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J., Fireman. Our study was strengthened both by its large sample size and our ability to follow infants through 6 months of age. 387, 187189 (2022). Most mothers (1032 of 1138) who received only one dose received the vaccine during the third trimester. 1.04-1.49) after adjusting for age, sex, and vaccine characteristics. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. J. Pediatr. J. Med. The objective of this study was to further evaluate the effectiveness of at least two doses of mRNA COVID-19 vaccination during pregnancy for preventing SARS-CoV-2 infection in infants during the first 2, 4, and 6 months of life during the Delta and Omicron variant periods. In-hospital death status was missing in 1.4% (weighted) of hospitalizations; these hospitalizations are otherwise included elsewhere in the analysis. MMWR Morb Mortal Wkly Rep 2022;71:466473. J. Med. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. This case-positive, control-test-negative design also referred to as the test-negative design (TND) has often been used in studies of vaccine effectiveness. Open 5, e2233273 (2022). The TND is designed to better control for bias related to health care-seeking behavior31,32. We ran separate models on the time periods associated with the Delta (7/01/2021 to 12/20/2021) and Omicron variants (12/21/2021 to 5/31/2022). Mortal. About half of long-COVID patients who were on sick leave at 4 months were still on sick leave at 2 years. J. A WHO spokesman says China informed the WHO about the case, which involves a 53-year-old woman, on Feb 24. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. 9-14 As of October 2022, 68% of the US population has completed primary series vaccination. Rep. 71, 429436 (2022). Morb. Over the entire study period, the crude rate of hospitalization with a SARS-CoV-2 positive test was lower during the first 6 months of life among infants whose mothers received at least two doses . Over the entire study period, the incidence of hospitalization for COVID-19 was lower during the first 6 months of life among infants of vaccinated mothers compared with infants of unvaccinated mothers (21/100,000 person-years vs. 100/100,000 person-years). Get the most important science stories of the day, free in your inbox. Surveillance officers abstracted data on sampled patients from medical charts. Vaccine 31, 31043109 (2013). Compared with the Delta-predominant period, the proportion of unvaccinated hospitalized Black adults increased during the Omicron-predominant period. Department of Health and Human Services. However, protection estimates greater than 90% might be too high if individuals with a previous infection were more likely than those without one to come forward for a test for reasons other than suspicion of COVID-19. SARS-CoV-2 variant data update, England: Version 21. Association of COVID-19 vaccination during pregnancy with incidence of SARS-CoV-2 infection in infants. wrote the initial manuscript. Pre-Omicron versions of Covid, in. Only 16% of children between the ages of 5 and 11 are fully vaccinated, and that number climbs to just over 50% of adolescents between ages 12 and 17, according to CDC data . Waning 2-dose and 3-dose effectiveness of mRNA vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalizations among adults during periods of delta and omicron variant predominanceVISION Network, 10 states, August 2021-January 2022. Overall, 63% of Americans are fully vaccinated. These findings are consistent with estimates of booster effectiveness against symptomatic Omicron infection using healthcare ascertainment. (2021) Omicron is supercharging the COVID vaccine booster debate. Among nonpregnant and pregnant adults aged 18 years, hospitalization rates were calculated overall, and by race/ethnicity and COVID-19 vaccination status. *** An additional 172 (3.4%, 95% CI = 2.7%4.2%) adults were partially vaccinated, 69 (0.9%, 95% CI=0.61.2) received a primary vaccination series <14 days before receiving a positive SARS-CoV-2 test result, and 186 (4.1%) had unknown vaccination status; these groups are not further described in this analysis. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. The results were unchanged when no adjustments for covariates were made (Supplemental Table3). NMF, SB, SFunk, ACG, DDA, and AMP acquired funding. All adults should stay up to date (1) with COVID-19 vaccination to reduce their risk for COVID-19associated hospitalization. Vaccine 35, 58505857 (2017). Although the study was unable to directly estimate VE against hospitalization due to the small number of hospitalized cases, it found that over the entire study period, the incidence rate of hospitalization during the first 6 months of life was much lower among the infants whose mothers were vaccinated during pregnancy compared with those whose mothers were not vaccinated. Article According to the Ontario Science Table's online dashboard, the hospital occupancy rate for the unvaccinated was 611 per million unvaccinated people in the province's population as of Jan. 7,. Wkly. Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine. PLoS ONE 15, e0229279 (2020). *** LTCF residents include hospitalized adults who were identified as residents of a nursing home/skilled nursing facility, rehabilitation facility, assisted living/residential care, long-term acute care hospital, group/retirement home, or other LTCF upon hospital admission. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. National influenza and COVID-19 surveillance report: 27 January 2022 (week 4). pdf files, Omicron: fewer adverse outcomes come with new dangers, Statement on offensive historical content, Redistribute or republish the final article, Reuse portions or extracts from the article in other works. The report found that, during the omicron wave 6,743.5 per 100,000 unvaccinated people were contracting COVID-19 and 187.8 per 100,000 were hospitalized. The stats are for COVID-associated hospitalizations, which may include people for whom COVID-19 was not the primary reason for admission. volume14, Articlenumber:894 (2023) Vaccinated patients were older (68 vs. 57 years), and 62% had at least one comorbidity Admission to the ICU was 20%, and the mortality rate at 30 days was 14%. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The difference between the two studies might be due to population characteristics and the timing of follow-up as ours went through May 31, 2022, while the Norwegian study ended in April 2022. The report shows people catching Omicron are: 31% to 45% less likely to go to A&E. 50% to 70% less likely to be admitted to hospital for treatment. All adults should stay up to date with COVID-19 vaccination to reduce their risk for COVID-19associated hospitalization. Durability of anti-spike antibodies in infants after maternal COVID-19 vaccination or natural infection. Mortal. Halasa, N. B. et al. Laurie M. Billing and Kenzie Teno report grants from the Council of State and Territorial Epidemiologists during the conduct of the study. image, https://doi.org/10.1038/s41586-022-04474-x, https://doi.org/10.1038/s41586-022-04479-6, https://doi.org/10.1101/2022.01.18.22269082, https://www.gov.uk/government/statistics/national-flu-and-covid-19-surveillance-reports-2021-to-2022-season, Download .pdf (.95 Frequency, characteristics and complications of COVID-19 in hospitalized infants. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. CAS Nursing home residents have been disproportionately affected by COVID-19; older age, comorbidities, and the congregate nature of nursing homes place residents at higher risk for infection and severe COVID-19-associated outcomes . However, infants aged <6 months are not currently eligible for any currently available COVID-19 vaccines and must rely on placentally acquired immunity from their mothers. Saving Lives, Protecting People, https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html, https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm, https://www.cdc.gov/nchs/nvss/bridged_race.htm, https://www.medrxiv.org/content/10.1101/2021.08.27.21262356v1, https://www.cdc.gov/mmwr/volumes/70/wr/mm7050e2.htm, https://www.nejm.org/doi/full/10.1056/NEJMoa2114255, https://medrxiv.org/cgi/content/short/2021.08.27.21262356v1, https://www.medrxiv.org/content/10.1101/2022.01.11.22269045v1, https://data.cdc.gov/Vaccinations/COVID-19-Vaccination-Demographics-in-the-United-St/km4m-vcsb, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html, https://doi.org/10.1001/jamanetworkopen.2021.30479, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services, American Indian or Alaska Native, non-Hispanic, Psychiatric admission requiring medical care. During Omicron predominance, children aged <6 months accounted for 44% of hospitalizations among children ages 04 years3. We examined the effectiveness of maternal vaccination against SARS-CoV-2 infection in 30,311 infants born at Kaiser Permanente Northern California from December 15, 2020, to May 31, 2022. These findings are consistent with the diminishing of pregnancy-derived antibodies in infants over time22. JAMA 326, 16291631 (2021). 552a; 44 U.S.C. By clicking Sign up, you agree to receive marketing emails from Insider These trends could result in epidemic phase bias if infection severity is correlated with time from infection to test. Methods: One hundred and . If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. KPNC members are similar to the broad catchment population in Northern California in terms of sociodemographic characteristics34. COVID-NET conducts population-based surveillance for laboratory-confirmed COVID-19associated hospitalizations in 99 counties across 14 states. COVID-19associated hospitalizations are those occurring among residents of a predefined surveillance catchment area who have a positive real-time reverse transcriptionpolymerase chain reaction (RT-PCR) or rapid antigen detection test result for SARS-CoV-2 during hospitalization or the 14 days preceding admission. However, a milder virus could still put pressure . CAS If ethnicity was unknown, non-Hispanic ethnicity was assumed. COVID-19 vaccination during pregnancy: coverage and safety. Adults whose vaccination status had not yet been verified using the immunization information system data were considered to have unknown vaccination status and