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Immunogenicity and Safety of BNT162b2 mRNA Vaccine in Chinese Adults: A Randomized Clinical Trial
35 Pages Posted: 19 May 2022More...
Background: BNT162b2, an mRNA vaccine against COVID-19, is being utilized worldwide, but immunogenicity and safety data in Chinese individuals are limited.
Methods: In this trial in healthy or medically stable individuals across two clinical sites in China aged 18–85 years, participants were stratified by age (≤55 or >55 years) and randomly assigned (3:1) by an independent randomization professional to receive two doses of intramuscular BNT162b2 30 μg or placebo administered 21 days apart. Study participants, study personnel, investigators, statisticians, and the sponsor’s study management team were blinded to treatment assignment. Primary immunogenicity endpoints were the geometric mean titers (GMTs) of neutralizing antibodies to live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seroconversion rates (SCR) one month after the second dose. Safety assessments included reactogenicity within 14 days of vaccination, adverse events, and clinical laboratory parameters. Randomized participants who received at least one dose were included in the immunogenicity and safety analyses on a complete case basis (incomplete/missing data not imputed). Results up to one month after the second dose are reported.
Findings: Overall, 959 participants received at least one injection (BNT162b2, n=720; placebo, n=239), recruited between Dec 5th, 2020 and Jan 9th, 2021. The 50% neutralizing GMT was 294·4 (95% CI; 281·1-308·4) in the BNT162b2 group and 5 in the placebo group. SCRs were 99·7% (95% CI; 99%-100%) and 0·8% (95% CI; 0·1%-3·0%) respectively (p<0·001 vs placebo). BNT162b2-elicited sera neutralized SARS-CoV-2 variants of concern. T-cell responses were detected in 58/73 (79·5%) BNT162b2 recipients. Reactogenicity was mild or moderate in severity and resolved within a few days after onset. There were no vaccine-related serious adverse events and unsolicited AEs were uncommon.
Interpretation: BNT162b2 vaccination induced a robust immune response and was well tolerated Chinese adults. However, follow-up duration was short and COVID-19 rates were not assessed. Safety data collection is continuing until 12 months after the second dose.
Trial Registration Details: ClinicalTrials.gov registration number: NCT04649021
Funding Information: BioNTech was the trial sponsor, and Shanghai Fosun Pharmaceutical Development Inc. (Fosun Pharma) conducted the trial, funded medical writing.
Declaration of Interests: U.S. and Ö.T. are management board members and employees at BioNTech SE. E.D., M.K., E.L., U.L., A.M., O.O., S.S., and Y. Shishkova are employees at BioNTech SE. M.B., S.H., and Z.K. are employees at BioNTech US. U.S., Ö.T., and A.M. are inventors on patents and patent applications related to RNA technology and COVID-19 vaccines. M.B., E.D., S.H., M.K., Z.K., E.L., U.L., A.M., O.O., S.S., U.S., and Ö.T. hold securities from BioNTech SE. A.H., L.G., X.W., J.Q., W.W., and J. Zheng, are employees of Fosun Pharma. J.L., L.Z., R.T., H.Y., M.L., F.P., Z.W., X.G., Y.S., H.P., J. Zhu, Z.S., F.Z. declare they have no conflicts of interests.
Ethics Approval Statement: The trial protocol was approved by the Institutional Review Board of the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu, China). The trial was conducted in compliance with the ethical requirements in the Declaration of Helsinki,9 the Good Clinical Practice guidelines from the International Council for Harmonization, and Chinese laws and regulations related to clinical studies. All participants provided written informed consent.
Keywords: BNT162b2 mRNA vaccine, COVID-19, intramuscular injection, messenger RNA, neutralizing antibodies, SARS-CoV-2, vaccination
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