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INTERNATIONALIZATION OF COVID-19 VACCINE USING THE BIOTECH INVS MODEL ed Tubman, Alliayah; Neubert, Michael; Dogra, Amit Abstract rr ev iew The purpose of this multiple case study is to explore the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 vaccine using the Biotechnology international new ventures (BioTech INVs) model as a conceptual framework. The sample consists of eight BioTech firms producing a COVID-19 vaccine, which is approved in at least one foreign market besides the home market in March 2021. The findings suggest that the sample firms are able to identify and to scale international market opportunities early and fast using different market entry modes, networks, and access to capital with governments, civil society, and within their own industry. The findings of our study contribute to the research about BioTech INVs and the speed of internationalization. We call for further qualitative research including interviews with subject-matter experts to better understand the internationalization behaviour of BioTech firms producing a COVID-19 vaccine. ee Keywords Pr ep rin t no tp International new venture; BioTech; Covid 19; Coronavirus; vaccine; internationalization; international business 1 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 Introduction ev iew ed As of early April 2021, the number of people confirmed to contract COVID-19 exceeded the figure of 132 million, along with additional 2.8 million people who lost their lives worldwide (WHO, 2021), as the COVID-19 is affecting 221 countries and territories (Worldometer, 2021). Also, the economic downturn due to the lockdowns is deeper than any other modern worldwide financial crisis that we have experienced in the recent past (Miguel, 2021), and a possibility of creating huge social, economic, and political effects (Tubman & Neubert, 2021). However, recent technological innovation that gave birth to COVID-19 vaccine is an enormous medical advancement (Wilson, 2020), and researchers operating in the laboratory to create vaccines for a broad range of similar coronaviruses, to pre-empt pandemics in the future (California Institute of Technology, 2021), BioTech firms producing a COVID-19 vaccine should internationalize early and fast to refinance their investments (Neubert & Van Der Krogt, 2017) and to increase the already 673 million COVID-19 vaccines administered worldwide as of early April 2021 (Mikulic, 2021) to support governments in the successful management of the pandemic. ee rr The size of Biotechnology market is to surpass the figure of USD 775 billion by 2024 as per a new research report due to the favourable government’s initiatives and growing demand for synthetic biology which will drive the growth of biotechnology industry over the forecast time span (Market Watch, 2021), and these BioTech firms producing a COVID-19 vaccine would be major contributors. Moreover, it is important to understand what happens in emerging markets. The specific problem is that BioTech firms producing a COVID-19 vaccine need to understand which internationalization processes, patterns, and behaviours they should apply to reach their strategic goals of early and fast internationalization (Tubman & Neubert, 2021). no tp The purpose of this study is to explore the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 vaccine using the Biotechnology international new ventures (BioTech INVs) model as a conceptual framework (Oviatt & McDougall, 2018). This study uses a qualitative multiple case study research design. Through the use of the replication logic, we aim to contribute to the development of a new conceptual framework for the internationalization of vaccines (Halkias & Neubert, 2020). ep rin t This study follows a call for research from Tubman and Neubert (2021) to explore the processes, behaviours, and patterns of BioTech firms producing a COVID-19 vaccine. This study should challenge and extend their findings with larger sample size, the integration of the developing markets’ perspective, and INVs as the conceptual framework. This study will try to contribute to the closure of the gap in the literature about the internationalization processes, patterns, and behaviours of BioTech firms producing COVID-19 vaccines. Pr Following this introduction, the literature review will discuss the current research, mostly from the last five years, and the conceptual framework. In chapter three, we will present the qualitative multiple case study design as our research methodology. Chapter three also covers our sampling strategy, the description of the sample, data collection and analysis methods as well as the research questions. The findings of our study will be described in the fourth chapter and discussed in chapter five. Finally, the sixth chapter includes the conclusion, limitations, implications, and recommendations for further research. 2 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 Literature Review and Conceptual Framework ev iew ed The literature review is based on the purpose of this study which is to explore the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID- 19 vaccine. It includes the literature search strategy and covers the current literature about the internationalization of BioTech firms producing vaccines and international new ventures (INVs) as the conceptual framework. In our literature search strategy, we searched the most common scientific databases like for example ProQuest, Ebsco, Google Scholar, Researchgate, SSRN, and Academia to identify literature with different keywords and keyword combinations about the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 or other vaccines from the last five years, except seminal articles. ee rr The international new venture (INV) model is employed for this study as the conceptual framework. Following the definition of Oviatt and McDougall (2018; 1994), INVs are firms seeking to gain a competitive advantage from the utilization of resources and sales in many nations immediately after their incorporation. In contrast to the born global firm model (Rennie, 1993), which focuses on early export sales, the INV includes the internationalization along the value chain. The lean global start-up model (Tanev, 2017; Rasmussen & Tanev, 2015) was developed based on the lean start-up model of Blank (2013) and Ries (2011). We don’t use this model as the conceptual framework, because the BioTech firms in our sample already have a business model (Blank, 2013) and uncertainty is low in comparison to other start-ups due to government funding (Ries, 2011). The most appropriate model for our study is the high-tech INV operating in the BioTech industry (Evers & Anderson, 2021), or how we will call it: BioTech INVs. ep rin t no tp Many scholars have concentrated on identifying the factors that explain how and why INVs are seeking promising circumstances worldwide independent of their place of origin and operational centre (Dzikowski, 2018; Morais & Ferreira, 2019; Schwens et al., 2018). Often INVs internationalize their activities from beginning, effectively moving employees, thoughts, technologies which are innovative, business models, and financial resources all throughout the world (Zahra, 2021). In general, they innovate the transfer of value and acquisition of value aspect as sales channels and logistical means more often than the other internationalizing companies, and also redesign their outside connections more seriously (Abrahamsson et al., 2019). Earlier research refrained from leading any comprehensive studies of network dynamics when INVs could infiltrate a few worldwide business sectors and thus required to adjust to challenge them (Domurath et al., 2020; Morais & Ferreira, 2019). The concepts, which frame our conceptual framework are market orientation, multiple entry and growth strategies, resources from governments and institutions, and technology and innovation (figure 1): Pr Bio-Tech INVs capabilities Market