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Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older.
JAMA Netw Open. 2020 05 01; 3(5):e204079.JN

Abstract

Importance

Every year, influenza vaccines are administered to millions of people worldwide to reduce morbidity and mortality from influenza. As new vaccine formulations are increasingly used, monitoring and comparing safety, in addition to vaccine effectiveness, in target populations are essential.

Objective

To assess the postmarketing safety profile of 2018 Southern Hemisphere influenza vaccines, particularly 2 new enhanced trivalent inactivated influenza vaccines: an adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3), among Australian individuals 65 years or older.

Design, Setting, and Participants

This cohort study used solicited short message service-based self-reported survey data on adverse events occurring within 3 to 5 days after receipt of an influenza vaccination. Participants included individuals 65 years or older who received routinely recommended influenza vaccines at 1 of 265 sentinel immunization sites, including primary care, hospital, and community-based clinics, participating in Australia's AusVaxSafety active vaccine safety surveillance system from April 1 to August 31, 2018. Data were analyzed from September 1, 2018, to June 30, 2019.

Exposure

Any licensed 2018 influenza vaccine administered in clinical practice.

Main Outcomes and Measures

Rates (overall, by brand, and by concomitant vaccine receipt) of adverse events, including medical attendance as a proxy for serious adverse events.

Results

Of 72 013 individuals 65 years or older who received an influenza vaccine in 2018, 50 134 individuals (69.6%) responded to the initial survey regarding adverse events experienced after vaccination (median [interquartile range] age, 71 [68-76] years; 27 056 [54.0%] women). Most individuals received an enhanced trivalent inactivated influenza vaccine, including 28 003 individuals (55.9%) who received aIIV3 and 19 306 individuals (38.5%) who received HD-IIV3; 2208 individuals (4.4%) received a quadrivalent inactivated influenza vaccine. Individuals who received HD-IIV3 reported significantly higher rates of any adverse event compared with individuals who received aIIV3 (1716 individuals [8.9%] vs 1796 individuals [6.4%]; P < .001) as well as specific adverse events, including fever (195 individuals [1.1%] vs 164 individuals [0.6%]; P < .001), injection site pain (383 individuals [2.1%] vs 350 individuals [1.3%]; P < .001), and injection site swelling or redness (256 individuals [1.4%] vs 248 individuals [0.9%]; P < .001). Adverse event rates reported by those receiving any quadrivalent inactivated influenza vaccine were similar to rates reported by those receiving aIIV3. Rates of medical care seeking for adverse events associated with aIIV3 and HD-IIV3 were low and comparable (80 individuals [0.3%] vs 56 individuals [0.3%]; P = .91).

Conclusions and Relevance

The findings of this large-scale participant-based postmarketing assessment of the safety of 2 new enhanced influenza vaccines used in individuals 65 years or older provide reassuring near-real-time and cumulative data to inform and support confidence in ongoing vaccine use.

Authors+Show Affiliations

National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, Australia. Faculty of Health and Medicine, University of Sydney, Camperdown, Australia.Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, Australia. Faculty of Health and Medicine, University of Sydney, Camperdown, Australia.Hunter New England Population Health, Newcastle, Australia.Faculty of Health and Medicine, University of Sydney, Camperdown, Australia. School of Medicine, University of Western Australia, Perth, Australia. Perth Children's Hospital, Perth, Australia. Department of Microbiology, PathWest Laboratory Medicine, QEII Medical Centre, Perth, Australia.SmartVax, Illawarra Medical Centre, Ballajura, Australia.National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, Australia. Faculty of Health and Medicine, University of Sydney, Camperdown, Australia.

