Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Feb 18;384(7):643-649.
doi: 10.1056/NEJMra2035343. Epub 2020 Dec 30.

Maintaining Safety with SARS-CoV-2 Vaccines

Mariana C Castells  1 , Elizabeth J Phillips  1
Affiliations
Review

Maintaining Safety with SARS-CoV-2 Vaccines

Mariana C Castells et al. N Engl J Med. .
No abstract available

PubMed Disclaimer

Figures

Figure 1
Figure 1. Assessing Reactions to Vaccines.
SARS-CoV-2 mRNA vaccines are built on the same lipid-based nanoparticle carrier technology; however, the lipid component of the Pfizer-BioNTech vaccine differs from that of the Moderna vaccine. Operation Warp Speed has led to an unprecedented response to the study of the safety and effectiveness of new vaccine platforms never before used in humans and to the development of vaccines that have been authorized for use less than a year after the SARS-CoV-2 viral sequence was discovered. The next few months could see the authorization of several such vaccines, and inevitably, adverse drug events will be recognized in the coming months that were not seen in the studies conducted before emergency use authorization. Maintenance of vaccine safety requires a proactive approach to maintain public confidence and reduce vaccine hesitancy. This approach involves not only vigilance but also meticulous response, documentation, and characterization of these events to heighten recognition and allow definition of mechanisms and appropriate approaches to prediction, prevention, and treatment. A systematic approach to an adverse reaction to any vaccine requires clinical recognition and appropriate initial treatment, followed by a detailed history and causality assessment. Nonimmune immediate reactions such as vasovagal reactions are common and typically manifest with diaphoresis, nausea, vomiting, pallor, and bradycardia, in contrast to the flush, pruritus, urticaria, angioedema, tachycardia, and laryngeal edema seen with anaphylaxis. Post-reaction clinical assessment by an allergist–immunologist that includes skin testing for allergy to components of the vaccine can be helpful. Use of other laboratory information may aid in clinical and mechanistic assessment and guide future vaccine and drug safety as well as management, such as rechallenge with alternative vaccines if redosing is required. A useful resource for searching the excipients of drugs and vaccines is https://dailymed.nlm.nih.gov/dailymed/. A useful resource for excipients in licensed vaccines is https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf.
See this image and copyright information in PMC

Comment in

  • Maintaining Safety with SARS-CoV-2 Vaccines.
    Rolla G, Brussino L, Badiu I. Rolla G, et al. N Engl J Med. 2021 Mar 11;384(10):e37. doi: 10.1056/NEJMc2100766. Epub 2021 Feb 10. N Engl J Med. 2021. PMID: 33567189 No abstract available.

References

    1. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020;383:2603-2615. - PMC - PubMed
    1. Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med 2020;383:1920-1931. - PMC - PubMed
    1. Dooling K, McClung N, Chamberland M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for allocating initial supplies of COVID-19 vaccine — United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1857-1859. - PMC - PubMed
    1. Bochner BS, Lichtenstein LM. Anaphylaxis. N Engl J Med 1991;324:1785-1790. - PubMed
    1. Castells M. Diagnosis and management of anaphylaxis in precision medicine. J Allergy Clin Immunol 2017;140:321-333. - PubMed

MeSH terms