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Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MS is supported via salary awards from the BC Children’s Hospital Foundation, the Canadian Child Health Clinician Scientist Program and the Michael Smith Foundation for Health Research. MS has been an investigator on projects funded by GlaxoSmithKline, Merck, Pfizer, Sanofi-Pasteur, Seqirus, Symvivo and VBI Vaccines. All funds have been paid to his institute, and he has not received any personal payments. All other authors declare no competing interest. SH has been an investigator on projects funded by GlaxoSmithKline, Merck, Pfizer, Sanofi-Pasteur, and CanSino; all funds have been paid to his University. SH has also served on ad hoc advisory boards for GSK, Sanofi, Pfizer, AsraZeneca, Merck, and IMV. .

Routine childhood vaccinations are key for the protection of children from a variety of serious and potentially fatal diseases. Current pediatric vaccine schedules mainly cover active vaccines. Active vaccination in infants is a highly effective approach against several infectious diseases; however, thus far, for some important viral pathogens, including respiratory syncytial virus (RSV), vaccine development and license by healthcare authorities have not been accomplished. Nirsevimab is a human-derived, highly potent monoclonal antibody (mAb) with an extended half-life for RSV prophylaxis in all infants. In this manuscript, we consider the potential implications for the introduction of an anti-viral mAb, such as nirsevimab, into the routine pediatric vaccine schedule, as well as considerations for coadministration. Specifically, we present evidence on the general mechanism of action of anti-viral mAbs and experience with palivizumab, the only approved mAb for the prevention of RSV infection in preterm infants, infants with chronic lung disease of prematurity and certain infants with hemodynamically significant heart disease. Palivizumab has been used for over two decades in infants who also receive routine vaccinations without any alerts concerning the safety and efficacy of coadministration. Immunization guidelines (Advisory Committee on Immunization Practices, Joint Committee on Vaccination and Immunization, National Advisory Committee on Immunization, Centers for Disease Control and Prevention, American Academy of Pediatrics, The Association of the Scientific Medical Societies in Germany) support coadministration of palivizumab with routine pediatric vaccines, noting that immunobiologics, such as palivizumab, do not interfere with the immune response to licensed live or inactivated active vaccines. Based on the mechanism of action of the new generation of anti-viral mAbs, such as nirsevimab, which is highly specific targeting viral antigenic sites, it is unlikely that it could interfere with the immune response to other vaccines. Taken together, we anticipate that nirsevimab could be concomitantly administered to infants with routine pediatric vaccines during the same clinic visit., Competing Interests: SE: Research support from GSK, Sanofi, and Vifor. Speaker’s fees from GSK, Janssen, Pfizer, Novartis, Sanofi Pasteur, and MSD in the past 3 years. BA is supported by the Canadian Health and Research Institute Vanier Canada scholarship. PB received grants for epidemiological and HTA research projects from GlaxoSmithKline, MSD, Sanofi Pasteur, Pfizer, Seqirus and Astra Zeneca, and fees for taking part in advisory boards on different vaccines from the same companies plus Janssen. FM has received honoraria from GSK, Pfizer, Sanofi Pasteur, MSD, Seqirus, and Janssen for taking part in advisory boards and expert meetings, and for acting as speaker in congresses outside the scope of the submitted work. FM has also acted as principal investigator in RCTs of the above-mentioned companies as well as Ablynx, Regeneron, Roche, Abbot, Novavax, and Medimmune, with honoraria paid to his institution. FM research activities received support from the Instituto de Salud Carlos III (Proyecto de Investigación en Salud, Acción Estratégica en Salud): project ReSVinext ISCIII/PI16/01569/Cofinanciado FEDER and project Enterogen (ISCIII/PI19/01090). KF is a member of the Australian Technical Advisory Group on Immunisation (ATAGI) but the views in this manuscript are her own and not necessarily those of ATAGI. KF has received honoraria as a member of the vaccine advisory boards for Seqiris and Sanofi Pasteur in the last 5 years. AM has received research grants from NIH, Janssen and Merck AND fees for participation in advisory boards from Janssen, Sanofi-Pasteur, Merck and Roche. MS reports research grants and personal fees for advisory boards from GSK, Pfizer, Sanofi-Pasteur, Janssen and Seqirus. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Esposito, Abu-Raya, Bonanni, Cahn-Sellem, Flanagan, Martinon Torres, Mejias, Nadel, Safadi and Simon.)

Newborns and infants are at risk for severe infections with some pathogens (eg, Bordetella pertussis , influenza, respiratory syncytial virus, group B Streptococcus ) during early life. To decrease this window of high susceptibility to some infections during early life and protect young infants, vaccination in pregnancy against some vaccine-preventable diseases (eg, influenza, pertussis, tetanus) has been recommended in an increasing number of countries with notable success. In addition, recent advances have been made in developing vaccines for pregnant women with the aim of reducing the respiratory syncytial virus and group B Streptococcus burden in infancy. In this article, we review the vaccines currently recommended during pregnancy and their benefits to newborns and infants. We also discuss progress made in the development of other vaccines that are expected to be evaluated in pregnant women in the near future., (Copyright © 2021 by the American Academy of Pediatrics.)

