Project Background

         Researching the viability of a SARS-CoV-2 (also known as Severe Acute Respiratory Syndrome, Coronavirus or Covid-19) vaccine within a year is important to gain an understanding of when a resolution to the current pandemic can be reached. Coronavirus has ravaged the entire world and shows no signs of stopping or slowing in the near future. As of November, the world has seen 50.1 million Coronavirus cases and 1.25 million Coronavirus related deaths since the pandemic began approximately 11 months ago. Vaccine research began the early part of March 2020 and is currently being tested in many countries across the world.

It is important to gain an understanding of the timeline in which it takes to develop, test and approve a vaccine. The typical timeline for vaccine development can take several years to create and is broken down into phases. Initial research and testing is typically done using animals like mice, rabbits and monkeys. Phase 1 is a small group of volunteers, typically 20-100, and lasts a few months. Phase 2 consists of several hundred participants and lasts anywhere from a few months to two years. Phase 3 utilizes several hundred to several thousand volunteers and timeframe for testing depends on results of participants (“U.S. Vaccine Safety-Overview, History and How it Works” 2020).

Currently, there are approximately 166 vaccines being developed and are in various stages of clinical trials. Vaccine types range from Live Attenuated and Whole Inactivated vaccines, Subunit Vaccines, Vectored Vaccines and Nucleic Acid Vaccines. The most promising are mRNA Nucleic Acid Vaccines being produced by Pfizer and Moderna. mRNA was advocated as a vaccine platform, perhaps being ideal in the sense that it brings together the immunological features of live attenuated vaccines such as endogenous antigen expression and T cell induction with those of killed or subunit vaccines like defined composition and safety (“Developing mRNA-Vaccine Technologies” 2012).

Both Pfizer and Moderna are in clinical trials and are working toward a Fast Track designation by the Federal Drug Administration (FDA). Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need (Fast Track, FDA.gov). Once the FDA has approved the Fast Track application, both Pfizer and Moderna can provide data to the FDA as it becomes available in order to move forward in the vaccine trials.

It’s important to study and develop mechanisms that would prevent further spread of Covid-19 in order to preserve life. Looking at past Coronaviruses outbreaks will help provide insight with the current Coronavirus pandemic. The first SARS-CoV outbreak that occurred in 2003 with 8,098 cases and 774 deaths. The United States saw eight cases during that time. Vaccine research started in 2003 using Inactivated SARS-CoV-based, S-Protein Based, and Vaccines based on Fragments containing neutralizing epitopes (“SARS Vaccine Development”, 2005). When new SARS-CoV-1 cases decreased, the need for a vaccine became less relevant. The MERS-CoV (Middle Eastern Respiratory Virus) outbreak that began in 2012 has seen approximately 1638 cases, with 587 deaths. Vaccine research has been done using DNA and DNA/Protein, recombinant virus, viral vectors, nanoparticle and subunit vaccines with none approved for human use (“Vaccines for the prevention against the threat of MERS-CoV”, 2016).

While Nucleic Acid vaccines look promising, there is little data that can be used as a comparison for viability. Nucleic Acid vaccines are not shelf stable and typically require freezer storage. A problem that may present issues when storing large quantities in hospitals and pharmacies. A secondary issue is vaccine safety which requires educating the public on the effectiveness of the vaccine and an appropriate timeline. High risk individuals including Seniors, Healthcare workers and people with co-morbidities would be the first to receive a vaccine. Individuals with documented cases of Coronavirus and those exposed to the virus would also receive priority before the general public has access.    

“This amazingly rapid development cycle is due to several factors: existing vaccine candidates, data, and animal models from SARS and MERS; the early publication of the full-length genome sequence of SARS-CoV-2; the striking sequence similarity in the S protein between SARS-CoV-1 and SARS-CoV-2; the use of DNA and RNA “plug and play” vaccine platforms; and reduced regulatory burdens due to the urgent nature of the outbreak” (Covid19 Comprehensive Status, 2020).