were included in total proportions but not stratified by vaccination status. We excluded these infants because we were primarily interested in estimating the effectiveness of mRNA vaccines received during pregnancy; (7) mothers who received adenovirus vector vaccines or any non-mRNA platform vaccines during pregnancy; (8) mothers who did not receive their mRNA vaccinations in accordance with CDC recommendationse.g., the timing between dose 1 and dose 2 was not within the recommended intervals; and (9) infants who did not become KPNC members within two calendar months of their birth. Severe cases may increase in the wake of holiday parties where people of all ages mixed. Data among adults over 50 showed that a booster shot gave even stronger protection. Vaccinations were limited only to those received during pregnancy. JAMA Intern. However, in contrast with the Norwegian study which reported that infants of mothers who were vaccinated had a 33% decreased risk of testing positive during the first 4 months of life during the Omicron period17, our study found a 13% reduced risk that was not statistically significant. Adults with no documented receipt of any COVID-19 vaccine dose before the test date were considered unvaccinated. 387, 227236 (2022). And in a second large study during the Omicron period, older people, men, and residents of nursing homes or in low-income areas were most at risk for post-booster COVID-19 death in England, but the risk was very low. As of December 25, the rate among unvaccinated people was 78 per 100,000, compared to 4 per 100,000 among fully vaccinated people, the CDC reported. Shook, L. L. et al. Dis. N. Engl. of Omicron-infected patients with a high rate of vaccination in China. Methods: This is a retrospective cohort study that was conducted in Israel's second-largest . In this primary design, all eligible infants meeting inclusion criteria were included without sampling which improved power and minimized bias related to selection. https://doi.org/10.1016/j.jpeds.2022.09.059 (2022). In conclusion, in this population-based cohort study, we found that infants born to mothers who received at least two doses of an mRNA COVID-19 vaccine during pregnancy were at lower risk of testing positive for SARS-CoV-2 and were at lower risk of hospitalization during the first 6 months of life compared with infants whose mothers were unvaccinated during pregnancy. NEW YORK and MAINZ, GERMANY, March 1, 2023 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster (fourth) dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years). Just 28% of children in the age group - around 8 million . While this proportion might not be representative of the proportion of vaccinated pregnant women within KPNC because of our exclusion criteria, more efforts are needed to promote COVID-19 vaccines for pregnant persons because vaccination provides protection to mothers and their infants until they are old enough to receive their own COVID-19 vaccines. The proportion of hospitalized Black adults who received a primary COVID-19 vaccination series with or without a booster or additional dose increased from 4.7% and 14.9%, respectively, during the Delta-predominant period to 14.8% and 25.5%, respectively, during the Omicron-predominant period; Hispanic adults experienced smaller increases. Nature. The study had limitations worth noting. Statistical codes are not publicly available but are available from the corresponding author. Maternal vaccination was protective, but protection was lower during Omicron than during Delta. Defined as one or more of the following: chronic lung disease including asthma, chronic metabolic disease including diabetes mellitus, blood disorder/hemoglobinopathy, cardiovascular disease, neurologic disorder, immunocompromising condition, renal disease, gastrointestinal/liver disease, rheumatologic/autoimmune/inflammatory condition, obesity, feeding tube dependency, and wheelchair dependency. All information these cookies collect is aggregated and therefore anonymous. Protection during both periods decreased as infants aged. conducted all statistical analysis in collaboration with O.Z. Effectiveness of COVID-19 vaccines in preventing hospitalization among adults aged 65 yearsCOVID-NET, 13 states, FebruaryApril 2021. Maternal SARS-CoV-2 vaccination and infant protection against SARS-CoV-2 during the first six months of life, https://doi.org/10.1038/s41467-023-36547-4. adjudicated chart reviews. We observed that infants protection through vaccination during pregnancy decreased as they aged from 2 months to 6 months. Mortal. The KPNC Institutional review board approved and waived consent for this study. Persons with multiple, unknown, or missing race accounted for 6.9% (weighted) of all cases. Andrews, N. et al. During the Delta period, receipt of one dose during the third trimester reduced infants risk of testing positive for SARS-CoV-2 by 74% (95% CI: 19, 92) during the first 6 months of life (Table3). Finally, the COVID-NET catchment areas include approximately 10% of the U.S. population; thus, these findings might not be nationally generalizable. Method: This case-control study aims to determine the hospitalization