What are the stages in vaccine development?

From initial discovery to regulatory approval and post-market monitoring – the different steps around vaccine manufacturing include rigorous research, testing, and approvals that shape our defenses against diseases.

Based on the classification issued by the Centers for Disease Control and Prevention, this article discusses the most important stages in vaccine development.¹ 

Vaccine discovery

Vaccine discovery marks the inception of the development process, involving extensive research and identification of potential antigens. Scientists explore various avenues to pinpoint antigens that trigger an immune response against the targeted pathogen. This phase relies on cutting-edge technology and innovative methodologies to identify the most promising vaccine approaches among numerous possibilities.

The selection criteria prioritize antigens capable of eliciting a robust immune response while ensuring safety and feasibility for further development stages. Successful antigen identification forms the cornerstone of subsequent vaccine development endeavors.

Concept optimization

Concept optimization encompasses the refinement and enhancement of vaccine candidates identified during the discovery phase. Pre-clinical testing plays a pivotal role, often conducted using animal models to evaluate safety, immune response, and potential side effects.

This allows researchers to fine-tune the formulation and dosage, aiming for optimal effectiveness in eliciting immune responses while ensuring safety standards are met. Rigorous assessments during concept optimization lay the groundwork for advancing promising candidates to the clinical trial phases.

Vaccine testing

Vaccine testing comprises distinct phases – Phase I, II, and III clinical trials –, each serving critical purposes and mandatory both for established and novel methods in vaccine manufacturing.

• Phase I primarily evaluates safety and dosage in a small group of healthy volunteers.
• Phase II expands the trial to a larger and more diverse population, assessing efficacy and further examining safety.
• Phase III, finally, involves a larger-scale study, often spanning regions or countries, to confirm efficacy, monitor adverse reactions, and compare the vaccine against a placebo or standard treatment.

These progressive phases rigorously scrutinize the vaccine's safety, efficacy, and potential for widespread use, forming the bedrock of regulatory approvals.

Up-scaling vaccine manufacturing

Up-scaling vaccine manufacturing involves transitioning from small-scale production to mass manufacturing while maintaining quality and consistency, and is one of the major challenges in vaccine development. Implementing scalable manufacturing systems from the outset is crucial to streamline scale-up.

Such an approach ensures seamless expansion when transitioning from clinical trials to large-scale production. Designing processes and systems that can readily adjust to increased demands allows for efficient and rapid production, meeting global needs during crises like pandemics as well as cGMP standards for vaccine manufacturing.

This proactive strategy can minimize delays, optimize production capacity, and ensure timely availability of vaccines without compromising quality, vital for addressing widespread health challenges.

Regulatory approval

Regulatory approval is a major goal for vaccine manufacturers. It involves thorough assessment by health authorities to ensure the vaccine meets strict safety and efficacy standards.

This stage scrutinizes clinical trial data and manufacturing processes to guarantee compliance with set criteria. Approval signifies the vaccine's readiness for public distribution, assuring its safety and effectiveness. This stringent process assures the public that only thoroughly vetted vaccines reach widespread use, upholding trust in their reliability.

Recommendation to use the vaccine

The recommendation to use a vaccine involves expert analysis and guidance from health authorities. Advisory committees review clinical trial results, considering efficacy, safety, and potential public health impact. Their evaluation informs recommendations for specific populations, dosage schedules, and priority groups for vaccination.

These recommendations provide essential guidance for healthcare professionals, policymakers, and the public on the vaccine's utilization, deploying vaccines effectively, and ensuring they reach those who stand to benefit most while maximizing their impact on public health.

Post-market monitoring

Post-market monitoring is the vigilant surveillance conducted after a vaccine is deployed to the public. This ongoing scrutiny ensures continued safety and effectiveness by detecting and assessing any adverse events or unexpected patterns.

Health agencies and manufacturers collaborate to gather real-world data, enabling prompt responses to emerging issues. Proactive monitoring and swift responses contribute to sustained public trust in vaccines, emphasizing a collective dedication to the ongoing well-being of communities worldwide.

Vaccine development with Single Use Support

Single-use technologies powered by Single Use Support accompany vaccine manufacturers from the early stages of vaccine development all the way down to large-scale vaccine production. This is possible thanks to the modular and scalable manufacturing solutions – cGMP-compliant, flexible and efficient.

As a dedicated platform for automated fluid management in vaccine production, RoSS.FILL is able to fill and dispense different volumes of liquids with high precision and in a sterile environment, reducing the need for manual intervention and thus the risk for human error.

In addition, RoSS.pFTU is a high-performance plate-freezing platform, able to bring vaccines to ultra-low temperatures with controlled freezing rate in order to prepare them for storage or transport. Controlling the freezing rate can reduce the damaging effects of uncontrolled freezing, such as cryoconcentration, which might be caused by slow, inconsistent freezing.

Combined with single-use consumables, these innovative solutions by Single Use Support are ready to encompass vaccine manufacturers in pushing progress in vaccine development and production.