Vaccine Development

Vaccines are among the greatest advancements in public health, and developing new vaccines remains one of the most difficult challenges we face. As vaccine development researchers achieve important success to control one devastating disease, another pathogen emerges. Your vaccine strategy represents an important blueprint for tackling some of the world’s most deadly and disabling diseases, ensuring science and society work together to protect public health.

At the PPD clinical research business of Thermo Fisher Scientific, we apply the expansive global footprint, development capabilities and expertise we’ve built in vaccine development to help customers attend to the unique needs of vaccine trials and accelerate development with proven solutions and dedicated resources.

Explore expert considerations and steps to ensure speed to market and maximize the value of your vaccine.

Vaccine Development Experience Across the Continuum of Drug Development

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Years of offering dedicated vaccine solutions

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Vaccine studies

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Countries supported vaccine studies within

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Sites with vaccine experience

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Patients supported

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Contributed to more than 30 vaccine licensures in the past 10 years

Les Enterline
Les Enterline

“Once everyone has a moment to pause and reflect, we’ll learn many lessons from this pandemic—whether it was learning to have clinical monitors in closer geographic proximity or developing the ability to do remote monitoring. There are multiple changes across the industry, and we’re not going to go backward. We’ll continue to move forward.”

Get to know our therapeutic leaders in vaccine development and hear how they can help move your vaccine program forward.

Vaccine Mega-Trials: Rare Behemoths in the Vaccine Trial Landscape

Mega-trials – enrolling 5,000 participants or more to demonstrate clinical efficacy of prophylactic vaccines – are rare in comparison with the large number of interventional vaccine clinical trials that are conducted.

Pandemic Preparedness and Rapid Response

During the pandemic, PPD developed leading approaches to help accelerate COVID-19 vaccines and other therapeutics for emerging and high-risk diseases.

PPD supported many COVID-19 vaccine studies and vaccine development efforts with its dedicated vaccines unit: an established global network of sites, principal investigators, clinical research associates (CRAs) and site staff with specific vaccine experience. We worked at warp speed to make sense of an evolving regulatory environment to accelerate vaccine development, while also solving customer challenges, such as recruiting diverse populations, boosting vaccine infrastructure to tackle future pandemics, and supporting the next generation of mRNA vaccines and therapeutics.

PPD emerged as an early leader in the COVID-19 pandemic space, conducting some of the very first clinical trials, which ultimately led to multiple vaccines receiving emergency use authorizations (EUAs) and rapid global marketing authorizations. We continue to innovate, refine and evolve the delivery of vaccine clinical trials to stay on the leading edge.

In 2021, PPD leveraged lessons learned to establish a blueprint for a pandemic preparedness rapid response workstream. At the foundation of our robust, expedited, end-to-end delivery model for pandemic response are proven strategies for vaccine development that help clients navigate and respond to future public health emergencies.

Watch our latest webinar on pandemic preparedness

Vaccine Clinical Trials Expertise and End-to-End Clinical Consulting

Our global team of therapeutic specialists is fully immersed in the latest advances in vaccine development with expertise in trial design, data analytics, manufacturing, project management, logistics, laboratory testing, pharmacovigilance and regulatory requirements. We combine our extensive therapeutic and laboratory expertise with our global resources to offer a distinctive caliber of vaccine development services.

Joining Thermo Fisher Scientific has allowed for the expansion of PPD’s end-to-end vaccine capabilities with the addition of manufacturing. Thermo Fisher Scientific, a global leader in vaccine clinical development and vaccine clinical trial services, partnered with global vaccine manufacturers during the COVID-19 pandemic to provide a wealth of end-to-end clinical consulting and clinical development services expertise. Our vast combined knowledge of the vaccine regulatory landscape, and global regulatory expertise, makes us the best CRO for vaccine development, especially in the emerging mRNA vaccines and therapeutics space.

PPD has vaccine experience across all populations and phases. Our vaccine development team comprises medical, operational and laboratory experts who are dedicated to vaccine clinical trials and supported by the resources of a leading global CRO. Our skilled, global clinical development team of more than 2,000 vaccine experts boast a historically low turnover rate. PPD’s dedicated business unit for vaccines offers consistency across assigned study teams and works fast to stay ahead of future public health challenges.

