Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial

Hui, Ai‐Min; Li, Jingxin; Zhu, Li; Tang, Rong; Ye, Huayue; Lin, Mei; Ge, Lei; Wang, Xiyuan; Peng, Fuzhong; Wu, Zhenggang; Guo, Xiling; Shi, Yunfeng; Pan, Hongxing; Zhu, Jiahong; Song, Zhizhou; Qiu, Jingjun; Wang, Wei; Zheng, Jianfei; Ozhelvaci, Orkun; Shpyro, Svetlana; Bushway, Meghan E.; Derhovanessian, Evelyna; Kühnle, Marie-Cristine; Luxemburger, Ulrich; Muik, Alexander; Shishkova, Yoana; Khondker, Zakaria; Hu, Shiqing; Lagkadinou, Eleni; Şahin, Uğur; Türeci, Özlem; Zhu, Fengcai

doi:10.1016/j.lanwpc.2022.100586

Cited by 8 publications

(9 citation statements)

References 32 publications

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“…Overall, the clinical development program for BNT162b2 included the largest pivotal registrational COVID-19 vaccine trial conducted to date and evaluated more than 44,000 participants >12 years of age from around the world ( Table 3 ). 19 , 38 These findings were supported by further study in different world regions 31 , 35 and Phase II/III trials in children >6 months of age. 21 , 36 , 37 …”

Section: Resultssupporting

confidence: 53%

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Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

van den Ouweland,

Charpentier,

Türeci

et al. 2024

Human Vaccines & Immunotherapeutics

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The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public access to protective vaccines while maintaining regulatory agency standards. Although development timelines for vaccines against SARS-CoV-2 were much quicker than standard vaccine development timelines, regulatory requirements for efficacy and safety evaluations, including the volume and quality of data collected, were upheld. Rolling review processes supported by sponsors and regulatory authorities enabled rapid assessment of clinical data as well as emergency use authorization. Post-authorization and pharmacovigilance activities enabled the quantity and breadth of post-marketing safety information to quickly exceed that generated from clinical trials. This paper reviews safety and reactogenicity data for the BNT162 vaccine candidates, including BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) and bivalent variant-adapted BNT162b2 vaccines, from preclinical studies, clinical trials, post-marketing surveillance, and real-world studies, including an unprecedentedly large body of independent evidence.

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Section: Resultssupporting

confidence: 53%

“…The reactogenicity and safety profile of BNT162b2 in this population was consistent with that of the global Phase II/III trial. 35 …”

Section: Resultsmentioning

confidence: 99%

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

van den Ouweland,

Charpentier,

Türeci

et al. 2024

Human Vaccines & Immunotherapeutics

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“…In the adult participants, the median of spots forming units (SFUs) per 10 6 PBMCs were elevated from 85 and 25 at baseline to 391 and 120 on Day 35 for IFN-γ-ELISpot, and from 8 and 5 at baseline to 118 and 80 on Day 35 for IL-2-ELISpot, in the 20-μg and 30-μg groups, respectively. In the elderly participants, the SFUs per 10 6 PBMCs were elevated from 15 and 8 at baseline to 120 and 43 on Day 28 for IFN-γ-ELISpot, and from 0 and 10 at baseline to 85 and 40 on Day 28 for IL-2-ELISpot, in the 20-μg and 30-μg groups, respectively. In comparison, cellular response was almost not observed in the placebo group ( Figure 5 ).…”

Section: Resultsmentioning

confidence: 99%

“…The second dose of SYS6006 did not result in higher AE incidences, which is different from previous reports. 6 , 7 , 17 Again, this phenomenon should be further studied in a larger sample in order to test the robustness. During the two trials, no study suspension or premature termination were triggered, indicating an acceptable tolerability for SYS6006.…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of primary vaccination with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants aged 18 years or more: Two randomized, observer-blinded, placebo-controlled and dose-escalation phase 1 clinical trials

Chen,

Qiu,

et al. 2023

Human Vaccines & Immunotherapeutics

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Vaccination plays a key role in preventing morbidity and mortality caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We aimed to evaluate the safety and immunogenicity of a SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccine SYS6006. In the two randomized, observer-blinded, placebo-controlled phase 1 trials, 40 adult participants aged 18–59 years and 40 elderly participants aged 60 years or more were randomized to receive two doses of SYS6006 or placebo (saline). Adverse events (AEs) were collected through 30 days post the second vaccination. Immunogenicity was assessed by live-virus neutralizing antibody (Nab), spike protein (S1) binding antibody (S1-IgG), and cellular immunity. The result showed that 7/15, 9/15 and 4/10 adult participants, and 9/15, 8/15 and 4/10 elderly participants reported at least one AE in the 20-µg, 30-µg and placebo groups, respectively. Most AEs were grade 1. Injection-site pain was the most common AE. Two adults and one elder reported fever. No vaccination-related serious AE was reported. SYS6006 elicited wild-type Nab response with a peak geometric mean titer of 232.1 and 130.6 (adults), and 48.7 and 66.7 (elders), in the 20-µg and 30-µg groups, respectively. SYS6006 induced moderate-to-robust Nab response against Delta, and slight Nab response against Omicron BA.2 and BA.5. Robust IgG response against wild type and BA.2 was observed. Cellular immune response was induced. In conclusion, two-dose primary vaccination with SYS6006 demonstrated good safety and immunogenicity during a follow-up period of 51 days in immunologically naive population aged 18 years or more. (Trial registry: Chictr.org.cn ChiCTR2200059103 and ChiCTR2200059104)

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“…Recent evidence indicates that frailty can independently predict the reduced antibody response after COVID-19 mRNA vaccines in elderly people [ 1 ]. More specifically, post-vaccination reaction is weaker and even uncommon in this age group when compared with young people; and serious adverse events are more common [ 2 ]. Although reduced vaccine efficacy in the setting of frailty is well defined, the immunological background of frailty is partially described, thereby demanding further research.…”

Section: Forewordmentioning

confidence: 99%

COVID-19 mRNA Vaccine Effectiveness against Elderly Frail People

Kountouras

Tzitiridou‐Chatzopoulou

Papaefthymiou

et al. 2023

Medicina

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The frail, elderly population is often characterized by poor immunogenicity post COVID-19 mRNA vaccination. “Inflamm-aging” and “immune-senescence” are pathogenetic mechanisms that might explain this phenomenon. Complex interplay with cytokines and microbiota is also implicated in this inflammatory cascade. The abovementioned population, although very important from immunologic perspective, has barely been included in the mRNA vaccination clinical trials.

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Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial

Cited by 8 publications

References 32 publications

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

Safety and immunogenicity of primary vaccination with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants aged 18 years or more: Two randomized, observer-blinded, placebo-controlled and dose-escalation phase 1 clinical trials

COVID-19 mRNA Vaccine Effectiveness against Elderly Frail People

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