posed by infectious pathogens. The cost of crisis response, once a major outbreak hits, far exceeds that of building resilient health systems for pandemic preparedness. In 2016, the Commission on a Global Health Risk Framework for the Future explained why an additional US$4.5 billion dedicated to pandemic preparedness each year would considerably improve global resilience against infectious disease.5 By comparison, the 2014–16 Ebola outbreak in West Africa cost an estimated US$53 billion in economic losses and 11,300 deaths.6 One year into the COVID-19 pandemic, estimated economic losses thus far have reached several trillions of dollars and deaths have surpassed 4 million, with extensive morbidity beyond.7,8 Furthermore, the tools needed to stop a viral outbreak are broadly applicable to any virus and routine care. Pandemic preparedness is not separate from, but rather core to, a healthcare system capable of fighting malaria, TB, neglected tropical diseases (NTDs), and the common cold. Anywhere in the world, the tools needed to stop our families, neighbors, and coworkers from falling ill are the same tools needed to stop an outbreak. Both pandemic preparedness and general healthcare work hand in hand to improve health and wellness worldwide. Finally, our universal vulnerability to infectious pathogens, made evident by COVID-19, means that everyone has an important role to play in outbreak prevention. Because of the exponential spread of viruses, one person can launch a pandemic, but one person can also stop it from spreading. To avoid future devastation, the global community must unite now in empowering every actor in the system to fully engage in their own health. This means eliminating global disparities in access to detection tools, countermeasures, and information technologies, connecting local health systems and providers with national, regional, and global health systems, and building newfound community trust in science and medicine.

The coronavirus pandemic highlights perceived conflict between the imperative for scientific rigor in drug development and the acute urgency of a public health emergency (Angus 2020). Different stakeholders—the public, governments, the scientific community, patients, research subjects, and drug developers—bring unique perspectives and priorities. Against the backdrop of a global health emergency, it is important to remember the ethical principles that anchor clinical research for new therapeutics and vaccines. Innovative clinical trial designs may alleviate emerging challenges, and greater cooperation and data-sharing between clinical trials can bring significant benefits. As we strive to align our efforts, it is crucial that lessons learned from current COVID-19 challenges become the foundation for effective strategies in future pandemics.

The scientific path to novel, life-saving treatment lies in a rigorous system of phased clinical trials, but this is a painstaking process that stretches over months and years. In the presence of COVID-19 contagion, acute and long-term health implications, and unprecedented mortality rate, the randomized clinical trial (RCT) gold standard may not always seem to be the fastest vehicle to speedy anti-coronavirus vaccine and therapeutic investigations compared to nonrandomized trials with smaller sample sizes. These single arm trials may attract participants more rapidly due to the absence of a control arm, given the reluctance of many to be randomly assigned to a perceived “inferior” therapy or placebo in a control arm. The magnitude of the pandemic inspires compassion for the suffering and dying, and anxious desire to spring into action, but the answer is not to skip steps to work faster, it is to leverage innovation and work smarter.

In the United States, the definition of what is an emergency, or a disaster, is very fluid. The Federal Emergency Management Agency (FEMA) has an incident typing system, where five is the lowest in terms of resources required and one is the highest, as shown in Figure 1: Emergency management has as one of its standards to “ratchet up and down” the resource support needed, based on the incident type. For example, when a Type 4 incident is still scaling up – meaning not yet under control or expanding – additional resources should be requested as if the incident could grow to a Type 3. While COVID-19 may have started in the United States as a small outbreak in Washington state on January 20, 2020, it expanded exponentially across the entire country in a matter of weeks. And at the same time, the virus spread worldwide.[4] The size and scope moved the incident typing off the scale[5]; there were no additional resources available anywhere, nor was there proper planning in place for this level of incident. There are hazards and threats for which emergency management cannot plan, organize, equip, train, and exercise because they are too complex. One way to quantify them is to describe them as Type 0 – Extinction Level Events.[6]

Diseases cause extinction all the time in animals. Humans are just as susceptible.

The global rise in antibiotic resistance poses a significant threat, diminishing the efficacy of common antibiotics against widespread bacterial infections. The 2022 Global Antimicrobial Resistance and Use Surveillance System (GLASS) report highlights alarming resistance rates among prevalent bacterial pathogens. Median reported rates in 76 countries of 42% for third-generation cephalosporin-resistant E. coli and 35% for methicillin-resistant Staphylococcus aureus are a major concern. For urinary tract infections caused by E. coli, 1 in 5 cases exhibited reduced susceptibility to standard antibiotics like ampicillin, co-trimoxazole, and fluoroquinolones in 2020. This is making it harder to effectively treat common infections. Klebsiella pneumoniae, a common intestinal bacterium, also showed elevated resistance levels against critical antibiotics. Increased levels of resistance potentially lead to heightened utilization of last-resort drugs like carbapenems, for which resistance is in turn being observed across multiple regions. As the effectiveness of these last-resort drugs is compromised, the risks increase of infections that cannot be treated. Projections by the Organization for Economic Cooperation and Development (OECD) indicate an anticipated twofold surge in resistance to last-resort antibiotics by 2035, compared to 2005 levels, underscoring the urgent need for robust antimicrobial stewardship practices and enhanced surveillance coverage worldwide.

Diseases can cause extinction. Proven on a small scale in Nature.