PPD services can be tailored across trial phases, for localized or global studies, for biotech and large pharmaceutical companies, and not-for-profit and governmental programs. Our footprint extends across six continents — with local expertise in all regions — to apply needed insights for trial approvals, site identification and close oversight during study conduct. Our technologies enable rapid and transparent risk assessments and data access for subject safety on a real-time basis. Our proven solutions cover the entire life cycle of vaccine development — from early development to Phase II/III, to pharmacovigilance, to peri- and post-approval services — to ensure your product’s success.

Read more about how to develop, assess and select endpoints

Comprehensive Solutions in a Complex Environment

Paving the way in mRNA vaccine and therapeutics development

The COVID-19 pandemic elevated the need for a rapidly testable and deployable vaccine, which could be produced amid supply chain disruptions and in line with regulatory considerations. The pandemic also shed light on the need for greater pandemic preparedness for vaccines in novel disease targets.

mRNA vaccines entered the limelight because they could be designed quickly and tested immediately. Companies continue to make advances in the mRNA space following the successful clinical development of the first mRNA vaccine to prevent hospitalization for severe disease and death in those infected with COVID-19. Thermo Fisher Scientific, the parent company of PPD, had the opportunity to partner with mRNA vaccine manufacturers to rise to the pandemic’s challenges.

Studies are in progress to validate mRNA vaccines for more viruses including CMV, RSV and influenza. Many of the vaccines currently in clinical development may also be used together as combination vaccines.

The mRNA vaccine landscape is nascent, with promising advances in store in the coming months and years. The market for COVID-19 vaccine boosters will continue to grow, and advances in mRNA vaccine technology have paved the way for new therapeutics. mRNA vaccine technology in development includes preventative vaccines, cancer vaccines, regenerative therapeutics (including cell and gene therapies), and vaccines to inject into solid tumors and to help combat heart disease.

As a global leader in vaccine clinical trial services, PPD is at the forefront of digital and decentralized clinical trials solutions, vaccine clinical research, and global regulatory expertise, and understands the challenges of mRNA vaccine and therapeutics development.

Learn more about how mRNA technology has ushered in a new era of vaccines and therapeutics development in this American Pharmaceutical Review feature

End-to-end solutions to support pandemic preparedness

PPD’s experience across many COVID-19 vaccine studies and end-to-end services allow us to provide customized and integrated solutions that accelerate vaccine development timelines. Our agile and flexible model can include risk-based monitoring, near real-time access to safety assessments via interactive dashboards, and digitally enabled technologies to conduct low- or no-contact trials. Our commitment to urgency includes:

  • Global operational teams with pandemic vaccine expertise, enabling us to deploy knowledgeable resources in expedited timeframes
  • Statistical and epidemiological modeling to aid trial planning, site selection processes and alignment of demography of study populations
  • Global network of Accelerated Enrollment Solutions (AES) sites for vaccine clinical trials with surge capability of up to 3,000 patients per week and experience in emerging disease vaccines
  • Digital solutions to speed recruitment and support remote/virtual patient follow-up post-vaccination
  • Deep experience navigating government contract requirements, and close collaboration with health authorities to avoid unnecessary delays
  • Global clinical supplies capabilities with direct-to-patient options
  • Digital and decentralized solutions to increase clinical trial access for patients, improve their overall experience, produce efficiencies and enhance data quality
  • Integrated PPD Laboratory services, including serology, neutralizing antibody and functional assays designed specifically for COVID-19 trials, as well as peripheral blood mononuclear cells (PBMCs) capabilities

Expertise and Flexibility to accelerate your vaccine program

PPD’s extensive therapeutic and laboratory expertise and global resources combine to offer a distinctive caliber of vaccine development services.

PPD’s vast footprint extends to vaccine research and development sites across six continents. With local expertise in all regions, we apply needed insights for trial approvals, site identification and close oversight during study conduct.  Our technologies enable rapid and transparent risk assessments and data access for subject safety on a real-time basis. Our vaccine network can deliver 30-day startup and activation times, along with subject enrollment that exceeds expectations in terms of participant enrollment and retention. We also provide depots for product and logistics management.

