An Overview of COVID-19 Vaccine Safety and Post-marketing Surveillance Systems

Younus, Manal M.; Al‐Jumaili, Ali Azeez

doi:10.24926/iip.v12i4.4294

Cited by 9 publications

(6 citation statements)

References 10 publications

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“…Vaccine development was also able to be expedited by building upon experience gained from development of severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) vaccines, 13 and because developers had clinical, regulatory, and manufacturing experience with mRNA formats and lipid nanoparticle (LNP)-based formulations. 14 , 15 In accordance with guidance issued in early 2020, led by the International Coalition of Medicines Regulatory Authorities (ICMRA), well-characterized toxicology data could be leveraged across closely related vaccines using the same platform technology (e.g., same RNA formats and LNPs).…”

Section: Resultsmentioning

confidence: 99%

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

van den Ouweland,

Charpentier,

Türeci

et al. 2024

Human Vaccines & Immunotherapeutics

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The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public access to protective vaccines while maintaining regulatory agency standards. Although development timelines for vaccines against SARS-CoV-2 were much quicker than standard vaccine development timelines, regulatory requirements for efficacy and safety evaluations, including the volume and quality of data collected, were upheld. Rolling review processes supported by sponsors and regulatory authorities enabled rapid assessment of clinical data as well as emergency use authorization. Post-authorization and pharmacovigilance activities enabled the quantity and breadth of post-marketing safety information to quickly exceed that generated from clinical trials. This paper reviews safety and reactogenicity data for the BNT162 vaccine candidates, including BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) and bivalent variant-adapted BNT162b2 vaccines, from preclinical studies, clinical trials, post-marketing surveillance, and real-world studies, including an unprecedentedly large body of independent evidence.

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Section: Resultsmentioning

confidence: 99%

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

van den Ouweland,

Charpentier,

Türeci

et al. 2024

Human Vaccines & Immunotherapeutics

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“…Therefore, it makes sense to be careful and conduct an extensive postmarketing surveillance, even though their safety and effectiveness were established in matching clinical trials. [ 7 ] Numerous clinical studies have shown that the majority of vaccines cause a Th1 response, increasing the serum levels of interleukin (IL)-2, tumour necrosing factor (TNF) and interferon (IFN), which are involved in the onset of lichen planus. [ 8 ] Up-regulation of Th1 and an increase in pro-apoptotic cytokines like TNF and IFN have been identified as important factors responsible for the basal keratinocyte death found in this skin disorder, despite the fact despite the fact that the exact pathophysiology is unknown.…”

Section: Discussionmentioning

confidence: 99%

Lichen planus triggered by COVID-19 vaccination: A case series

Narasimhan,

Ramakrishnan,

Varri

et al. 2024

Journal of Family Medicine and Primary Care

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Lichen planus, an autoimmune inflammatory condition, has been linked to medications, vaccinations, and infections. Several clinical studies have shown that majority of vaccines trigger a Th1 response, which raises the blood levels of IL-2, TNF & IFN, and may be linked to the development of lichen planus. It has recently been documented to happen with mRNA-based COVID-19 vaccinations, especially the Pfizer/BioNTech vaccine. We present a case series of lichen planus that appeared after receiving the COVISHIELD vaccine from Oxford-AstraZeneca. In order to rule out any further potential triggers, like recent infections, prior drug use, smoking, dental treatments, etc., a thorough history was collected in each instance. Skin biopsies were used to confirm each case’s diagnosis. In nearly all of the cases, skin biopsies revealed typical dermatopathological features of lichen planus.

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“…Other potentially beneficial AMS intervention opportunities include monitoring for reactogenicity and safety after vaccination, following up with patients to ensure series completion, and ensuring the quality use of vaccines, including appropriate storage, preparation, and administration. Where vaccine development previously took 15 years or longer, the COVID-19 pandemic has accelerated regulatory pathways, with new vaccines now able to enter the market in just 10–18 months [ 69 ]. This is significant as in surveys of self-reported ‘vaccine hesitant’ individuals, a lack of long-term data is provided as one of the main reasons for their beliefs [ 70 ].…”

Section: Discussionmentioning

confidence: 99%

The Role of Adult Vaccines as Part of Antimicrobial Stewardship: A Scoping Review

Williams,

Zaidi,

Saini

et al. 2023

Antibiotics

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Background: Antimicrobial resistance (AMR) is a significant global health concern, causing an estimated 700,000 deaths annually. Although immunisation has been shown to significantly reduce AMR, the role of vaccines as part of antimicrobial stewardship (AMS) practices is often overlooked. Objective: To identify and examine the available literature on the role of vaccines as part of AMS practices. Method: A scoping review was conducted in the following databases: MEDLINE, Embase, Scopus, CINAHL, CCRCT, IPA, and WoS, along with grey literature sources. The review was conducted using the JBI Methodology for Scoping Reviews and reported in line with the PRISMA-SCr checklist. Results: Among the 1711 records identified, 34 met the inclusion criteria; 8 discussed only the concept, while 26 discussed both the concept and the vaccine implementation method in AMS practices. There were eight recommended and/or utilised types of AMS activities identified involving vaccines, under four key themes of vaccine-related AMS strategies: Education, Screening, Vaccination, and Monitoring. Influenza and pneumococcal vaccines had the most evidence for inclusion. Conclusion: Overall, the evidence supports the role of vaccines as part of AMS practices and the value of their inclusion in creating improved and comprehensive AMS strategies to further combat the development of AMR.

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An Overview of COVID-19 Vaccine Safety and Post-marketing Surveillance Systems

Cited by 9 publications

References 10 publications

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

Lichen planus triggered by COVID-19 vaccination: A case series

The Role of Adult Vaccines as Part of Antimicrobial Stewardship: A Scoping Review

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