JAMA Network Open: Effects of trialic adsive vs trialic high-dose inactivated influenza vaccine on safety, responsiveness, and health-related quality of life in older adults

Older people are at high risk of developing severe influenza disease, cardiovascular events, hospitalization, decreased function and death after influenza virus infection.
1-10 hospitalizations for laboratory-confirmed influenza in people 65 years of age or older were 10 times higher than among young people.
estimates that 71 to 90 percent of influenza deaths occur in adults 65 years of age or older.
, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that you get a U.S.-approved, age-appropriate flu vaccine every year.
In the United States, only influenza vaccines allowed for use by people 65 years of age and older include triple-price high-dose influenza inactivated vaccine (HD-IIV3), tri-price adulation influenza inactivated vaccine (aIIV3), four-price high-dose influenza inactivated vaccine (HD-IIV4) and four-price inactivated influenza vaccine (aIIV4).
study found that HD-IIV3 and aIIV3 were slightly more effective than the three-price standard dose of adulation-free inactivated influenza vaccine (SD-IIV3).
a study of Medicare beneficiaries 65 and older found that nearly three-quarters of those vaccinated received aIIV3 or HD-IIV3 during the 2017-2018 flu season.
the safety and responsiveness of these vaccines may also be a factor in the selection of vaccines.
compared with SD-IIV3, the proportion of local and systemic reactions of aIIV3 and HD-IIV3 was higher, and in the same clinical trial, there was no direct comparison of the safety of aIIV3 and HD-IIV3, nor was there a comparison of the relative effects of aIIV3 and HD-IIV3 reactions on the health-related quality of life (HRQOL) in older adults after short-term vaccination.
To further collect data on the relative safety, reactivity, and health-related quality of life (HRQOL) effects of these vaccines, a recent study published by JAMA Network Open conducted qualification assessments and corresponding statistical analysis of 778 adult community residents over the age of 65 between 2017 and 2018 and 2018 and 2019 flu seasons.
researchers assessed the eligibility of 778 participants in two flu seasons.
8 participants withdrew and 13 others did not meet the eligibility criteria, resulting in 757 random participants; 378 people were treated with aIIV3 and 379 with HD-IIV3.
of the 757 random participants, 420 were women (55%) and 589 were white (78%), with a middle age (range) of 72 (65-97).
demographic and clinical characteristics of the two groups of random subjects were similar.
study registration flowchart showed that the post-vaccination of aIIV3 (12 subjects (3.2 per cent) was the most severe compared to HD-IIV3 (22 subjects (5.8 per cent)) The proportion of pain and limited mobility at the injection site (main results) was no less than that of HD-IIV3 (22 subjects (5.8%)) (difference 2.7%; 95% CI, 5.8 to 0.4).
10 reactions met the non-poor performance criteria of aIIV3 and 4 cases (moderate to severe injection site pressure, joint pain, fatigue, discomfort) did not meet.
whether the four reactions showed up at a higher percentage of participants after aIIV3 were available.
no participants sought medical attention for the vaccine response.
AECI was not observed.
9 participants had at least ONE (2.4%; 95% CI, 1.1% to 4.5%) after a IIV3, and 3 participants had at least 1 SAE (0.8%; 95% CI, 0.2% to 2.2%) after HD-IIV3.
no SAE is associated with vaccination.
changes in HRQOL scores before and after vaccination were not clinically significant and there was no difference between the two groups.
the difference between the reactions of the triethic adrenatic inactivated vaccine (aIIV3) and the triple-price high-dose inactivated vaccine (HD-IIV3), the safety of aIIV3 and HD-IIV3 was consistent with the safety found in the pre-insurance studies of each vaccine.
4.2 percent and 4.0 percent of patients who received the aIIV3 and HD-IIV3 vaccines in the pre-insurance study had moderate to severe injection site pain, respectively, compared with 3.2 percent and 5.8 percent in the study.
, there were no serious adverse vaccine-related events in the trials comparing aIIV3 and HD-IIV3 in older adults, and the safety results were consistent with pre-insurance data.
of participants with moderate to severe injection site pain after aaIIV3 was no higher than HD-IIV3.
HRQOL is similar after vaccination.
from a safety perspective, the results suggest that any vaccine is an acceptable option to prevent influenza in older adults.
: Schmader KE, Liu CK, Harrington T, et al. Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2021; 4(1):e2031266. doi:10.1001/jamanetworkopen.2020.31266MedSci Original Source: MedSci Original Copyright Notice: All noted on this website "Source: Metz Medicine" or "Source: MedSci Original" text, images and audio and video materials, copyrights are owned by Metz Medical, without authorization, no media, website or individual may reproduce, authorized to reproduce with the words "Source: Mets Medicine".
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