The Biggest Problems We Face Fighting Infectious Diseases
This interview with Dr. Martina Kovac, vice president of global product development, vaccines at PPD, was originally published on Mediaplanet’s futureofpersonalhealth.com.
What is the biggest problem related to infectious diseases the world is facing now or will face in the future?
The reactive nature of drug and vaccine development is a persistent hurdle to preventing infectious disease outbreaks.
COVID-19 has placed a spotlight on how interconnected the world has become and how this creates an environment for the rapid spread of infectious diseases, such as the 2019 novel coronavirus.
However, when it comes to drug and vaccine development we often are not connected. Moreover, there has historically been a reactive mindset toward infectious disease threats. Rather than preparing for the next pandemic, we are reacting to the latest “shiny object.”
These factors create an uncertain public health environment, which can lead to a loss of government and industry funding for drug and vaccine clinical trials in favor of more visible projects, a lack of continued and sustained investment in pre-clinical development for the prevention and treatment of potentially dangerous pathogens, and the lingering potential for sidelined diseases to become the next pandemic (e.g., Zika, SARS, MERS, influenza).
How can the world solve this problem?
Increased government and industry commitment to product development investment.
The global COVID-19 pandemic is changing how vaccine development is undertaken and will serve to teach us how to deal with future infectious diseases outbreaks. We have seen great examples of collaboration, innovative technologies, and partnerships that will enable faster initiation and execution of clinical development, and can be used as a model going forward.
Large pharma manufacturers are coming together in partnerships to expedite the development of vaccines and therapies. This momentum of global collaboration – and connectivity – between large pharma, biotech companies, government, and academia has created communities where know-how, expertise, tools, and databases are shared and enhanced by artificial intelligence and digital platforms. Integral to this progress has been the rapid issuance of clinical trial guidance, regulatory review, and approval processes on a global scale.
Collaborative partnerships between private and public sectors and government are increasing, which is enabling scientific dialogue, accelerating clinical development, and providing agility to scale up production.
For example, the Biomedical Advanced Research and Development Authority (BARDA) and the Coalition for Epidemic Preparedness Innovations (CEPI) have secured investments for vaccine research, clinical testing, and manufacturing in response to the current outbreak.
Operation Warp Speed (OWS) is driving development of a more efficient approach to vaccine development, and Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a National Institutes of Health (NIH)- led initiative, is testing multiple inpatient and outpatient COVID-19 therapeutics with a streamlined trial design. Both of these initiatives have required unprecedented collaboration between government and industry.
Technology and telemedicine also are part of the solution, playing a larger role due to the travel restrictions and social distancing requirements that have been imposed in response to COVID-19. The use of digital technology in trials is creating effective adaptations through virtual participant visits, in-home care, wearable devices to monitor participant safety, and more.
The COVID-19 experience will transform the way we conduct clinical trials in the future. Digital capabilities will
continue to evolve as an essential strategy beyond the current pandemic to help increase access to clinical trials for more participants and reduce the burden of clinical trials, while simultaneously providing new opportunities for investigators to capture more consistent data.
These collective efforts represent a new era in global mobilization, connectivity, and preparedness for mitigating risks to public health. The hope is that this will continue with the updating of existing government policies and the creation of new ones to support public health and international cooperation.
Why is it important to raise public awareness about infectious diseases?
The new product development process is an integral part of ongoing U.S. and global public health efforts. An educated public can help drive changes that prioritize proactive public health preparedness and product development – both from government and industry.
During an infectious disease outbreak, the value of drug and vaccine development takes on greater clarity when lives are at risk. The role of public awareness is vital to ensuring visibility persists until we have truly conquered the threat. Public support for drug and vaccine development efforts can help contain the spread, reach various socio-economic groups, prevent new outbreaks, and prepare the world for the next unknown pathogen.
Most people don’t realize that truly eliminating a disease takes a concerted effort over an extended period of time. For example, the eradication of smallpox, touted as the biggest achievement in international public health, took a concerted global effort over more than 20 years.
Furthermore, grassroots activism in the HIV space of the late 1980s greatly empowered patients, was critical to mobilizing the government and industry to prioritize HIV, and led to expedited research and treatment breakthroughs. Giving the public a voice through education and awareness will help us achieve the right level of investment in research and clinical trials to prevent and treat infectious diseases, eliminate the current COVID-19 threat, and prepare us for the next novel pathogen.
What is one thing you wish more people knew about infectious diseases?
In vaccine development, the safety of vaccine recipients is paramount.
While the vaccine development arms of industry and government can seem cumbersome and opaque, much of this infrastructure is in place to ensure patient safety. Global efforts to identify an effective COVID-19 vaccine involve tens of thousands of healthy volunteers. This helps ensure the safety of the vaccine across a wide variety of groups of people with diverse characteristics, such as age, ethnic background, gender, and underlying medical conditions.
Vaccines are given to millions of healthy people — including children — to prevent serious diseases, so they are held to very high safety standards. Even after a vaccine is licensed and recommended for use, health agencies still continue to monitor its safety and effectiveness.
A typical vaccine study consists of assessment of safety, reactogenicity (i.e., an adverse reaction to the vaccination such as pain at the injection site), immunogenicity (i.e., the desired antibody response to the vaccination), and efficacy (i.e., percentage reduction of disease in vaccinated people).
Vaccine trials are typically shorter than drug trials, with most of the data collected at somewhat standardized time points within post-vaccination period (0-50 days up to 12 months). In comparison, Phase III drug trials typically take one to three years. Enrollment of participants and the vaccination periods are also typically shorter than many other kinds of studies.
Rapid progress in the generation of new technologies and laboratory testing platforms is also helping speed vaccine trials. In addition, the development of molecular approaches to quickly identify and characterize viruses and bacteria has opened the doors to major scientific breakthroughs that are contributing to the quick emergence of new vaccines.
Vaccines are known to be more cost effective in terms of development compared to disease treatments (one dose of a vaccine is typically a fraction of the cost of a drug treatment for the same disease), and the up-front expenditure for vaccine development is entirely offset by the costs averted through disease prevention. For every dollar spent on childhood vaccinations, our country saves over $10. And the CDC estimates the vaccination of children born between 1994 and 2018 has saved the United States nearly $406 billion in direct medical costs and $1.88 trillion in total society costs.
The old adage “an ounce of prevention is worth a pound of cure” has never been more meaningful than during this current pandemic. Vaccines offer prevention and prevention is priceless. Increased awareness of the true value of vaccination and disease prevention is of great importance in today’s world.