IFC’s appraisal considered the environmental and social management planning process and documentation for the Project and gaps, if any, between these and IFC’s requirements. Where necessary, corrective measures, intended to close these gaps within a reasonable period of time, are summarized in the paragraphs that follow and (if applicable) in an agreed Environmental and Social Action Plan (ESAP). Through implementation of these measures, the Project is expected to be designed and operated in accordance with Performance Standards objectives.
IFC PS1: Assessment and Management of Environmental and Social Risks and Impacts
Policy
Biovac has an Environmental, Social and Corporate Governance (“ESG”) Policy that affirms the company’s commitment to ESG principles. The policy covers monitoring, reporting, periodic review, and has board approval.
Identification of Risks and Impacts
New Facility Construction Risks and Impacts
Based on national legislation, an Environmental and Social Impact Assessment (ESIA) and environmental authorization are not required for the construction or operation of the project, as the associated activities do not meet the legislated criteria. Nevertheless, the client is planning to undertake an ESIA with a consultant. As part of this process, air and noise studies will be included to address stakeholder concerns identified during previous consultations (see ESAP #7 and #8). The scope and depth of the risk assessment within the ESIA will be commensurate with the level of risk and impact associated with the project.
To identify and manage E&S risks and impacts during the construction phase, Biovac will develop an environmental, health and safety (“EHS”) risk register and environmental and social management plan (“ESMP”) and contractually require the construction contractor to implement these components (ESAP#1). The risk register and ESMP will be informed by the findings from the ESIA and will be appropriate to the nature and scale of the project and risks.
The company will also establish monitoring and reporting mechanisms to ensure compliance with the ESMP.
The client has already planned and undertaken Hazard and Operability (“HAZOPs”) Studies during the design phase to identify and address potential risks. A HAZOP for the construction and fit-out phases will also be conducted. Separate HAZOPs for process equipment will also be developed. These measures complement the Environmental and Social Management Plan (ESMP) and the project risk register.
Operational Risks and Impacts
At the existing facility, Biovac has implemented an environmental and social management system (“ESMS”) for operations that ensures compliance with applicable national standards, regulatory permits, and good international industry practices. The company maintains an enterprise-wide risk register based on Hazard Identification and Risk Assessments for each production facility that addresses operational and related E&S risks. This approach is aligned with IFC PS1.
For operations at the new facility, the client will develop an ESMS based on the framework currently in place for the existing operations. The existing ESMS will be updated to integrate activities, risks and impacts at the new facility and address any additional risks it may pose to the current operations (ESAP#2).
Management Programs
Biovac manages operational risks through the MySHEQ online management platform, and it forms the basis for the ESMS. This consolidates core EHS functions, including incident reporting and investigation, audit and inspection management, training records, corrective and preventative action tracking, risk assessments, and document control, into a streamlined digital system. The platform also provides dashboards for performance monitoring and automated compliance reminders, supporting a structured “plan, do, check, act” approach.
To ensure continued alignment with IFC PS1, the MySHEQ system will be extended to the new facility, incorporating the outcomes of risk assessments. (ESAP #2).
Comprehensive EHS management programs, logs and standard operating procedures have been established for all relevant operational aspects, clearly outlining roles, responsibilities, and implementation protocols (e.g. purchase of raw biological and chemical procedures, waste management, access control, personal protective equipment and confined space entry).
Organizational Capacity and Competency
The SHEQ Officer is currently acting as the interim EHS Manager. As per ESAP#3, an EHS Manager will be appointed. . The EHS Manager will be responsible for developing and implementing the Biovac ESMS, overseeing ESMP implementation and reporting on EHS performance to senior management.
Every three months, heads of departments and senior management meet to discuss Biovac’s EHS performance, progress against targets and emerging risks and issues.
Emergency Preparedness and Response Plans (“EPRP”)
Key emergency risks associated with the existing and new facilities include fire, explosion, flooding, pipe bursts, chemical/biological spills and accidental release of noxious gases and liquid nitrogen. There have been no notable emergency events at the existing facility since inception.
