To perform any experiment, it is vital to ensure that enough data is collected. Too little data can not only mean imprecise results, but also makes distinguishing between reality and statistical fluke difficult. This concept of statistical power – and, inherent within, sample size – is a key component of trial design: consideration must be…
In In Vitro vs In Vivo Potency Assays: Modern Vaccine Batch Release, we examined the pros and cons of two methods of testing vaccine potency: in vivo assays, which use animal models, and in vitro assays, which use laboratory experiments. As we established in that blog, the direction of travel is towards the improved analytical…
One key challenge when developing vaccines for human use is that it is often infeasible or unethical to assess the efficacy of the candidate vaccine directly in humans. As we’ve discussed previously, diseases which are severe, rare, or both are difficult to accommodate in human testing. This poses a quandary: these diseases are often the…
When we discuss the performance of a vaccine, properties such as its immunogenicity, adverse event frequency, and any correlates of protection are usually among the first to be mentioned. A property which is considered less often is when a patient can expect to be protected after they have received the vaccine. This is known as…
Vaccines are one of the few medical interventions which are regularly undertaken by healthy individuals. As a result, the bar for ensuring the safety of a vaccine is extremely high. It would be difficult to justify administering a preventative vaccine for a disease an individual might contract if that vaccine regularly causes serious side effects…
Vaccine development often only hits the headlines when there’s a breakthrough clinical trial or final approval. Behind every successful vaccine, however, is a lesser-known stage of research that quietly lays the groundwork: preclinical studies. Don’t be fooled: these early investigations are essential for answering crucial questions which underpin the future of the vaccine. Is the…
The earliest stages of the development of any vaccine involve laying out the roadmap for its design and testing. A vast network of interlinked paths from a new idea to a needle in a patient’s arm stretch ahead into the future, each with unique regulatory and ethical implications. Should the vaccine target a certain strain…
Vaccines are among the most important technological developments in human history. From the earliest attempts to prevent smallpox by variolation to modern mRNA vaccines built without a virus needing to have entered the development lab, the vaccine has become a vital string in the bow of public health officials. As with all medicines, batches of…