Publications by authors named "Pedro L Moro"

76 Publications

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.

N Engl J Med 2021 06 21;384(24):2273-2282. Epub 2021 Apr 21.

From the Immunization Safety Office, Division of Healthcare Quality Promotion (T.T.S., T.R.M., P.L. Moro, L.P., P.L. Marquez, C.K.O., C.L., B.C.Z., J.M.G.), and the Arboviral Diseases Branch, Division of Vector-Borne Diseases (S.W.M.), National Center for Emerging and Zoonotic Infectious Diseases, the Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities (S.Y.K., V.K.B., C.J.G., D.M.M.-D.), the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion (T.O., K.T.C., S.R.E., A.N.S.), the World Trade Center Health Program, National Institute for Occupational Safety and Health (R.L.), and the Epidemic Intelligence Service (K.T.C.) - all at the Centers for Disease Control and Prevention, Atlanta; and the Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD (M.A., A.M.-J.).

Background: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy.

Methods: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons.

Results: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases).

Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1056/NEJMoa2104983DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117969PMC
June 2021

Postmarketing safety surveillance of quadrivalent recombinant influenza vaccine: Reports to the vaccine adverse event reporting system.

Vaccine 2021 03 5;39(13):1812-1817. Epub 2021 Mar 5.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia. Electronic address:

On October 7, 2016, the Food and Drug Administration approved recombinant hemagglutinin quadrivalent influenza vaccine (RIV4) (Spodoptera frugiperda cell line; Flublok Quadrivalent) for active immunization for the prevention of influenza disease in individuals 18 years of age and older. Clinical trials did not reveal any major differences in adverse events or serious adverse events following Flublok Quadrivalent versus standard-dose quadrivalent inactivated influenza vaccine. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized adverse event reports after Flublok Quadrivalent administration to the Vaccine Adverse Event Reporting System (VAERS). Through June 30, 2020, VAERS received 849 reports after RIV4 vaccination. The vast majority (810; 95%) were non-serious. Among serious events, there were 10 cases of Guillain-Barré syndrome, including 5 people who required mechanical ventilation and 2 people who died. Many allergic reactions were reported as non-serious, but required interventions to treat a life-threatening event, e.g., epinephrine, nebulizers, albuterol, glucocorticoids, and supplemental oxygen. Two people experienced a positive rechallenge (i.e., allergic reactions after repeated vaccination with RIV4), including a person who-despite premedication with antihistamines-developed respiratory difficulties, required epinephrine, and was transported to the emergency department. The occurrence of anaphylaxis and other allergic reactions in some individuals may reflect an underlying predisposition to atopy that may manifest itself after an exposure to any drug or vaccine, and does not necessarily suggest that Flublok Quadrivalent is particularly allergenic. Postmarketing safety surveillance will continue to be vital for understanding the benefits and risks of quadrivalent recombinant influenza vaccine.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2021.02.052DOI Listing
March 2021

Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020.

Vaccine 2021 01 25;39(4):678-681. Epub 2020 Dec 25.

Immunization Safety Office, Division of Healthcare Quality Promotion, United States.

Background: In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the United States for adults aged ≥18 years. A quadrivalent version (ccIIV4) was later approved in 2016 and replaced ccIIV3. The safety of ccIIV3 or ccIIV4 (ccIIV) was not assessed for pregnant women or their infants during pre-licensure studies.

Objective: To assess the safety of ccIIV administered during pregnancy in pregnant women and their infants whose reports were submitted to VAERS during 2013-2020.

Material And Methods: We searched VAERS for United States reports of adverse events (AEs) in pregnant women who received ccIIV from 1 July 2013 through 31 May 2020. Clinicians reviewed reports and available medical records and assigned a primary clinical category for each report. Reports were coded as serious based on the Code of Federal Regulations definition.

Results: VAERS received 391 reports following ccIIV administered to pregnant women. Twenty-four (6.1%) were serious. Two neonatal deaths were reported. No maternal deaths occurred. Among reports with trimester information (n = 340), ccIIV was administered during the second trimester in 170 (50%). The most frequent pregnancy-specific AE was premature delivery in 85 (21.7%) reports, followed by dysmature placenta in 13 (3.3%) and pre-eclampsia/eclampsia in ten (2.3%). The most common non-pregnancy specific conditions were infectious conditions in 32 (8.2%). Among infant conditions, low birth weight was reported in 62 (15.9%) reports. Fifteen birth defects were reported; in 12 with gestational age information, administration of the vaccine occurred late in the second trimester or later.

Conclusions: Review of maternal ccIIV reports in VAERS was not unexpectedly different from other maternal influenza vaccine safety VAERS reviews.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2020.12.045DOI Listing
January 2021

Safety profile of rotavirus vaccines among individuals aged ≥8 months of age, United States, vaccine adverse event reporting system (VAERS), 2006-2019.

