In a recent report, the Government Accountability Office (GAO) highlighted some of the key variables necessary in COVID-19 vaccine development and what the Federal government is currently working on.
According to the report, at least three vaccines in development are receiving Federal funding and efforts are underway to accelerate a process that, under normal circumstances, would take 10 to 15 years to complete. The three vaccines receiving Federal funding, are all currently using different mechanisms to prompt the human body to produce antibodies.
- The first candidate is using a molecule coded to generate proteins that would induce an immune response.
- The second uses a recombinant protein to produce a protein that mimics part of the spike protein found on the surface of the COVID-19 virus and may be enough produce an immune response.
- The third candidate uses adenovirus 26 – with its infectious aspects removed – to be used as a “vector” for delivering a piece of COVID-19 to produce a protective immune response.
An accelerated process can lead to different challenges along the way, however. GAO identified three different challenges for the vaccine development process, including: virus mutations, risk of adverse effects through rapid development, and manufacturing and supply issues.
Currently, the Food and Drug Administration (FDA) has four programs to expedite the review and approval of vaccines for treatment and prevention of serious or life-threatening conditions. The programs include: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review. Additionally, FDA can issue Emergency Use Authorizations to review vaccine candidates that “have not completed all phases of development if there is sufficient scientific evidence on the product’s safety, effectiveness, risks, and benefits.”
Moving forward, GAO says that further policy question marks will remain, such as how to scale up vaccine manufacturing, where a vaccine can be purchased or distributed, and what Americans should expect for a “second wave” of COVID-19 outbreaks should a vaccine not be developed and available soon.