Biovac has a documented EPRP for fires, including an evacuation procedure and up-to-date fire prevention and protection equipment maintenance plans and records. Simulation drills are conducted twice per year. Emergency response equipment, such as extinguishers and hydrants, are inspected and certified annually by a qualified third party.
The new facility will be designed and constructed in accordance with South African national life and fire safety standards. In line with legislation, the building will require approval of the fire-protection plans, a formal fire-safety inspection and clearance by the City’s Fire Services Department, and the issuance of a Certificate of Occupancy by the City prior to the commencement of operations at the new facility. Key provisions include the installation of sprinklers, internal and external fire hydrants, fire hose reels, and portable fire extinguishers. The design incorporates multiple emergency exits and escape routes. The facility will also have a fire detection and alarm system. A dedicated fire water storage and pumping system are also included in the design.
Per ESAP#4, the Company will develop and implement an EPRP for the new facility and this will include protocols for notification and coordination with neighboring industrial businesses and residential communities in the event of an emergency. It will also include provisions for all possible emergency scenarios (e.g. explosions, flooding, pipe bursts etc.). A training schedule will be developed and implemented on the EPRP.
Monitoring and Reporting
Biovac has implemented a structured internal audit program to assess EHS performance at its facilities. Internal audits are conducted by the OHS Officer using standardized templates. The audits evaluate compliance across key thematic areas including emergency preparedness, first aid, safety, health, environment, fire safety, housekeeping, chemical and biological safety, and waste management. Findings are documented with corrective actions assigned.
Stakeholder Engagement, External Communications and Grievance Mechanism
As part of the initial IFC investment, Biovac was required to develop a Stakeholder Engagement Plan (“SEP”), which included stakeholder mapping and the establishment of a Community Forum. Engagement activities now include quarterly meetings with the forum, during which community concerns are addressed and environmental monitoring data is shared. In addition, Biovac has established a WhatsApp communication group to facilitate ongoing dialogue with residents. As per ESAP#5, the Company will update and extend its SEP to incorporate stakeholders of the new facility.
A whistleblower hotline, established in 2023 and accessible via the company’s website, provides a confidential channel for raising concerns.
IFC PS2: Labor and Working Conditions
The company currently employs approximately 325 workers, comprising permanent staff and a small number of temporary project-specific employees. Contractors conduct equipment maintenance, cleaning and security. 53% of the permanent workforce are female. Operations occasionally run a two-shift system, including night shifts, depending on production demand. A well-resourced HR team is in place. With the implementation of the new project, the total workforce is expected to double. Workforce planning is underway, and existing HR policies and procedures are under review to ensure they are fit for purpose.
Working Conditions and Management of Worker Relationships
HR Policies and Procedures
Compliance with national labor legislation ensures alignment with the requirements of this PS and going forward the company will apply similar HR policies and procedures to the new facility.
Biovac has a comprehensive set of HR policies and a code of conduct that addresses aspects related to conflict of interest, employment equity, disciplinary procedures, retrenchment and performance management. They are aligned with national legislation and IFC PS 2. Policies are communicated to employees during onboarding and are accessible via the company’s intranet.
Working Conditions and Terms of Employment
Biovac provides all employees (permanent and term) with a written contract of employment that complies with South Africa’s Basic Conditions of Employment Act and Labor Relations Act and aligns with IFC PS2.
The permanent contract specifies the employee’s position, reporting lines, place of work, hours of work, remuneration, benefits, leave entitlements, performance review processes, and termination provisions. Benefits include medical insurance, provident fund contributions, and life insurance. Leave provisions exceed statutory minimums.
The fixed term contract specifies the position, reporting lines, hours of work, remuneration, benefits, and leave entitlements. It defines the fixed-term nature of employment, including start and end dates. Remuneration is a fixed monthly gross amount with benefits including annual and sick leave aligned to statutory requirements. The contract references company policies and procedures.
