Vaccine-associated enhanced respiratory disease

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Vaccine-associated enhanced respiratory disease (VAERD), or simply enhanced respiratory disease (ERD), is an adverse event where an exacerbated course of respiratory disease occurs with higher incidence in the vaccinated population than in the control group. It is a barrier against vaccine development that can lead to its failure. [1]

Immunologically, VAERD is characterized with an exaggerated Th2 response and eosinophilic pulmonary infiltrations. [2] It may result from antibody-mediated complement activation followed by weak neutralization. [3]

Historical instances of the phenomenon were seen in vaccine candidates for respiratory syncytial virus (RSV), SARS-CoV, Middle East Respiratory Syndrome (MERS), and some influenza strains. [1] [4] [5] Thus, COVID-19 vaccine clinical research involved monitoring for VAERD because the vaccine target, SARS-CoV-2, belongs to the same viral subfamily as SARS-CoV and MERS. The effect was not shown in phase III clinical trials for Tozinameran or for the Moderna vaccine. [2] [6]

References

  1. 1 2 Acosta, Patricio L.; Caballero, Mauricio T.; Polack, Fernando P.; Papasian, C. J. (2016). "Brief History and Characterization of Enhanced Respiratory Syncytial Virus Disease". Clinical and Vaccine Immunology. 23 (3): 189–195. doi: 10.1128/CVI.00609-15 . ISSN   1556-6811. PMC   4783420 . PMID   26677198.
  2. 1 2 Baden, Lindsey R.; El Sahly, Hana M.; Essink, Brandon; Kotloff, Karen; Frey, Sharon; Novak, Rick; Diemert, David; Spector, Stephen A.; Rouphael, Nadine; Creech, C. Buddy; McGettigan, John; Khetan, Shishir; Segall, Nathan; Solis, Joel; Brosz, Adam; Fierro, Carlos; Schwartz, Howard; Neuzil, Kathleen; Corey, Larry; Gilbert, Peter; Janes, Holly; Follmann, Dean; Marovich, Mary; Mascola, John; Polakowski, Laura; Ledgerwood, Julie; Graham, Barney S.; Bennett, Hamilton; Pajon, Rolando; Knightly, Conor; Leav, Brett; Deng, Weiping; Zhou, Honghong; Han, Shu; Ivarsson, Melanie; Miller, Jacqueline; Zaks, Tal (2021). "Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine". New England Journal of Medicine. 384 (5): 403–416. doi: 10.1056/NEJMoa2035389 . ISSN   0028-4793. PMC   7787219 . PMID   33378609.
  3. Richard W. Compans; Michael B. A. Oldstone (8 October 2014). Influenza Pathogenesis and Control - Volume I. Springer. pp. 315–320. ISBN   978-3-319-11155-1.
  4. Agrawal, Anurodh Shankar; Tao, Xinrong; Algaissi, Abdullah; Garron, Tania; Narayanan, Krishna; Peng, Bi-Hung; Couch, Robert B.; Tseng, Chien-Te K. (2016). "Immunization with inactivated Middle East Respiratory Syndrome coronavirus vaccine leads to lung immunopathology on challenge with live virus". Human Vaccines & Immunotherapeutics. 12 (9): 2351–2356. doi: 10.1080/21645515.2016.1177688 . ISSN   2164-5515. PMC   5027702 . PMID   27269431.
  5. Bottazzi, Maria Elena; Strych, Ulrich; Hotez, Peter J.; Corry, David B. (2020). "Coronavirus vaccine-associated lung immunopathology-what is the significance?". Microbes and Infection. 22 (9): 403–404. doi:10.1016/j.micinf.2020.06.007. ISSN   1286-4579. PMC   7318931 . PMID   32599077.
  6. FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request (PDF) (Report). U.S. Food and Drug Administration (FDA). 10 December 2020. Retrieved 11 December 2020.