risk associated with the inactivated BBIBP-CorV (Sinopharm) and mRNA BNT162b2 (Pfizer . As with previous variants, being vaccinated greatly protects you from severe disease with omicron. TN, NMF, WH, and SA wrote the software. TN, NMF, SFlax, SFunk, SA, SB, and ST did the formal analysis. COVID-19 vaccination coverage among pregnant women during pregnancyEight Integrated Health Care Organizations, United States, December 14, 2020-May 8, 2021. Despite several studies showing that vaccination during pregnancy is safe for pregnant people24,25,26,27,28, vaccine uptake has been suboptimal in this group29. In all models, we used calendar days as the time scale to account for changes over time in SARS-CoV-2 circulation and vaccine uptake. In our primary analysis, we implemented a cohort study design where we used Cox proportional hazards models that allow for time-varying covariates to estimate the SARS-CoV-2 infection hazard ratio (HR) in infants of mothers vaccinated with at least 2 doses of mRNA COVID-19 vaccines during pregnancy and 1 dose only versus mothers who were unvaccinated during pregnancy. the date of publication. The risk of hospitalisation appeared to increase when comparing delta with alpha infections. Implementing strategies that result in the equitable receipt of COVID-19 vaccinations among persons with disproportionately higher hospitalizations rates, including non-Hispanic Black adults, is an urgent public health priority. In the US, as of the end of September 2022, almost 15 million children ages <18 years have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Coronavirus Disease 2019 (COVID-19). MMWR Morb Mortal Wkly Rep 2020;69:134754. There were only one hospitalized case among the children of vaccinated mothers and nine hospitalized cases among the children of unvaccinated mothers (Table1). O.Z., N.P.K., and B.F. conceived and designed the study. We were not able to evaluate more detailed measures of relative clinical severity in hospitalised patients (such as intensive care unit admittance), but our finding that estimated severity reductions comparing omicron with delta are larger for more severe endpoints (death and hospital admission versus hospital attendance) agrees with observations that the proportion of hospitalised COVID-19 patients requiring intensive care or mechanical ventilation (or both) has been substantially lower during the omicron wave in England than the preceding delta wave. American Academy of Pediatrics. Starting the week ending December 4, 2021, Maryland data are not included in calculations but are included in previous weeks. Late last year, as Omicron was spreading fast in the US, hospitalization rates per 100,000 rose sharply among unvaccinated adults, while rates in those who were fully vaccinated remained. PubMed Ousseny Zerbo. supervised chart reviews. Adults who received booster doses were classified as those who completed their primary vaccination series and received an additional or booster dose of vaccine on or after August 13, 2021, at any time after the completion of their primary series, and 14 days before a positive test result for SARS-CoV-2, because COVID-19associated hospitalizations are a lagging indicator, and time passed after receipt of a booster dose has been shown to be associated with reduced rates of COVID-19 infection (https://www.nejm.org/doi/full/10.1056/NEJMoa2114255). Med. Models were adjusted for the covariates listed above. N. Engl. The funders played no direct role in the study. However, vaccination during pregnancy was less effective at protecting infants against SARS-CoV-2 infection during the Omicron period. During the Omicron dominant period, receipt of 2 doses during pregnancy reduced the risk of the infant testing SARS-CoV-2 positive by 21% (95% CI: 21, 48) during the first 2 months of life, 14% (95% CI: 8, 32) during the first 4 months of life, and 13% (95% CI: 3, 26) during the first 6 months of life (Table2). Among the infants in the cohort, 19,418 (64.06%) of the mothers were unvaccinated during pregnancy, 1138 (3.75%) of the mothers received one dose of an mRNA COVID-19 vaccine and 9755 (32.18%) received 2 doses during pregnancy (Table1). Google Scholar. and JavaScript. Kharbanda, E. O. et al. Risk of hospitalisation associated with infection with SARS-CoV-2 lineage B.1.1.7 in Denmark: an observational cohort study. Abbreviations: COVID-NET = COVID-19Associated Hospitalization Surveillance Network; ICU=intensive care unit; IMV=invasive mechanical ventilation; LTCF=long-term care facility; NA = not applicable. Using previously described methods (3), investigators collected clinical data on a representative sample of adult patients (7.9%) hospitalized during July 1, 2021January 31, 2022, stratified by age and COVID-NET site. 61) indicates a lower risk of hospitalisation with omicron versus delta, averaging over all age groups and vaccination strata. Atlanta, GA: US Department of Health and Human Services, CDC; 2022. Garg S, Patel K, Pham H, et al. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of T.R. On the bias of estimates of influenza vaccine effectiveness from test-negative studies. 