Workers’ Organizations
Freedom of Association is specifically permitted in the Biovac Code of Conduct. There are no trade unions at the facility, however, a worker forum is in place that provides a platform for employees to raise workplace issues. The forum comprises elected representatives from different business areas and a representative from the HR team. Minutes are kept from these meetings.
Non-Discrimination and Equal Opportunity
Biovac has implemented an Employment Equity Policy that fosters equal opportunity and includes a commitment to eliminating discrimination. An Employment Equity Committee has been established, comprised of staff representatives and the Head of Human Resources. This committee is responsible for overseeing the implementation of the Employment Equity Policy.
The Social, Ethics, and Transformation Committee meets bi-annually and is comprised of non-executive members, chaired by the Head of Human Resources. It is responsible for overseeing the company’s approach to social responsibility, ethical conduct, and diversity initiatives. The Committee also provides strategic direction and oversight for stakeholder engagement. Committee members have received Gender-Based Violence and Harassment training provided by IFC, as part of support under the previous transaction.
Retrenchment
The company has no history of forced retrenchments. Following the loss of a tender with Pfizer in 2023, workforce reductions were managed on a voluntary basis and undertaken in accordance with national labor legislation.
Grievance Mechanism
The client has a comprehensive grievance mechanism that outlines the process for lodging grievances, associated timelines, and clear roles and responsibilities for resolution. Alternative reporting channels are available if the grievance is against the employee’s line manager, and the process includes an appeal mechanism with provision for an independent facilitator. Employees may also seek recourse through an independent body if grievances remain unresolved. A whistle blower line is available to staff to lodge anonymous grievances. As per ESAP#6, the Company will update the existing grievance mechanism to include provisions for workers engaged through third-parties to have access to the mechanism, where the contractor does not have an adequate mechanism.
The company has a Sexual Harassment Policy in place that prohibits all forms of harassment in the workplace and applies to employees, contractors, suppliers, clients, and other stakeholders. Sexual harassment, including physical, verbal, and non-verbal conduct, quid pro quo harassment, and sexual favoritism, is treated as a dismissible offence. The policy sets out confidential grievance procedures, protects complainants from victimization or retaliation, and requires all cases to be addressed promptly, sensitively, and in line with company disciplinary procedures.
Protecting the Workforce
Given the professional nature of the work and makeup of the workforce, child and forced labor is not a risk. Staff are required to provide a copy of their government issued identity document prior to commencement of employment.
Occupational Health and Safety (“OHS”)
Key OHS risks associated with vaccine manufacturing include heat hazards from the use of pressurized steam and hot water in fermentation and cleaning processes, which present risks of burns; chemical hazards from inhalation or dermal exposure to volatile organic compounds (“VOCs”), solvents, sterilizing agents (such as formaldehyde) and other hazardous chemicals, as well as inhalable dusts generated during operations; and risks associated with cleaning, fumigation and sterilization processes. In addition, pathogenic and biological hazards may occur due to exposure to live micro-organisms or biologically active materials during fermentation, formulation, and downstream processing activities.
In line with national legislation, Biovac’s Biosafety Policy outlines its commitment to safeguarding employee health. This also aligns with international guidance from the WHO Laboratory Biosafety Manual.
Biovac has implemented a Medical Surveillance Program at the existing facility that includes pre-employment, periodic, and exit medical examinations based on occupational risk profiles.
To support the identification and management of occupational health risks, Biovac has implemented a process whereby Occupational Risk and Exposure Profiles (“OREPs”) are developed for all job categories. Each OREP documents the physical, chemical, biological, and environmental hazards associated with each role, and includes quantified assessments of exposure and consequences to generate a risk index. Examples of occupational risks assessed include exposure to hazardous chemicals, biological agents for vaccines, high noise levels, high temperatures, lighting, confined spaces, and ergonomic risks. The OREPs inform medical surveillance requirements, fitness-to-work evaluations, and mitigation measures.
