Early clinical trial data and real‐world assessment of COVID‐19 vaccines: Insights from the Society of Infectious Diseases Pharmacists

Abstract

As of August 2021, there were three COVID‐19 vaccines available in the United States for the prevention of coronavirus 2019 (COVID‐19). The purpose of this narrative review is to examine the early experience from the Emergency Use Authorization (EUA) of BNT162b2 (Pfizer, Inc./BioNTech), mRNA‐1273 (Moderna, Inc.), and Ad26.COV2.S (Johnson and Johnson/Janssen Global Services, LLC) through July 2021. The EUA data from the clinical trials have largely been corroborated by real‐world effectiveness investigations post‐authorization. These studies indicate that immunity is obtained within 2 weeks post‐vaccination and may endure for 6 months. The immunity conferred by the vaccines may also be effective against SARS‐CoV‐2 variants of concern. Additionally, populations not included in the emergency use authorization studies may also benefit from vaccination. This look back at the initial clinical experience can be used by the global community to inform and develop COVID‐19 vaccine programs.

Prevalence of COVID-19 Infection among Patients with Diabetes and Their Vaccination Coverage Status in Saudi Arabia: A Cross-Sectional Analysis from a Hospital-Based Diabetes Registry

“…In terms of sex, 56.2% (n = 6506) were female, while 43.8% (n = 5067) were male. The mean age (standard deviation) of the patients was 57.71 (12.07), and the median (interquartile range) was 58 (50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63)(64)(65).…”

“…Considering that effective pharmacological treatment to combat COVID-19 is still emerging, vaccination has become an important pillar for controlling the COVID-19 pandemic [43][44][45]. As different types of vaccines have shown positive results and are now available for clinical use [3,[46][47][48][49][50], it is quite important for patients with diabetes to receive vaccinations to avoid serious debilitating COVID-19 infection [51][52][53]. Pfizer-BioNtech was the first COVID-19 vaccine approved by the Saudi Food and Drug Authority (SFDA) on 10 December 2020 and was subsequently introduced in Saudi Arabia [54].…”

Immune Response and Safety of SARS-CoV-2 mRNA-1273 Vaccine in Patients With Myasthenia Gravis

“…In addition, although we were unable to measure the complete immune response, the methods we used were sufficiently efficient to assess immune response for the purposes of this study. 32 The main strength of this study is that it included a cohort of patients with MG taking a wide range of immunosuppressive therapies. Also this study gathered important information about the immune response after the COVID-19 vaccination protocol and adds new evidence to support the safety and efficacy of mRNA vaccines in patients with MG.…”

In vitro Characterization of SARS-CoV-2 Protein Translated from the Moderna mRNA-1273 Vaccine

“…The current coronavirus (COVID-19) pandemic has resulted in several FDA approved emergency use authorizations (EUA) to slow the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1 -3]. Messenger ribonucleic acid (mRNA) vaccines were at the forefront of these EUAs based on their efficacy and how they could be formulated to enter cells after intramuscular injection [4][5][6]. RNA delivery to cells had been a challenge for decades, however, the development of lipid nanoparticles and the modification with N1-methylpseudouridine greatly enhanced the efficacy of both Moderna's (Spikevax) and Pfizer-BioNTech's (Comirnaty) mRNA vaccines [7].…”