A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults

Abstract

We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 μg BNT162b2 or placebo 21 days apart. Overall, 160 individuals were randomized: 119 received BNT162b2, and 41 received placebo. Participants were stratified by age: 20–64 years (n = 130) and 65–85 years (n = 30). More than 97% of BNT162b2 recipients received 2 doses. Local reactions and systemic events were generally transient and mild to moderate. Severe adverse events were uncommon; there were no serious adverse events. One month after dose 2, SARS-CoV-2 50% serum neutralizing geometric mean titers were 571 and 366, and geometric mean fold rises were 55.8 and 36.6, in the younger and older age groups, respectively. In summary, BNT162b2 has an acceptable safety profile and produces a robust immune response, regardless of age, in Japanese adults. (ClinicalTrials.gov, NCT04588480).

Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial

“…Interestingly, the incidence of fever in the present study after the second vaccination (all grade, 9/150 [6.0%]; grade ≥ 3, 1/150 [0.7%]) appeared to be lower than that of mRNA vaccines, tested in Asian populations [9] , [10] . In a phase 1/2 study conducted in Japan, the SARS-CoV-2 BNT162b2 mRNA vaccine administered at the recommended dose of 30 µg was associated with fever after the second dose in ∼ 37% of adult participants (aged 20–64 years) and in ∼ 14% of older participants (aged 65–85 years), with grade 3 events occurring in 1% of the younger and 0% of the older participants [10] . No new safety concerns were identified in the present study.…”

Efficacy, immunogenicity and safety of COVID-19 vaccines in older adults: a systematic review and meta-analysis

“…All eligible studies were phase I to III clinical trials, and no data from phase IV clinical trials were reported. Approximately one-third of the eligible studies were observer-blinded (n = 10) ( 51 , 52 , 55 , 58 , 59 , 65 , 67 , 71 , 73 , 74 ), and two-thirds were double-blind (n = 22) ( Tables 2 , 3 , and Table S1 ). Additionally, the assessment results of the bias risk for individual studies are illustrated in Figure S6 .…”

Efficacy and safety of mRNA SARS-CoV-2 vaccines in lung transplant recipients

“…On the other hand, the Japanese controls in our study had more episodes of systemic fever than the recipients (62.5% vs. 4.9%, p < .0001). Systemic fever, especially after the 2nd dose, is common in the Japanese population; 44.1% of health-care workers had body temperatures ≥38.0 °C [ 21 ], and approximately 40% of participants in different placebo-controlled studies developed fever [ 22 ]. Chapin-Bardales et al presented that 8.6% and 29.5% of vaccinated US citizens developed fever following the 1st and 2nd doses of mRNA vaccines, respectively [ 23 ].…”