scholarly journals Vaccines and Allergic reactions: the past, the current COVID-19 pandemic, and future perspectives

2021 ◽  
Author(s):  
Vanitha Sampath ◽  
Grace Rabinowitz ◽  
Mihir Shah ◽  
Surabhi Jain ◽  
Zuzana Diamant ◽  
...  
Keyword(s):  
Disease Burden ◽  
Adverse Reactions ◽  
Future Research ◽  
Allergic Reactions ◽  
The Past ◽  
Post Marketing Surveillance ◽  
Different Types ◽  
Post Marketing ◽  
Underlying Mechanisms ◽  
Favorable Safety

Vaccines are essential public health tools with a favorable safety profile and prophylactic effectiveness that have historically played significant roles in reducing infectious disease burden in populations, when the majority of individuals are vaccinated. The COVID-19 vaccines are expected to have similar positive impacts on health across the globe. While serious allergic reactions to vaccines are rare, their underlying mechanisms and implications for clinical management should be considered to provide individuals with the safest care possible. In this review, we provide an overview of different types of allergic adverse reactions that can potentially occur after vaccination and individual vaccine components capable of causing the allergic adverse reactions. We present the incidence of allergic adverse reactions during clinical studies and through post-authorization and post-marketing surveillance and provide plausible causes of these reactions based on potential allergenic components present in several common vaccines. Additionally, we review implications for individual diagnosis and management and vaccine manufacturing overall. Finally, we suggest areas for future research.

Incidence of Roentgen Contrast Medium Reactions after Intravenous Injection in Pre-Registration Trials and Post-Marketing Surveillances

1993 ◽  
Vol 34 (3) ◽  
pp. 210-213 ◽  
Author(s):  
E. Andrew ◽  
T. Haider
Keyword(s):  
Relative Risk ◽  
Adverse Drug Reactions ◽  
Odds Ratio ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Feasible Method ◽  
Ionic Contrast ◽  
Different Types ◽  
Post Marketing ◽  
The Absolute

The relative risk of adverse drug reactions of ionic versus non-ionic contrast media injected i.v. were compared for different types of trials using odds-ratio. The absolute and relative risk found in large post-marketing trials were compared with that found in the iohexol pre-registration trials. The absolute risks were 2 to 10 times higher in the pre-registration trials compared to the post-marketing surveillances. The relative risk for all adverse drug reactions was 3 to 6 times higher for ionic vs. non-ionic media and independent of pre- or post-registration studies. The odds-ratio seems to be a feasible method of comparing the relative risk of adverse reactions in various trials.

scholarly journals Marine Cyanobacteria and Microalgae Metabolites—A Rich Source of Potential Anticancer Drugs

Marine Drugs ◽  
2020 ◽  
Vol 18 (9) ◽  
pp. 476
Author(s):  
Arijit Mondal ◽  
Sankhadip Bose ◽  
Sabyasachi Banerjee ◽  
Jayanta Kumar Patra ◽  
Jai Malik ◽  
...  
Keyword(s):  
Anticancer Drugs ◽  
Biological Activities ◽  
Structural Diversity ◽  
Critical Discussion ◽  
Future Research ◽  
Pharmaceutically Active Compounds ◽  
Action Current ◽  
The Past ◽  
Marine Metabolites ◽  
Underlying Mechanisms

Cancer is at present one of the utmost deadly diseases worldwide. Past efforts in cancer research have focused on natural medicinal products. Over the past decades, a great deal of initiatives was invested towards isolating and identifying new marine metabolites via pharmaceutical companies, and research institutions in general. Secondary marine metabolites are looked at as a favorable source of potentially new pharmaceutically active compounds, having a vast structural diversity and diverse biological activities; therefore, this is an astonishing source of potentially new anticancer therapy. This review contains an extensive critical discussion on the potential of marine microbial compounds and marine microalgae metabolites as anticancer drugs, highlighting their chemical structure and exploring the underlying mechanisms of action. Current limitation, challenges, and future research pathways were also presented.

scholarly journals “How to Do Things With Words”: Mechanisms Bridging Language and Action in Management Research

2018 ◽  
Vol 45 (1) ◽  
pp. 7-34 ◽  
Author(s):  
Christi Lockwood ◽  
Simona Giorgi ◽  
Mary Ann Glynn
Keyword(s):  
Future Research ◽  
Management Research ◽  
Quarter Century ◽  
Organizational Settings ◽  
The Past ◽  
Underlying Mechanisms

We review the past quarter century of literature linking language and action in management research published from 1993 through 2017. Different from recent in-depth reviews that focus narrowly on particular forms that words take, we look across these different kinds of word assemblages to uncover broad themes and mechanisms that link words with action outcomes in organizational settings. Classifying common conceptual approaches and prominent outcomes, we systematize and synthesize existing work on how to do things with words, identifying points of tension or contradiction as well as consistencies or overlaps across areas of research and methodologies. In addition, we go beyond typologies of how words are constructed to unearth how words function in the service of action; in so doing, we articulate three underlying mechanisms that connect words to action—resonance, enactment, and power—and discuss each. We end with a discussion of promising avenues for future research.

Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance

2015 ◽  
Vol 14 (9) ◽  
pp. 1341-1351 ◽  
Author(s):  
Maurizio Sessa ◽  
Claudia Rossi ◽  
Annamaria Mascolo ◽  
Enrico Grassi ◽  
Sonia Fiorentino ◽  
...  
Keyword(s):  
Contrast Media ◽  
Adverse Reactions ◽  
Campania Region ◽  
Post Marketing Surveillance ◽  
Suspected Adverse Reactions ◽  
Post Marketing

scholarly journals Risks of Skin, Hair, and Nail Supplements

2020 ◽  
pp. e2020089
Author(s):  
Emily K. Burns ◽  
Ariadna Perez-Sanchez ◽  
Rajani Katta
Keyword(s):  
Allergic Reactions ◽  
Post Marketing Surveillance ◽  
Increased Risk ◽  
Surveillance Programs ◽  
Post Marketing ◽  
Potential Risks ◽  
High Doses ◽  
Risk Of Cancer ◽  
Very High

Skin, hair, and nail supplements, sometimes referred to as “beauty supplements” or “ingestible skin care”, are a large and growing industry. These products may contain vitamins and minerals, sometimes in very high doses. They may also contain herbs, hormones, microbes, or animal derivatives such as fish oils and collagen powders. Dietary supplements are regulated as foods, not drugs, by the U.S. Food and Drug Administration. Therefore, manufacturers do not need to provide any proof of safety, efficacy, or quality prior to sale. This is of serious concern, as many adverse effects due to supplement components have been reported. The potential risks cover multiple categories. These include acute toxicities such as choking, as well as chronic toxicities, such as increased risk of diabetes. Teratogenicity and interaction with drugs and laboratory testing have been documented in research studies. Other risks include potentially increased risk of cancer with long-term use, allergic reactions, and others. It is vital that physicians educate their patients on these risks. As no post-marketing surveillance programs are required for supplements, our understanding of supplement risks is incomplete. Physicians should be wary of these risks and encourage further research and regulation.

Immediate allergic reactions after vaccinations – a post-marketing surveillance review

2001 ◽  
Vol 161 (1) ◽  
pp. 21-25 ◽  
Author(s):  
Olaf Zent ◽  
Cornelia Arras-Reiter ◽  
Michael Broeker ◽  
Renald Hennig
Keyword(s):  
Allergic Reactions ◽  
Post Marketing Surveillance ◽  
Post Marketing

scholarly journals THE HUMAN GUT MICROBIOME: CONSIDERATIONS TOWARD REGULATORY TESTING FOR DRUGS AND VACCINES

2021 ◽  
Vol 9 (02) ◽  
pp. 451-452
Author(s):  
Antonio Villanueva
Keyword(s):  
Medical Devices ◽  
Scientific Knowledge ◽  
Gut Microbiome ◽  
Human Gut ◽  
Human Gut Microbiome ◽  
Regulatory Authorities ◽  
The Past ◽  
Post Marketing Surveillance ◽  
Regulatory Testing ◽  
Post Marketing

Health regulatory authorities worldwide are tasked with approving drugs, medical devices, and vaccines to ensure their safety, efficacy, and quality for public use. Significantly over the past three decades, testing of these products has witnessed increasingly stringent tests due to advancing scientific knowledge and technology. Specifically, the relatively new field of studies on the human gut microbiome and its interactions with drugs and vaccines may accumulate enough evidence in the future to justify its testing prior to regulatory approval or during post-marketing surveillance.

scholarly journals Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

2021 ◽  
pp. 276-288
Author(s):  
S. Narmada ◽  
M. P. Gowrav ◽  
Akhilesh Akki ◽  
Vishakharaju Motupalli ◽  
V. Balamuralidhara ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Healthcare Providers ◽  
The United States ◽  
Reporting Rate ◽  
Global Perspective ◽  
Drug Reactions ◽  
Paediatric Patients ◽  
Post Marketing Surveillance ◽  
Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

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