Vaccine 2021 01 29;39(4):746-750. Epub 2020 Nov 29.

Viral Gastroenteritis Branch, Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention USA.

Introduction: In 2006 and 2008, two live, oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), were introduced into the routine immunization program in the United States. A previous rotavirus vaccine, RotaShield, was associated with an increased risk of intussusception, with data suggesting an age-dependent variation in risk. Advisory Committee on Immunization Practices (ACIP) currently recommends that RV5 or RV1 immunization be initiated by age 14 weeks and 6 days and completed by 8 months 0 days.

Methods: We searched for U.S. VAERS reports of RV5, RV1, or unknown rotavirus vaccine brand among individuals aged ≥8 months. We analyzed reports by 2 age groups (individuals aged ≥8 months-≤5 years and ≥6 years), vaccine brand name, adverse event (AE) reported, classification of seriousness (death, non-death serious, and non-serious) and mode of exposure (direct vs. indirect exposure). For serious reports we reviewed available medical records and assigned a primary diagnosis.

Results: VAERS received a total of 344 U.S. reports following rotavirus vaccination among individuals ≥8 months of age, 32 (9.3%) were serious. In the younger age-group, 307 (99%) of 309 reports followed direct vaccination of the child. In contrast, in individuals aged ≥6 years, 21 (60%) of 35 reports were via potential indirect exposure to a vaccinated child. The frequently reported AEs in the younger age-group were inappropriate schedule of drug administration 104 (34%) and drug administered to patient of inappropriate age 45 (15%); in the older group these were accidental exposure 9 (26%) and eye irritation 7 (20%). No difference in the safety profile was observed between RV1 and RV5.

Conclusions: We did not identify any unexpected AEs for RV vaccines among individuals aged ≥8 months. Health care providers should adhere to the ACIP recommended schedule and older individuals should apply necessary precautions to prevent potential secondary exposure from vaccinated children.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2020.11.026DOI Listing
January 2021

The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barré syndrome.

Vaccine 2020 11 7;38(47):7458-7463. Epub 2020 Oct 7.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Background: Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine.

Objectives: To determine the sensitivity of VAERS in capturing AE reports of anaphylaxis and Guillain-Barré syndrome (GBS) following vaccination and whether this is consistent with previous estimates for other severe AEs.

Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. We used data from VAERS safety reviews as the numerator, and estimated incidence rates of anaphylaxis and GBS following vaccination from the Vaccine Safety Datalink (VSD) studies as the denominator. We defined reporting sensitivity as the VAERS reporting rate divided by the VSD incidence rate. Sensitivity was reported as either a single value, or a range if data were available from >1 study.

Results: VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. For anaphylaxis, VAERS captured 13-27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. For GBS, VAERS captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine.

Conclusions: For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2020.09.072DOI Listing
November 2020

Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016.

Vaccine 2020 09 31;38(40):6291-6298. Epub 2020 Jul 31.

Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.

Background: Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM conjugate vaccine (MenACWY-CRM). To provide an updated general safety assessment, we reviewed reports of AEs following MenACWY-D submitted to the Vaccine Adverse Event Reporting System (VAERS).

Methods: VAERS is a national spontaneous reporting vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. We searched the VAERS database for U.S. reports of AEs after administration of MenACWY-D from January 2005 through June 2016. We conducted clinical reviews of serious reports after MenACWY-D administered alone, reports of MenACWY-D use during pregnancy, and reports of selected pre-specified outcomes. We screened for disproportionate reporting of AEs after MenACWY-D using empirical Bayesian data mining.

Results: VAERS received 13,075 U.S. reports after receipt of MenACWY-D; most (86%) described vaccination in adolescents, were classified as non-serious (94%), and described AEs consistent with pre-licensure studies. We did not find any evidence that reported deaths were related to vaccination. In serious reports, GBS and meningococcal infection were the most commonly reported medical conditions. Many reports of MenACWY-D use during pregnancy described inadvertent vaccination; most (61%) did not report any AE.

Conclusions: Findings from our comprehensive review of reports to VAERS following MenACWY-D are consistent with data from pre-licensure studies and provide further reassurance on the safety of MenACWY-D.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2020.07.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7495357PMC
September 2020

Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019.

Vaccine 2020 08 21;38(37):5923-5926. Epub 2020 Jul 21.

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States.

Background: On 12/23/2009 a new high-dose trivalent inactivated influenza vaccine (IIV3-HD) was licensed for adults aged ≥65 years. We assessed the post-licensure safety data for IIV3-HD in the Vaccine Adverse Event Reporting System (VAERS) during 2011-2019.

