Summary of Current SARS-CoV-2 Vaccine Trials
Many clinical trials are underway in a race to develop a safe and effective vaccine against severe acute respiratory SARS-CoV-2, the virus that causes COVID-19.
Many clinical trials are underway in a race to develop a safe and effective vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). As of August 26, 2020, the World Health Organization reported approximately 23.7 million confirmed COVID-19 cases, including 815,038 deaths.1 Of those totals, the United States accounts for approximately 5.6 million confirmed cases and 176,201 deaths.1
Operation Warp Speed (OWS) was initiated due to the severity of the pandemic. OWS seeks to accelerate the development and manufacturing of potential COVID-19 vaccines, not only by selecting the most promising candidates, but also by providing coordinated government support while preserving safety and efficacy standards.2
In order to support SARS-CoV-2 vaccine research efforts, the US Department of Health and Human Services (HHS) funded approximately $1.95 billion to Pfizer, $1 billion to Johnson & Johnson, and $1.5 billion to Moderna to further study their investigational vaccines and support the large-scale manufacturing and delivery of at least 100 million doses to the US government. With support from the HHS, AstraZeneca’s candidate vaccine, developed in conjunction with the University of Oxford, may receive up to $1.2 billion in an agreement to supply the United States with at least 300 million doses, the first distribution of which may be delivered as early as October 2020.2
Currently, there are 3 leading COVID-19 vaccines. Table 1 highlights key aspects of their respective clinical trials and preliminary results from the available data.
Although there are 3 leading vaccines in clinical trials, other vaccines are also being investigated. Six are currently in phase 1 or combined phase 1 and 2 trials (Table 2), and 4 are under preclinical trial investigation (Table 3).
The 3 leading vaccines anticipate primary completion as early as Spring 2021. As the public eagerly awaits availability of a COVID-19 vaccine, it remains paramount for pharmacists to continue to educate and promote proper preventative measures as the fight to reduce the spread of COVID-19 continues. As vaccines progress through investigational phases, pharmacists must critically evaluate available preliminary data for vaccine efficacy and safety.
The authors have nothing to disclose. The purpose of this document is to provide readers with a summarized update on the COVID-19 vaccines currently in clinical trials for educational purposes.
- World Health Organization. WHO coronavirus disease (COVID-19) dashboard overview. WHO website. covid19.who.int/. Updated August 26, 2020. Accessed August 26, 2020.
- US Department of Health and Human Services. Fact sheet: explaining operation warp speed. HHS website. hhs.gov/coronavirus/explaining-operation-warp-speed/index.html. Accessed August 25, 2020.
- Study to describe the safety, tolerability, immunogenicity, and efficacy of RNA vaccine candidates against COVID-19 in healthy adults. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04368728. Published April 30, 2020. Accessed July 31, 2020.
- Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study to describe the safety and immunogenicity of a COVID-19 RNA vaccine candidate (BNT162b1) in adults 18 to 55 years of age: interim report. medRxiv. Preprint posted July 1, 2020.
- A study of a candidate COVID-19 vaccine (COV001). US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04324606. Published March 27, 2020. Accessed July 31, 2020.
- Folegatti PM, Ewer KJ, Aley PK, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020;396(10249):467-478.
- Investigating a vaccine against COVID-19. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04400838. Published May 26, 2020. Accessed July 31, 2020.
- Safety and immunogenicity study of 2019-nCoV vaccine (mRNA-1273) for prophylaxis of SARS-CoV-2 infection (COVID-19). US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04283461. Published February 25, 2020. Accessed August 2, 2020.
- Dose-confirmation study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 COVID-19 vaccine in adults aged 18 years and older. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04405076. Published May 28, 2020. Accessed July 31, 2020.
- A study to evaluate efficacy, safety, and immunogenicity of mRNA-1273 vaccine in adults aged 18 years and older to prevent COVID-19. US National Library of Medicine. clinicaltrials.gov/ct2/show/study/NCT04470427. Published July 14, 2020. Accessed July 30, 2020.
- Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2 - preliminary report. N Engl J Med. 2020. doi: 10.1056/NEJMoa2022483.
- A study of Ad26COVS1 in adults. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04436276. Published June 18, 2020. Accessed July 31, 2020.
- A study to evaluate the safety, reactogenicity and immunogenicity of vaccine CVnCoV in healthy adults. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04449276. Published June 26, 2020. Accessed July 31, 2020.
- Smith TRF, Patel A, Ramos S, et al. Immunogenicity of a DNA vaccine candidate for COVID-19. Nat Commun. 2020;11(1):2601.
- Evaluation of the safety and immunogenicity of a SARS-CoV-2 rS (COVID-19) nanoparticle vaccine with/without matrix-m adjuvant. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04368988. Published April 30, 2020. Accessed July 31, 2020.
- Novavax announces positive phase 1 data for its COVID-19 vaccine candidate. Gattusburg, MD: Novavax, Inc.; August 4, 2020. ir.novavax.com/news-releases/news-release-details/novavax-announces-positive-phase-1-data-its-covid-19-vaccine. Accessed August 6, 2020.
- SCB-2019 as COVID-19 vaccine. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04405908. Published May 28, 2020. Accessed July 31, 2020.
- Queensland Government. COVID-19 fast facts. Queensland Government website. advance.qld.gov.au/covid-19-fast-facts. Updated July 15, 2020. Accessed July 30, 2020.
- Phase 1/2 ascending dose study of investigational SARS-CoV-2 vaccine ARCT-021 in healthy adult subjects. US National Library of Medicine. clinicaltrials.gov/ct2/show/study/NCT04480957. Published July 22, 2020. Accessed July 31, 2020.
- COVID-19 vaccine tracker. Milken Institute. covid-19vaccinetracker.org. Updated July 29, 2020. Accessed July 30, 2020.
- A dose-confirmation study to evaluate the safety, reactogenicity and immunogenicity of vaccine CVnCoV in healthy adults. US National Library of Medicine. clinicaltrials.gov/ct2/show/NCT04515147. Published August 17, 2020. Accessed August 23, 2020.