Browsing by Author "Smallcomb, Laura"

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    BNT162b2 mRNA Vaccination Against Coronavirus Disease 2019 is Associated With a Decreased Likelihood of Multisystem Inflammatory Syndrome in Children Aged 5-18 Years-United States, July 2021 - April 2022
    (Oxford University Press, 2023) Zambrano, Laura D.; Newhams, Margaret M.; Olson, Samantha M.; Halasa, Natasha B.; Price, Ashley M.; Orzel, Amber O.; Young, Cameron C.; Boom, Julie A.; Sahni, Leila C.; Maddux, Aline B.; Bline, Katherine E.; Kamidani, Satoshi; Tarquinio, Keiko M.; Chiotos, Kathleen; Schuster, Jennifer E.; Cullimore, Melissa L.; Heidemann, Sabrina M.; Hobbs, Charlotte V.; Nofziger, Ryan A.; Pannaraj, Pia S.; Cameron, Melissa A.; Walker, Tracie C.; Schwartz, Stephanie P.; Michelson, Kelly N.; Coates, Bria M.; Flori, Heidi R.; Mack, Elizabeth H.; Smallcomb, Laura; Gertz, Shira J.; Bhumbra, Samina S.; Bradford, Tamara T.; Levy, Emily R.; Kong, Michele; Irby, Katherine; Cvijanovich, Natalie Z.; Zinter, Matt S.; Bowens, Cindy; Crandall, Hillary; Hume, Janet R.; Patel, Manish M.; Campbell, Angela P.; Randolph, Adrienne G.; Overcoming COVID-19 Investigators; Pediatrics, School of Medicine
    Background: Multisystem inflammatory syndrome in children (MIS-C), linked to antecedent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, is associated with considerable morbidity. Prevention of SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19) by vaccination might also decrease MIS-C likelihood. Methods: In a multicenter, case-control, public health investigation of children ages 5-18 years hospitalized from 1 July 2021 to 7 April 2022, we compared the odds of being fully vaccinated (2 doses of BNT162b2 vaccine ≥28 days before hospital admission) between MIS-C case-patients and hospital-based controls who tested negative for SARS-CoV-2. These associations were examined by age group, timing of vaccination, and periods of Delta and Omicron variant predominance using multivariable logistic regression. Results: We compared 304 MIS-C case-patients (280 [92%] unvaccinated) with 502 controls (346 [69%] unvaccinated). MIS-C was associated with decreased likelihood of vaccination (adjusted OR [aOR]: .16; 95% CI: .10-.26), including among children ages 5-11 years (aOR: .22; 95% CI: .10-.52), ages 12-18 years (aOR: .10; 95% CI: .05-.19), and during the Delta (aOR: .06; 95% CI: .02-.15) and Omicron (aOR: .22; 95% CI: .11-.42) variant-predominant periods. This association persisted beyond 120 days after the second dose (aOR: .08; 95% CI: .03-.22) in 12-18-year-olds. Among all MIS-C case-patients, 187 (62%) required intensive care unit admission and 280 (92%) vaccine-eligible case-patients were unvaccinated. Conclusions: Vaccination with 2 doses of BNT162b2 is associated with reduced likelihood of MIS-C in children ages 5-18 years. Most vaccine-eligible hospitalized patients with MIS-C were unvaccinated.
