A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while traveling at warp speed or hyperspace. But what about the safety of vaccines being developed and tested at warp speed?
Compared to the processes of 20 years ago, development of the current SARS-CoV-2 vaccine candidates has been remarkably swift thanks to genetic engineering and the additional resources afforded via Operation Warp Speed. In the past, it could take years to develop an investigational vaccine and several additional years for testing in clinical trials. In 2020, gene therapy techniques shortened that development timeframe to mere weeks. What has changed? Is this new approach used to develop COVID-19 vaccines safe?
Genetic Engineering for Faster Development
Traditional vaccine development techniques involve culturing microorganisms in a lab. The microbe is grown for multiple generations outside of its natural host until random mutations cause it to lose the ability to cause disease in the natural host. The attenuated or weakened organism can then be tested as a vaccine strain. However, enough organism must be grown to utilize for testing. This process can be quite lengthy. For example, the tuberculosis (TB) vaccine utilized in much of the world took 13 years to develop before it could be tested in clinical trials. Gene therapy techniques provide incredible efficiencies, safety, and efficacy in comparison to the “old fashioned” approach. Rather than depending on random mutations to occur over prolonged periods of culture in culture to create an ever-safer vaccine product, researchers can design the vaccine and engineer safety features directly into the product. The approach utilized by Moderna Therapeutics and the NIH provide a prime example of the benefits of this approach. Once the genetic sequence of the SARS-CoV-2 virus was available researchers were able to identify the part of the virus to target in their vaccine and introduce safety features. The resulting genetic sequence was placed into Moderna’s mRNA based vaccine platform and produce an investigational vaccine ready for clinical trials within six weeks.
Vaccine Research for Safety and Efficacy
Before any vaccine candidate can be made available for use by the general public in the United States, FDA and other regulations require rigorous testing to ensure the product is safe and effective at protecting against viral infection. All clinical trials involving human participants must be approved and overseen by an independent institutional review board (IRB), which makes sure participants are adequately informed of the risks and benefits and the research study is appropriately designed. For most research involving genetically engineered products like the new COVID-19 vaccines, an institutional biosafety committee (IBC) also approves and oversees the research. IBCs make sure the additional risks posed by genetically modified materials are properly managed and that anyone who comes in contact with the investigational product are appropriately protected—including participants, research staff, and the community in which the research is being conducted.
While the urgency of the COVID-19 pandemic has resulted in research at unprecedented speed, these oversight requirements remained in place. Independently administered IRBs and IBCs, like Advarra’s, helped ensure research was conducted appropriately without slowing things down. Independent oversight committees also provide an extra level of protection and vaccine safety beyond the already strenuous requirements of the US FDA.
IRBs and IBCs were originally established at individual research institutions and universities. Each institution’s IRB and IBC would review the research conducted at that location; so for a study involving many research sites, this could mean dozens of individual IRB reviews. The potential result: a traditional 20-year development cycle for a new vaccine. The COVID-19 pandemic has taught us that research can’t always wait that long. Today, centralized IRB and IBC review from companies like Advarra can provide the same scientific, ethical, and safety review for many research sites at (pardon the pun) warp speed.
Operation Warp Speed has also provided a path for speeding timelines by allowing research and development processes to be conducted in parallel, rather than in a linear series as has historically been done. All required testing and regulatory oversight activities remain in place, and no corners have been cut.
Advarra is proud to have contributed to the rapid development of multiple COVID-19 vaccines. Together with our partners in industry, institutions, and regulatory agencies we will continue to help support safe and effective vaccines approved for use in the US in record time.
Find out more about how Advarra has supported the research community during the COVID-19 crisis in our blog By the Numbers: Our Response to COVID-19.
At Advarra we know Gene Therapy Research. We offer the industry’s only truly integrated IBC and IRB service with optimized collaboration; and, with Advarra’s worldwide presence we have reviewed more protocols than any other integrated IRB and IBC. Our exclusive network of Gene Therapy Ready sites is standing by to rapidly start-up your gene therapy research. All backed by our amazing biosafety consulting team ready to help you from site selection through to market approval. Contact us today to learn why when you think Gene Therapy think Advarra!
Sites — Is your site part of the Advarra’s Gene Therapy Ready network? Get signed up today.
Sponsors/CROs — Looking to place your next Gene Therapy treatment or vaccine trial? Contact us to learn more about Advarra’s Gene Therapy Ready network and how we can support your next trial with integrated central IRB and IBC review.