A permit to work procedure and lock out and tag out procedures are in place for hot work, confined spaces and working at height
A training plan and competency framework is in place including periodic training on EHS to relevant staff.
In 2024 there were three lost time injuries. This is 0.58 per 100 full-time workers, which is below the US national benchmark. This metric is monitored at the departmental level and reported to senior management.
At the existing facility, Biovac consistently monitor the rooms where raw materials are managed, including the sample booth, dispensary, and formulation suite for any particulates and viable micro-organisms. Additionally, filling areas and other high-risk areas are subject to continuous particle monitoring.
Workers Engaged by Third Parties
A “Know Your Vendor” contractor management system is in place to oversee contractors, and the SHEQ system includes a contractor management procedure, including a permit to work procedure.
Key OHS risks associated with the construction of the new facility include injuries from operating or working near heavy machinery and equipment; falls from height; accidents in confined spaces with limited ventilation or access; dust; elevated noise levels, and vehicle-pedestrian collisions.
To ensure alignment with applicable national OHS legislation and IFC Performance Standard 2, Biovac has already planned to require the construction contractor to engage an EHS consultant. The consultant will provide ongoing support throughout the construction phase. In addition, the Biovac EHS Manager that will be appointed will conduct monthly audits of the site and the construction contractor’s performance.
IFC PS3: Resource Efficiency and Pollution Prevention
Resource Efficiency
For the new facility EDGE Green building certification is being considered. Similar resource efficiency measures will be in place at the new facility as at the existing facility and are detailed below.
Greenhouse Gases
In 2024, Biovac’s combined Scope 1 and Scope 2 emissions totaled 11,482.24 tCO2e. They have committed to reduce their carbon emissions by 50% by 2030.
Scope 1 GHG emissions at Biovac are primarily generated from backup diesel generators, a small fleet of company-owned vehicles, and paraffin consumption from two 630 kW boilers. These boilers will also be utilized to produce steam for the new facility. Other point source emissions are from high-efficiency particulate air filtration systems, which are tested monthly to ensure operational integrity.
Scope 2 emissions are from electricity purchased from the national grid. To mitigate Scope 2 emissions, solar rooftop panels have been installed at the existing facility and will also be installed at the new facility.
Electricity consumption is monitored in real time, and targets have been set to reduce paraffin and electricity usage.
Water Consumption
At the existing facility, water is used in the vaccine manufacturing process for steam generation via paraffin-fired boilers (used for sterilization, cleaning, and heating), HVAC system cooling, and domestic purposes. Water is sourced from the City of Cape Town, with on-site storage tanks at the existing facility providing backup capacity of 80 000 liters for supply interruptions. Water consumption at the existing facility is tracked in real time, and annual targets are set to maintain 2024 usage levels. In 2024, 30 213kL of water was consumed across the operations.
The new facility will use similar volumes of water. A licensed borehole will be installed at the new facility to provide a backup supply in case of constraints on the primary source.
Biovac has implemented several water-saving initiatives, including the installation of rainwater harvesting tanks, reuse of treated process water as grey water and condensate recovery from the steam generation process, with recycled water used for domestic purposes. Similar practices will also apply at the new facility.
Pollution Prevention
Air Quality
The paraffin boilers and diesel generators produce nitrogen oxides, carbon monoxide, dust (particulate matter) and VOCs. No stack emissions monitoring has occurred to date. VOCs are also generated from formulation and solution preparation, solvent use, cleaning, and fugitive emissions from equipment. These emissions are discharged via the HVAC systems, apart from emissions from the diesel generators. Emissions from the new facility will match those of the existing facility, as the paraffin boilers currently in use will continue to be operated by the new facility.