Methods: We searched VAERS for reports after IIV3-HD during 1/1/2011-06/30/2019 in persons aged ≥65 years. Medical records were reviewed for all death reports and for certain pre-specified conditions (e.g. Guillain Barré Syndrome [GBS], anaphylaxis). We also reviewed certain groups who received IIV3-HD erroneously (e.g. pregnant women, children). Empirical Bayesian data mining was used to identify disproportional reporting.

Results: VAERS received 12,320 reports after IIV3-HD;723 reports (5.9%) were serious. The most common adverse events (AEs) among serious reports were pyrexia (30.2%), asthenia (28.9%), and dyspnea (24.9%), and among non-serious reports were injection site erythema (16.8%), pain in extremity (15.8%), and injection site pain (14.2%). Among 55 death reports, the most common causes of death were diseases of the circulatory system (n = 23;41.8%). Based on medical record review, there were 61 reports of GBS and 13 of anaphylaxis. There were 13 reports of pregnant-women who inadvertently received IIV3-HD; three reports described arm pain or local reactions, and 10 did not report any AE. Among 59 reports of children who erroneously received IIV3-HD, 31 experienced an AE (most commonly injection site or constitutional reactions) and the remaining 28 reports did not describe any AE.

Conclusions: Post-licensure safety data of IIV3-HD during 9 influenza seasons revealed no new or unexpected safety concerns among individuals ≥65 years. Inadvertent administration of IIV3-HD to children or pregnant women was observed, although with no serious AEs reported. Training and education of providers in vaccine recommendations and groups for whom the vaccine is indicated may help in preventing these vaccine administration errors. This review provides baseline information for future monitoring of the quadrivalent-high-dose influenza vaccine.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2020.07.007DOI Listing
August 2020

Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccines: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2019.

MMWR Morb Mortal Wkly Rep 2020 Jan 24;69(3):77-83. Epub 2020 Jan 24.

Since 2005, a single dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine has been recommended by the Advisory Committee on Immunization Practices (ACIP) for adolescents and adults (1,2). After receipt of Tdap, booster doses of tetanus and diphtheria toxoids (Td) vaccine are recommended every 10 years or when indicated for wound management. During the October 2019 meeting of ACIP, the organization updated its recommendations to allow use of either Td or Tdap where previously only Td was recommended. These situations include decennial Td booster doses, tetanus prophylaxis when indicated for wound management in persons who had previously received Tdap, and for multiple doses in the catch-up immunization schedule for persons aged ≥7 years with incomplete or unknown vaccination history. Allowing either Tdap or Td to be used in situations where Td only was previously recommended increases provider point-of-care flexibility. This report updates ACIP recommendations and guidance regarding the use of Tdap vaccines (3).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.15585/mmwr.mm6903a5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7367039PMC
January 2020

Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥65 years, Vaccine Adverse Event reporting System (VAERS), United States, September 2010-December 2018.

Vaccine 2020 02 26;38(6):1476-1480. Epub 2019 Dec 26.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Introduction: The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group.

Methods: We searched for and analyzed U.S. VAERS reports of Tdap among individuals ≥65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting.

Results: VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n = 468), injection site pain (19%; n = 335), injection site swelling (18%; n = 329), and erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected.

Conclusions: We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults ≥65 years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2019.11.074DOI Listing
February 2020

Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017.

Vaccine 2020 01 26;38(5):1137-1143. Epub 2019 Nov 26.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), United States.

Background: Vaccines administered into or too close to underlying joint structures have the potential to cause shoulder injuries. Limited data exist on the epidemiology of such events.

Objective: To describe case reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine (IIV).

Methods: We searched the Vaccine Adverse Event Reporting System (VAERS) database from July 2010 to June 2017 for reports of atypical shoulder pain and dysfunction following IIV. When identifying reports, we made no assumptions about true incident injury or causality with respect to vaccination. Pain had to begin <48 h after vaccination and signs and symptoms had to continue for >7 days to differentiate from self-limited local reactions. We conducted descriptive analysis.

Results: We identified 1220 reports that met our case definition (2.0% of all IIV reports, range 1.5%-2.5% across influenza seasons). Median age was 52 years (range 16-94) and most patients (82.6%) were female. Shoulder pain (44.1%), injected limb mobility decreased (40.8%), joint range of motion decreased (21.2%), rotator cuff syndrome (9.2%), and bursitis (9.0%) were frequently reported. In 86.6% of reports, signs and symptoms had not resolved by the time of report submission. In reports that included descriptions suggesting contributing factors (n = 266), vaccination given "too high" on the arm was cited in 81.2%. Nearly half (n = 605, 49.6%) of reports described a healthcare provider evaluation. Treatments included non-narcotic analgesics, physical therapy, and corticosteroid injection. Vaccinations were most commonly administered in a pharmacy or retail store (41.0%) or doctor's office or hospital (31.6%).