orientation Multiple entry and growth strategies Resources from governments and institutions Technology and innovation Bio-Tech INVs Figure 1: conceptual framework (authors) Market orientation 3 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 no tp ee rr ev iew ed Market orientation (MO) is a way to deal with business that focuses on recognizing the requirements and wants of customers and making products and services that gratify them. Organizations that possess a market orientation acknowledge the point of views and necessities of their target market as an important factor of their research and development (R&D) for new offerings (Kopp, 2021). INVs with MO contrasted with those without MO have a superior comprehension of the necessities and needs of foreign consumers, strategies and capacities of competitors and extrinsic forces and can react suitably in an well timed way to the prerequisites of a changing atmosphere and hence take benefit of an upper hand in the competition (Knight and Liesch, 2016; Acosta et al., 2018). Likewise, INVs with MO can exploit these assets and capacities to connect cultural distance and select culturally inaccessible business sectors in return for more market opportunities and better financial achievements (Deutscher et al., 2016; Mu et al., 2017; Acosta et al., 2018). Also, there is a scope of proof that corroborates the way in which MO affects the global accomplishments of organizations (Escandon-Barbosa et al., 2016). Consequently, MO is an important, uncommon, unique and non-replaceable capacity and it can produce perpetual competitive advantage (Papadas et al., 2019; Tho, 2019). Da Rocha et al. (2017) conjured the idea of borderless companies. As indicated by the authors, the qualities of INVs are (i) value-added operations spread across multiple countries and regions; (ii) entrepreneurs not limited by a home country; (iii) international founders and management teams or both; and (iv) international employees. However, international markets intricacy expands the interest for formulation, dispersal and market intelligence abilities (Hagen et al., 2017; Genc et al., 2019) while the working of worldwide corporate incorporates the powerful management of a diverse organization with various worldwide sites (Sayles, 2017). A recent report discovered that to handle unpredictability in foreign markets, entrepreneurs frequently decide to create collaborative partnerships (Liu and Almor, 2016). With the development of globalization, it has gotten progressively normal for INVs to look for development potential outside of the customarily characterized borders (Kristianto et al., 2017), however a few researchers have expressed their worry that the ongoing COVID-19 pandemic may lastingly affect globalization primarily and more explicitly on the manners in which INVs coordinate their cross-border operations (Altman, 2020; Irwin, 2020). Multiple entry and growth strategies Pr ep rin t Market entry is the act associated with bringing a product or service to a targeted market (Wang & Duan, 2018). There are three types of market entry modes based on their characteristics, which are trade-related entry modes (exporting, subcontract, and countertrade), resource transfer mode (licensing, franchising, international management contract, and build-operate-transfer), and investment-related mode (joint venture, and whollyowned subsidiaries) (Buckley et al., 2018; Neubert, 2011; 2013). Mergers and acquisitions have been influential in changing national organizations into enormous worldwide corporations (Sherman, 2018). Bio-Tech INVs use multiple market entry strategies like wholly owned subsidiaries, strategic alliances, strategic partnership, contract manufacturing, commercialization partnership, export and expansion strategies like diversification, cooperation, and global internationalization strategies to go abroad (Tubman & Neubert, 2021). Two market expansion strategies can also be used together as a market combination (Schellenberg et al., 2017), and market diversification is a strategic decision that firms take to expand internationally into areas with varying characteristics (Sun & Govin, 2017). However, local adaptation is adapting the products based on the local market needs; whereas, global standardization is the process to standardize a product globally (Leung et al., 2020; Wafler & Badir, 2017; Rac-Nicholson & Khan, 2017). Bio-Tech INVs use global standardization in 4 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 entering international markets even though they need national (or regional in the European Union) approval (Tubman & Neubert, 2021). rr ev iew ed Odlin and Benson-Rea (2017) have featured the function of network and strategic alliances in the internationalization procedure of small and medium businesses (SMBs) in New Zealand. A new research of Lew et al. (2016) proposes that INVs' network connections are probably going to include both a business (formal) and a social (informal) composition, which increases their transformation to international markets. Moreover, the importance of networks is an essential system by which INVs make up for their absence of resources in penetrating new international markets (Knight & Liesch, 2016). Especially, it has been expressed that network contacts assist these organizations with conquering resource shortages (Blesa & Ripolles, 2021) and absence of foreign market authenticity (Bembom & Schwens, 2018), which contribute to early market entry. With expanding market knowledge and relationship advancement (Vahlne & Bhatti, 2019), this will decrease the liability of foreignness and outsidership, and also enhanced comprehension about how to move their firm-explicit benefits to this market (Neubert & Van Der Krogt, 2017; Neubert, 2018). In this way, acquiring such advantages from global networks requires a level of consistency and balance to guarantee the flow of information, and different resources like financial resources (Khan et al., 2018). no tp ee According to Zahra (2021), the appearance of COVID-19 harmed international establishments, changing belief systems, altering patterns of global activities and also disturbed global business networks which are broadly saw as crucial for innovation, learning, approach to resources, worldwide expansion, and opportunity acknowledgment (Lorenz et al., 2018; Pedersen et al., 2019). The interruption of long-lived establishments and networks is probably going to stretch out to industry and business environments and similar stages that exist all throughout the world. These business environments have become significant fields where organizations access resources, partners and opportunities that advance development (Nambisan et al., 2019). As of now, there are indications that the flow of venture funding across worldwide boundaries, particularly emerging economies, is decreasing (Rist, 2020). In this manner, in managing their activities, INVs may need to depend largely on ethnic and family ties, and professional associations (Li et al., 2019). Changes in the institutional setting are probably going to bring about significant changes in worldwide ventures' objectives, decision principles and strategic behaviour (Odlin, 2019). Pr ep rin t Additionally, it is essential to know when INVs enter a foreign market. Entering as a pioneer means that a firm enters a new foreign market and creates consumer preferences, enlarges the market, and makes changes in the behaviour of the consumer (Tubman & Neubert 2021) whereas joining as a follower means that a firm has a clear picture of the market and can develop strategies to win over the pioneer of the market (Hochleitner et al., 2016). The advantage of pioneering in the market is that the firms sustained competitive advantage over the market follower (Gupta & Bose, 2019). For the timing of entering the market it is essential to know the organization’s standing in the international market (Jiang et al., 2019). The market entry timing is not only a decision