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Multicenter Study
. 2023 Mar:254:48-53.e1.
doi: 10.1016/j.jpeds.2022.09.059. Epub 2022 Oct 15.

Effectiveness of BNT162b2 Vaccination During Pregnancy in Preventing Hospitalization for Severe Acute Respiratory Syndrome Coronavirus 2 in Infants

Affiliations
Multicenter Study

Effectiveness of BNT162b2 Vaccination During Pregnancy in Preventing Hospitalization for Severe Acute Respiratory Syndrome Coronavirus 2 in Infants

Dana Danino et al. J Pediatr. 2023 Mar.

Abstract

Objective: To assess the clinical effectiveness of the BNT162b2 vaccine during pregnancy in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) hospitalizations of infants.

Study design: A retrospective, multicenter, 1:3 case-control (test-negative) study. Symptomatic hospitalized infants less than 6 months of age, with a positive SARS-CoV-2 polymerase chain reaction test between January 3, 2021, and March 11, 2021, were matched by age and time to negative controls, hospitalized with symptoms compatible with SARS-CoV-2 infection. Mothers were defined as fully vaccinated who received 2 doses of BNT162b2 with the second given 2 weeks to 6 months before delivery; or partially vaccinated, if they received only 1 dose or 2 doses with the second given more than 6 months or less than 2 weeks before delivery. Severe SARS-CoV-2 was defined as a need for assisted ventilation.

Results: We matched 116 SARS-CoV-2 positive infants with 348 negative controls with symptoms compatible with SARS-CoV-2 infection. The effectiveness of fully vaccinated mothers was 61.6% (95% CI, 31.9-78.4) and the effectiveness of partially vaccinated mothers was not significant. Effectiveness was higher in infants 0-2 vs 3-6 months of age. The effectiveness (57.1%; 95% CI, 22.8-76.4) was similar when excluding mothers who were infected with SARS-CoV-2 during pregnancy. The OR of severe infection in infants born to unvaccinated vs fully vaccinated mothers was 5.8.

Conclusions: At least 2 doses of BNT162b2 vaccine administered during the second or third trimester of pregnancy had an effectiveness of 61.6% in decreasing hospitalization for SARS-CoV-2 infection in infants less than 6 months of age.

Keywords: Maternal vaccination; SARS-CoV-2; infants' hospitalizations; pregnancy.

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Figures

Figure 2
Figure 2
Study enrollment.
Figure 3
Figure 3
Outcomes of infants according to maternal vaccination status.
Figure 1
Figure 1
Telephone questionnaire for mothers.

References

    1. Allotey J., Stallings E., Bonet M., Yap M., Chatterjee S., Kew T., et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020;370:m3320. - PMC - PubMed
    1. Yarden Bilavski H., Balanson S., Damouni Shalabi R., Dabaja-Younis H., Grisaru-Soen G., Youngster I., et al. Benign course and clinical features of COVID-19 in hospitalised febrile infants up to 60 days old. Acta Paediatr. 2021;110:2790–2795. - PMC - PubMed
    1. Healy C.M., Baker C.J. Prospects for prevention of childhood infections by maternal immunization. Curr Opin Infect Dis. 2006;19:271–276. - PubMed
    1. Israeli Ministry of Health Up-to-date guidelines for validating and releasing test results for the new Corona virus by the Israeli Ministry of Health. https://govextra.gov.il/media/18274/ld-176449420.pdf
    1. Collier A.Y., McMahan K., Yu J., Tostanoski L.H., Aguayo R., Ansel J., et al. Immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating women. JAMA. 2021;325:2370–2380. - PMC - PubMed

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