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    BNT162b2 Protection against the Omicron Variant in Children and Adolescents
    (Massachusetts Medical Society, 2022) Price, Ashley M.; Olson, Samantha M.; Newhams, Margaret M.; Halasa, Natasha B.; Boom, Julie A.; Sahni, Leila C.; Pannaraj, Pia S.; Irby, Katherine; Bline, Katherine E.; Maddux, Aline B.; Nofziger, Ryan A.; Cameron, Melissa A.; Walker, Tracie C.; Schwartz, Stephanie P.; Mack, Elizabeth H.; Smallcomb, Laura; Schuster, Jennifer E.; Hobbs, Charlotte V.; Kamidani, Satoshi; Tarquinio, Keiko M.; Bradford, Tamara T.; Levy, Emily R.; Chiotos, Kathleen; Bhumbra, Samina S.; Cvijanovich, Natalie Z.; Heidemann, Sabrina M.; Cullimore, Melissa L.; Gertz, Shira J.; Coates, Bria M.; Staat, Mary A.; Zinter, Matt S.; Kong, Michele; Chatani, Brandon M.; Hume, Janet R.; Typpo, Katri V.; Maamari, Mia; Flori, Heidi R.; Tenforde, Mark W.; Zambrano, Laura D.; Campbell, Angela P.; Patel, Manish M.; Randolph, Adrienne G.; Overcoming Covid-19 Investigators; Pediatrics, School of Medicine
    Background: Spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.1.529 (omicron) variant, which led to increased U.S. hospitalizations for coronavirus disease 2019 (Covid-19), generated concern about immune evasion and the duration of protection from vaccines in children and adolescents. Methods: Using a case-control, test-negative design, we assessed vaccine effectiveness against laboratory-confirmed Covid-19 leading to hospitalization and against critical Covid-19 (i.e., leading to receipt of life support or to death). From July 1, 2021, to February 17, 2022, we enrolled case patients with Covid-19 and controls without Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2 messenger RNA vaccine) at least 14 days before illness among case patients and controls, according to time since vaccination for patients 12 to 18 years of age and in periods coinciding with circulation of B.1.617.2 (delta) (July 1, 2021, to December 18, 2021) and omicron (December 19, 2021, to February 17, 2022) among patients 5 to 11 and 12 to 18 years of age. Results: We enrolled 1185 case patients (1043 [88%] of whom were unvaccinated, 291 [25%] of whom received life support, and 14 of whom died) and 1627 controls. During the delta-predominant period, vaccine effectiveness against hospitalization for Covid-19 among adolescents 12 to 18 years of age was 93% (95% confidence interval [CI], 89 to 95) 2 to 22 weeks after vaccination and was 92% (95% CI, 80 to 97) at 23 to 44 weeks. Among adolescents 12 to 18 years of age (median interval since vaccination, 162 days) during the omicron-predominant period, vaccine effectiveness was 40% (95% CI, 9 to 60) against hospitalization for Covid-19, 79% (95% CI, 51 to 91) against critical Covid-19, and 20% (95% CI, -25 to 49) against noncritical Covid-19. During the omicron period, vaccine effectiveness against hospitalization among children 5 to 11 years of age was 68% (95% CI, 42 to 82; median interval since vaccination, 34 days). Conclusions: BNT162b2 vaccination reduced the risk of omicron-associated hospitalization by two thirds among children 5 to 11 years of age. Although two doses provided lower protection against omicron-associated hospitalization than against delta-associated hospitalization among adolescents 12 to 18 years of age, vaccination prevented critical illness caused by either variant.