of the Bio-Tech INVs, because it mainly depends on when their products receive approval (Tubman & Neubert, 2021). Resources from governments and institutions Backings of the national government and the U.S. private sector were utilized by Operation Warp Speed (OWS) to speed up the testing, supply, improvement, and dissemination of safe and successful vaccines, therapeutics, and diagnostics to respond to COVID-19 (Miller, 5 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 ed 2020). The federal government invested more than $18 billion (Bloomberg, 2020) in a selection of six hopeful vaccine possibilities via its Operation Warp Speed program (Barone, 2020). Interestingly, the United Kingdom (U.K.) created a special vaccine team in May that provided £18.5m in vaccine research, and then invested more £65.5m to get the AstraZeneca vaccine working (Pharmaceutical Technology, 2020). The U.K. additionally made every effort to get production of vaccine within Britain, accelerating a few products and effectively worked out with vaccine creators to utilize British manufacturing sites (The Canadian Press, 2021). ev iew Furthermore, a sum of US$445 million was invested by Germany in BioNTech, a Germany company that collaborated with the firm Pfizer from the United States in order to get BioNTech's mRNA vaccine developed (Blankenship, 2020). Germany also put an amount of US$300 million in second national firm, CureVac, which is using messenger RNA technology to create a COVID-19 vaccine (Albert, 2020a). rr Additionally, the European Commission agreed on six advance contracts with vaccine manufacturers that will permit to buy a COVID-19 vaccine once it is available (Medicines Law & Policy, 2021). “It has made over €2 billion available to ensure we have sufficient production capacity in the EU. With all these actions added to the global pledging efforts, the Union’s long track-record of funding cutting-edge science and its ability to bring together leading scientists and innovators in the field, the EU is at the forefront of international efforts to produce a vaccine” (European Commission, 2020). tp ee China has approved three vaccine candidates developed by Sinovac and state-owned Sinopharm for emergency use. All these companies are backed by funds from the state (Reuters, 2021a). The first country to accord regulatory approval for COVID-19 vaccine was Russia, Russian authorities were able to do it without the completion of large-scale trials that worried scientists and doctors due to the safety and efficacy factors of the vaccine. Moscow’s Gamaleya Research Institute created the Sputnik V vaccine and then it was marketed by the Russian Direct Investment Fund (RDIF) which is their sovereign wealth fund (Segreti, 2020). no The examples above show that resources from governments and institutions play an important role for the development of COVID-19 vaccines (Tubman & Neubert, 2021). In this multiple case study, we will explore the role of resources from governments and institutions provided for BioTech firms producing a COVID-19 vaccine. ep rin t Technology and innovation Pr The situation of International New Ventures (INVs) keeps on developing on account of technological proceeds (Blesa and Ripolles, 2021). These organizations are diminishing physical and social distances, and working with human resources mobility (Paul & RosadoSerrano, 2019). Digital technology and requirement of the market have additionally empowered joint effort in advancing all throughout the planet. For instance, the web has empowered global cooperation to discover new answers for Covid-19 (Zahra, 2021) and Schroeder (2020) forecasts such a pattern to team up to advance will keep on going, benefiting from the exponential development in telehealth, distant patient checking and the utilization of AI in healthcare. As the accomplishment of digital entrepreneurs turns out to be more obvious, this is probably going to speed up the production of new INVs that profit by promising circumstances across national borders (Jean et al., 2020; Ojala et al., 2018). INVs can employ in their internationalization process various optimization plans such as Functional Excellence (FE), Operations Excellence (OE), Balance Score Cards (BSC), Financial Reporting (FR), Custom Satisfaction Surveys (CSS) etc. Business technology perspective 6 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 includes information management toolsets; Enterprise Resource Planning (ERP), Process Control Systems (PCS), Business Systems (BS) and more recently Manufacturing Execution Systems (MES) (Hansen & Schaltegger, 2016; Aqlan & Al-Fandi, 2018). ev iew ed For numerous international ventures, the increasing utilization of digital technologies implies less expensive and more prominent access, greater coordination and higher efficiency and lower prices (Jean et al., 2020; Williams et al., 2020) and fast speed of internationalization (Neubert, 2018; Neubert &Van Der Krogt, 2018). Lead firms have created refined procedures to permit groups of individuals in various worldwide urban communities to work together in the creation of intangibles by setting up intrafirm linkages to competence-creating subsidiaries or by creating inter-firm associations (Bathelt et al., 2018). When new information blends are prepared, these would then be moved to the country of origin or different areas to upgrade the parent firm’s innovation performance (Cano-Kollmann et al., 2016). Platforms (particularly digitally-based) that rule the present environment have become basic methods for arriving at the markets, giving INVs prompt, economical and dependable admittance to clients, business partners and other supply chain partners around the world (Nambisan, 2017). ee rr INVs need to innovate their business models which includes re-evaluating their supply chain and tasks to discover approaches to proceed with creation and delivery (Zahra 2021), for instance, Canadian automotive brands and car manufacturer like Ford are delivering lifesaving medical gadgets (Meyer et al., 2020). The pattern toward digital entrepreneurship (i.e., making organizations that exploit these innovations to tackle the market requirements) has been solid in the years before Covid (Nambisan, 2017). no tp This literature review shows that there is a gap in the literature to better understand the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 vaccine and a need to increase the speed of internationalization in these times of pandemic (Tubman & Neubert, 2021; Zahra, 2021). We will use the INV model with its 4 concepts market orientation, multiple expansion strategies, resources from governments and institutions, and technology and innovation (figure 1), and a multiple case study analysis of all BioTech firms having an approved COVID-19 vaccine in more than one country to contribute to filling the gaps in the literature and to extend knowledge about BioTech INVs. Research Methodology ep rin t The exploratory character of the research problem and the purpose of this study is qualitative. A multiple case study research design seems to be the most appropriate to answer the research questions, because it helps to get deeper insights in a new phenomenon in its specific context like the internationalization of BioTech firms producing a vaccine during a pandemic (Yin, 2017; Halkias & Neubert, 2020). Based on the purpose of this study, the overarching research question is: What are the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 vaccine? Pr Analyzing the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 vaccine through the lens of our conceptual INV framework leads to the following sub-questions: 1. How do BioTech firms producing a COVID-19 vaccine identify international market opportunities? 