Background: The Canadian National Advisory Committee on Immunization recommends universal vaccination against pertussis in pregnancy. We assessed the cost-effectiveness of vaccination with tetanus-diphtheria-acellular pertussis (Tdap) vaccine in pregnancy in Canada., Methods: We conducted a cost-utility analysis comparing a vaccination program to no program corresponding with the 2017 Canadian guideline for economic evaluation from the Canadian Agency for Drugs and Technologies in Health. We developed 2 models - part decision tree, part Markov model - to estimate the long-term cost and quality-adjusted life-years (QALYs) for pregnant women and their infants. We obtained epidemiologic data from 2006 to 2015, and derived costs and utility values from relevant sources. Results were reported in 2019 Canadian dollars. We obtained expected values through probabilistic analysis, with methodologic and structural uncertainty assessed through scenario analyses. The analysis adopted an acquisition price of Tdap vaccine of $12.50, with scenario analysis conducted to identify the threshold price for vaccination to be cost-effective., Results: In the base-case scenario, for every 1000 pregnant women vaccinated, the program would lead to a gain of 0.3 QALYs, occurring solely in infants, at an increased total cost of $12 987, or $44 301 per QALY gained. Based on a threshold of $50 000 per QALY gained, vaccination would have been cost-effective in 6 of the 10 years included in the model (range of incremental costs $20 463-$100 348 per QALY gained). The threshold cost for Tdap vaccine to be cost-effective over the 10-year horizon was $14.03., Interpretation: Based on a threshold of $50 000 per QALY gained, vaccination against pertussis in pregnancy would be cost-effective if the acquisition cost per vaccine were $14.03 or less. Province- and territory-specific analyses should be done to inform local decision-making., Competing Interests: Competing interests: Manish Sadarangani is supported via salary awards from the BC Children’s Hospital Foundation, the Canadian Child Health Clinician Scientist Program and the Michael Smith Foundation for Health Research. He has been an investigator on projects funded by Merck, VBI Vaccines, Pfizer, Seqirus, Sanofi Pasteur and GlaxoSmithKline; all funds have been paid to his institute, and he has not received any personal payments. Scott Halperin has been an investigator on projects funded by Merck, VBI Vaccines, Pfizer, Seqirus, Sanofi Pasteur and GlaxoSmithKline, and has served on ad hoc advisory boards for Merck, Sanofi Pasteur, GlaxoSmithKline and Pfizer; all funds have been paid to his university, and he has not received any personal payments. No other competing interests were declared., (Copyright 2020, Joule Inc. or its licensors.)

Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Edwards serves as an advisor for Bionet and Merck and on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer; and Dr Abu-Raya has indicated he has no potential conflicts of interest to disclose.

Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Optimal timing of gestational tetanus-diphtheria-acellular pertussis (Tdap) vaccination is not well-defined. No well-established specific anti-pertussis antibody level correlates with protection, suggesting the importance of antibody quality such as avidity. We aimed to determine the effect of timing of vaccination with Tdap in pregnancy on the avidity of cord anti-pertussis toxin (PT) immunoglobulin G (IgG). Methods: Prospective study of newborns in a tertiary hospital (Melbourne, Australia) born to women vaccinated with Tdap in pregnancy. Ammonium thiocyanate was used as a bond-breaking agent to measure the avidity of anti-PT IgG using concentrations between 0.25 M (to measure low avidity antibodies) and 3 M (to measure very high avidity antibodies). Anti-PT IgG levels achieved at each ammonium thiocyanate concentration in cord samples of women vaccinated during 28-32 weeks gestation (WG) vs. 33-36 WG, and women vaccinated 5-12 vs. 1-4 weeks prior to delivery were compared using t -tests. Results: Newborns of women vaccinated with Tdap during 28-32 WG ( n = 43) had statistically significant higher concentrations of medium and high avidity anti-PT IgG compared with newborns of women vaccinated during 33-36 WG ( n = 47), 11.6 IU/ml (95% CI, 8.8-15.2) IU/ml vs. 6.7 IU/ml (95% CI, 5.2-8.6) and 10.1 IU/ml (95% CI, 7.4-13.8) vs. 5.7 (95% CI, 3.6-8.9) IU/ml ( p = 0.007 and p = 0.035), respectively. Newborns of women vaccinated 5-12 weeks before delivery ( n = 64) had statistically significant higher concentrations of high and very high avidity anti-PT IgG compared with newborns of women vaccinated within 4 weeks before delivery ( n = 25), 10.3 IU/mL (95% CI, 7.9-13.4) vs. 3.3 IU/mL (95% CI, 1.7-6.4), 12.6 IU/mL (95% CI, 9.4-16.9) vs. 4.3 IU/mL (95% CI, 2.2-8.5) (all p < 0.03), respectively. Conclusions: Quantification of levels of anti-PT IgG with different avidities demonstrated that pertussis vaccination 5-12 weeks before delivery was associated with higher anti-PT IgG avidity compared with vaccination within 4 weeks before delivery. Pertussis vaccination during 28-32 WG was associated with higher anti-PT IgG avidity compared with vaccination during 33-36 WG, supporting vaccination at 28-32 over 33-36 WG for optimal protection against pertussis in infancy., (Copyright © 2019 Abu-Raya, Giles, Kollmann and Sadarangani.)

Invasive meningococcal disease causes meningitis and septicemia worldwide with highest rates of disease occurring in children <2 years of age, and in particular young infants. Vaccination during pregnancy has been a successful strategy for prevention of other infections in young infants, most notably tetanus, pertussis and influenza. However, few studies of meningococcal vaccines in pregnancy have been undertaken, and none include the most commonly used current vaccines to prevent disease by capsular groups A, B, C, W and Y. The limited data suggest that the older polysaccharide vaccines are immunogenic, but the impact on prevention of infant disease has not been measured. Further studies of MenB protein vaccines and MenA protein-polysaccharide conjugate vaccines in particular are needed if vaccination in pregnancy is to be utilized as an approach to prevention of meningococcal disease in young infants.