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Cited by 328

The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.

Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine

Open access
Moreira, Edson D., Kitchin, Nicholas, Xu, Xia, Dychter, Samuel S., Lockhart, Stephen, Gurtman, Alejandra, Perez, John L., Zerbini, Cristiano, Dever, Michael E., Jennings, Timothy W., Brandon, Donald M., Cannon, Kevin D., Koren, Michael J., Denham, Douglas S., Berhe, Mezgebe, Fitz-Patrick, David, Hammitt, Laura L., Klein, Nicola P., Nell, Haylene, Keep, Georgina, Wang, Xingbin, Koury, Kenneth, Swanson, Kena A., Cooper, David, Lu, Claire, Türeci, Özlem, Lagkadinou, Eleni, Tresnan, Dina B., Dormitzer, Philip R., Şahin, Uğur, Gruber, William C., Jansen, Kathrin U.·2022·New England Journal of Medicine
DOI 10.1056/nejmoa2200674
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Abstract

BACKGROUND: Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after the primary two-dose vaccine series, data are needed on the safety and efficacy of offering a third (booster) dose in persons 16 years of age or older. METHODS: In this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a third dose of the BNT162b2 vaccine or with placebo. We assessed vaccine safety and efficacy against Covid-19 starting 7 days after the third dose. RESULTS: A total of 5081 participants received a third BNT162b2 dose and 5044 received placebo. The median interval between dose 2 and dose 3 was 10.8 months in the vaccine group and 10.7 months in the placebo group; the median follow-up was 2.5 months. Local and systemic reactogenicity events from the third dose were generally of low grade. No new safety signals were identified, and no cases of myocarditis or pericarditis were reported. Among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated, Covid-19 with onset at least 7 days after dose 3 was observed in 6 participants in the vaccine group and in 123 participants in the placebo group, which corresponded to a relative vaccine efficacy of 95.3% (95% confidence interval, 89.5 to 98.3). CONCLUSIONS: A third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against Covid-19 as compared with two doses of the BNT162b2 vaccine during a median follow-up of 2.5 months. (Funded by BioNTech and Pfizer; C4591031 ClinicalTrials.gov number, NCT04955626.).

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Metadata

Authors
Moreira, E. D., Kitchin, N., Xu, X., Dychter, S. S., Lockhart, S., Gurtman, A., Perez, J. L., Zerbini, C., Dever, M. E., Jennings, T. W., Brandon, D. M., Cannon, K. D., Koren, M. J., Denham, D. S., Berhe, M., Fitz-Patrick, D., Hammitt, L. L., Klein, N. P., Nell, H., Keep, G., Wang, X., Koury, K., Swanson, K. A., Cooper, D., Lu, C., Türeci, Ö., Lagkadinou, E., Tresnan, D. B., Dormitzer, P. R., Şahin, U., Gruber, W. C., & Jansen, K. U.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2022-05-19
Volume
386
Issue
20
Pages
1910-1921
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2200674
OpenAlex
W4220814092
Cited by
328
References
22
FWCI
34.82
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine. https://app.cochat.ai/papers/10.1056/nejmoa2200674
The paper
Moreira, E. D., Kitchin, N., Xu, X., Dychter, S. S., Lockhart, S., Gurtman, A., Perez, J. L., Zerbini, C., Dever, M. E., Jennings, T. W., Brandon, D. M., Cannon, K. D., Koren, M. J., Denham, D. S., Berhe, M., Fitz-Patrick, D., Hammitt, L. L., Klein, N. P., Nell, H., . . . Jansen, K. U. (2022). Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2200674

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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