Happy Thanksgiving!

Happy Thanksgiving!

As I am writing the rough draft of my paper, I'm reminded of how grateful I am for this opportunity. It's been such a great experience and I look forward to continuing my research on Covid-19 and vaccinations. 

This week I've taken some time to understand the workings of mRNA vaccines and the approval of the Ebola vaccine. Looking at the timeframe it took to study and approve the Ebola vaccine has given me some insight into what we can expect with the Covid-19 vaccine. Research was conducted through all 3 phases within a year. The approval process itself took several years and had to be approved by foreign agencies prior to usage within many African countries. Trials began October 2014 and a vaccine was approved for use in December of 2019. 

I still need to finish the last of my rough draft and get some feedback on a few details since research was primarily done through peer reviewed articles.

Here is an image of the SARS-CoV-2 virus:

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).

Research Proposal: SARS-CoV-2 Vaccine

Research Proposal: SARS-CoV-2 Vaccine

Research Question: Can a SARS-CoV-2 vaccine become available within a year?

Hypothesis: If research is being conducted in human clinical trials, then a SARS-CoV-2 vaccine available to the public, is feasible within 6 months up to 2 years.

Researching the viability of a SARS-CoV-2 (also known as 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 a better 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).

Research will be conducted using scholarly articles and utilizing data from previous vaccines developed in a similar manner. A vaccine for the Ebola virus has been developed and approved by the FDA for use in the United States. Data on the Ebola virus will provide context and clues that may help develop a timeline for a Coronavirus vaccine.

Based on current data, a Coronavirus vaccine could be available within a year. A main cause for concern is implementing a vaccine that has not been thoroughly tested, creating a distrust in vaccine science and/or unintended medical issues causally related to side effects.

 

Jeyanathan, M., Afkhami, S., Smaill, F., Miller, M., Lichty, B., & Xing, Z. (2020, September 04). Immunological considerations for COVID-19 vaccine strategies. Retrieved November 13, 2020, from https://www.nature.com/articles/s41577-020-00434-6

Kaur, S., & Gupta, V. (2020, August 13). COVID-19 Vaccine: A comprehensive status report. Retrieved November 13, 2020, from https://www.sciencedirect.com/science/article/pii/S0168170220310212

Lazarus, J., Ratzan, S., Palayew, A., Gostin, L., Larson, H., Rabin, K., . . . El-Mohandes, A. (2020, October 20). A global survey of potential acceptance of a COVID-19 vaccine. Retrieved November 13, 2020, from https://www.nature.com/articles/s41591-020-1124-9?campaign_id=154

Poland, G., Ovsyannikova, I., Crooke, S., & Kennedy, R. (2020, July 30). SARS-CoV-2 Vaccine Development: Current Status. Retrieved November 13, 2020, from https://www.sciencedirect.com/science/article/pii/S0025619620308272

Researching Ebola in Africa. (n.d.). Retrieved from https://www.niaid.nih.gov/diseases-conditions/researching-ebola-africa

U.S. Vaccine Safety - Overview, History, and How It Works. (2020, September 09). Retrieved November 13, 2020, from http://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html

Research being conducted on vaccines

This week, I’ve been looking at the type of vaccines that researchers are testing to combat SARS-CoV-2.

Live-attenuated vaccines: this uses a weakened version of the virus to create a vaccine. The measles, mumps and rubella vaccine were created by using a Live-attenuated vaccine. Usually provides a lifetime protection from the virus. (Currently being tested in India and Hong Kong)

Subunit Vaccines: uses specific parts of the virus. In several studies, researchers are using pieces of the protein within the virus to develop a vaccine. These vaccines are great for a wide variety of people including those with weakened immune systems. Current vaccines developed using this method are Hepatitis B, HPV, and Shingles. Most studies have focused on the S-Protein (Spike protein, pictured below). Australia, Russia, and China are currently focusing on this research.

Nucleic Acid Vaccines: DNA/RNA vaccines stimulate the immune system with a modified infectious agent that causes no harm or disease but ensures that when a host is confronted, the immune system can adequately neutralize it before causing any ill effect (WHO.int). Germany, China, and United States are working to develop a vaccine using DNA technology.

Vectored Vaccines: use a form of live attenuated vaccines that adapt existing successful and safe viral vectors to express coronavirus proteins on immunization (Poland, Gregory). Canada, South Africa, and United Kingdom are using this method of testing.

Poland, Gregory A., et al. “SARS-CoV-2 Vaccine Development: Current Status.” Mayo Clinic Proceedings, Elsevier, 30 July 2020, www.sciencedirect.com/science/article/pii/S0025619620308272.

Photo: https://www.scielo.br/scielo.php?pid=S1677-55382020000700006&script=sci_arttext

https://www.who.int/biologicals/areas/vaccines/dna/en/

https://www.vaccines.gov/basics/types