Drugs and vaccines play an important role in improving public health. Vaccines can help reduce the spread of contagious diseases, such as whooping cough and measles, while medications can help treat different illnesses, from cancer to diabetes.
Developing new treatments is a lengthy process. Vaccines may take up to ten years before they’re approved for public use, while drugs may take up to 15 years or more to hit the market. This is due to careful research conducted by scientists and medical professionals, which consists of several distinct phases. Before a vaccine or drug can be approved, it must undergo pre-clinical testing, clinical trials testing and approval by the regulatory authorities.
Following is an overview of the development pathway.
Pre-clinical research testing is aimed at assessing the safety and efficacy of a new compound in a laboratory setting. During this process, scientists evaluate how a drug or vaccine works in animals. However, in America, the US Food and Drug administration (FDA) recently passed new legislation waiving the requirement for new medicines to be tested on animals in order to receive FDA approval. The Law allows the FDA to promote a drug to human trials after either animal or non-animal testing. Computer modelling and other non-animal testing methods developed in the last 15 years are strongly being encouraged.
The pre-clinical phase can take several months to several years, depending on the complexity of the drug or vaccine and whether it needs to be reformulated.
If the pre-clinical tests are successful, the vaccine or drug is moved to clinical trials. This part involves testing the vaccine or drug in humans and is necessary for Therapeutic Goods Administration (TGA) approval. (The TGA is Australia’s government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods).
Clinical trials are conducted in three phases.
- In Phase 1, a small number of healthy volunteers are given the vaccine or drug to assess its safety.
- In Phase 2, a larger group of people are given the vaccine or drug to determine its effectiveness and safety.
- In Phase 3, several thousand people are given the vaccine or drug to confirm the safety and effectiveness established from the previous phases. During this phase, the vaccine or drug is also tested against existing treatments and monitored for side effects.
If the vaccine or drug fails at any point, it will not move forward to the next step, which is why this stage takes several years. Learn more about these phases in our previous blog.
Regulatory review and approval
After successful clinical trials, researchers submit the data to regulatory authorities, such as the TGA in Australia, for review. The TGA then reviews the data and determines if a vaccine or drug is safe enough to approve. This process can take several months.
Marketing, distribution and monitoring
Following approval, the vaccine or drug is made available for public use (usually through prescription). Monitoring of the drug needs to remain in effect for ongoing safety and efficacy requirements.
What affects the duration of drug and vaccine development?
The complexity of the disease or condition being targeted can have a significant impact on the duration of drug and vaccine development. For example, developing a treatment or cure for a complex disease like cancer or Alzheimer’s can take longer than creating a vaccine for a viral illness.
Availability of funding and resources can also affect the timeline for drug and vaccine development. A lack of funding can limit the ability of researchers and organisations to pursue the research needed to advance the development of new treatments and vaccines.
Regulations and approval processes also play a crucial role in the duration of drug and vaccine development. Because regulatory agencies follow strict rules and guidelines to bring a new treatment or vaccine to market, they add time to the process.
Clinical trial design, enrollment, efficacy and safety data requirements, manufacturing and supply chain logistics can also impact the timeline for drug and vaccine development.
Finally, competition and market factors can extend timelines. The presence of other treatments or vaccines in development for the same condition can drive competition and influence the speed at which new medicines and vaccines are brought to market.
The declaration of a public health emergency, such as a pandemic, can also affect the duration of drug and vaccine development and, in this case, may work to hasten timelines as increased resources and regulatory flexibility may be available to speed up the development process.
White Coats Foundation
White Coats is a Not for Profit Australian-based charity. The Foundation was established in recognition of the need to raise awareness about the role of clinical trials in advancing medical science and healthcare. We are providing information about clinical trials through our Webinar Series and Our Blogs. We also provide access to credible resources and information to help guide people’s journey in understanding clinical trials and consumer and community involvement in research.
Please note: White Coats blogs are informational only and do not constitute advice. Please contact your relevant healthcare professional for advice on clinical trials for you.