ABSTRACT
Introduction: This study assessed the immunogenicity and safety of BNT162b2 mRNA vaccine in lung cancer patients receiving anticancer treatment using two immunoassays. Methods: We enrolled lung cancer patients receiving anticancer treatment and non-cancer patients with chronic diseases; all participants were fully vaccinated with the BNT162b2 vaccine. Blood samples were collected before the first and second vaccinations and 4 {+/-} 1 weeks after the second vaccination. Anti-acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein S1 subunit receptor-binding domain antibody titers were measured using the Architect SARS-CoV-2 IgG II Quant (Abbott Laboratory) and Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics). Results: Fifty-five lung cancer patients and 38 non-cancer patients were included in the immunogenicity analysis. Lung cancer patients showed significant increase in the geometric mean antibody titer, which was significantly lower than that in the non-cancer patients after the first (30 vs. 121 AU/mL, p<0.001 on Architect; 4.0 vs 1.2 U/mL, p<0.001, on Elecsys) and second vaccinations (1632 vs. 3472 AU/mL, p=0.005, on Architect; 213 vs 573 A/mL, p=0.002, on Elecsys). The adjusted odds ratio (OR) for seroprotection was significantly lower in the lung cancer patients. Analysis of the anticancer treatment types showed that the adjusted OR for seroprotection was significantly lower in lung cancer patients receiving cytotoxic agents. Lung cancer patients showed no increase in the number of adverse reactions. Conclusions: BNT162b2 vaccination in lung cancer patients undergoing anticancer treatment significantly increased antibody titers and showed acceptable safety. However, the immunogenicity in these patients could be inadequate compared with that in non-cancer patients.
Subject(s)
Coronavirus Infections , Neoplasms , Chronic Disease , Lung Neoplasms , COVID-19ABSTRACT
Background: Although high vaccine effectiveness of messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines was reported in studies in several countries, data is limited from Asian countries, especially against the Delta (B.1.617.2) variant. Methods: We conducted a multicenter test-negative case-control study in patients aged [≥]16 visiting hospitals or clinics with signs or symptoms consistent with COVID-19 from July 1 to September 30, 2021, when the Delta variant was dominant ([≥]90% of severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] infections) nationwide in Japan. Vaccine effectiveness of BNT162b2 or mRNA-1273 against symptomatic SARS-CoV-2 infections was evaluated. Waning immunity among patients aged 16 to 64 was also assessed. Results: We enrolled 1936 patients, including 396 test-positive cases and 1540 test-negative controls for SARS-CoV-2. The median age was 49 years, 53.4% were male, and 34.0% had underlying medical conditions. Full vaccination (receiving two doses [≥]14 days before symptom onset) was received by 6.6% of cases and 38.8% of controls. Vaccine effectiveness of full vaccination against symptomatic SARS-CoV-2 infections was 88.7% (95% confidence interval [CI], 78.8 to 93.9) among patients aged 16 to 64 and 90.3% (95% CI, 73.6 to 96.4) among patients aged [≥]65. Among patients aged 16 to 64, vaccine effectiveness within one to three months after full vaccination was 91.8% (95% CI, 80.3 to 96.6), and was 86.4% (95% CI, 56.9 to 95.7) within four to six months. Conclusions: mRNA COVID-19 vaccines had high effectiveness against symptomatic SARS-CoV-2 infections in Japan during July 1 to September 30, 2021, when the Delta variant was dominant nationwide.