Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. Today, we are pleased to welcome a guest post from Abby Bownas, manager, Adult Vaccine Access Coalition to discuss the importance of COVID-19 vaccine development.
The emergence of a novel coronavirus in December 2019 took much of the world by surprise and its rapid spread forced many of us to drastically change the way we live. Even as stay-at-home orders are lifted and restaurants and businesses begin to reopen, rising COVID-19 infections will remain a risk until vaccines are developed. Fortunately, the infrastructure is in place to allow for advanced manufacturing and critical technological developments that will allow the development and manufacturing of a COVID-19 vaccine to take place with unprecedented speed. Applications for approval must meet FDA’s robust standards for safety, purity and potency, and include data generated during pre-clinical testing and clinical trials, in addition to significant information on the manufacturing process.
The Adult Vaccine Access Coalition (AVAC) recently developed an infographic comparing the process for developing vaccines during infectious disease pandemics, like COVID-19, to the standard vaccine development process. While previous vaccines could take 10 to 20 years to reach the public, officials are predicting that the first COVID-19 vaccine could be available after only 12 to 18 months.
COVID-19 vaccine candidates will be subject to the same regulatory standards as other products, including standards for safety, purity, and potency. They will have to meet the same standards for clinical trials and evidentiary and quality controls and will also be subject to the FDA’s rigorous regulatory review and approval process by the FDA. Once approved, these products will be subject to the same regulatory standards governing post-approval safety monitoring. However, innovative techniques allow for the advancement of vaccine research at a faster pace than has ever been done before. Strategies like conducting simultaneous clinical trials in multiple countries and applying parts of the development, manufacturing and regulatory review stages in parallel are just a few of the innovative ways that companies are accelerating the development of vaccines that are urgently needed to stop the global spread of COVID-19.
In conjunction with the launch of their infographic, AVAC is hosting a virtual briefing for Congressional staff on “Immunizing During the Covid-19 Pandemic.” While adult vaccine rates are already below Healthy People goals, in recent months rates for preventative care have plummeted during the epidemic. During these unprecedented times, there is a unique opportunity to improve access to all recommended vaccines and renew our commitment to reducing racial, socioeconomic and geographic disparities.
We can strengthen the immunization infrastructure, invest in immunization information systems, and support our health care providers. Now is the time to think outside the box and implement new and innovative ways to deliver current and future vaccines within the immunization neighborhood. We must prioritize improved access to and utilization of vaccines through the reduction in technological, logistical, geographic, socioeconomic and financial barriers. When a vaccine for COVID-19 is developed, these foundations will be critical for ensuring that members of the public are able to access the vaccine — because annual readiness is emergency preparedness.
To learn more about the process for developing vaccines during infectious disease pandemics, like COVID-19, to the standard vaccine development process, click here.