Conclusions: Reports of atypical shoulder pain and dysfunction following IIV were uncommon, considering the amount of IIV use, and stable across influenza seasons. While specific etiology of cases is unknown, improperly administered vaccine, which is preventable, might be a factor. Prevention strategies include education, training, and adherence to best practices for vaccine administration.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2019.11.023DOI Listing
January 2020

Shoulder Injury Related to Vaccine Administration (SIRVA): Petitioner claims to the National Vaccine Injury Compensation Program, 2010-2016.

Vaccine 2020 01 23;38(5):1076-1083. Epub 2019 Nov 23.

National Vaccine Injury Compensation Program, Health Resources and Services Administration, U.S. Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857, United States.

Background: Since 2010, petitioner claims of shoulder injury related to vaccine administration (SIRVA) to the National Vaccine Injury Compensation Program (VICP) have been increasing.

Objective: To conduct a scientific review of clinical characteristics of SIRVA petitions to the VICP.

Methods: We queried the VICP's Injury Compensation System database for medical reports of alleged SIRVA and SIRVA-like injuries. Medical reports are summaries of petitioner claims and supporting documentation along with a VICP clinician reviewer diagnosis and assessment of criteria for concession. We conducted a descriptive analysis of SIRVA petitioner claims recommended by the VICP for concession as SIRVA injuries.

Results: We identified 476 petitioner claims recommended for concession. Claims per year increased from two in 2011, the first full year in the analytic period, to 227 in 2016. Median age was 51 years, 82.8% were women, and median body mass index was 25.1 (range 17.0-48.9). Four hundred cases (84.0%) involved influenza vaccine. Pharmacy or store (n = 168; 35.3%) was the most common place of vaccination followed by doctor's office (n = 147; 30.9%). Fewer than half of cases reported a suspected administration error; 172 (36.1%) reported 'injection too high' on the arm. Shoulder pain, rotator cuff problems, and bursitis were common initial diagnoses. Most (80.0%) cases received physical or occupational therapy, 60.1% had at least one steroid injection, and 32.6% had surgery. Most (71.9%) healthcare providers who gave opinions on causality considered the injury was caused by vaccination. A minority (24.3%) of cases indicated that symptoms had resolved by the last visit available in medical records.

Conclusions: Most conceded claims for SIRVA were in women and involved influenza vaccines. Injection too high on the arm could be a factor due to the risk of injecting into underlying non-muscular tissues. Healthcare providers should be aware of proper injection technique and anatomical landmarks when administering vaccines.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2019.11.032DOI Listing
January 2020

Challenges in evaluating post-licensure vaccine safety: observations from the Centers for Disease Control and Prevention.

Expert Rev Vaccines 2019 10 19;18(10):1091-1101. Epub 2019 Oct 19.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.

: Vaccination is one of the most successful and cost-effective public health interventions. Although vaccines undergo extensive safety and efficacy evaluations prior to licensure, vaccine safety assessment post-licensure is essential for detecting rare and longer-term adverse events (AEs) and maintaining public confidence in vaccines and recommended immunization programs. Despite the proven effect of vaccines to save lives and prevent disease and overwhelming evidence of vaccines' safety and societal benefit, like any drug, no vaccine can be considered as completely safe and completely effective. New vaccines continue to be introduced and require rapid safety assessment post-licensure through pharmacovigilance reports as well as epidemiologic studies to investigate any potential safety signals.: We discuss selected challenges for conducting pharmacovigilance and epidemiologic studies of AEs after vaccination in the United States using the post-licensure safety surveillance infrastructure of the Centers for Disease Control and Prevention (CDC).: The availability of specific post-licensure surveillance systems to monitor and study AEs after vaccination, such as the Vaccine Adverse Event Reporting System, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment Project, each with its unique set of strengths and limitations, provide a harmonized and supportive approach to meet several of these barriers.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/14760584.2019.1676154DOI Listing
October 2019

Adverse events following purified chick embryo cell rabies vaccine in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 2006-2016.

Travel Med Infect Dis 2019 May - Jun;29:80-81. Epub 2018 Oct 26.

Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, GA, 30333, United States.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.tmaid.2018.10.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6946544PMC
July 2019

Is there any harm in administering extra-doses of vaccine to a person? Excess doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2007-2017.

Vaccine 2019 06 30;37(28):3730-3734. Epub 2019 May 30.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention, USA.

Background: The administration of an extra dose of a vaccine may occur due to a programmatic error (e.g., vaccination error) when there is need to provide one of the antigens of a combination vaccine not readily available as a single antigen, or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refugees). There is little data available on the safety of an extra dose of vaccine.