7 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 2. What market entry modes and growth strategies do BioTech firms producing a COVID-19 vaccine internationalize use? ed 3. What is the role of resources from governments and institutions for BioTech firms producing a COVID-19 vaccine and their internationalization behaviour? ev iew BioNTech and other BioTech firms started to develop their vaccine immediately after China published the genetic sequence of the Corona virus on January 12th 2020 (WHO, 2020a). We will use a purposive sampling method to identify the most appropriate case study firms or the most advanced BioTech firms producing a COVID-19 vaccine to answer these research questions (Hancock & Algozzine, 2017; Stake, 2006). To qualify for our sample the BioTech firms must produce a COVID-19 vaccine, which • is at least approved preliminarily (= emergency use authorization) by the government authorities in more than one market besides the home market • have delivery contracts with government authorities of more than one country. Clinical phase Vaccine Efficacy Doses Approved in and sold to at least one country Sinopharm China 3 79% 2 Yes Gamaleya Russia 3 92% 2 Yes BioNTech/Pfizer Germany, U.S. 2 and 3 95% 2 Yes Moderna U.S. 3 95% 2 Yes AstraZeneca UK, Sweden 2 and 3 62% - 90% 2 Yes Sinovac China 3 50% 2 Yes Janssen (Johnson & Johnson) Netherlands, U.S. 3 61% - 72% 1 Yes CanSino China 3 66% 1 Yes tp Country of origin ep rin t no Bio-Tech firms ee rr These inclusion criteria are fundamental to identify the internationalization processes, patterns, and behaviours of our sample firms. At the beginning of March 2021, eight BioTech firms producing a COVID-19 vaccine met both criteria (table 1). We assume that this sample size is sufficient to reach saturation (Eisenhardt, 1989; 2020; Halkias & Neubert, 2020). Table 1: Case Study firms (authors) Data about the case study firms is collected through different sources of evidence. Besides data from the case study firms themselves (e.g., corporate websites, brochures, announcements), we use data from governments (e.g., ministries of health, medicine agencies like the European Medicine Agency, supranational organizations like the WHO), NGOs, academics as well as researchers. Pr The main challenge of the data analysis is the triangulation of the different sources of evidence to develop codes and themes. Besides manual coding, we will use a QDAS like for example NVivo or Atlas.ti (Thomas, 2021). We will start with a with-in analysis of each case study firm. Then, we will try to replicate, compare, and contrast the themes of each case study firm with the other case study firms of this sample through the lens of our conceptual framework to identify similarities and differences with the goal to contribute to filling the gap 8 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 ed in the literature and to better understand the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 vaccine (Eisenhardt, 2020; Halkias & Neubert, 2020). Results ev iew Research question 1: How do BioTech firms producing a COVID-19 vaccine identify international market opportunities? The analysis of the data collected disclosed the following findings about how BioTech firms producing a COVID-19 vaccine identify international market opportunities. ee rr When the genetic sequence of the coronavirus was published (WHO, 2020a) and the WHO’s Director-General announced the novel coronavirus outbreak as a public health emergency of international concern (PHEIC) in January 2020 (WHO, 2020b), pharmaceutical companies, BioTech firms, universities, governments and institutions started to develop and to sell a COVID-19 vaccine to governments and supranational organizations all over the world. We define the usage of a market opportunity as a signed delivery contract between a BioTech firm producing a COVID-19 vaccine and a national government or a supranational organization like for example the EU or the WHO. The BioTech firms of our sample used these market opportunities and signed delivery contracts even before their products were developed or government approval was granted. tp Although the vaccines are against the same virus, they have different product characteristics, which might influence the attractiveness of foreign markets like for example product technology (mRNA, inactivated virus, adenovirus-based, viral vector), price, storage requirements, number of required doses, efficacy or level of protection. Other factors are for example the country of origin and related to this government support (table 2). Product Technology Government Approval Price (estimates) Production Storage requirement Sinopharm (China) Inactivated virus Argentina, Bahrain, Cambodia, China, Egypt, Hungary, Iran, Iraq, Jordan, Lebanon, Morocco, Nepal, Pakistan, Peru, UAE, Venezuela $62 China, Dubai, Egypt Temperature refrigerated (normal) Pr ep rin t no BioTech INVs 9 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 mRNA Argentina, Qatar, Bahrain, Chile, Ecuador, EU, Iraq, Israel, Jordan, Malaysia, Panama, Canada, Oman, Philippines, Saint Vincent and the Grenadines, Saudi Arabia, Canada, Mexico, Kuwait, Singapore, Hong Kong, South Korea, Costa Rica, Switzerland, UAE, USA, Australia, Moderna (USA) mRNA Brazil, China, India, South Korea, Russia Can be stored 18ºC - ed BioNTech/Pfizer (Germany/USA) $6 ev iew Algeria, Angola, Argentina, Armenia, Bahrain, Belarus, Bolivia, Djibouti, Egypt, Gabon, Ghana, Guatemala, Guinea, Guyana, Honduras, Hungary, Iran, Iraq, Kazakhstan, Kyrgyzstan, Laos, Lebanon, Mexico, Moldova, Mongolia, Montenegro, Myanmar, Nicaragua, Palestine, Pakistan, Paraguay, Republic of the Congo, Republika Srpska, Russia, Saint Vincent and the Grenadines, SanMarino, Serbia, Slovakia, Sri Lanka, Syria, Tunisia, Turkmenistan, UAE, Uzbekistan, Venezuela rr Adenovirusbased $14 Belgium, China, Germany, USA New data to allow vials to be stored between -25ºC and -15ºC for two weeks no tp ee Gamaleya (Russia) $31 Manufactured in the USA, Switzerland and Spain. Must be transported at -20º C. Has a lifespan of 30 days when refrigerated at between 2ºC and 8OC UK, EU, India, Argentina, Brazil, Australian, Bangladesh, Canada, El Salvador, Mexico, Pakistan, Philippines, Saint Vincent and the Grenadines, South Korea, Dominican Republic, Sri Lanka, Taiwan, Malaysia, Thailand, Nepal, $5 Manufactured in Argentina, Belgium, India, Italy, Mexico, South Korea, Thailand, UK and USA Needs to be refrigerated between 2ºC and 8ºC but does not expire. ep rin t Canada, EU, Israel, Singapore, Saint Vincent and the Grenadines, Switzerland, USA Pr AstraZeneca (UK/Sweden) Adenovirusbased 10 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 Vietnam,WHO Inactivated virus Bolivia, Chile, China, Colombia, Turkey, Indonesia, Thailand, the Philippine, Malaysia, Tunisia $21 Brazil, China, Can be transported Indonesia, Malaysia at room temperature Janssen (Johnson & Johnson) (USA) Adenovirusbased Bahrain, Canada, Saint Vincent and the Grenadines, South Africa, USA, EU $9 France, Italy, Spain, Needs to be stored USA between 2ºC and 8ºC CanSino Biologics (China) Viral vector China, Pakistan, Russia, Mexico $? Bharat (India) Inactivated virus India, Iran, Mauritius, Nepal, Zimbabwe $6 ev iew ed Sinovac (China) Can be stored between 2ºC and 8ºC India, USA Can be stored between 2ºC and 8ºC rr China, Russia Table 2: Countries of origin, product types, approvals, price estimations, production, and storage requirements of COVID-19 vaccines (source: authors) ee Our data shows the following internationalization patterns of BioTech firms producing a COVID-19 vaccine: BioNTech/Pfizer and Moderna with their mRNA product technology seem to focus on developed countries in the Europe, North and Central America, the Middle East, and in Asia with a higher percentage of vulnerable populations. Reasons for this internationalization pattern seem to be the high level of efficacy of their vaccines, the requirement for a closed cool chain (especially BioNTech/Pfizer), and to a lower extent the country of origin. • The Chinese firms Sinovac, CanSino, and Sinopharm seem to focus on developing markets in Latin America, Asia, and the Middle East without own vaccine development