a. In total, 29 companies replied to the two surveys. These companies employ approximately 4,000 full-time staff.

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1 Mapping the Global Vaccine Manufacturing Workforce: Preliminary Results of a Survey among Vaccine Manufacturers Abstract The World Health Organization (WHO) developed and implemented a web-based survey among vaccine manufacturers worldwide to address a lack of baseline data on this topic and to create evidence regarding workforce capacity in this sector. This project was carried out between April and November In total, 29 vaccine manufacturers worldwide submitted replies. The survey met its primary objectives which were threefold: (1) map the global influenza vaccine manufacturing workforce (2) gather information on influenza vaccine manufacturers' approaches to recruitment and retention of a skilled local workforce and (3) determine the type of trainings available to the workforce, their funding sources and their target audience. Select findings drawn from the data analysis include the following: In terms of personnel composition, production plant staff comprises the largest personnel category followed by facility management business staff and R&D laboratory staff; The main source of recruitment of personnel is the local market; In terms of recruitment of laboratory, production plant and administrative staff, the entrylevel education and professional experience is very basic requiring completion of either high-school or a bachelor degree, plus 1 to 3 years of experience. Management level positions usually require a master degree or PhD and a minimum of 3 years of professional experience; The majority of entry-level production staff are recruited directly from universities/technical colleges; Companies have difficulty recruiting and retaining managerial staff. Moving forward, it will be important to deepen the analysis and to examine the data through different lenses to help answer new questions that arose during the survey process. WHO used the information generated from these surveys to provide content and context for the WEGWVM, which took place in Cape Town, South Africa, from 30 th November to 2 nd December WHO will also use the information to accomplish several of the following goals: generate new ideas for partnerships between vaccine manufacturers and other entities that may contribute to their success on a national/regional level in producing safe and 1

2 effective vaccines; support the dialogue to overcome existing challenges to recruiting, training, and retaining local vaccine production staff; and identify current needs and gaps in human capacity for vaccine manufacturing that should be addressed in order to meet the public health needs. Drivers and obstacles to developing sustainable vaccine manufacturing human resources capacity have not been well understood or communicated to the donor and policymaking community. WHO anticipates that the quantifiable data from this survey will encourage further dialogue, and spark interest among stakeholders to work cooperatively towards the development of sustainable vaccine production worldwide. 2

3 Introduction In preparation for the Workshop on Enhancing the Global Workforce for Vaccine Manufacturing (WEGWVM), co-organized with the U.S. Department of Health and Human Services (HHS), the organizers sought to gather information on the workforce situation among vaccine manufacturers. After an extensive literature review revealed a lack of baseline data on this topic, WHO determined that surveying influenza vaccine manufacturers worldwide could be a useful approach to addressing this knowledge gap. The primary objectives of the survey were to: Map the global influenza vaccine manufacturing workforce; Gather information on influenza vaccine manufacturers' approaches to recruitment and retention of a skilled local workforce; Determine the type of trainings available to the workforce, their funding sources and their target audience. The survey team s initial intent was to survey only influenza vaccine manufacturers but based on the positive outcome and recommendations from the first survey, WHO decided to expand the scope of the survey beyond influenza and include all vaccine manufacturers. This report presents the outcomes of both phases of the survey. Methodology Phase I WHO technical staff developed a web-based survey instrument consisting of multiple choice and short answer questions. The questionnaire was divided into six sections: (1) General Information (2) Company Goals (3) Employee Demographics (4) Employee Training (5) Workforce Recruitment and Retention and (6) International Affiliations and Vaccine Manufacturing Networks The survey questionnaire was developed in English. Due to resource constraints it was not possible to translate it into any other languages. In light of this limitation, the survey was piloted by a volunteer company in a country where English is not the primary spoken language. The survey team made final revisions to the questionnaire based on the company's valuable inputs on readability and ease of understanding as well as substantive issues. The WHO survey team identified a total of 53 influenza vaccine manufacturers worldwide that met any or a combination of the following inclusion criteria: (1) Produces a seasonal and/or human pandemic influenza vaccine (2) Has licensed (or has started the licensing procedure) 3