Objective: To assess for the presence of adverse events (AEs) most commonly reported following the administration of excess doses of vaccine in the Vaccine Adverse Event Reporting System (VAERS).

Methods: We searched VAERS for US reports where an excess dose of vaccine was administered to a person received from 1/1/2007 through 1/26/2018. We reviewed medical records for all serious reports and a random sample of non-serious reports. The most common AEs among reports of excess dose of vaccine administered were compared with the corresponding AEs for all vaccines reported to VAERS during the same period.

Results: Out of 366,815 total VAERS reports received, 5067 (1.4%) reported an excess dose of vaccine was administered; 3898 (76.9%) did not describe an adverse health event (AHE). The most common vaccines reported were trivalent inactivated influenza (15.4%), varicella (13.9%), hepatitis A (11.4%), and measles, mumps, rubella, varicella (11.1%). Among reports where only AHEs were reported, the most common were pyrexia (12.8%), injection site erythema (9.7%), injection site pain (8.9%), and headache (6.6%). The percentage of AHEs among these reports was comparable to all reports submitted to VAERS during the same study period.

Conclusion: More than three-fourths of reports of an excess dose of vaccine did not describe an AHE. Among reports where an AHE event was reported, we did not observe any unexpected conditions or clustering of AEs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2019.04.088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6925972PMC
June 2019

Introduction of new vaccines for immunization in pregnancy - Programmatic, regulatory, safety and ethical considerations.

Vaccine 2019 05 6;37(25):3267-3277. Epub 2019 May 6.

Department of Global Health, University of Washington, Seattle, USA; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.

Immunizing pregnant women is a promising strategy to reduce infectious disease-related morbidity and mortality in pregnant women and their infants. Important pre-requisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient numbers of healthcare workers to deliver the vaccines; close integration of immunization programs with antenatal care and Maternal and Child Health services; adequate access to antenatal care by pregnant women in the country (especially in low and middle-income countries (LMIC)); and a high proportion of births occurring in health facilities (to ensure maternal and neonatal follow-up can be done). The framework needed to advance a vaccine program from product licensure to successful country-level implementation includes establishing and organizing evidence for anticipated vaccine program impact, developing supportive policies, and translating policies into local action. International and national coordination efforts, proactive planning from conception to implementation of the programs (including country-level policy making, planning, and implementation, regulatory guidance, pharmacovigilance) and country-specific and cultural factors must be taken into account during the vaccines introduction.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2019.04.075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771279PMC
May 2019

Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018.

Vaccine 2019 03 7;37(11):1516-1520. Epub 2019 Feb 7.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Background: Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the United States (U.S.) in 2015 for adults aged ≥65 years and has been in use since the 2016-17 influenza season.

Methods: We analyzed U.S. reports for aIIV3 submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. Medical records were reviewed for serious reports. Among individuals ≥65 years of age, the relative frequency of the most commonly reported adverse events (AEs) after aIIV3 were compared with non-adjuvanted inactivated influenza vaccines given to adults aged ≥65 years, high-dose trivalent influenza vaccine (IIV3-HD) and trivalent or quadrivalent vaccines (IIV3/IIV4). Data mining analyses were undertaken to identify whether AEs for aIIV3 occurred disproportionately more than expected compared to all influenza vaccines.

Results: VAERS received 630 reports after aIIV3, of which 521 (83%) were in adults aged ≥65 years; 79 (13%) in persons <65 years and in 30 (5%) reports age was missing; 19 (3%) reports were serious, including two deaths (0.4%) related to myocardial infarction and Sjogren's syndrome. The most common AEs reported in adults aged ≥65 years were injection site pain (21%) and erythema (18%), with similar proportions reported for IIV3-HD (17% and 19%, respectively) and for IIV3/IIV4 (15%, each). Except for reports related to vaccination of inappropriate age (n = 79) and syringe malfunction (n = 6), data mining did not identify other disproportionately reported AEs.

Conclusions: Although our review of aIIV3 in VAERS did not identify any unexpected health conditions of concern, we observed more than twice the expected number of reports with administration of the vaccine to persons outside of the age range for which the vaccine is approved in the U.S. Health care providers should be educated on the age groups for whom aIIV3 is recommended.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2019.01.052DOI Listing
March 2019

Safety of 9-valent human papillomavirus vaccine administration among pregnant women: Adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), 2014-2017.

Vaccine 2019 02 16;37(9):1229-1234. Epub 2019 Jan 16.

Emory University Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory University Rollins School of Public Health, Hubert Department of Global Health, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory Vaccine Center, 954 Gatewood Road, Atlanta, GA 30329, United States. Electronic address:

Introduction: 9-valent human papillomavirus vaccine (9vHPV) was approved by the Food and Drug Administration (FDA) in December 2014. 9vHPV is not recommended during pregnancy, but some women of childbearing age may be inadvertently exposed. This study aims to evaluate reports submitted to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women exposed to 9vHPV.

