The COVID-19 Vaccine Race: Challenges and Opportunities in Vaccine Formulation
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Review Article The COVID-19 Vaccine Race: Challenges and Opportunities in Vaccine Formulation Jieliang Wang,1 Ying Peng,2 Haiyue Xu,1 Zhengrong Cui,1 and Robert O. Williams III1,3
Received 1 June 2020; accepted 2 July 2020 Abstract. In the race for a safe and effective vaccine against coronavirus disease (COVID)-19, pharmaceutical formulation science plays a critical role throughout the development, manufacturing, distribution, and vaccination phases. The proper choice of the type of vaccine, carrier or vector, adjuvant, excipients, dosage form, and route of administration can directly impact not only the immune responses induced and the resultant efficacy against COVID-19, but also the logistics of manufacturing, storing and distributing the vaccine, and mass vaccination. In this review, we described the COVID-19 vaccines that are currently tested in clinical trials and provided in-depth insight into the various types of vaccines, their compositions, advantages, and potential limitations. We also addressed how challenges in vaccine distribution and administration may be alleviated by applying vaccinestabilization strategies and the use of specific mucosal immune response-inducing, noninvasive routes of administration, which must be considered early in the development process. KEY WORDS: coronavirus; vaccine; adjuvant; route of administration; mucosal vaccination.
INTRODUCTION First reported in late 2019, the COVID-19 has become a pandemic across the world. As of the time of writing this review (May 29, 2020), there are more than 5 million confirmed cases and over 357,000 deaths due to COVID-19. The elderly have a higher mortality rate than other age groups. The pathogen that causes COVID-19 is the severe acute respiratory syndrome coronavirus (SARS-CoV-2), a betacoronavirus that is genetically homologous to the SARS coronavirus from the 2003 outbreak (SARS-CoV) (1). Initial work suggests that the SARS-CoV-2 enters the host cells by binding to the angiotensin-converting enzyme 2 (ACE2), similar to the case SARS-CoV (2). Potential therapeutics including antiviral medications, protease inhibitors, and monoclonal antibodies are being developed or in clinical trials. Remdesivir, a nucleoside analog prodrug developed by Gilead, is the most advanced antiviral drug undergoing clinical investigation against COVID-19 (NCT04292899, NCT04292730, NCT04280705, NCT04315948, NCT04257656). In a recent placebo-controlled, randomized clinical trial with 1063 patients, remdesivir shortened the
1
Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, Texas, USA. 2 Division of Chemical Biology and Medicinal Chemistry, College of Pharmacy, The University of Texas at Austin, Austin, Texas, USA. 3 To whom correspondence should be addressed. (e–mail: [email protected])
medium recovery time by 4 days, from 15 to 11 days, and reduced the mortality by 14 days from 11.9 to 7.1% (3). In a separate study, remdesivir was shown to be ineffective for patients with sever
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