Nicola P. Klein

ORCID: 0000-0003-1777-4814
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About
Contact & Profiles
Research Areas
  • Vaccine Coverage and Hesitancy
  • Influenza Virus Research Studies
  • SARS-CoV-2 and COVID-19 Research
  • Bacterial Infections and Vaccines
  • Respiratory viral infections research
  • Pneumonia and Respiratory Infections
  • Viral gastroenteritis research and epidemiology
  • Hepatitis B Virus Studies
  • COVID-19 Impact on Reproduction
  • Virology and Viral Diseases
  • Herpesvirus Infections and Treatments
  • Viral Infections and Immunology Research
  • COVID-19 Clinical Research Studies
  • Cervical Cancer and HPV Research
  • Peripheral Neuropathies and Disorders
  • Heparin-Induced Thrombocytopenia and Thrombosis
  • Genital Health and Disease
  • COVID-19 epidemiological studies
  • Neonatal Respiratory Health Research
  • Hepatitis Viruses Studies and Epidemiology
  • Asthma and respiratory diseases
  • Pneumocystis jirovecii pneumonia detection and treatment
  • Pregnancy and Medication Impact
  • Animal Virus Infections Studies
  • COVID-19 and healthcare impacts

Kaiser Permanente
2016-2025

Kaiser Permanente Oakland Medical Center
2016-2025

Harvard Pilgrim Health Care
2015-2025

University of Colorado Denver
2015-2024

Intermountain Healthcare
2021-2024

Baylor Scott & White Health
2022-2024

Atrium Health Wake Forest Baptist
2024

Vanderbilt University Medical Center
2024

Yale University
2015-2024

Hennepin County
2024

BackgroundUntil very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective are needed to protect this population, facilitate in-person learning and socialization, contribute herd immunity.MethodsIn ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants a 1:1 ratio receive two injections, 21 days apart, 30 μg...

10.1056/nejmoa2107456 article EN New England Journal of Medicine 2021-05-27

Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.This study represents an interim analysis safety data from Vaccine Datalink. The 10 162 227 vaccine-eligible members 8 participating US plans were monitored with administrative updated weekly supplemented medical record review for selected December 14, 2020, through June 26,...

10.1001/jama.2021.15072 article EN JAMA 2021-09-03

In the United States, children receive five doses of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine before 7 years age. The duration protection after DTaP is unknown.We assessed risk in California relative to time since fifth dose from 2006 2011. This period included a large outbreak 2010. We conducted case-control study involving members Kaiser Permanente Northern who were vaccinated with at 47 84 months compared confirmed by positive polymerase-chain-reaction (PCR) assay two...

10.1056/nejmoa1200850 article EN New England Journal of Medicine 2012-09-12

BackgroundThere are limited data on the effectiveness of vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in United States with respect to hospitalization, admission an intensive care unit (ICU), or ambulatory emergency department urgent clinic.MethodsWe conducted a study involving adults (≥50 years age) Covid-19–like illness who underwent molecular testing for severe acute respiratory syndrome 2 (SARS-CoV-2). We assessed 41,552 admissions 187 hospitals...

10.1056/nejmoa2110362 article EN New England Journal of Medicine 2021-09-08

CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion primary vaccination series and immunocompromised third dose.* Waning protection 2 doses has been observed during the period SARS-CoV-2 B.1.617.2 (Delta) variant predominance† (1-5), but little is known about durability 3 periods Delta or B.1.1.529 (Omicron) predominance. A test-negative case-control study design using data from eight VISION Network sites§ examined...

10.15585/mmwr.mm7107e2 article EN MMWR Morbidity and Mortality Weekly Report 2022-02-11

Estimates of COVID-19 mRNA vaccine effectiveness (VE) have declined in recent months (1,2) because waning induced immunity over time,* possible increased immune evasion by SARS-CoV-2 variants (3), or a combination these and other factors. CDC recommends that all persons aged ≥12 years receive third dose (booster) an ≥5 after receipt the second immunocompromised individuals primary dose.† A BNT162b2 (Pfizer-BioNTech) increases neutralizing antibody levels (4), three studies from Israel shown...