projects. Reasons for this internationalization pattern might be political support from the Chinese government as well as the established and good political relations between these countries. ep rin t no tp • Gamaleya from Russia seems to pursue a global market penetration strategy. So far, it has the highest number of approvals. Reasons for this market success might be the willingness to set up production facilities in the markets they are serving and to license their technology, and the ability to seize market opportunities like for example in the European Union (example: Hungary). • It will be interesting how Janssen’s vaccine will be received in the market. Jansen might be considered as late follower, but their vaccine has a strong competitive advantage: it needs just one dose to get immunity, can be stored in a refrigerator, and is available at an attractive price point. Pr • BioTech firms producing a COVID-19 vaccine identify international market opportunities 11 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 early before and parallel to the development, the approval, and the production of their vaccines. Currently, political support and government relations seem to drive internationalization even more than product characteristics. ed Research question 2: Which market entry modes and growth strategies do BioTech firms producing a COVID-19 vaccine internationalize use? ev iew The analysis of the data collected revealed the following findings about which market entry modes and growth strategies BioTech firms producing a COVID-19 vaccine use to internationalize. The BioTech firms producing COVID-19 vaccines use similar market entry modes. First, they all use export to sell the vaccines, which are produced in their own factories (table 3). Due to export controls imposed for example by the European Union (Voxeu.org, 2021), the BioTech firms in our sample also use contract manufacturing or own production facilities abroad, a smaller number also intellectual property (IP) licensing (table 3). ee rr Growth strategies include the collaboration and partnerships mainly with pharmaceutical companies to quickly ramp up production and research institutions to increase the speed of product development (table 3). Growth or market entry barriers as government approvals, doubts about patent protection, export controls, and logistics (e.g., cool chain) are similar for all BioTech firms in our sample (table 3). Except the pioneers BioNTech/Pfizer and Gamaleya, all other BioTech firms of our sample seem to use a (fast) follower strategy focusing for example on specific markets (table 3). Sinopharm Market entry modes Growth strategies no BioTech Firms tp The following table 3 shows the market entry modes, growth strategies, entry barriers, timing strategies followed by the case study profiles. Collaboration, Government approval, production, contract partnership logistics, patent protection, ep rin t Export, own Collaboration, production, contract partnership Market entry timing barriers Export, own manufacturing Gamaleya Growth and market entry Follower export controls Pioneer manufacturing Pr BioNTech/Pfizer Moderna Export, contract Strategic alliance, manufacturing, collaboration, licensing, own partnership Pioneer production Export, contract Collaboration, manufacturing partnership Fast Follower 12 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 Sinovac Export, licensing, Strategic alliances, contract collaboration, manufacturing technology transfer Export, own Strategic alliance, production partnership, Fast Follower ed AstraZeneca Follower Janssen (Johnson & Export, own Strategic alliance, Johnson) production, contract partnership, manufacturing technology transfer, collaboration CanSino Export, own Partnership rr Export, licensing, Collaboration, own production commercialization Follower ee partnership Follower Follower production Bharat ev iew technology transfer tp Table 3: Market entry modes, timing, and growth strategies (source: authors) no Sinopharm cooperated with the Beijing Institute of Biological Products to create a COVID19 vaccine. According to Sinopharm's Chariman Yang Xioyun, the firm might be able to manufacture one billion doses of vaccine in 2021 (Crasto, 2021a). Dubai's G42 Healthcare agreed upon manufacturing contracts with Sinopharm to furnish UAE and other regional countries with BBIBP-CorV (Crasto, 2021a). Sinopharm agreed with another firm Biological Products & Vaccines from Egypt to the manufacturing of vaccines at their local facilities which would then be delivered to other African nations as well (Crasto, 2021a). Pr ep rin t Gamaleya Research Institute of Epidemiology and Microbiology, the sovereign wealth fund and Russian Direct Investment Fund, are collaborating to produce the COVID-19 vaccine of the Sputnik V. More than 50 nations requested for vaccine doses and the vaccines are produced for the whole world by partner countries like India, Brazil, China, South Korea, Hungary, and other countries (Osborn & Nikolskaya, 2020). The Hadassah Medical Center of Israel agreed for a commercial memorandum of perception to obtain 1.5–3 million doses and also a contract of manufacturing more than 100 million doses of COVID-19 vaccine which has been produced with Dr. Reddy's Laboratories in India (Crasto, 2021b). Additionally, the Gamaleya National Center, the Russian Direct Investment Fund, AstraZeneca and R-Pharm joined forces under a contract to develop and implement a clinical research program to analyse the immunogenicity and safety of the vaccines when used in combination with one of the elements of the Sputnik V vaccine created by the Gamaleya Centre, and other element of the AZD1222 vaccine, created by AstraZeneca and the University of Oxford (Russian Direct Investment Fund, 2020). 13 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 ev iew ed BioNTech in collaboration with Pfizer also developed a COVID-19 vaccine, which was the 1st vaccine ever for COVID-19 that got approval from by a strict regulatory agency for use in the case of emergency and then it was also the 1st vaccine allowed for normal utilization (WHO, 2020c). BioNTech is the first creator of the COVID-19 vaccine who allied with Pfizer for the purpose of succeeding at the clinical research, clinical trials, logistics, finances and for global manufacturing apart from China (Crasto, 2021c). Fosun Pharmaceutical, in conjunction with its investment in BioNTech bought the right to produce and administer the vaccine in China (Thomas et al., 2020; Burger, 2020). Pfizer and BioNTech have been producing the COVID-19 vaccine at their own manufacturing sites in the United States of America (USA) and in European continent. BioNTech decided to use the vaccine production sites of Novartis in Marburg, Germany, in order to increase the production of their COVID19 vaccine (BioNTech, 2020). ee rr Moderna, the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) from the United States collaborated and produced a vaccine for COVID-19 that they codenamed mRNA-1273 (Crasto, 2021d). Moderna has been heavily dependent on the organizations that offer contract manufacturing and Moderna is managing to increase its vaccine production process in this way (Crasto, 2021d). Moderna and Lonza Group agreed to manufacture the vaccine at the Lonza’s site in Portsmouth, New Hampshire in the United States (US), and in Switzerland at Visp; and for the procedure of filling and packaging the vials, Moderna started the contracts with the company named Catalent in the US and in Spain with Laboratorios Farmacéuticos Rovi (Crasto, 2021d). ep rin t no tp COVID-19 vaccine of AstraZeneca, with codename of AZD1222, produced together by University of Oxford and AstraZeneca as a COVID-19 vaccine, then AstraZeneca and Emergent BioSolutions agreed upon a deal of US$87 million to produce vaccine doses particularly for the United States market (Crasto, 2021e). This was result of the previous president Donald Trump who started Operation Warp Speed (OWS) and