41, e81e86 (2022). COVID-19Associated Hospitalizations Among Adults During SARS-CoV-2 Delta and Omicron Variant Predominance, by Race/Ethnicity and Vaccination Status COVID-NET, 14 States, July 2021January 2022. Real-world data suggest lower COVID-19 vaccine effectiveness against Omicron variants11,12,13,14. During the Omicron-predominant period, weekly COVID-19associated hospitalization rates (hospitalizations per 100,000 adults) peaked at 38.4, compared with 15.5 during Delta predominance. N. Engl. Children born at Kaiser Permanente Northern California from December 15, 2020, through May 31, 2022. BNT162b2 mRNA Covid-19 vaccine in a nationwide mass vaccination setting. J. Med. 26 Among those fully vaccinated individuals 5 years of age who are booster eligible, only 49% have received a . Although both approaches adjusted for the same confounding factors, the effectiveness estimates from the TND were higher than those from the cohort design, which is consistent with our previous analyses of influenza vaccine effectiveness in which we also observed that the TND tended to result in higher vaccine effectiveness estimates than did our cohort analyses30. We thank staff at UKHSA and members of the UK Government SPI-M committee and the UKHSA Variant Technical Group for valuable discussions. Among all adults, relative to the Delta-predominant period, COVID-19related illness was the primary reason for admission for a smaller percentage of hospitalizations (87.5% versus 95.5%, p<0.01), and median length of stay was shorter (4 versus 5 days, p<0.01) during the Omicron-predominant period; during this period, the proportion of patients admitted to an intensive care unit, who received invasive mechanical ventilation, and who died in-hospital decreased significantly (all p<0.01). The second study, led by Office for National Statistics researchers in Wales, involved death rates and risk factors in adults in England who had received an mRNA booster at least 14 days before Dec 31, 2021. Morb. Infections are rare and can be severe or fatal, but so far scientists don't see genetic changes that pose an increased threat to people. A recent study found that the mean titer of maternally derived antibodies in infants of vaccinated mothers were higher at age 2 months compared with antibody titers at age 6 months23. KPNC has a comprehensive electronic health record system (Kaiser Permanente HealthConnect, a customized EPIC system), that captures detailed information on all medical services, including immunization, membership enrollment including place of residence, demographics, and pregnancy-related care from pregnancy onset to delivery, and beyond. TN and NMF were responsible for visualisation. As a result, the number of total hospitalizations exceeds the sum of unvaccinated adults, adults who received a primary series without a booster or additional dose, and adults who received a primary series with a booster or additional dose. A and B, Markers indicate estimates, with vertical lines indicating 95% CIs. Vaccinated patients during the Delta wave were 37% (over with two doses), while during the Omicron wave they were 57%. The cumulative monthly age-adjusted hospitalization rate during January 2022 among unvaccinated adults (528.2) was 12 times the rates among those who had received a booster or additional dose (45.0) and four times the rates among adults who received a primary series, but no booster or additional dose (133.5). JAMA Netw. Maryland did not contribute data after December 4, 2021, but did contribute data for previous weeks. Adults with no documented receipt of any COVID-19 vaccine dose before the test date were considered unvaccinated. J. M.G. Coinciding with Omicron variant predominance, COVID-19associated hospitalization rates among adults increased in late December 2021 and peaked in January 2022; rates increased more among Black adults relative to rates among adults of other racial and ethnic groups. 3501 et seq. SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland, Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy, Effectiveness of a third BNT162b2 mRNA COVID-19 vaccination during pregnancy: a national observational study in Israel, Covid-19 vaccination programme effectiveness against SARS-CoV-2 related infections, hospital admissions and deaths in the Apulia region of Italy: a one-year retrospective cohort study, Post-vaccination outcomes in association with four COVID-19 vaccines in the Kingdom of Bahrain, Effectiveness and protection duration of Covid-19 vaccines and previous infection against any SARS-CoV-2 infection in young adults, The indirect effect of mRNA-based COVID-19 vaccination on healthcare workers unvaccinated household members, SARS-CoV-2 infection and COVID-19 vaccination in pregnancy, Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar, https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%209.29.22%20FINAL.pdf?_ga=2.255000394.335550773.1665001859-370326403.1636740765, https://doi.org/10.1016/j.jpeds.2022.09.059, http://creativecommons.org/licenses/by/4.0/. TN, NMF, SFlax, MC, DDA, AMP, and ST conceptualised the work. But those countries have high vaccination rates, and there, too, Omicron has spread most quickly among younger adults.