Methods: We searched the VAERS database, a national post-licensure vaccine safety surveillance system, for reports of pregnant women vaccinated with 9vHPV in the United States between December 10, 2014 and December 31, 2017. Disproportionate reporting of adverse events (AEs) was assessed using proportional reporting ratios (PRRs).

Results: A total of 82 pregnancy reports were identified. Sixty reports (73.2%) did not describe an AE and were submitted only to report the vaccine exposure during pregnancy. The most frequently reported pregnancy-specific AE was spontaneous abortion (n = 3; 3.7%), followed by vaginal bleeding (n = 2; 2.4%). Among non-pregnancy-specific AEs, injection site reaction (n = 3; 3.7%) was most common. No disproportionate reporting of any AE was found.

Discussion: No unexpected AEs were observed among these pregnancy reports.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2018.11.077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6505695PMC
February 2019

Anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System, 1990-2016.

J Allergy Clin Immunol 2019 04 14;143(4):1465-1473. Epub 2019 Jan 14.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Ga.

Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination.

Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016.

Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician's diagnosis.

Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician's diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity.

Conclusion: Anaphylaxis after vaccination is rare in the United States and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jaci.2018.12.1003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6580415PMC
April 2019

Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women.

Vaccine 2018 10 13;36(42):6354-6360. Epub 2018 Sep 13.

Department of Pediatrics, Vanderbilt University, Nashville, TN, USA.

Objective: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertusiss (Tdap) vaccine is recommended during each pregnancy, regardless of prior receipt. Data on reactogenicity and immunogenicity, particularly after repeated Tdap, are limited. We compared local injection-site and systemic reactions and serologic response following Tdap in (1) pregnant and nonpregnant women and (2) pregnant women by self-reported prior Tdap receipt.

Study Design: Pregnant women (gestational age 20-34 weeks) and nonpregnant women receiving Tdap were enrolled in this observational study. Injection-site and systemic reactions were assessed for one week post-vaccination. Pertussis toxin, filamentous hemagglutinin, pertactin, fimbriae, tetanus and diphtheria specific IgG antibody titers were determined by standardized enzyme-linked immunosorbent assay at baseline and 28 days post-vaccination. Reactogenicity and serologic responses were compared by pregnancy status, and within pregnant women by self-reported prior Tdap receipt.

Results: 374 pregnant and 225 nonpregnant women were vaccinated. Severe local or systemic reactions or "any" fever were uncommon (≤3% for both groups). Moderate/severe injection-site pain was significantly higher in pregnant (17.9%) versus nonpregnant (11.1%) women, but did not prompt a healthcare visit. Proportions of other moderate/severe or any severe reactions were not significantly higher in pregnant compared to nonpregnant women. Moderate/severe (including pain) and severe reactions were not significantly higher in pregnant women receiving repeat versus first-time Tdap. Antibody titers increased from baseline to post-vaccination for all vaccine antigens in pregnant and nonpregnant women; post-vaccination titers against pertussis toxin and filamentous hemagglutinin were significantly higher in nonpregnant versus pregnant women (p < 0.01).

Conclusion: Tdap was well-tolerated in pregnant and nonpregnant women. Pregnant women were more likely to report moderate/severe pain at the Tdap injection-site compared with nonpregnant women, but did not necessitate medical visits. Prior Tdap receipt did not increase occurrence of moderate/severe local or systemic reactions in pregnant women. Serologic responses to all vaccine antigens were robust. Clinical Trial [email protected] NCT02209623. https://clinicaltrials.gov/ct2/show/NCT02209623.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2018.07.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6675450PMC
October 2018

Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines.

Pediatrics 2018 07 4;142(1). Epub 2018 Jun 4.

Immunization Safety Office, Division of Healthcare Quality Promotion and.

Objective: To assess the safety of currently licensed diphtheria-tetanus-acellular pertussis (DTaP) vaccines in the United States by using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

Methods: We searched VAERS for US reports of DTaP vaccinations occurring from January 1, 1991, through December 31, 2016, and received by March 17, 2017. We reviewed available medical records for all death reports and a random sample of reports classified as nondeath serious. We used Empirical Bayesian data mining to identify adverse events that were disproportionally reported after DTaP vaccination.

Results: VAERS received 50 157 reports after DTaP vaccination; 43 984 (87.7%) of them reported concomitant administration of other vaccines, and 5627 (11.2%) were serious. Median age at vaccination was 19 months (interquartile range 35 months). The most frequently reported events were injection site erythema (12 695; 25.3%), pyrexia (9913; 19.8%), injection site swelling (7542; 15.0%), erythema (5599; 11.2%), and injection site warmth (4793; 9.6%). For 3 of the DTaP vaccines, we identified elevated values for vaccination errors using Empirical Bayesian data mining.