got into an agreement to produce then swiftly increase the production before the end of 2020 of chosen vaccines (Crasto, 2021e). The finishing and packaging process will be handled by Catalent and then in order to deliver one billion vaccines of the University of Oxford to poor countries, a licensing agreement was signed between the two firms Serum Institute of India (SII) from India and AstraZeneca (Crasto, 2021e). Also, AstraZeneca agreed to transfer technology to Mexico and Argentina to manufacture at least 400 million vaccine doses for administer in all Latin America (Crasto, 2021e). Argentina would be manufacturing the active ingredients and then sending to Mexico so that the distribution can be completed (Crasto, 2021e). SK Bioscience, a company from South Korea agreed to produce the products of vaccine of AstraZeneca and this agreement requires the South Korean firm to produce AZD1222 not only for national but also for international areas (Crasto, 2021e). Pr Moreover, CoronaVac is created by Sinovac BioTech as a COVID-19 vaccine and then in the first month of 2021, it was decided to two-fold the yearly production capability to one billion vaccines of CoronaVac from the month of February by the firm Sinovac after completion of its another manufacturing unit (Reuters, 2021b). Butantan Institute from Brazil assisted CoronaVac in developing the vaccine and then they had started negotiating to sell their vaccine to other South American countries, which would be manufactured in the city of Sao Paulo in Brazil. The approval from government regulatory agencies was needed so that the 14 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 ed vaccines could be bought. In the meantime, Malaysian company named Pharmaniaga agreed to obtain huge quantities of the vaccine along with technology transfer from Sinovac and will produce, fill, and finish CoronaVac. Also, Butantan Institure in Brazil started constructing a manufacturing site to make 100 million vaccines annually and targets to fill and finish 1 million doses every day on its production line. ee rr ev iew A sister Company of Johnson & Johnson (J&J), Janssen Pharmaceuticals and an Israeli company named Beth Israel Deaconess Medical Center (BIDMC) cooperated to create the candidate of vaccine use the similar technique used to create vaccine for Ebola. J&J also partnered up with Catalent to avail huge level production of the Johnson & Johnson vaccine at Indiana site of Catalent and their Italian site of Catalent's Anagni, Then, J&J agreed with Grand River Aseptic Manufacturing to assist in the manufacturing of the COVID-19 vaccine, involving the transfer of technology and to fill the bottles and then finish manufacturing, at the site in Michigan. Furthermore, J&J with a Spanish pharmaceutical firm Reig Jofre, agreed to produce the vaccine at site in Spain at Barcelona. In addition, J&J and Sanofi got into contract by which Sanofi will give assistance and provide infrastructure in France at their site in Marcy-l'Étoile to produce around 12 million vaccines of J&J every month when approved. Lately, J&J and Merck & Co agreed for the firm of Merck for the production of the J&J COVID-19 vaccine at couple of sites in the US to assist in increasing the production capability of the COVID-19 doses utilizing resources of the Act of Defense Production. no tp Similar to J&J, CanSino Biologics (CanSinoBIO) in collaboration with the Chinese military institute for infectious disease developed a vaccine, AD5-nCOV and tradenamed Convidicea, that is effective with only one dose. The company has the capacity to produce a large number of the vaccine at its facility. At the same time, CanSinoBIO and a Malaysian firm named Solution Biologics agreed to a contract for producing, marketing and distributing in the Malaysia. Chinese authorities granted first invention patent to COVID-19 vaccine candidateAD5-nCOV, a recombinant adenovirus vaccine called Ad5-nCoV codeveloped by CanSino Biologics. Pr ep rin t Bharat BioTech, the Indian Council of Medical Resesrch and National Institute of Virology (NIV) worked together to create India’s first vaccine COVID-19 named COVAXIN (Bharat Biotech, 2020). Moreover, Bharat BioTech agreed on a contract with Precisa Medicamentos of Brazil to provide COVAXIN (The Economic Times, 2021) and drew a contract with Washington University School of Medicine that uses the technology of a novel chimpadenovirus, to produce one dose intranasal vaccine (Pharmaceutical Technology, 2020b). Further, Ocugen and Bharat BioTech, a global leader in vaccine got made a conclusive deal to co-operate, commercialize and supply Bharat BioTech’s COVAXIN (a candidate for vaccine) which was an advanced stage based on whole-virion inactivated, to be used in the United States (Eyewire News, 2021). Moreover, the United States will be receiving the technology from Bharat BioTech to assist the US to produce the vaccines on their soil. The US market would be considered for the exclusive license, the profits will be shared from selling COVAXIN to United States between Bharat Biotech and Ocugen (45% of the profits). (GlobeNewswire, 2021). The analysis of the data collected shows that BioTech firms producing a COVID-19 vaccine mainly use market entry modes and growth strategies, which require few resources, to internationalize early and fast. All firms in our sample use export modes and strategic 15 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 alliances leading to complex networks with for example pharmaceutical companies, governments, and research institutions to increase the speed of international growth. Some like Gamaleya also use IP licensing. ed Research question 3: What is the role of resources from governments and institutions for BioTech firms producing a COVID-19 vaccine and their internationalization behaviour? ev iew The analysis of the data collected revealed the following findings about the role of governments and institutions in the internationalization of BioTech firms producing a COVID-19 vaccine. no tp ee rr Government funding is used to finance product development and clinical testing until government approval (here: FDA) is achieved as the case study firms Moderna and Johnson & Johnson show. A sum of $483 million as the starting fund was given to Moderna by Biomedical Advanced Research and Development Authority (BARDA) to assist in the ramp up of mRNA-1273 and the clinical development, at first with a smaller expected number of people in the clinical trial of Phase 3 (Moderna, 2020a). BARDA updated the terms of the contract to increase their help in the firm’s late stage clinical development of mRNA-1273, involving 30,000 people in Phase 3 study in the United States. The new allocated fund was around $955 million (Moderna, 2020b). In the end, COVID-19 vaccine contract of the US government with Moderna was worth about $1.5 billion (HHS.gov, 2020). Moderna stated in its original BARDA funding press release (Moderna) "BARDA will fund the advancement of mRNA-1273 to FDA licensure"— "made clear the extent of BARDA's 100% funding of the program (Herman, 2020). Like Moderna, Johnson & Johnson entered a partnership with BARDA, and they all at the same time pledged more than $1 billion to invest in the research of COVID-19 vaccine, development, and clinical testing (Johnson & Johnson, 2020). In order to focus on these efforts, Johnson & Johnson will use its approved vaccine platform and it will allocate resources, involving employees and infrastructure worldwide, as required, At the same time, BARDA and the firm of J&J have given extra funding to expand the efforts in the research of promising antiviral medicine for the COVID-19 (Johnson & Johnson, 2020). Pr ep rin t Government funding is also used to finance manufacturing and distribution as the case studies of Astra Zeneca and Johnson & Johnson show. AstraZeneca, Gavi and CEPI got into a contract to assist in the production, obtainment and administering of 300 million units of the promising COVID-19 