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    Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19–Associated Hospitalization in Infants Aged <6 Months — 17 States, July 2021–January 2022
    (Center for Disease Control, 2022-02-18) Halasa, Natasha B.; Olson, Samantha M.; Staat, Mary A.; Newhams, Margaret M.; Price, Ashley M.; Boom, Julie A.; Sahni, Leila C.; Cameron, Melissa A.; Pannaraj, Pia S.; Bline, Katherine E.; Bhumbra, Samina S.; Bradford, Tamara T.; Chiotos, Kathleen; Coates, Bria M.; Cullimore, Melissa L.; Cvijanovich, Natalie Z.; Flori, Heidi R.; Gertz, Shira J.; Heidemann, Sabrina M.; Hobbs, Charlotte V.; Hume, Janet R.; Irby, Katherine; Kamidani, Satoshi; Kong, Michele; Levy, Emily R.; Mack, Elizabeth H.; Maddux, Aline B.; Michelson, Kelly N.; Nofziger, Ryan A.; Schuster, Jennifer E.; Schwartz, Stephanie P.; Smallcomb, Laura; Tarquinio, Keiko M.; Walker, Tracie C.; Zinter, Matt S.; Gilboa, Suzanne M.; Polen, Kara N.; Campbell, Angela P.; Randolph, Adrienne G.; Patel, Manish M.; Overcoming COVID-19 Investigators; Overcoming COVID-19 Network; Pediatrics, School of Medicine
    COVID-19 vaccination is recommended for persons who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future, to protect them from COVID-19.§ Infants are at risk for life-threatening complications from COVID-19, including acute respiratory failure (1). Evidence from other vaccine-preventable diseases suggests that maternal immunization can provide protection to infants, especially during the high-risk first 6 months of life, through passive transplacental antibody transfer (2). Recent studies of COVID-19 vaccination during pregnancy suggest the possibility of transplacental transfer of SARS-CoV-2-specific antibodies that might provide protection to infants (3-5); however, no epidemiologic evidence currently exists for the protective benefits of maternal immunization during pregnancy against COVID-19 in infants. The Overcoming COVID-19 network conducted a test-negative, case-control study at 20 pediatric hospitals in 17 states during July 1, 2021-January 17, 2022, to assess effectiveness of maternal completion of a 2-dose primary mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization in infants. Among 379 hospitalized infants aged <6 months (176 with COVID-19 [case-infants] and 203 without COVID-19 [control-infants]), the median age was 2 months, 21% had at least one underlying medical condition, and 22% of case- and control-infants were born premature (<37 weeks gestation). Effectiveness of maternal vaccination during pregnancy against COVID-19 hospitalization in infants aged <6 months was 61% (95% CI = 31%-78%). Completion of a 2-dose mRNA COVID-19 vaccination series during pregnancy might help prevent COVID-19 hospitalization among infants aged <6 months.
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    Factors Associated With COVID-19 Non-vaccination in Adolescents Hospitalized Without COVID-19
    (Oxford University Press, 2023) Sahni, Leila C.; Price, Ashley M.; Olson, Samantha M.; Newhams, Margaret M.; Pannaraj, Pia S.; Maddux, Aline B.; Halasa, Natasha B.; Bline, Katherine E.; Cameron, Melissa A.; Schwartz, Stephanie P.; Walker, Tracie C.; Irby, Katherine; Chiotos, Kathleen; Nofziger, Ryan A.; Mack, Elizabeth H.; Smallcomb, Laura; Bradford, Tamara T.; Kamidani, Satoshi; Tarquinio, Keiko M.; Cvijanovich, Natalie Z.; Schuster, Jennifer E.; Bhumbra, Samina S.; Levy, Emily R.; Hobbs, Charlotte V.; Cullimore, Melissa L.; Coates, Bria M.; Heidemann, Sabrina M.; Gertz, Shira J.; Kong, Michele; Flori, Heidi R.; Staat, Mary A.; Zinter, Matt S.; Hume, Janet R.; Chatani, Brandon M.; Gaspers, Mary G.; Maamari, Mia; Randolph, Adrienne G.; Patel, Manish M.; Boom, Julie A.; Pediatrics, School of Medicine
    Background: Pfizer-BioNTech COVID-19 vaccine received emergency use authorization for persons ≥ 16 years in December 2020 and for adolescents 12-15 years in May 2021. Despite the clear benefits and favorable safety profile, vaccine uptake in adolescents has been suboptimal. We sought to assess factors associated with COVID-19 non-vaccination in adolescents 12-18 years of age. Methods: Between June 1, 2021 and April 29, 2022, we assessed factors associated with COVID-19 non-vaccination in hospitalized adolescents ages 12-18 years enrolled in the Overcoming COVID-19 vaccine effectiveness network. Demographic characteristics and clinical information were captured through parent interviews and/or electronic medical record abstraction; COVID-19 vaccination was assessed through documented sources. We assessed associations between receipt of the COVID-19 vaccine and demographic and clinical factors using univariate and multivariable logistic regression and estimated adjusted odds ratios (aOR) for each factor associated with non-vaccination. Results: Among 1665 hospitalized adolescents without COVID-19, 56% were unvaccinated. Unvaccinated adolescents were younger (median age 15.1 years vs. 15.4 years, p < .01) and resided in areas with higher social vulnerability index (SVI) scores (median 0.6 vs 0.5, p < .001) than vaccinated adolescents. Residence in the Midwest [aOR 2.60 (95% CI: 1.80, 3.79)] or South [aOR 2.49 (95% CI: 1.77, 3.54)] US census regions, rarely or never receiving influenza vaccine [aOR 5.31 (95% CI: 3.81, 7.47)], and rarely or never taking precautions against COVID-19 [aOR 3.17 (95% CI: 1.94, 5.31)] were associated with non-vaccination against COVID-19. Conclusions: Efforts to increase COVID-19 vaccination of adolescents should focus on persons with geographic, socioeconomic, and medical risk factors associated with non-vaccination.
