Covid-19: Pfizer asks US regulator to authorise fourth vaccine dose for over 65s

Tanne, Janice Hopkins

doi:10.1136/bmj.o711

Cited by 6 publications

(3 citation statements)

References 2 publications

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“…highlight the potential benefit from booster vaccination, specifically in vulnerable populations living with multimorbidity, and support the recent focus on older people and those with chronic conditions for future booster doses of SARS-CoV-2 vaccines beyond the first booster. 43…”

Section: Discussionmentioning

confidence: 99%

Booster vaccination with inactivated whole-virus or mRNA vaccines and COVID-19–related deaths among people with multimorbidity: a cohort study

Lai

Yan

et al. 2023

CMAJ

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Section: Discussionmentioning

confidence: 99%

Booster vaccination with inactivated whole-virus or mRNA vaccines and COVID-19–related deaths among people with multimorbidity: a cohort study

Lai

Yan

et al. 2023

CMAJ

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“…At the beginning of 2022, Pfizer and BioNTech applied to the Food and Drug Administration (FDA) for the approval of a fourth dose of BNT162b2 in order to enhance the vaccine’s efficacy in reducing the rates of infection and severe illness, especially in adults 65 years and older [ 14 ]. The application of a fourth BNT162b2 dose in non-immunocompromised patients requires further study.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Immunization, Adverse Events, and Efficacy of a Fourth Dose of BNT162b2 Vaccine in Health Workers in Mexico, a Pilot Study

Romero-Ibarguengoitia

González-Cantú

Rivera-Salinas

et al. 2022

Vaccines

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There is scarce information on seroconversion and adverse events after immunization (AEFI) with the fourth dose of BNT162b2. Our aim was to correlate the magnitude of the antibody response to this vaccination regimen in terms of clinical conditions and AEFI. This was an observational pilot study in which SARS-CoV-2 S1–S2 IgG antibodies titers were measured 21–28 days after the first and second dose, three months after the second dose, 1–7 and 21–28 days after the third dose, before the fourth dose, and 21–28 days after the fourth dose. We recruited 112 subjects in a hospital in Mexico, 74% women, with an average age of 43 (SD 9) years. After the first dose, subjects had a median IgG AU/mL (IQR) of 122 (1904) that increased to 1875 (2095), 3020 (2330), and 4230 (3393) 21–28 days after the second, third, and fourth doses, respectively (p < 0.01). The number (%) who experienced any AEFI between the first and fourth doses was 90 (80.4), 89 (79), 65 (58), and 69 (61.5), respectively (p < 0.001). After the fourth dose, the most frequent of AEFI was pain at the injection site (87%). There was a correlation between AEFI and gender after the fourth dose, as well as with antibody levels (p < 0.05). During the Omicron outbreak, six (5.3%) had mild COVID-19 for 8–28 days after the fourth dose. The median increase in S1/S2 IgG was 30.8-fold after the fourth BNT162b2 dose when compared with the first dose and caused mild AEFI.

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“…8 At the beginning of 2022, Pfizer and BioNTech applied to the Food and Drug Administration (FDA) for the approval of a fourth dose of BNT162b2 in order to enhance the vaccine's efficacy in reducing the rates of infection and severe illness, especially in adults 65 years and older. 9 The application of a fourth BNT162b2 dose in non-immunocompromised patients is less studied. Therefore, our study aimed to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and adverse events following immunization (AEFI) of a fourth dose of BNT162b2 mRNA in health workers.…”

Section: Introductionmentioning

confidence: 99%

Analysis of immunization, adverse events, and efficacy of a fourth dose of BNT162b2 vaccine

Romero-Ibarguengoitia

González-Cantú

Rivera-Salinas

et al. 2022

Preprint

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ImportanceScarce information exists concerning the seroconversion and adverse events after immunization (AEFI) of the fourth dose of a SARS-COV-2 vaccine.ObjectiveCorrelate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI of the fourth dose of BNT162b2 mRNA.DesignObservational study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers were measured 21-28 days after the exposition of the first, and second dose, three months after the second dose, 1-7 days after the third dose, before the fourth dose, and 21-28 days after the fourth dose of BNT162b2 mRNA.SettingThe study was conducted on healthcare workers of a private hospital in Northern Mexico.ParticipantsInclusion criteria were healthcare workers of both genders, any age, who planned to conclude the immunization regimen. The exclusion criteria were previously given any SARS-CoV-2 vaccine prior to study entry.InterventionSubjects were exposed to four doses of the BNT162b2 mRNA vaccine.Main Outcome and Measures:The anti-S1 and anti-S2 IgG antibodies against SARS-CoV-2 in plasma samples were measured with chemiluminescence immunoassay developed by DiaSorin.ResultsWe recruited 112 subjects [43 (SD 9) years old, 74% women].After the first dose, subjects had a median (IQR) AU/ml IgG of 122(1904), with an increase to 1875 (2095) after the second dose, 3020 (2330) after the third dose, and 4230 (3393) after 21-28 of a fourth dose (p<0.01). The number (%) of any AEFI between doses was 90 (80.4), 89(79), 65(58), 69 (61.5), after first, second, third, and fourth, respectively, p<0.001. After the fourth dose, the most frequent AEFI was pain at the injection site (87%). Fever was slightly more frequent after the third and fourth doses, 9 (13.8) and 8 (11.4%) cases, respectively, and adenopathy was more frequent after the fourth dose [in11(15.7%) cases]. There was a correlation between AEFI in the fourth dose with gender and antibody levels (p<0.05). The highest proportion of AEFI was considered mild after the fourth dose. During the Omicron outbreak, 6 (5.3%) had mild SARS-CoV-2 during 8-28 days of the fourth dose.Conclusions and RelevanceThe fourth dose of BNT162b2mRNA increases S1/S2 IgG 33.6 times with mild adverse events.Registration numberNCT05228912Key pointsQuestionWhat is the magnitude of antibody response to vaccination and adverse events after immunization (AEFI) of a fourth dose of BNT162b2 mRNA?FindingsThis cohort included 112 healthcare workers. We measured S1/S2 IgG vs. SARS-CoV-2 after the first, second, third and fourth dose. Compared to the first dose, antibodies increased 33.6 times the antibody levels after the fourth dose. We found minimal to moderate adverse events. The change in antibodies correlated with AEFI. During the Omicron outbreak 6 (5.3%) had mild SARS-CoV-2.MeaningA fourth dose of BNT162b2mRNA increases S1/S2 IgG with mild to moderate adverse events.

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Covid-19: Pfizer asks US regulator to authorise fourth vaccine dose for over 65s

Cited by 6 publications

References 2 publications

Booster vaccination with inactivated whole-virus or mRNA vaccines and COVID-19–related deaths among people with multimorbidity: a cohort study

Booster vaccination with inactivated whole-virus or mRNA vaccines and COVID-19–related deaths among people with multimorbidity: a cohort study

Analysis of Immunization, Adverse Events, and Efficacy of a Fourth Dose of BNT162b2 Vaccine in Health Workers in Mexico, a Pilot Study

Analysis of immunization, adverse events, and efficacy of a fourth dose of BNT162b2 vaccine

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