vaccine (CEPI, 2020; AstraZeneca, 2020). Actually, AstraZeneca was the second company to receive substantial U.S. government funding after Regeneron. Additionally, the UK government granted £65.5 million to fund the COVID-19 vaccine which is developed by the University of Oxford as the coronavirus vaccine trials advance. This funding assists in starting the production right away, and as a result it will allow having vaccine available as soon as possible, at the same time respecting the strictest safety standards. The methods developed in the UK will also enable the production of vaccine for other countries (University of Oxford, 2020). This implies that the United Kingdom would have become the first nation to get access to the COVID-19 vaccine, on its success (GOV.UK, 2020). Moreover, the European Commission paid a sum of €336 million to AstraZeneca to lock at least 300 million vaccines COVID-19 vaccine (potential vaccine at that time). The agreement covered creation, liability and other expenses incurred by AstraZeneca. The EU has also sealed an alternative to buy 100 million more vaccines which were being created. AstraZeneca agreed to provide the 300 million vaccines to the United 16 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 States at the price of $1.2 billion, then 30 million doses to the UK at the cost of 65.5 million pounds (Guarascio, 2020a). ev iew ed Johnson & Johnson is also committed to BARDA and it is increasing company’s worldwide production capability, like setting up a new U.S. vaccine production facility and ramping up capacity in other countries. The additional facility would help in the fast manufacturing of COVID-19 vaccine and it will allow the supply of more than one billion doses of a safe and effective vaccine worldwide (Johnson & Johnson, 2020). The European Union paid an undisclosed amount to J&J in order to have the vaccines, and this supports the statement in which it shared its plans again to put aside a sum of up to 500 million for extra doses from mid-2021 for the countries which are not rich (VOA News, 2020). EU members will pay the whole price only in the case when they will order it. The price and liability agreements were kept undisclosed (Guarascio, 2020b). no tp ee rr Contrary to Moderna, AstraZeneca and Johnson & Johnson, Pfizer didn’t get any financial aid from Operation Warp Speed (OWS) for the development, clinical trial and manufacturing of the vaccine rather, on the other hand BioNTech availed $445 million from the government of Germany in a deal to assist to increase the production of the vaccine through building of the manufacturing sites and production capability in the German market (Bloomberg, 2020). Even though, Pfizer didn't get the funding from the government of the United States, it still got one of the largest supply contracts under Operation Warp Speed (Lupkin, 2020). Furthermore, once the first100 million doses are received, the U.S. government will pay the amount of $1.95 billion to the firms following FDA authorization or approval. The U.S. government is also capable of acquiring up to extra 500 million doses (Pfizer, 2020). Operation Warp Speed tapped most of the vaccine front-runners to dispense their doses through a government partnership with McKesson Corp., on the contrary Pfizer is handling its own delivery of its products. The firm has manufactured its reusable containers that can keep the doses at very cold temperatures, and is assembling trucks and flights to move them (Bloomberg, 2020). Presumably to avoid possible federal control of IP and pricing, Pfizer choose not to take any federal money. But those companies were then able to quickly scaleup costly clinical trials and simulations the mass production of promising vaccines, whether they worked or not. Funding from Bill Gates’ foundation and other philanthropies also helped supercharge research (Douglass, 2021). Pr ep rin t The Indian government supported and provided financial assistance to all vaccines developed or produced in the country. The Indian Council of Medical Research (ICMR) gave financial resources for clinical-trial, site-fees for Serum Institute of India’s ongoing bridging trials in the case of Covishield. The CEO of Serum Institute of India, Adar Poonawalla mentioned that the aim of this health research public private partnership (PPP) is to have a partnership to come together in scaling up the management and containing of the spread of the virus (The Wire, 2021). ICMR funded and furnished other support to Bharat BioTech, Zydus Cadila and few other pharmaceutical firms that are developing COVID-19 vaccines. It assisted in the progress of regulatory approvals for Covishield and Covaxin. Moreover, an amount of USD 300 million has been provided by the Bill and Melinda Gates Foundation so far to aid SII manufacture potential vaccine candidates and to obtain vaccines through the international Covax alliance (The Wire, 2021). The Sputnik V vaccine from Russian was created by Moscow’s Gamaleya Research Institute 17 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 ed and marketed by Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF) (Segreti, 2020). Both organizations are part of the Russian government. Russia became the first country to give regulatory approval to a COVID-19 vaccine and just like China, it did not disclose funding amount (Wang, 2021). ev iew Governments and supranational organizations like the EU and the WHO as well as philanthropies like the Bill and Melinda Gates’ foundation support BioTech firms producing a COVID-19 vaccine in different ways. They are funding product development and clinical testing until government approval, manufacturing and distribution, the funds are provided through shares, grants, or bonds, no global perspectives but only national. Discussion ee rr Still in the middle of the pandemic even worse than the last year, the only sure way to exit seems to be a vaccine with sufficient efficacy that can lead to herd immunity and stop the virus from spreading (MacIntyre, 2021). As not every country has home grown vaccine, it is of uttermost importance to understand the internationalization process, patterns and behaviors of the BioTech firms producing a COVID-19 vaccine. The firms producing this vaccine should internationalize early and fast so that they can refinance their investments (Neubert & Van Der Krogt, 2017) and increase the number of already administered vaccines worldwide to support the governments in successfully managing the pandemic. In order to reach the objectives of this study the Biotechnology international new ventures (BioTech INVs) model as a conceptual framework was employed (Oviatt & McDougall, 2018). In this section, we discuss the findings of this multiple-case study in the light of the extant literature. Pr ep rin t no tp The aim of the first research question is to understand the process employed by the BioTech firms in identifying the international market opportunities. The findings indicate that the BioTech companies sensed the opportunity early and once the genetic sequence of the coronavirus was published and when WHO confirmed the novel coronavirus as a public health emergency of international concern (WHO, 2020a; WHO, 2020b), BioTech firms mobilized their resources to develop COVID-19 vaccine and even pre-sold to governments and supranational organizations all over the world (Dance, 2021). The BioTech firms analyzed in our study signed delivery contracts of COVID-19 vaccine with governments and other organizations even if the vaccines were not ready and the vaccines of these firms were granted any approval (Medicines Law & Policy 2021). This demonstrates that they successfully took advantage of this opportunity at an international level and tremendously reduced the level of risk. Most of the BioTech firms in our sample were funded by the governments and as a result it dropped the level of uncertainty for them. This supports the argument of Ries (2011) who stated that level of uncertainty falls due to the government funding. Even though, these firms were developing the vaccine against the same virus, they took different routes while understanding the requirements of their consumers either from developed or developing countries. The characters like product technology, efficacy, price and storage requirements played a crucial role in the development of their individual vaccine. 