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RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study.
medRxiv. 2020 Aug 20M

Abstract

BACKGROUND

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of people globally. Multiple vaccine candidates are under development, but no vaccine is currently available.

METHODS

Healthy adults 18-55 and 65-85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS-CoV-2 full-length spike. In each of 13 groups of 15 participants, 12 received vaccine and 3 received placebo. Groups were distinguished by vaccine candidate, age of participant, and vaccine dose level. Interim safety and immunogenicity data of BNT162b1 in younger adults have been reported previously from US and German trials. We now present additional safety and immunogenicity data from the US Phase 1 trial that supported selection of the vaccine candidate advanced to a pivotal Phase 2/3 safety and efficacy evaluation.

RESULTS

In both younger and older adults, the 2 vaccine candidates elicited similar dose-dependent SARS-CoV-2-neutralizing geometric mean titers (GMTs), comparable to or higher than the GMT of a panel of SARS-CoV-2 convalescent sera. BNT162b2 was associated with less systemic reactogenicity, particularly in older adults.

CONCLUSION

These results support selection of the BNT162b2 vaccine candidate for Phase 2/3 large-scale safety and efficacy evaluation, currently underway.

Authors

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Pub Type(s)

Preprint

Language

eng

PubMed ID

32839784

Citation

Walsh, Edward E., et al. "RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study." MedRxiv : the Preprint Server for Health Sciences, 2020.
Walsh EE, Frenck R, Falsey AR, et al. RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study. medRxiv. 2020.
Walsh, E. E., Frenck, R., Falsey, A. R., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Mulligan, M. J., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P. Y., Türeci, Ö., Thompkins, K. R., ... Gruber, W. C. (2020). RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study. MedRxiv : the Preprint Server for Health Sciences. https://doi.org/10.1101/2020.08.17.20176651
Walsh EE, et al. RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study. medRxiv. 2020 Aug 20; PubMed PMID: 32839784.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study. AU - Walsh,Edward E, AU - Frenck,Robert, AU - Falsey,Ann R, AU - Kitchin,Nicholas, AU - Absalon,Judith, AU - Gurtman,Alejandra, AU - Lockhart,Stephen, AU - Neuzil,Kathleen, AU - Mulligan,Mark J, AU - Bailey,Ruth, AU - Swanson,Kena A, AU - Li,Ping, AU - Koury,Kenneth, AU - Kalina,Warren, AU - Cooper,David, AU - Fontes-Garfias,Camila, AU - Shi,Pei-Yong, AU - Türeci,Özlem, AU - Thompkins,Kristin R, AU - Lyke,Kirsten E, AU - Raabe,Vanessa, AU - Dormitzer,Philip R, AU - Jansen,Kathrin U, AU - Sahin,Uğur, AU - Gruber,William C, Y1 - 2020/08/20/ PY - 2020/8/26/entrez PY - 2020/8/26/pubmed PY - 2020/8/26/medline JF - medRxiv : the preprint server for health sciences JO - medRxiv N2 - BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of people globally. Multiple vaccine candidates are under development, but no vaccine is currently available. METHODS: Healthy adults 18-55 and 65-85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS-CoV-2 full-length spike. In each of 13 groups of 15 participants, 12 received vaccine and 3 received placebo. Groups were distinguished by vaccine candidate, age of participant, and vaccine dose level. Interim safety and immunogenicity data of BNT162b1 in younger adults have been reported previously from US and German trials. We now present additional safety and immunogenicity data from the US Phase 1 trial that supported selection of the vaccine candidate advanced to a pivotal Phase 2/3 safety and efficacy evaluation. RESULTS: In both younger and older adults, the 2 vaccine candidates elicited similar dose-dependent SARS-CoV-2-neutralizing geometric mean titers (GMTs), comparable to or higher than the GMT of a panel of SARS-CoV-2 convalescent sera. BNT162b2 was associated with less systemic reactogenicity, particularly in older adults. CONCLUSION: These results support selection of the BNT162b2 vaccine candidate for Phase 2/3 large-scale safety and efficacy evaluation, currently underway. UR - https://www.unboundmedicine.com/medline/citation/32839784/RNA_Based_COVID_19_Vaccine_BNT162b2_Selected_for_a_Pivotal_Efficacy_Study_ L2 - https://doi.org/10.1101/2020.08.17.20176651 DB - PRIME DP - Unbound Medicine ER -
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