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SAFETY AND EFFICACY OF A THIRD DOSE OF BNT162B2 COVID-19 VACCINE
Author
Moreira Jr, 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
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
Affilliation
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil.
Vaccine Research and Development. Pfizer. Hurley, United Kingdom.
Vaccine Research and Development. Pfizer. Collegeville, PA.
Vaccine Research and Development. Pfizer. San Diego, California.
Vaccine Research and Development. Pfizer. Hurley, United Kingdom.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Collegeville, PA.
Centro Paulista de Investigação Clínica. São Paulo, SP, Brasil.
Clinical Neuroscience Solutions. Orlando.
Clinical Research Professionals. Chesterfield, MO.
California Research Foundation. San Diego, California.
Accellacare. Wilmington, NC.
Jacksonville Center for Clinical Research. Jacksonville, Florida.
Clinical Trials of Texas. San Antonio, Texas.
North Texas Infectious Diseases Consultants. Dallas, Texas.
East-West Medical Research Institute. Honolulu, Hawaii.
Johns Hopkins Bloomberg School of Public Health. Baltimore.
Kaiser Permanente Vaccine Study Center. Oakland.
Tiervlei Trial Centre, Karl Bremer Hospital. Cape Town, South Africa.
Vaccine Research and Development. Pfizer. Hurley, United Kingdom.
Vaccine Research and Development. Pfizer. Collegeville, PA.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
BioNTech. Mainz, Germany.
BioNTech. Mainz, Germany.
Worldwide Safety. Safety Surveillance and Risk Management. Pfizer. Groton, CT.
Vaccine Research and Development. Pfizer. Pearl River, NY.
BioNTech. Mainz, Germany.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Hurley, United Kingdom.
Vaccine Research and Development. Pfizer. Collegeville, PA.
Vaccine Research and Development. Pfizer. San Diego, California.
Vaccine Research and Development. Pfizer. Hurley, United Kingdom.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Collegeville, PA.
Centro Paulista de Investigação Clínica. São Paulo, SP, Brasil.
Clinical Neuroscience Solutions. Orlando.
Clinical Research Professionals. Chesterfield, MO.
California Research Foundation. San Diego, California.
Accellacare. Wilmington, NC.
Jacksonville Center for Clinical Research. Jacksonville, Florida.
Clinical Trials of Texas. San Antonio, Texas.
North Texas Infectious Diseases Consultants. Dallas, Texas.
East-West Medical Research Institute. Honolulu, Hawaii.
Johns Hopkins Bloomberg School of Public Health. Baltimore.
Kaiser Permanente Vaccine Study Center. Oakland.
Tiervlei Trial Centre, Karl Bremer Hospital. Cape Town, South Africa.
Vaccine Research and Development. Pfizer. Hurley, United Kingdom.
Vaccine Research and Development. Pfizer. Collegeville, PA.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
BioNTech. Mainz, Germany.
BioNTech. Mainz, Germany.
Worldwide Safety. Safety Surveillance and Risk Management. Pfizer. Groton, CT.
Vaccine Research and Development. Pfizer. Pearl River, NY.
BioNTech. Mainz, Germany.
Vaccine Research and Development. Pfizer. Pearl River, NY.
Vaccine Research and Development. Pfizer. Pearl River, NY.
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.
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