18 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 ed ev iew Fig. Characters of COVID-19 Vaccine rr For instance, BioNTech/Pfizer and Moderna used mRNA product technology (Albert, 2020b) to have higher efficacy in order to target the developed countries where they have higher percentage of vulnerable population (European Medicines Agency, 2021; European Centre for Disease Prevention and Control, 2021) and the storage requirement for a closed cool chain which make these vaccines more expensive compared to others (Simmons-Duffin, 2021) but still affordable by the developed countries and thus became a good fit through identifying the international opportunity. As a result of ongoing crisis, these BioTech firms are getting political and government support which is driving their internationalization more than the characteristics of their products. However, the final question boils down to will the internationalization process of these BioTech firms follow the same trajectory in the absence of urgent need of their products like we do now because of the global pandemic. Pr ep rin t no tp ee The aim of the second research question is to identify market entry modes and growth strategies used by BioTech firms producing a COVID-19 vaccine to internationalize. The findings imply that the BioTech firms producing COVID 19 vaccine use similar market entry modes, as indicated by the data analysis of this study. All of them adopted the trade-related entry mode in the form of export to sell their vaccines that they produced in their own facilities. And as a growth strategy, these firms collaborated and partnered up mainly with pharmaceutical companies to rapidly increase production and with research institutions to speed up the product development. As per the report released by Moderna, they have built a global commercial network which allows them to commercialize their entire pipeline without a large pharmaceutical partner and they have subsidiaries, distributors or partners in nine countries mostly in Europe and North America (Moderna, 2021). Apart from the pioneers BioNTech/Pfizer and Gamaleya, all other BioTech firms are using a follower strategy and focusing on specific markets. Collaboration and partnership remains the main growth strategies of these firms followed by strategic alliance and technology transfer. The strategies used by firms in our sample required few resources in order to internationalize early and fast. These findings are supported by Tubman and Neubert (2021) who posited that BioTech INVs use multiple market entry strategies like strategic alliances, strategic partnership, contract manufacturing, export and expansion strategies like diversification, cooperation, and global internationalization strategies to internationalize. BioNTech/Pfizer and Gamaleya entered the market as pioneers however the follower AstraZeneca managed to penetrate more countries than the pioneers. As per the New York Times Covid-vaccinations-tracker, AstraZeneca has been used in 114 countries as of early April 2021 (Holder, 2021). Even if coming as a pioneer in the market leads to enter a new foreign market and creates consumer preferences, enlarges the market, and makes changes in the behavior of the consumer (Tubman & Neubert 2021), AstraZeneca being a follower with a clear picture of the market developed strategies to win over the pioneer of the market (Hochleitner et al., 2016). The third research question tried to understand the role of resources from governments and institutions for BioTech firms producing a COVID-19 vaccine and their internationalization behavior. The findings revealed that the government along with philanthropic foundations like Bill and Melinda Gates Foundation funded the product development, initial clinical 19 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 ev iew ed testing, and later stages of clinical development, manufacturing and distribution of the vaccine (Bill & Melinda Gates Foundation, 2020; Allen, 2020). However in the US, most of the vaccine front-runners that have been tapped by Warp Speed/ Government and they will have to dispense their vaccine via a government partnership; which can also be seen in countries like Kenya where private import of vaccines is not allowed however other countries like Uganda, Pakistan and Colombia have allowed the private import (Nakkazi, 2021; Reuters, 2021c). And presumably that is the reason why Pfizer did not choose to take any federal money to avoid possible federal control of IP and pricing. Other companies were able to quickly scale-up costly clinical trials and simulations of the mass production of promising vaccines because of the government funding even if there were some stipulations attached to it. It is apparent that the resources from government and intuitions have played a positive role for the BioTech firms in producing a COVID-19 vaccine and internationalizing them. The findings are in line with the study of Tubman and Neubert (2021) in which they found that resources from governments and institutions play an important role for the development of COVID-19 vaccines. rr Conclusion ee The purpose of this multiple case study is to explore the internationalization processes, patterns, and behaviours of BioTech firms producing a COVID-19 vaccine using the Biotechnology international new ventures (BioTech INVs) model as a conceptual framework. The sample consists of eight BioTech firms producing a COVID-19 vaccine, which is approved in at least one foreign market besides the home market in March 2021. no tp The findings of our multiple case study suggest that BioTech firms producing a COVID-19 vaccine identify international market opportunities early before and parallel to the development, the approval, and the production of their vaccines. Currently, political support and government relations seem to drive internationalization and international market success as well as product characteristics. ep rin t The analysis of the data collected shows that BioTech firms producing a COVID-19 vaccine mainly use market entry modes and growth strategies, which require few resources, to internationalize early and fast. The firms in our sample use market entry forms with low resource requirements like for example export modes, IP licensing, and strategic alliances leading to complex networks with for example pharmaceutical companies, governments, and research institutions to increase the speed of international growth. Pr Governments and supranational organizations like the EU and the WHO as well as philanthropies like the Bill and Melinda Gates’ foundation support BioTech firms producing a COVID-19 vaccine in different ways. They are funding product development and clinical testing until government approval, manufacturing and distribution, and thus almost all activities throughout the value chain. The funds are provided through shares, grants, or bonds, no global perspectives but only national. The findings of our study contribute to the research about BioTech INVs and the speed of internationalization continuing the research of Tubman and Neubert (2021). Practitioners like politicians and managers may benefit from the insights of this study to increase the global availability of COVID-19 vaccines to reduce the negative social and economic impact of this 20 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3860031 pandemic. Pr ep rin t no tp ee rr ev iew ed This study has several limitations based on the sample size, the research methodology, and the limited availability of reliable data. 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