4 in at least one country (3) Is a recipient of a WHO grant to build capacity for influenza vaccine production. WHO ultimately invited 47 companies 1 to complete the survey in April 2011; as for the remaining 6 companies it had been impossible to establish a contact. Of the 47 companies surveyed, 24 (53%) submitted replies. Phase II WHO refined the original survey instrument based on the results and feedback from Phase I. Some questions were modified to enhance clarity and/or in order to capture more in-depth data. Additional questions were also added in order to help address new questions raised in Phase I. The survey team identified a total of 120 vaccine manufacturers worldwide (including influenza vaccine manufacturers) that met any or a combination of the following criteria: (1) Produces human vaccine (2) Has licensed (or has started the licensing procedure) in at least one country (3) Is a recipient of the WHO grant to build capacity for influenza vaccine production. WHO ultimately invited 96 companies to complete the survey in October 2011 as it was impossible to establish a contact with the remaining 23 companies. Of the 96 companies surveyed, 17 (18%) submitted replies. Data Analysis The WHO survey team tabulated and cleaned the data and then applied descriptive statistics to the datasets and subsets. Whenever possible, results from Phase I and Phase II of the survey were collated; however, due to differences between the Phase I and Phase II questionnaires, data from several questions was analyzed separately (by Phase). Data presented in this report are based entirely on the respondents' replies to the selfadministered survey. All data is presented in aggregate form in order to maintain confidentiality. Results 2 1. Workforce Mapping at Company Level a. In total, 29 companies replied to the two surveys. These companies employ approximately 4,000 full-time staff. 1 The term company as used in this report refers to any vaccine manufacturing entity including, but not limited to: companies, institutions, and public-private partnerships. 2 Data reported herein are the collated results from Phase I and Phase II of the survey. In cases where the questions differed between the Phase I and II questionnaires, data are labeled accordingly. 4

5 b. Of the 29 respondents, 14 (48%) are public companies; 13 (45%) are privately owned companies; and 2 (7%) are public-private partnerships 3. One public company will be privatized in 2012, thereby raising the percentage of privately owned companies to 48%. c. The respondents are distributed among five of the WHO geographic regions. Table 1. Distribution of survey respondents by WHO geographic region EMRO 1 EURO 10 AMRO/PAHO 2 SEARO 7 WPRO 9 Total 29 d. Of the 29 companies who responded to the survey, 11 are located in high-income countries and 18 in low and middle-income countries 4. e. The total number of annual seasonal influenza vaccines produced worldwide in 2009 is estimated to be approximately 876M doses 5. Of the 29 companies surveyed, 16 provided information regarding their seasonal influenza vaccine production. Collectively, these companies produce ~ 246M doses (28%) of the global total. f. Six respondents provided data on the other types of vaccines produced, for a total of approximately billion doses. 3 For the purpose of the survey, Public-Private Partnership was defined as a government service or private business venture which is funded and operated through a partnership of government and one or more private sector companies. 4 Using the classification of the World Bank and OECD 2011 to determine country's income level (web site accessed 6 June 2011) 5 Vaccine production capacity for seasonal and pandemic (H1N1) 2009 influenza, Nicolas Collin, Xavier de Radiguès and the World Health Organization H1N1 Vaccine Task Force, available on line at: 5