Conclusions: No new or unexpected adverse events were detected. The observed disproportionate reporting for some nonserious vaccination errors calls for better education of vaccine providers on the specific indications for each of the DTaP vaccines.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1542/peds.2017-4171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6476554PMC
July 2018

Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.

Vaccine 2018 01 11;36(4):559-564. Epub 2017 Dec 11.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Introduction: Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system.

Methods: We searched VAERS for reports of AEs following single antigen HepB vaccine and HepB-containing vaccines (either given alone or with other vaccines), from January 2005 - December 2015. We conducted descriptive analyses and performed empirical Bayesian data mining to assess disproportionate reporting. We reviewed serious reports including reports of special interest.

Results: VAERS received 20,231 reports following HepB or HepB-containing vaccines: 10,291 (51%) in persons <2 years of age; 2588 (13%) in persons 2-18 years and 5867 (29%) in persons >18 years; for 1485 (7.3%) age was missing. Dizziness and nausea (8.4% each) were the most frequently reported AEs following a single antigen HepB vaccine: fever (23%) and injection site erythema (11%) were most frequent following Hep-containing vaccines. Of the 4444 (22%) reports after single antigen HepB vaccine, 303 (6.8%) were serious, including 45 deaths. Most commonly reported cause of death was Sudden Infant Death Syndrome (197). Most common non-death serious reports following single antigen HepB vaccines among infants aged <1 month, were nervous system disorders (15) among children aged 1-23 months; infections and infestation (8) among persons age 2-18 years blood and lymphatic systemic disorders; and general disorders and administration site conditions among persons age >18 years. Most common vaccination error following single antigen HepB was incorrect product storage.

Conclusions: Review current U.S.-licensed HepB vaccines administered alone or in combination with other vaccines did not reveal new or unexpected safety concerns. Vaccination errors were identified which indicate the need for training and education of providers on HepB vaccine indications and recommendations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2017.11.079DOI Listing
January 2018

Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016.

Vaccine 2018 01 27;36(1):50-54. Epub 2017 Nov 27.

Immunization Safety Office (ISO), Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), United States.

Background: The safety of hepatitis B vaccination during pregnancy has not been well studied.

Objective: We characterized adverse events (AEs) after hepatitis B vaccination of pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

Methods: We searched VAERS for AEs reports involving pregnant women who received hepatitis B vaccine from January 1, 1990-June 30, 2016. All reports and available medical records were reviewed by physicians. Observed AEs were compared to expected AEs and known rates of pregnancy outcomes to assess for any unexpected safety concern.

Results: We found 192 reports involving pregnant women following hepatitis B vaccination of which 110 (57.3%) described AEs; 12 (6.3%) were classified as serious; one newborn death was identified in a severely premature delivery, and there were no maternal deaths. Eighty-two (42.7%) reports did not describe any AEs. Among pregnancies for which gestational age was reported, most women were vaccinated during the first trimester, 86/115 (74.7%). Among reports describing an AE, the most common pregnancy-specific outcomes included spontaneous abortion in 23 reports, preterm delivery in 7 reports, and elective termination in 5 reports. The most common non-pregnancy specific outcomes were general disorders and administration site conditions, such as injection site and systemic reactions, in 21 reports. Among 22 reports describing an AE among infants born to women vaccinated during pregnancy, 5 described major birth defects each affecting different organ systems.

Conclusion: Our analysis of VAERS reports involving hepatitis B vaccination during pregnancy did not identify any new or unexpected safety concerns.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2017.11.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6626541PMC
January 2018

Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System.

J Adolesc Health 2017 Nov;61(5):577-582

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.

Purpose: Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS).

Methods: We searched the VAERS database for reports of POTS following any type of HPV vaccination (bivalent, quadrivalent, or nonavalent) from June 2006 to August 2015. We reviewed reports and applied established POTS diagnostic criteria. We calculated unadjusted POTS case reporting rates based on HPV vaccine doses distributed and conducted empirical Bayesian data mining to screen for disproportional reporting of POTS following HPV vaccination.

Results: Among 40,735 VAERS reports following HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of these, 27 (93.1%) were in females and mean age was 14 years (range 12-32). Median time from vaccination to start of symptoms was 43 days (range 0-407); most (18, 75.0%) had onset between 0 and 90 days. Symptoms frequently reported concomitantly included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3%) were most common. Approximately one POTS case is reported for every 6.5 million HPV vaccine doses distributed in the United States. No empirical Bayesian data mining safety signals for POTS and HPV vaccination were detected.

