vaccne paper 2 (1)

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The ERVEBO vaccine has a proven efficacy of 100% in a phase III open-label cluster-randomized ring vaccination trial l (Henao-Restrepo et al., 2015). However, if reformulation is done, Ervebo might be easier to administer, store and dispense. Currently, it requires an ultra-cold chain for long-term storage, which makes delivery and storage in African countries difficult and expensive (Woolsey & Geisbert, 2021). Some scientists think a nasal Ebola vaccine could theoretically overcome some of the issues with cold-chain requirements while being easy to administer (Jonsson-Schmunk & Croyle, 2015). For instance, nasal vaccines would be more co nvenient for people that are scared of needles . Also, since Ervebo is made with rice-derived recombinant human serum albumin, individuals that have a rice allergy are unable to receive this vaccine because they are at risk of an anaphylactic reaction (CDC, 2023). Reformulating the vaccine to account for allergies and other contraindications will help to improve the safety of the vaccine. Both Ervebo and Zabdeno/Mvabea have been shown to be safe, but they have only been approved for use against the Zaire ebolavirus strain (Woolsey & Geisbert, 2021). New vaccine technologies could improve existing approved Ebola vaccines by targeting other ebolavirus species or being formulated to be stable at warmer temperatures. Some scientists think a nasal Ebola vaccine could theoretically overcome some of the issues with cold-chain requirements while being easy to administer (Jonsson- Schmunk & Croyle, 2015). Module 10: Target populations and schedules  Is the current target population(s) appropriate for your vaccine(s)?  Since we have an aging population should older people be specifically targeted for your vaccine(s)? Ervebo is suitable for use for adults and children that are one year or older In places outside of the US that have a high burden of active disease, such as Congo and Sudan, I would distribute the vaccine by using the ring vaccination strategy1. This focuses on vaccinating the close contacts of positive cases, healthcare and frontline workers, and others that have the highest risk of infection. By doing this, herd immunity would be achieved more quickly. What would be your priority 2-3 targets for the vaccine and why? Neonates, Children, adults, health care workers, vulnerable population (elderly etc.)? My first priority will be to vaccinate healthcare workers in the endemic areas. Most likely, the first line of care for an infected individual will be a clinic or hospital, so prioritizing the vaccination of healthcare workers will reduce the risk of exposure. Another group that I will prioritize vaccination for are individuals that have been in close contact with a confirmed case of Ebola. This establishes immunity around the confirmed cases, which in turn prevents the virus from spreading further. The current target population for ERVEBO includes adults and children aged one year or older. Considering the aging population, older individuals may be specifically targeted, especially in regions with a high burden of active disease. In these endemic areas like Congo and Sudan, distributing the

vaccine using the ring vaccination strategy is beneficial. This focuses on vaccinating the close contacts of positive cases, healthcare and frontline workers, and others that have the highest risk of infection. By doing this, herd immunity would be achieved more quickly. prioritizing healthcare workers and close contacts of confirmed cases through a ring vaccination strategy is crucial. Neonates, children, and vulnerable populations, such as the elderly, should be prioritized to create a robust defense against the virus.  Module 11: Vaccine strategies  What new strategies might be considered for insuring that your vaccine(s) are available to the global target population?  Logistic strategies? Economic strategies? Manufacturing strategies (e.g., local versus central)? Cultural strategies (e.g., some cultures very anti- vaccine).  New logistics strategies, such as improving cold chain storage requirements, can be utilized by developing technology that minimize reliance on ultra-cold storage refrigerators, which in turn allows for the vaccine to be distributed and stored long-term in areas without specialized freezers. Economic strategies, such as affordability initiatives through collaboration with local and international organizations and public-private partnerships, ensure accessibility to low-income populations. Cultural strategies focus on community engagement programs and tailored educational campaigns to address vaccine hesitancy. During the educational and engagement programs, being respectful, relatable and communicating properly help to form relationships with trust where which it reduces whatever drawback people have to the vaccines. Global collaboration and funding initiatives aim to share resources and respond rapidly to outbreaks. Public awareness campaigns through social media, digital outreach, and celebrity endorsements contribute to overcoming challenges, ultimately enhancing the global availability and acceptance of vaccines like ERVEBO  allowing the vaccine to reach areas with limited infrastructure. Last-mile delivery solutions, such as drone deliveries and mobile vaccination clinics, provide novel ways to reach remote and underserved locations. Economic tactics, such as collaboration with international organizations and public- private partnerships, ensure that the vaccination is accessible to low- income populations. To develop a decentralized and robust manufacturing network, manufacturing techniques include establishing local production capacities and encouraging knowledge transfer. Cultural techniques involve local leaders and influencers in community involvement programs and tailored educational efforts to combat vaccine reluctance. Digital and data strategies include the use of digital immunization records and data.