In response to a community complaint regarding potential air quality impacts from Biovac’s existing operations, an independent ambient air quality assessment was undertaken in August 2025. The study involved a three-week monitoring period using samplers at five locations at the facility’s perimeter to evaluate concentrations of VOCs. Results found that VOC levels were below legislated limits.
As per ESAP#7, the client will conduct an air quality assessment for the existing facility and baseline for the new facility. This will include: (i) stack emissions monitoring for paraffin boilers (NO?, CO, PM) per the WBG General EHS Guidelines at the existing facility; (ii) vent monitoring for VOCs per IFC EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing at the existing facility; and (iii) ambient VOC monitoring at both facilities. The Company will also develop and implement an air quality management and monitoring plan covering both facilities that will be informed by the results of the air quality assessment and define mitigation measures in line with the IFC EHS Guidelines and national legislation. It will also include requirements to engage the stakeholder engagement forum periodically on the results.
Noise
The existing and new facilities are located adjacent to a residential area, separated by a railway line, and surrounded in the remaining directions by industrial activities. The company has received noise-related complaints from nearby residents, primarily due to utility infrastructure such as HVAC units positioned on the side of the building closest to residences. Biovac has installed noise-blocking panels, adjusted operation schedules to limit nighttime activity, and regularly monitors noise to stay within legal limits. A generator exhaust pipe was also redirected away from the residential area to further reduce noise.
Post-mitigation monitoring in May and November 2024 showed a reduction of between 5 and 13 dB(A) in ambient noise levels following implementation of the attenuation measures referenced. The highest recorded level at the site boundary closest to the residential area was 62 dB(A) during operations, which is within the national regulatory limit and WBG EHS Guidelines of 70 dB(A) for daytime/nighttime hours.
Noise attenuation measures will be implemented at the new facility using building materials with sound reduction properties in walls, roofs, and façades. Additionally, HVAC systems will be designed to minimize vibration and noise, including strategic placement of air handling units. These systems will also comply with relevant South African standards.
As per ESAP#8, Biovac will undertake a comprehensive noise assessment for the existing and new facilities. The assessment will include sampling during both day and nighttime periods at the site boundary and sensitive receptor locations in the vicinity of the operations. Based on the findings of the assessment, Biovac will agree with IFC on mitigation measures required and develop and implement a noise management and monitoring plant.
Waste
At the existing facility, hazardous waste generated on site includes used agar plates, serological pipettes, microscope slides, cuvettes, syringes, needles, sharps, contaminated glassware, wipes, gloves, and masks, as well as chemical waste including cleaning agents, quality control reagents, acids, bases, flammables, lubricants, solvents, and expired raw materials. Non-hazardous waste streams primarily consist of packaging and domestic waste, with approximately 50% of non-hazardous waste being recycled.
Biovac maintains a comprehensive Waste Management Standard Operating Procedure (SOP) that governs the handling, segregation, and disposal of all waste streams generated across its operations. All hazardous waste is appropriately stored and collected by a licensed hazardous waste disposal contractor, and waste volumes are measured with key performance indicators set and monitored. This SOP will be extended to the new facility as part of the ESMS development (ref. ESAP#2).
Wastewater
The existing and new facility produces domestic wastewater and industrial wastewater from production processes.
In 2024, the client reported the generation of 28 683 m3 of wastewater, which was discharged to the municipal wastewater network. The City of Cape Town and an independent accredited lab (contracted by Biovac) conduct monthly effluent sampling at the existing facility with no reported breeches.
At the new facility, domestic wastewater will be routed directly to the municipal sewage system, with grease removal implemented for canteen effluent in accordance with local requirements. The wastewater management process incorporates good practices by segregating industrial wastewater into bio-negative and bio-positive streams. Bio-negative wastewater, which does not contain active biological agents, will be collected centrally and, where necessary, pre-treated (e.g., pH adjustment) before discharge to the municipal industrial sewer.