At the heart of our vaccine recruitment solution is our geo-targeted centralized recruiting platform that finds and recruits the right volunteer populations on a massive scale. PPD’s global clinical site network, which was named Best Site Network at the 2021 Vaccine Industry Excellence Awards, includes ready-to-deploy, vaccine-enabled sites purpose-built for large volume studies.

PPD can rapidly enroll diverse patient populations based on existing partnerships with targeted vendors. Our priority vaccine sites network has experience with recruiting special populations, including pediatric, adolescent, elderly, pregnant women and immunocompromised participants. Our proven ability to recruit in targeted local communities and build connections with trusted advisors enhanced recruitment of diverse populations in COVID-19 vaccine development, exceeding diversity milestones set by the U.S. government.

The patient experience does not begin and end with recruitment. It takes the right insights and strategy to create a patient-centric engagement plan and the infrastructure and global reach to execute it. Evidera, the provider of evidence-based solutions for PPD, has the experience and resources to attract the right patients and keep them engaged throughout the life of your study.

PPD’s full spectrum of laboratory capabilities are integrated into clinical development, with a dedicated vaccine sciences lab that interfaces with our bioanalytical, central and Good Manufacturing Practices (GMP) labs. No other laboratory has readily developed assays (not owned by any one company) that can be deployed to speed development of any asset.

Our Vaccines Academy platform trains vaccine team members on present-day science and operational challenges, such as immunology for vaccines, vaccine types, vaccine clinical development and more. As part of the Vaccines Academy platform, staff complete ongoing training courses devoted to COVID-19 vaccines, genetic vaccines and trial considerations for vaccines that requires employee certification.

Evidera uses mathematical modeling that forecasts local data, optimizing country and site selection, allowing for an evidence-based approach to enhance vaccine clinical trials’ feasibility. The Preclarus data analytics dashboard also ensures a more centralized, data analytics-driven monitoring approach to patient monitoring, signal tracking and deviation management. PPD also champions decentralized and digital clinical trials capabilities, such as ePRO and mobile sites, which can help reach special populations, such as older participants (including training and patient concierge support services). Preclarus provides integrated clinical and laboratory data to clinical teams in near real-time, helping customers make more informed decisions faster.

PPD’s geo-targeting centralized recruiting platform enables patient recruitment on a massive scale. Our experienced global network is purpose-built for large volume studies. Consistent site operations and quality control are overseen by highly trained principal investigators and clinical support staff conducting vaccine studies in high-priority vaccine areas. Our site infrastructure ensures consistent site operations and quality are achieved through experienced principal investigators and site staff dedicated to vaccine research.

PPD’s dedicated regulatory experts have pandemic vaccine expertise. They can provide early integrated scientific advice and can access planning that can help vaccine developers save time and money. Our vaccine business unit understands the complex global regulatory and payor environments, and is skilled in demonstrating the burden of disease, public health, safety, effectiveness and value of your vaccine, whether upholding a U.S. federal government contract requirement or working elsewhere in the world.

PPD can deploy rapidly, using our award-winning vaccine site network with surge capabilities, close collaboration with health authorities and proven global clinical supply capabilities.

PPD is a trusted COVID-19 vaccine development leader, achieving successful development across the end-to-end spectrum for a COVID-19 preventative vaccine currently on the market. Bespoke solutions include flexible, vaccine-specific pricing models.

PPD understands the challenging and complex market access issues for vaccines. Our ongoing relationships and engagement with regulators, national immunization technical advisory groups (NITAGS), health-technology assessment (HTA) bodies, payors, site networks, and patient advocacy groups helps you navigate market access challenges for emerging therapeutics and vaccines.

PPD has over 35 years’ experience in real-world evidence development, including patient insights and outcomes, long-term safety and effectiveness studies, use of real-world data sources, and data analysis methods for actionable insights.

PPD’s exceptional expertise and capabilities in vaccine development, including mRNA vaccine development, stem from its status as one of the only CROs to deliver an end-to-end full product development for a fully approved COVID-19 vaccine on the market. Unlike other CROs, we are ready to execute vaccine development programs from day one with precision, speed and quality. Whether responding to a global pandemic or supporting urgent research into a therapeutic vaccine, our experienced team and comprehensive global network are poised for immediate deployment.

