Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 12 of 14)
14.10 Immunogenicity of the Bivalent Vaccine (Original and Omicron BA.1) Administered as a Second Booster Dose
In an analysis of a subset from Study 4, a total of 610 participants greater than 55 years of age who had previously received a 2-dose primary series and 1 booster dose with Pfizer-BioNTech COVID-19 Vaccine received 1 of the following as a second booster dose: Pfizer-BioNTech COVID-19 Vaccine or bivalent vaccine (Original and Omicron BA.1). GMRs and seroresponse rates were evaluated at 1 month after vaccination with the bivalent vaccine (Original and Omicron BA.1). The bivalent vaccine (Original and Omicron BA.1) booster dose was administered 4.7 to 11.5 months (median 6.3 months) after the first booster dose. The Pfizer-BioNTech COVID-19 Vaccine booster dose was administered 5.3 to 13.1 months (median 6.3 months) after the first booster dose.
The primary objective of the study was to assess superiority with respect to level of NT50 and noninferiority with respect to seroresponse rate of the anti-Omicron BA.1 immune response induced by a dose of the bivalent vaccine (Original and Omicron BA.1) relative to the response elicited by a dose of Pfizer-BioNTech COVID-19 Vaccine given as a second booster dose in participants greater than 55 years of age.
A secondary objective of the study was to assess noninferiority with respect to level of NT50 to the Original SARS-COV-2 strain induced by a dose of the bivalent vaccine (Original and Omicron BA.1) relative to the response elicited by a dose of Pfizer-BioNTech COVID-19 Vaccine given as a second booster dose. A comparison of seroresponse rates to the Original strain was descriptive.
Superiority of the anti-Omicron BA.1 NT50 for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met, as the lower bound of the 2-sided 95% CI for GMR was >1. Noninferiority of the anti-Original NT50 for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met, as the lower bound of the 2 sided 95% CI for GMR was >0.67 and the point estimate of the GMR was ≥0.8 (Table 38).
Non-inferiority of the seroresponse rate to the Omicron BA.1 variant for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met as the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is >-5% (Table 38). A descriptive summary of seroresponse to the Original strain is also included in Table 39.
| Abbreviations: GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.Note: Immunogenicity subset = a random sample of 230 participants in each vaccine group.Note: Participants who had no serological or virological evidence (prior to the 1-month post–study vaccination blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] result negative at the study vaccination and the 1-month post–study vaccination visits, negative NAAT [nasal swab] result at the study vaccination visit, and any unscheduled visit prior to the 1-month post–study vaccination blood sample collection) and had no medical history of COVID-19 were included in the analysis. | |||||
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| Assay | Vaccine Group (as randomized) | Sampling Time Point * | N † | GMT (95% CI ‡ ) | GMR (95% CI § ) |
| SARS-CoV-2 neutralization assay — Omicron BA.1 — NT50 (titer)¶ | Pfizer-BioNTech COVID-19 Vaccine | 1 month | 163 | 455.8 (365.9, 567.6) | |
| Bivalent Vaccine (Original and Omicron BA.1) | 1 month | 178 | 711.0(588.3, 859.2) | 1.56(1.17, 2.08) | |
| SARS-CoV-2 neutralization assay — Original strain — NT50 (titer)¶ | Pfizer-BioNTech COVID-19 Vaccine | 1 month | 182 | 5998.1 (5223.6, 6887.4) | |
| Bivalent Vaccine (Original and Omicron BA.1) | 1 month | 186 | 5933.2 (5188.2, 6785.2) | 0.99 (0.82, 1.20) | |
| Abbreviations: LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.Note: Immunogenicity subset = a random sample of 230 participants in each vaccine group.Note: Seroresponse is defined as achieving ≥4-fold rise from baseline (before the second booster dose). If the baseline measurement is below the LLOQ, the postvaccination measure of ≥4 × LLOQ is considered a seroresponse.Note: Participants who had no serological or virological evidence (prior to the 1-month post–study vaccination blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] result negative at the study vaccination and the 1-month post–study vaccination visits, negative NAAT [nasal swab] result at the study vaccination visit, and any unscheduled visit prior to the 1-month post–study vaccination blood sample collection) and had no medical history of COVID-19 were included in the analysis. | |||||
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| Assay | Vaccine Group (as randomized) | Sampling Time Point * | N † | ||
| SARS-CoV-2 neutralization assay — Omicron BA.1 — NT50 (titer)Þ | Pfizer-BioNTech COVID-19 Vaccine | 1 month | 149 | 85 (57.0)(48.7, 65.1) | |
| Bivalent Vaccine (Original and Omicron BA.1) | 1 month | 169 | 121 (71.6)(64.2, 78.3) | 14.6(4.0, 24.9) | |
| SARS-CoV-2 neutralization assay — Original strain — NT50 (titer)Þ | Pfizer-BioNTech COVID-19 Vaccine | 1 month | 179 | 88 (49.2)(41.6, 56.7) | |
| Bivalent Vaccine (Original and Omicron BA.1) | 1 month | 186 | 93 (50.0)(42.6, 57.4) | ||
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