The Future of Vaccine Development

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries. Members of the science and medicine team have additionally worked on hundreds of other vaccine trials involving hundreds of thousands more volunteers.

While vaccine development has come a long way, there is much to accomplish in the future. Let’s take a brief look at the history of vaccines, how the COVID-19 pandemic changed the landscape, and where the future of vaccine development is headed.

A quick history of vaccine development

When we think about early vaccine development, smallpox provides a good example. It was a terribly infectious disease and came with a high death toll (one of the deadliest diseases to humans), beginning as early as 1350 BCE.

The first smallpox vaccine came in 1796, created from a case of cowpox. Over the years, the smallpox vaccine evolved, and by 1801, it proved to be an effective defense from the disease. This was a massive stride for disease prevention, and to some degree step to the future of vaccine development. Today, smallpox is the only human disease to have been eradicated.

How the COVID pandemic changed vaccine development

The global coronavirus outbreak prompted clinical development research teams to expeditiously investigate potential vaccine candidates. Despite extreme pressure and numerous unprecedented challenges along the way, several successful vaccines emerged and achieved authorizations for emergency use or full regulatory approval.

The development of the COVID vaccines raised awareness about how devastating a new pathogen could be to the entire world. Given the spread of the illness and the severity of the resulting disease, it highlighted that we have deficiencies in our ability to respond to a pandemic, and if we learn from it, it can provide important changes in health care policy, preparedness, and equity that can be employed to prevent or at least mute the extent of devastation caused by the eventual recurrence of such a calamity.

Despite well-constructed and rigorous clinical trials looking at the vaccines, there were those that would not be immunized leading to further death and spread of the disease. The studies reported the outcomes of thousands of volunteers who participated in the clinical trials which showed safety and efficacy of the vaccine.

The Messenger RNA (mRNA) technology that resulted from the COVID vaccine was in development for many years prior to the covid vaccine deployment of the technology, and is going to be employed in many other disease prevention applications.

There are many other technologies employed for the development of vaccine candidates other than mRNA platforms. Some vaccines use an uncommon virus that has been rendered incapable of causing disease and then adhering certain epitopes onto the viral vector or carrier that binds to corresponding receptors in the human target cells and cause the cells to begin the immunity process with the result in the person gaining the ability to fend off the disease when they encounter it in the wild.

As with any vaccine, if the study volunteer has been previously exposed to the virus, that can affect their natural immunity and the study result; and the same goes for if they’re reintroduced to the virus.

Prior to COVID, there was never a time in history where a vaccine got tested and approved so quickly. The timeline was impacted by the quickly increasing death toll rate, along with the strain on hospitals.

What’s important to understand is that this is not the last potential pandemic that we’ll see, but the groundwork that was laid during COVID will help us in the future.

The future of vaccine development

In the coming years, vaccine development will cover many different areas, including:

Decentralized trials and the role of technology

One significant development during the pandemic was the realization that clinical trials could be performed with scientific integrity using more activities and data gathered in the real-world setting, and decentralized clinical trials became an option. In the past, the patient would come into a traditional trial site, and every step of the study would occur at the trial site with few exceptions.

The pandemic changed that, and there’s now more tolerance for remote activities, and that’s where Signant is very strong – facilitating the capture of integral data regardless of where the study volunteer is reporting from. The development of reporting mechanisms that can be used to gather the required information is vital to continue to make the educated and rigorous scientific interpretation of the study data seamless for the sponsors and regulators.

I expect decentralized trials will continue to evolve. Having remote options does make it easier for people to participate in a clinical trial. With the right technology, participants can remain engaged in the trial, but also work and travel. Having remote options also makes participation more accessible for elderly folks who may not be comfortable driving or for anyone who’s experiencing symptoms during a study. eConsent makes the consent process easy for patients, informs them more fully, and provides a platform for site coordinators and PIs to ask more probing questions to ensure understanding.

Technology also improves data quality. For example, our eCOA solution allows comprehensive assessment in real-time post-exposure to a vaccine. Our large library of study designs also lets sponsors evaluate immunogenicity and reactogenicity in a very granular way while also saving cost and speeding the trial process.

RTSM solutions are methodologies that act as traffic control systems for laboratory supplies and test article distribution to the Investigative trial site. These will continue to be vital as well since vaccine studies tend to be heavily frontloaded. Often, the earliest part of a clinical trial for vaccines is usually the busiest time. This is when large volumes of volunteers are recruited and brought into the Investigative sites for screening procedures. Then if they meet all the requirements of the trial, they are given the vaccine and whatever supplies and instructions they need. Often, this involves hundreds, if not thousands, of people. The demands on the supply chain are most acute at this stage and the right partner to manage this aspect will be critical.

When you look at general medicine or CNS trials, enrollment is fairly linear. In vaccine trials, especially in a pandemic, hundreds or thousands of patients could be coming into a trial in a week. Having a mechanism where we can get supplies where they need them the most will be essential; nothing is worse than a site with a lot of volunteers but no drugs or kits.

In these ways, the data demands of a vaccine trial are different. Having the technology and logistics to manage that amount of data is critical. We also have a methodology to look at data in a blinded fashion to pick up outliers such as sites that need further training, or those that may be entering data incorrectly, or even worse, fraud. Direct monitoring is vital – it allows study teams to focus their training and monitoring, resulting in a better trial with better data. Telemedicine is also key because we can look at reactogenicity in a better way by monitoring the patient at home, directing their care remotely, and seeing them more frequently.

Science-backed technology and software will continue to streamline the process.

Picking up where we left off research on the flu, Zika, and West Nile

Many vaccine development efforts were put on the backburner during the pandemic to focus on the imminent threat. However, there will now be a reinvigorated attempt to go back to some of the things that had to be postponed, such as creating a more universal vaccine for influenza alone and in combination with covid and RSV, chikungunya, influenza, and many other pathogens.

Creating protective mechanisms

There is also an interest in creating a protective mechanism for an organism that can be weaponized, such as anthrax. A lot of what we do is to make sure there’s an adequate supply of preventative or treatment medicine if one of those events occurs.

Protections against vector-borne diseases

As we continue to encroach more on typical animal habitats, the more vectors or hosts could transmit diseases to humans, and we must be prepared to respond to those as well. Travel has affected how agents spread; a new ability for an organism to travel around the world. The crux of this solution entails isolating a piece of the organism that can be used to produce an immune response when given to people that protects them from developing the full disease.

Combating challenges with education

One challenge in developing vaccines is misinformation, and we must combat what’s put online or in non-reputable journals. There have always been people who distrust science, which is why medical advancement should be paired with education to minimize distrust.

The anti-vaccine sentiment also raises issues for public health. Where does someone’s personal freedom end in relation to their responsibility to their community? One person’s decision to avoid immunization can affect vulnerable populations, especially in public schools and other close communities. We must find balance as a society that allows dissent but minimizes misinformation with good communication and education.

In summary

The coronavirus pandemic accelerated how clinical trials are conducted and the rate at which results can be implemented. While that certainly won’t be our only pandemic, it laid the foundation for the future. As for what’s next in vaccine development, the proliferation and acceptance of technology in clinical trials can help us investigate questions more deeply. For instance, how do you keep someone in a trial long enough to see length of time after inoculation to when they reach a status where they’ll be protected, how long the protection lasts, and at what point does it wane to where they’re at risk and you want to give booster immunizations? We also must combat misinformation with education. When we utilize science-backed solutions, it makes participation easier and results in comprehensive, clean endpoint data for immunizations and treatments.