6 2. Workforce Mapping at Personnel level Phase I of the survey recognized seven functional personnel categories: R&D management, R&D laboratory staff, production plant management, production plant staff, clinical and regulatory management, clinical and regulatory administrative staff 6 and facility 7 management. Phase II of the survey recognized eight personnel categories due to the fact that the facility management category was split into two arms: business and marketing. a. In terms of personnel composition, production plant staff comprises the largest personnel category followed by facility management business staff and R&D laboratory staff. Table 2. Personnel composition at the facility level (n=21) 8 Personnel Category Total number of Percentage of personnel per personnel category R & D Management 96 2% R & D Management 96 2% R & D Laboratory Staff % Production Plant Management 118 3% Production Plant Staff % Clinical & Regulatory Management % Clinical & Regulatory Administrative Staff 91 2% Facility Management % Total % b. Facility management staff comprises 17% of total personnel; based on phase II data we see that this category is composed of 71% business management staff and 29% marketing staff. 6 Administrative staff in the clinical and regulatory affairs department provide diverse project, administrative and logistical support and is responsible for managing day-to-day departmental activities, including ensuring regulatory documentation is appropriately maintained and tracked, assisting in the preparation of regulatory filings for new and modified products and various other administrative activities. 7 The term facility as used in this report refers to any human vaccine manufacturing site. 8 The number of personnel corresponds to the number of full time equivalencies per year (FTE). One FTE equals one person working 12 months per year at 30 or more hours per week.three people working 4 months per year equals one FTE. 6

7 3. Recruitment Policies and Practices a. In terms of recruitment, the entry-level education and professional experience for non-managerial positions is very basic requiring either the completion of high school or a bachelor degree, in addition to 1 to 3 years of experience. Management-level positions usually require a master degree or PhD and a minimum of 3 years of professional experience. b. Most companies surveyed in Phase I rely on the local market to recruit personnel (69%) followed by direct contacts with academia (23%) and in fewer cases, the international market (8%). The majority of companies in Phase II recruit their personnel from universities and technical colleges (43%), from other biomanufacturing facilities (32%) or from academia and research centers (21%). c. Phase II data revealed an average of six vacancies per company. This number can serve as a proxy for the average vacancy rate in the influenza manufacturing industry since, according to the research conducted by the survey team, there is no other publicly available figure of this sort. Table 3. Number of vacancies at facility level (n=10) Personnel Category Total vacancies in Average number Percentage of all companies of vacancies total vacancies R & D Management % R & D Laboratory Staff % Production Plant Management % Production Plant Staff % Clinical & Regulatory Management % Clinical & Regulatory Administrative Staff % Facility Management- Business % Facility Management-Marketing % Totals % 7

8 Table 4. Difficulties in recruitment Personnel Category Percentage of companies with difficulties in recruitment R & D Management 82% R & D Laboratory Staff 56% Production Plant Management 72% Production Plant Staff 31% Clinical & Regulatory Management 73% Clinical & Regulatory Administrative Staff 50% Facility Management 61% of which (phase II only): Business Management Marketing Staff 33% 17% d. In Phase II the facility management category has been further detailed requiring data for business staff and marketing staff. Phase II data on recruitment difficulties suggests that within the facility management category, there are no difficulties in hiring marketing staff although 33% of respondents declared difficulties in hiring business staff. 4. Retention Policies and Practices a. Based on data from Phase II, the highest turnover occurs among clinical & regulatory administrative staff (13%) and R&D management and staff (11% and 10% respectively). 8

9 Table 5. Turnover rate (n=10) Personnel Category Number of personnel that left Turnover rate over the last 12 months R & D Management 7 11% R & D Laboratory Staff 44 10% Production Plant Management 4 4% Production Plant Staff 92 6% Clinical & Regulatory Management 29 7% Clinical & Regulatory Administrative Staff 9 13% Facility Management 21 5% R & D Management 18 9% b. More than half of the respondents (57%) reported that they have retention measures and/or policies in place. Retention incentives utilized by the respondents can be divided into three categories: i. Economic advantages: higher welfare packages than other companies, salary raises, discounted or free company shares, and income protection. ii. Working conditions: on-site childcare center, extra leave days, volunteer leave days, and flexible work arrangements. iii. Individual capacity development: internal exchanges, promotion, employee assistance programs, study assistance, internal and external training opportunities (GMP), and continuing education programs. 5. Human Resource Development Strategies a. According to Phase II data, 92% (n=12) of respondents have a formal human resource development strategy or policy in place. b. In terms of specific human resource development initiatives, 100% of companies provide internal training, 91% offer external training, 73% have partnerships with schools, colleges and universities, 64% have an internal employee exchange programmes (e.g. at other facilities owned by the company), 45% hire laterally (from other bio manufacturers) and 18% offer external employee exchange programmes. 9