PPD Laboratories has supported 19 FDA and EMA approved vaccines and three COVID-19 vaccine programs that have emergency use authorization or international approval.

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sq. ft. vaccine lab

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High-Quality Results through our Vaccine Sciences Labs

Our vaccine sciences lab offers custom assay development, clinical testing and submission support services for new, modified and existing vaccines. Our capabilities and more than 25 years of specialized vaccine laboratory experience ensure development of innovative analytical methods and accurate, high-quality test results. We work with clients of all sizes across a wide spectrum of vaccine programs — from legacy vaccines to emerging pathogens. Our vast global footprint enables rapid deployment of teams to support the staffing needs of vaccine studies, including separate unblinded teams. We offer:

  • PPD priority vaccine sites and networks to support rapid startup and timely enrollment with performance guarantees
  • Expertise with seasonal studies and Northern/Southern Hemisphere execution strategies
  • Innovative, real-time data technology to support safety trends analysis and decision-making during trial conduct
  • Operational expertise to deliver pivotal, field-efficacy studies globally and across a range of targeted populations
  • Rapid site identification and capacity to support large vaccine efficacy trials
  • Broad experience with cold-chain management and sample logistics
  • Distinct quality control for serology specimens, including storage facilities with centralized alarm systems to protect serum integrity
  • Expertise in immune assay development and laboratory testing

Integrated Biostatistics Experts

We have an experienced biostatistics group that is fully integrated into our PPD Laboratory services operations from scheduling through data archiving. Our proprietary, fully electronic system supports the development, qualification, validation and routine maintenance of vaccine assays with tools specifically created to support complex bio functional assays and molecular genomics studies.

  • Streamlined the documentation process
  • Complete electronic audit trail
  • Improved data integrity and quality
  • Reduced full-time equivalent (FTE) time and cost

Whether you’re starting a new vaccine clinical trial or need help with commercialization and life cycle management, PPD can help.

Awards

PPD is nationally and internationally recognized in the vaccine development landscape.
Our awards, recognition and achievements include:

VIE Awards

14th and 15th Vaccine Industry Excellence (ViE) Awards (2021 and 2022 World Vaccine Congresses): Best CRO (2021 and 2022) ViE Awards 2022 Winners for vaccine expertise, dedicated team members, and a bespoke integrated vaccine delivery model

Eagle award

2021 Eagle Award from the Society for Clinical Research Sites (SCRS): for commitment to advancing clinical research through a strong, site-focused approach and partnerships.

Citeline

Citeline Award: Clinical Research Team of the Year: PPD’s vaccines therapeutic unit (2021) Citeline Awards 2021 l Pharma Intelligence

AVEA awards

Asia-Pacific Vaccine Excellence (AVEA) Award: Best Vaccine CRO (2021) PPD Named ‘Best Vaccine CRO of the Year’ in Asia-Pacific

Eagle award

Society for Clinical Research Sites (SCRS) Eagle Award: CRO that best exemplifies a site-focused approach (2021) SCRS Announces PPD and Pfizer as 2021 Eagle Award Recipients – Society for Clinical Research Sites

TOPRA Awards for Regulatory Excellence

The Organisation for Professionals in Regulatory Affairs (TOPRA) Awards for Regulatory Excellence: PPD’s regulatory affairs team with Novavax for COVID-19 vaccine approval (2021). PPD’s important partnership of their regulatory affairs teams in expediting Moderna’s vaccine submission and approval during the COVID-19 global pandemic (2023).  Previous winners and nominees

ACDM awards

Association for Clinical Data Management (ACDM) Award: Team excellence for support of COVID vaccine studies (2022) 2022 ACDM Awards Results

VIE awards logo

Vaccine Industry Excellence (ViE) Award: Best central laboratory (2020)

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Vaccine Industry Excellence (ViE) Award Finalist: Accelerated Enrollment Solutions (AES) highly commended in the category of Best Clinical Trial Network (2020)

AVEA awards

APAC Vaccine Excellence Awards: Best Vaccine CRO of the year (2022)