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32369177

Citation

Pillsbury, Alexis J., et al. "Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older." JAMA Network Open, vol. 3, no. 5, 2020, pp. e204079.
Pillsbury AJ, Fathima P, Quinn HE, et al. Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older. JAMA Netw Open. 2020;3(5):e204079.
Pillsbury, A. J., Fathima, P., Quinn, H. E., Cashman, P., Blyth, C. C., Leeb, A., & Macartney, K. K. (2020). Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older. JAMA Network Open, 3(5), e204079. https://doi.org/10.1001/jamanetworkopen.2020.4079
Pillsbury AJ, et al. Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older. JAMA Netw Open. 2020 05 1;3(5):e204079. PubMed PMID: 32369177.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older. AU - Pillsbury,Alexis J, AU - Fathima,Parveen, AU - Quinn,Helen E, AU - Cashman,Patrick, AU - Blyth,Christopher C, AU - Leeb,Alan, AU - Macartney,Kristine K, Y1 - 2020/05/01/ PY - 2020/5/6/entrez PY - 2020/5/6/pubmed PY - 2020/10/27/medline SP - e204079 EP - e204079 JF - JAMA network open JO - JAMA Netw Open VL - 3 IS - 5 N2 - Importance: Every year, influenza vaccines are administered to millions of people worldwide to reduce morbidity and mortality from influenza. As new vaccine formulations are increasingly used, monitoring and comparing safety, in addition to vaccine effectiveness, in target populations are essential. Objective: To assess the postmarketing safety profile of 2018 Southern Hemisphere influenza vaccines, particularly 2 new enhanced trivalent inactivated influenza vaccines: an adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3), among Australian individuals 65 years or older. Design, Setting, and Participants: This cohort study used solicited short message service-based self-reported survey data on adverse events occurring within 3 to 5 days after receipt of an influenza vaccination. Participants included individuals 65 years or older who received routinely recommended influenza vaccines at 1 of 265 sentinel immunization sites, including primary care, hospital, and community-based clinics, participating in Australia's AusVaxSafety active vaccine safety surveillance system from April 1 to August 31, 2018. Data were analyzed from September 1, 2018, to June 30, 2019. Exposure: Any licensed 2018 influenza vaccine administered in clinical practice. Main Outcomes and Measures: Rates (overall, by brand, and by concomitant vaccine receipt) of adverse events, including medical attendance as a proxy for serious adverse events. Results: Of 72 013 individuals 65 years or older who received an influenza vaccine in 2018, 50 134 individuals (69.6%) responded to the initial survey regarding adverse events experienced after vaccination (median [interquartile range] age, 71 [68-76] years; 27 056 [54.0%] women). Most individuals received an enhanced trivalent inactivated influenza vaccine, including 28 003 individuals (55.9%) who received aIIV3 and 19 306 individuals (38.5%) who received HD-IIV3; 2208 individuals (4.4%) received a quadrivalent inactivated influenza vaccine. Individuals who received HD-IIV3 reported significantly higher rates of any adverse event compared with individuals who received aIIV3 (1716 individuals [8.9%] vs 1796 individuals [6.4%]; P < .001) as well as specific adverse events, including fever (195 individuals [1.1%] vs 164 individuals [0.6%]; P < .001), injection site pain (383 individuals [2.1%] vs 350 individuals [1.3%]; P < .001), and injection site swelling or redness (256 individuals [1.4%] vs 248 individuals [0.9%]; P < .001). Adverse event rates reported by those receiving any quadrivalent inactivated influenza vaccine were similar to rates reported by those receiving aIIV3. Rates of medical care seeking for adverse events associated with aIIV3 and HD-IIV3 were low and comparable (80 individuals [0.3%] vs 56 individuals [0.3%]; P = .91). Conclusions and Relevance: The findings of this large-scale participant-based postmarketing assessment of the safety of 2 new enhanced influenza vaccines used in individuals 65 years or older provide reassuring near-real-time and cumulative data to inform and support confidence in ongoing vaccine use. SN - 2574-3805 UR - https://www.unboundmedicine.com/medline/citation/32369177/Comparative_Postmarket_Safety_Profile_of_Adjuvanted_and_High_Dose_Influenza_Vaccines_in_Individuals_65_Years_or_Older_ L2 - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/10.1001/jamanetworkopen.2020.4079 DB - PRIME DP - Unbound Medicine ER -