10.15585/mmwr.mm7104e3 article EN MMWR Morbidity and Mortality Weekly Report 2022-01-21

Active immunization with the BNT162b2 vaccine (Pfizer–BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during disease 2019 (Covid-19) pandemic. In light of reports waning protection occurring 6 months after primary two-dose series, data are needed on safety and efficacy offering third (booster) dose in persons 16 years age or older.

10.1056/nejmoa2200674 article EN New England Journal of Medicine 2022-03-23

In February 2008, we alerted the Advisory Committee on Immunization Practices to preliminary evidence of a twofold increased risk febrile seizures after combination measles-mumps-rubella-varicella (MMRV) vaccine when compared with separate measles-mumps-rubella (MMR) and varicella vaccines. Now data twice as many recipients, our goal was reexamine seizure MMRV vaccine.Using 2000-2008 Vaccine Safety Datalink data, assessed fever visits among children aged 12 23 months MMR + We that vaccines...

10.1542/peds.2010-0665 article EN PEDIATRICS 2010-06-29

Vaccination against pertussis during pregnancy is recommended to protect newborns, yet there limited information about the effectiveness of maternal tetanus toxoid, reduced diphtheria acellular (Tdap) vaccine before first infant dose diphtheria, and (DTaP) year life in infants who have received DTaP.In a retrospective cohort study born at Kaiser Permanente Northern California from 2010 2015, we estimated vaccination for protecting newborns 2 months accounting each DTaP dose.Among 148 981...

10.1542/peds.2016-4091 article EN PEDIATRICS 2017-04-03

Although current rotavirus vaccines were not associated with an increased risk of intussusception in large trials before licensure, recent postlicensure data from international settings suggest the possibility a small increase after monovalent vaccination. We examined this population United States.Participants infants between ages 4 and 34 weeks who enrolled six integrated health care organizations Vaccine Safety Datalink (VSD) project. reviewed medical records visits for within 7 days...

10.1056/nejmoa1311738 article EN New England Journal of Medicine 2014-01-14

In 2010, due to a pertussis outbreak and neonatal deaths, the California Department of Health recommended that tetanus toxoid, reduced diphtheria acellular vaccine (Tdap) be administered during pregnancy. Tdap is now by Advisory Committee on Immunization Practices for all pregnant women, preferably between 27 36 weeks' gestation. Limited data exist safety pregnancy.To evaluate whether maternal vaccination pregnancy associated with increased risks adverse obstetric events or birth...

10.1001/jama.2014.14825 article EN JAMA 2014-11-11

Parental refusal and delay of childhood vaccines has increased in recent years is believed to cluster some communities. Such clusters could pose public health risks barriers achieving immunization quality benchmarks. Our aims were (1) describe geographic underimmunization vaccine refusal, (2) compare with different vaccines, (3) evaluate whether may high rates.We analyzed electronic records among children born between 2000 2011 membership Kaiser Permanente Northern California. The study...

10.1542/peds.2014-2715 article EN PEDIATRICS 2015-01-20

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech Moderna COVID-19 vaccines, in February 2021, FDA an EUA Janssen (Johnson & Johnson) vaccine. After each EUA, Advisory Committee on Immunization Practices (ACIP) interim recommendations vaccine use; currently is authorized recommended persons aged ≥12 years ≥18 (1-3). Both administered as 2-dose series, are mRNA-based whereas vaccine, a single dose, recombinant...

10.15585/mmwr.mm7032e4 article EN MMWR Morbidity and Mortality Weekly Report 2021-08-10

Immunocompromised persons, defined as those with suppressed humoral or cellular immunity resulting from health conditions medications, account for approximately 3% of the U.S. adult population (1). adults are at increased risk severe COVID-19 outcomes (2) and might not acquire same level protection mRNA vaccines do immunocompetent (3,4). To evaluate vaccine effectiveness (VE) among immunocompromised adults, data VISION Network* on hospitalizations persons aged ≥18 years COVID-19-like illness...