10 6. Training Opportunities a. Over half (59%) of Phase I respondents indicated that their workforce had received training in the previous 18 months. 84% of the training events focused on production techniques, good manufacturing practice and quality control. Similarly, 55% of Phase II respondents indicated that their workforce had received training in the previous 12 months with 67% of these training events focusing on production techniques, good manufacturing practices and quality control. b. The majority of training events were sponsored by the companies themselves. Most of the personnel selected to participate were either mandated by a regulatory agency or identified internally. 7. Participation in Vaccine Manufacturing Networks 67% of the respondents reported that they are affiliated with a national, regional and/or global association or network. The most frequently cited benefit from this affiliation is the fact that this allows access to educational and informational material. Discussion Summary of Findings Overall, the survey met its primary objectives. It yielded data that helped map the global influenza vaccine manufacturing workforce, shed light on vaccine manufacturers' approaches to recruitment and retention of a skilled local workforce, and described the type of training available to the workforce, their funding sources and their target audience. The survey also generated a wealth of additional data which provided a helpful first look at overall vacancy and turnover rates in the industry and illustrated the value added in belonging to a vaccine manufacturing network. Key points for consideration that arose from the preliminary data analysis are summarized thus: The main source of recruitment of personnel is the local market: this reinforces the need for stakeholders to work cooperatively to find ways to develop a sustainable pool of skilled local workers. The majority of entry-level production staff is recruited directly from universities/technical colleges. This points towards opportunities for local stakeholders to partner and develop academia-industry pathways. 10

11 Companies find it difficult to hire staff categories related to management, emphasizing the need to retain and promote experienced personnel who will contribute to the strategic direction and effective and efficient operation of the facilities. Limitations and Scope for Further Analysis While there were many positive outcomes from the survey, it is also important to note the limitations of this study. First, the survey was only available in English which proved to be a challenge for some respondents in countries where English was not the primary spoken language. Second, companies may have had different interpretations of some of the questions leading to a wide range of responses; particularly in the case of the open-ended questions. Third, the breadth of information provided by each company varied greatly some provided extensive information and detail whereas others did not. The proprietary nature of the information requested resulted in some respondents being unable to provide certain information due to company disclosure policies. Fourth, the survey did not account for the differences in recruitment policies between public and private companies. Fifth and finally, the number of companies that responded in the second phase is very limited, providing only a very limited coverage of companies not producing influenza vaccines. There remains significant scope for furthering the analysis of the study and/or examining the data through different lenses in order to help answer new questions that arose during the survey process. These questions include: What are the major differences in recruitment policies between public and private institutions? In terms of personnel totals, what is the breakdown between developing country vaccine manufacturers and developed country vaccine manufacturers? Do facilities that produce influenza vaccine have more vacancies than facilities that produce other types of vaccine? The WHO survey team proposes one-on-one interviews with respondents as a reasonable approach to filling these gaps and clean the datasets from outliers. Concluding Remarks Drivers and obstacles to developing sustainable vaccine manufacturing human resources capacity have not been well understood or communicated to the donor and policymaking community. WHO anticipates that the quantifiable data from these surveys will encourage further dialogue and spark interest among stakeholders to work cooperatively towards the development of sustainable vaccine production worldwide. WHO used the information 11

12 generated from these surveys to provide content and context for the Workshop on Enhancing the Global Workforce for Vaccine Manufacturing (WEGWVM), which took place in Cape Town, South Africa, from 30 th November to 2 nd December Looking forward, WHO will also use the information to accomplish a number of goals. These include: Generating new ideas for partnerships between vaccine manufacturers and other entities that may contribute to their success on a national/regional level in producing safe and effective vaccines; Supporting the dialogue to overcome existing challenges to recruiting, training, and retaining local vaccine production staff; Identifying the current needs and gaps in human capacity for vaccine manufacturing that should be addressed in order to meet the public health needs. 12