New logistic strategies, such as cold chain optimization, can be imple- mented by investing in technologies that reduce reliance on ultra-cold storage, thereby extending the vaccine's reach to regions with limited in- frastructure. Last-mile delivery solutions, including drone deliveries and mobile vaccination clinics, offer innovative ways to efficiently reach re- mote and underserved areas. Economic strategies, such as affordability initiatives through collaboration with international organizations and public-private partnerships, ensure the vaccine's accessibility to low-in- come populations. Manufacturing strategies involve establishing local production capacities and facilitating technology transfer to create a de- centralized and resilient manufacturing network. Cultural strategies fo- cus on community engagement programs and tailored educational cam- paigns to address vaccine hesitancy by involving local leaders and influ- encers. Digital and data strategies encompass the implementation of digital immunization records and data analytics for targeted interven- tions. Global collaboration and funding initiatives, including international cooperation and emergency funding mechanisms, aim to share re- sources and respond rapidly to outbreaks. Public awareness campaigns through social media, digital outreach, and celebrity endorsements fur- ther contribute to overcoming challenges, ultimately enhancing the global availability and acceptance of vaccines like ERVEBO.

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Which category(ies) do(es) your vaccine(s) fit into in the list of vaccine strategies? Ring vaccination is the most relevant strategy used against Ebola. A trial showing the efficacy of the Ervebo vaccine used a ring vaccination strategy (Henao- Restrepo et al., 2017). Does the concept of herd immunity fit the disease your vaccine prevents? If not why not? According to Masterson et al., more than 80% of the population would need to be vaccinated against Ebola for herd immunity, which is an unrealistic goal because many of the African populations affected by Ebola refuse the vaccine (2018). What diseases have been completely or mostly eradicated with vaccines? Globally? In US? Smallpox has been eradicated globally (Strassburg, 1982). Polio is close to eradication, but is still endemic in Pakistan and Afghanistan (CDC, 2023). Measles was eliminated in the United States, but travel and anti-vaccination sentiment has threatened its eliminated status (Moss & Strebel, 2011). Could the disease(s) that your vaccine prevents be eradicated? Ebola has an animal reservoir, thought to be bats (CDC, 2018). This would make eradication unlikely. Module 12: Vaccine Safety  What measures are used to ensure the safety of your vaccine(s)?  What might be done to make them safer, if anything?  What improvements in vaccine safety surveillance might be implemented for your vaccine(s)?  What strategies are or should be used to provide public with reassurance about the safety of your vaccine(s)?  Is your disease potentially eradicable with your vaccine (s)?  Is the organism that causes your disease eradicable by your vaccine(s)? Ebola Vaccine Safety Discussion What are the variations across state Health recommendations for your vaccine(s) if any? If none, should there be differences and why or why not?  There are no state-level variations in recommendations for Ebola vaccination in the United States. There should not be variations, as Ebola is rare in the United States (only 4 confirmed cases of Zaire ebolavirus in the United States during the 2014-2016 outbreak) (Centers for Disease Control and Prevention, 2023).  The current guidelines for Ebola vaccination in the US are for those with the highest risk for occupational exposure (healthcare workers who work at special

pathogen treatment centers and staff at laboratories where Ebola specimens may be used or stored) (Malenfant et al., 2021). What was the process for safety approval of your vaccine?  Safety was evaluated for the Ervebo vaccine in multiple trials conducted in parallel by several sponsors during the 2014-2016 outbreak (Wolf et al., 2021).  It was difficult to synthesize all of the safety data, but safety data across all trials showed that Ervebo is acceptably safe (Wolf et al., 2021).  The FDA approved Ervebo after an accelerated vaccine trial program (Wolf et al., 2021). What types of adverse events have been reported to VAERS and vaccine safety datalink for your vaccine(s)? Was there a phase 4 study of your vaccines?  A phase 4 study on Ervebo is set to begin in January 2024 (REVIVE, n.d.).  Ervebo vaccine currently demonstrates a robust safety profile, with rare adverse effects reported. As of 11/24/2023, 216 adverse events have been reported in response to Zaire ebolavirus vaccination in the United States in the VAERS system (VAERS, 2023). Pain, chills, pyrexia, headache, fatigue, and nausea are the most common adverse events (VAERS, 2023). These adverse events were also some of the most reported events in official trials (Wolf et al., 2021).  Safety measures include rigorous testing in clinical trials, monitoring for ad- verse events, and adherence to good manufacturing practices. To enhance safety, continuous research could focus on refining the formulation to mitigate the need for an ultra-cold chain, thereby increasing accessibility. Additionally, addressing allergenic concerns by exploring alternative ingredients may im- prove inclusivity and safety.  Surveillance of vaccine safety is critical. Improved monitoring systems, such as enhanced pharmacovigilance, can be implemented to quickly detect and re- spond to adverse events. Continuous evaluation and transparency in reporting adverse events contribute to maintaining public trust. Strategies for reassuring the public about vaccine safety include effective communication through public health campaigns, leveraging social media, and engaging with healthcare pro- fessionals as trusted sources.  While Ervebo has demonstrated efficacy, eradicating Ebola with this vaccine depends on several factors. The disease's potential eradicability hinges on fac- tors like the duration of immunity, vaccine coverage, and the role of asympto- matic carriers. Conducting long-term studies to assess the vaccine's impact on transmission dynamics and addressing challenges like reaching remote popula- tions are essential for achieving eradication goals.

Module 13  What diseases remain out of the reach of current vaccines, and what might be done to change that?  References

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vaccne paper 2 (1)

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