Bio-positive wastewater, originating from areas handling live or potentially hazardous biological materials, will undergo an on-site decontamination process. This includes chemical inactivation, where formaldehyde is used to render biological agents non-viable, hot water rinsing and sterilization via pressurized steam. Wastewater containing formaldehyde and inactivated biological material is then transferred to a kill tank, where it is subjected to high-temperature sterilization. Following this, the effluent is cooled and neutralized to ensure safe pH levels before being discharged into the municipal sewerage system.
Hazardous Materials Management
The facility will handle a range of hazardous materials including biological agents such as live and inactivated viruses and bacteria (including vibrio cholerae, adenoviral vectors, and rotavirus), as well as a variety of chemicals and reagents used in buffer and media preparation, cleaning, and sterilization processes (e.g., sodium hydroxide, hydrogen peroxide, and other disinfectants).
The facility will be designed in accordance with the WHO recommendations and guidelines regarding biosafety. Key provisions from the WHO Laboratory Biosafety Manual that will be implemented include the use of engineering controls such as physical containment (e.g., biosafety cabinets and segregated vaccine manufacturing suites), decontamination procedures (including vaporized hydrogen peroxide fumigation and thermal inactivation), restricted access to bio-positive areas, and training and vaccination programs.
At Biovac’s existing facility, hazardous chemicals are stored in a standalone, access-controlled storage room. Chemical storage procedures are in place to ensure safe handling and segregation, including protocols that prevent the co-location of combustible chemicals. These procedures are designed to minimize fire risk and ensure compliance with applicable safety standards. The same approach will be implemented at the new facility,
IFC PS4: Community Health, Safety and Security
Infrastructure and Equipment Design and Safety and Hazardous Materials Management
The new facility will be constructed in full compliance with South African national building regulations, including SANS 10400 and associated structural, fire safety, and environmental standards. In addition, the design adheres to internationally recognized guidelines such as EU and US FDA Good Manufacturing Practices (GMP), ISO 14644 standards for cleanrooms, and WHO biosafety and pharmaceutical manufacturing requirements.
A formal plan to conduct an Operational Readiness Review and Completion Audit before commissioning is in place. This process includes testing and verification of systems, equipment, and utilities and installation checks. In parallel, a Validation Master Plan will guide validation efforts throughout the project lifecycle to ensure all components meet design specifications and regulatory requirements.
Road Traffic Safety
Traffic risks at the Biovac site are currently limited, with only a small number of truck movements, primarily by contractors for deliveries and waste removal. With the construction and operation of the new facility, traffic-related risks, particularly at site access points and along internal circulation routes, will increase. A Traffic Impact Assessment has been completed as a standalone study, confirming that the new facility will have a limited impact on local traffic conditions.
All transport of vaccine materials is conducted by third-party logistic providers. As per ESAP#9 the ESMS will be updated to include a Road Safety Management Plan focused on oversight of third-party logistics providers for vaccines and any material posing a biosafety hazard.
Security Personnel
Security is provided on the site by third-party unarmed contractors. As per ESAP#10 requirements, all security personnel operating on the site will receive human rights training in line with the Voluntary Principles on Security and Human Rights.
PS5: Land Acquisition and Involuntary Resettlement
The site for the new facility will be located on land adjacent to the company’s existing facility, which at the time of appraisal was in the process of being purchased from the City of Cape Town, and was being utilized by five individuals on an informal and itinerant basis.
In accordance with IFC Performance Standard 5, Biovac appointed an independent social consultant to conduct a census and needs assessment. They subsequently prepared a Resettlement Action Plan (“RAP”) documenting entitlements for eligible occupants.
After the development of the RAP, the occupants vacated the land at their own will and despite efforts by the company, cannot currently be located or contacted. Eligibility and entitlements, and implementation of the RAP as defined in ESAP#11, will remain relevant as the client continues to locate the affected people on a best effort basis. In addition, Biovac will establish a grievance mechanism to further support engagement in relation to the resettlement.