10.15585/mmwr.mm7044e3 article EN MMWR Morbidity and Mortality Weekly Report 2021-11-02

The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, 16-17 years (1-3). Limited real-world data on 2-dose mRNA effectiveness (VE) persons 12-17 (referred to as this report) have also indicated high levels protection SARS-CoV-2 (the virus causes COVID-19) infection COVID-19-associated hospitalization (4-6); however, VE B.1.1.529 (Omicron) variant duration are...

10.15585/mmwr.mm7109e3 article EN MMWR Morbidity and Mortality Weekly Report 2022-03-01

To estimate the effectiveness of mRNA vaccines against moderate and severe covid-19 in adults by time since second, third, or fourth doses, age immunocompromised status.Test negative case-control study.Hospitals, emergency departments, urgent care clinics 10 US states, 17 January 2021 to 12 July 2022.893 461 (≥18 years) admitted one 261 hospitals 272 department 119 centers for covid-like illness tested SARS-CoV-2.The main outcome was waning vaccine with BNT162b2 (Pfizer-BioNTech) mRNA-1273...

10.1136/bmj-2022-072141 article EN cc-by-nc BMJ 2022-10-03

Data on COVID-19 vaccine effectiveness (VE) since the B.1.617.2 (Delta) variant of SARS-CoV-2, virus that causes COVID-19, became predominant circulating strain in United States are limited (1-3). CDC used VISION Network* to examine medical encounters (32,867) from 187 hospitals and 221 emergency departments (EDs) urgent care (UC) clinics across nine states during June-August 2021, beginning date Delta accounted for >50% sequenced isolates each facility's state. Network methods have been...

10.15585/mmwr.mm7037e2 article EN MMWR Morbidity and Mortality Weekly Report 2021-09-10

This report describes that the prevalences of prepregnancy obesity and gestational diabetes were higher among pregnant women hospitalized for COVID-19–related illness than those admitted pregnancy-related treatment or procedures found to have COVID-19.

10.15585/mmwr.mm6938e2 article EN MMWR Morbidity and Mortality Weekly Report 2020-09-16

Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified clinical trials such as Guillain-Barré syndrome (GBS), which has background rate 1 to 2 per 100 000 person-years.To describe cases and incidence GBS following COVID-19 vaccination assess the risk after for Ad.26.COV2.S (Janssen) mRNA vaccines.This cohort study used surveillance data from Vaccine Safety Datalink at 8 participating integrated health care systems United States. There...

10.1001/jamanetworkopen.2022.8879 article EN cc-by-nc-nd JAMA Network Open 2022-04-26

The COVID-19 pandemic has affected routine vaccine delivery in the US and globally. magnitude of these disruptions their association with childhood vaccination coverage are unclear.To compare trends pediatric before during to evaluate proportion children up date (UTD) vaccinations by age, race, ethnicity.This surveillance study used a prepandemic-postpandemic control design data from 8 health systems California, Oregon, Washington, Colorado, Minnesota, Wisconsin Vaccine Safety Datalink....

10.1001/jamapediatrics.2021.4251 article EN JAMA Pediatrics 2021-10-10

The Omicron variant (B.1.1.529) of SARS-CoV-2, the virus that causes COVID-19, was first identified in United States November 2021, with BA.1 sublineage (including BA.1.1) causing largest surge COVID-19 cases to date. sublineages BA.2 and BA.2.12.1 emerged later by late April 2022, accounted for most cases.* Estimates vaccine effectiveness (VE) can be reduced newly emerging variants or evade vaccine-induced immunity (1), protection from previous SARS-CoV-2 infection unvaccinated persons (2),...

10.15585/mmwr.mm7129e1 article EN MMWR Morbidity and Mortality Weekly Report 2022-07-15
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