Conclusions: POTS is rarely reported following HPV vaccination. Our review did not detect any unusual or unexpected reporting patterns that would suggest a safety problem.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jadohealth.2017.08.004DOI Listing
November 2017

Hospital-based collaboration for epidemiological investigation of vaccine safety: A potential solution for low and middle-income countries?

Vaccine 2018 01 21;36(3):345-346. Epub 2017 Oct 21.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2017.10.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6524777PMC
January 2018

Postmarketing safety surveillance of trivalent recombinant influenza vaccine: Reports to the Vaccine Adverse Event Reporting System.

Vaccine 2017 10 5;35(42):5618-5621. Epub 2017 Sep 5.

Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.

On January 16, 2013, the Food and Drug Administration approved recombinant hemagglutinin influenza vaccine (RIV3) (Spodoptera frugiperda cell line; Flublok), which is the first completely egg-free flu vaccine licensed in the United States. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized reports to the Vaccine Adverse Event Reporting System (VAERS) following RIV3. Through June 30, 2016, VAERS received 88 reports. Allergic reactions, including anaphylaxis, were the most common type of adverse event. Based on medical review, 10 cases met the Brighton Collaboration case definition of anaphylaxis, 21 reports described allergic reactions other than anaphylaxis, and 11 reports described signs and symptoms that suggested hypersensitivity. Other adverse events included injection site reactions, fatigue, myalgia, headache, and fever. The occurrence of anaphylaxis and other allergic reactions in some individuals may reflect an underlying predisposition to atopy that may manifest itself after an exposure to any drug or vaccine, and it does not necessarily suggest a causal relationship with the unique constituents that are specific to the vaccine product administered. Further research may elucidate the mechanism of allergic reactions following influenza vaccination: it is possible that egg proteins and influenza hemagglutinin play little or no role. Vaccination remains the single best defense against influenza and its complications. The information summarized here may enable policy makers, health officials, clinicians, and patients to make a more informed decision regarding vaccination strategies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2017.08.047DOI Listing
October 2017

Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014.

Birth Defects Res 2017 Jul;109(13):1057-1062

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.

Background: Major birth defects are important infant outcomes that have not been well studied in the postmarketing surveillance of vaccines given to pregnant women. We assessed the presence of major birth defects following vaccination in the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system used to monitor the safety of vaccines in the United States.

Methods: We searched VAERS for reports of major birth defects during January 1, 1990, through December 31, 2014. We excluded birth defects from vaccines that had been studied in pregnancy registries or other epidemiological studies (e.g., human papilloma virus, varicella, measles/mumps/rubella, and anthrax vaccines). Birth defects were categorized into trimester of vaccination and classified based on the organs and/or systems affected. If several birth defects affecting different systems were described, we classified those as multiple body systems. Empirical Bayesian data mining was used to assess for disproportionate reporting.

Results: We identified 50 reports of major birth defects; in 28 reports, the vaccine was given during the first trimester; 25 were reports with single vaccines administered. Birth defects accounted for 0.03% of all reports received by VAERS during the study period and 3.2% of pregnancy reports; reported defects affected predominately the musculoskeletal (N = 10) or nervous (N = 10) systems. No unusual clusters or specific birth defects were identified.

Conclusion: This review of the VAERS database found that major birth defects were infrequently reported, with no particular condition reported disproportionally. Birth defects after routine maternal vaccination will continue to be monitored in VAERS for signals to prompt future studies. Birth Defects Research 109:1057-1062, 2017. © 2017 Wiley Periodicals, Inc.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/bdr2.23622DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6528469PMC
July 2017

Cholera vaccination: pregnant women excluded no more.

Lancet Infect Dis 2017 05 2;17(5):469-470. Epub 2017 Feb 2.

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S1473-3099(17)30055-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6507405PMC
May 2017

Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015.

Vaccine 2016 12 9;34(50):6330-6334. Epub 2016 Nov 9.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, United States.

Background: The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65years.

Methods: We assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting.

Results: VAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19-64years and 86% were in persons aged ⩾65years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19-64years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged ⩾65years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19-64years old; injection site reactions, general malaise and Guillain-Barré syndrome among those ⩾65years (Table 2). Data mining did not detect disproportional reporting for any unexpected AE.

Conclusions: The results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2016.10.052DOI Listing
December 2016

Obstetrical and neonatal case definitions for immunization safety data.

Vaccine 2016 12 20;34(49):5991-5992. Epub 2016 Aug 20.

Brighton Collaboration Foundation, Spitalstrasse 33, 4056 Basel, Switzerland.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vaccine.2016.08.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5149590PMC
December 2016

Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015.

PLoS Negl Trop Dis 2016 07 13;10(7):e0004846. Epub 2016 Jul 13.

Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of America.

Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States.

Objective: To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

Methods: We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV.

Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination.

Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1371/journal.pntd.0004846DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4943633PMC
July 2016