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    Maternal Vaccination and Risk of Hospitalization for Covid-19 among Infants
    (Massachusetts Medical Society, 2022) Halasa, Natasha B.; Olson, Samantha M.; Staat, Mary A.; Newhams, Margaret M.; Price, Ashley M.; Pannaraj, Pia S.; Boom, Julie A.; Sahni, Leila C.; Chiotos, Kathleen; Cameron, Melissa A.; Bline, Katherine E.; Hobbs, Charlotte V.; Maddux, Aline B.; Coates, Bria M.; Michelson, Kelly N.; Heidemann, Sabrina M.; Irby, Katherine; Nofziger, Ryan A.; Mack, Elizabeth H.; Smallcomb, Laura; Schwartz, Stephanie P.; Walker, Tracie C.; Gertz, Shira J.; Schuster, Jennifer E.; Kamidani, Satoshi; Tarquinio, Keiko M.; Bhumbra, Samina S.; Maamari, Mia; Hume, Janet R.; Crandall, Hillary; Levy, Emily R.; Zinter, Matt S.; Bradford, Tamara T.; Flori, Heidi R.; Cullimore, Melissa L.; Kong, Michele; Cvijanovich, Natalie Z.; Gilboa, Suzanne M.; Polen, Kara N.; Campbell, Angela P.; Randolph, Adrienne G.; Patel, Manish M.; Overcoming Covid-19 Investigators; Pediatrics, School of Medicine
    Background: Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (Covid-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal Covid-19 vaccination may confer protection against Covid-19 in infants. Methods: We used a case-control test-negative design to assess the effectiveness of maternal vaccination during pregnancy against hospitalization for Covid-19 among infants younger than 6 months of age. Between July 1, 2021, and March 8, 2022, we enrolled infants hospitalized for Covid-19 (case infants) and infants hospitalized without Covid-19 (control infants) at 30 hospitals in 22 states. We estimated vaccine effectiveness by comparing the odds of full maternal vaccination (two doses of mRNA vaccine) among case infants and control infants during circulation of the B.1.617.2 (delta) variant (July 1, 2021, to December 18, 2021) and the B.1.1.259 (omicron) variant (December 19, 2021, to March 8, 2022). Results: A total of 537 case infants (181 of whom had been admitted to a hospital during the delta period and 356 during the omicron period; median age, 2 months) and 512 control infants were enrolled and included in the analyses; 16% of the case infants and 29% of the control infants had been born to mothers who had been fully vaccinated against Covid-19 during pregnancy. Among the case infants, 113 (21%) received intensive care (64 [12%] received mechanical ventilation or vasoactive infusions). Two case infants died from Covid-19; neither infant's mother had been vaccinated during pregnancy. The effectiveness of maternal vaccination against hospitalization for Covid-19 among infants was 52% (95% confidence interval [CI], 33 to 65) overall, 80% (95% CI, 60 to 90) during the delta period, and 38% (95% CI, 8 to 58) during the omicron period. Effectiveness was 69% (95% CI, 50 to 80) when maternal vaccination occurred after 20 weeks of pregnancy and 38% (95% CI, 3 to 60) during the first 20 weeks of pregnancy. Conclusions: Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age.