Immunogenicity and safety of an inactivated virus vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases

Abstract

CoronaVac(SARS-CoV-2 inactivated vaccine) has been largely used as the main immunogen for COVID-19 in several countries. However, its immunogenicity in immunocompromised individuals has not been established. This was a prospective controlled study of 910 adult ARD patients and 182 age- and sex-matched control group(CG) who received two doses of CoronaVac in a 28-days interrval. Anti-SARS-Cov-2 IgG and neutralizing antibodies were assessed at each vaccine shot and 6 weeks after the 2nd dose. Vaccine adverse events(AE) were similar in both groups. We observed significant lower anti-SARS-Cov-2 IgG seroconversion(70.4% vs. 95.5%,p < 0.001) and titers[12.1(95%CI 11.0-13.2) vs. 29.7(95%CI 26.3–33.5),p < 0.001], frequency of neutralizing antibodies(56.3% vs. 79.3%),p < 0.001) and median (interquartile range) neutralization activity [58.7(43.1–77.2) vs. 64.5(48.4–81.4),p = 0.013] in ARD patients compared to CG. A significant decline in the number of COVID-19 cases (p < 0.0001) were observed 10 days after the second dose, with a predominant P1 variant. Safety analysis revealed no moderate/severe AEs. In conclusion, CoronaVac has an excellent safety profile and reasonable rates of quantitative serology(70.4%)/neutralization(56.3%) in ARD patients. The impact of this reduced immunogenicity in vaccine effectiveness warrants further evaluation.

Equity Considerations in COVID‐19 Vaccination Studies of Individuals With Autoimmune Inflammatory Rheumatic Diseases

“…All 19 studies described participant age and sex. Five studies (26%) described the distribution of participant race or ethnicity ( 21 , 23 , 24 , 25 , 26 ), and 4 studies (21%) described multimorbidity ( 20 , 27 , 28 , 29 ). Two studies (11%) focused on assessing response to vaccination in health care workers; thus occupation was described ( 20 , 27 ).…”

“…The remaining 17 studies quantitatively analyzed outcomes. Eight studies (47%) controlled for at least 1 PROGRESS‐Plus factor by 1 of the following methods: covariate adjustment ( 20 , 21 , 22 , 24 , 33 ), limiting analyses to 1 category of a selected confounder ( 34 ), or matching individuals with AIRDs with healthy controls ( 20 , 28 , 33 , 35 ).…”

“…One study accounted for the difference in age of individuals with AIRDs compared to healthy controls by restricting analysis to participants age ≤55 years ( 34 ). Of the 9 studies with a comparison between participants with AIRDs and healthy controls ( 20 , 21 , 22 , 23 , 28 , 29 , 33 , 34 , 35 ), 4 (44%) matched by age and sex ( 20 , 28 , 33 , 35 ).…”

“…Excluding the 2 studies that reported findings narratively ( 27 , 31 ), 8 of 17 studies (47%) analyzed outcomes across at least 1 PROGRESS‐Plus factor ( 20 , 24 , 28 , 30 , 33 , 36 , 37 , 38 ). Subgroup analysis across age was conducted in all 8, followed by sex (6 studies, 35%) ( 24 , 28 , 33 , 36 , 37 , 38 ), race or ethnicity (4 studies, 24%) ( 28 , 36 , 37 , 38 ), and occupation (1 study, 6%) ( 20 ).…”

“…Ten studies (53%) discussed at least 1 PROGRESS‐Plus factor in the applicability of the results ( 20 , 21 , 22 , 25 , 26 , 28 , 29 , 32 , 34 , 37 ). Age was most commonly discussed (9 studies, 47%) ( 20 , 22 , 25 , 26 , 28 , 29 , 32 , 34 , 37 ), followed by race or ethnicity (3 studies, 16%) ( 21 , 25 , 37 ), sex (3 studies, 16%) ( 25 , 26 , 37 ), multimorbidity (2 studies, 11%) ( 20 , 22 ), and occupation (1 study, 5%) ( 20 ).…”