PMID: 

Obstet Gynecol. 2018 07 ;132(1):35-44. PMID: 29889760

Abstract Title: 

Risk of Spontaneous Abortion After Inadvertent Human Papillomavirus Vaccination in Pregnancy.

Abstract: 

OBJECTIVE: To evaluate the risk of spontaneous abortion after quadrivalent human papillomavirus (4vHPV) vaccination before and during pregnancy across seven integrated health systems within the Vaccine Safety Datalink.METHODS: Within a retrospective observational cohort, we compared risks for spontaneous abortion after 4vHPV in three exposure windows: distal (16-22 weeks before the last menstrual period [LMP]), peripregnancy (within 6 weeks before the LMP), and during pregnancy (LMP through 19 weeks of gestation). Women 12-27 years of age with a pregnancy between 2008 and 2014, with continuous insurance enrollment 8 months before and through pregnancy end, and with a live birth, stillbirth, or spontaneous abortion were included. Pregnancies were identified through validated algorithms. Spontaneous abortions and stillbirths were verified by chart review with spontaneous abortions adjudicated by clinical experts. We excluded multiple gestations, spontaneous abortions before 6 weeks of gestation, and women using medications increasing risk of spontaneous abortion. Spontaneous abortion risk after 4vHPV during pregnancy was compared with distal vaccination using time-dependent covariate Cox models. Spontaneous abortion risk for peripregnancy compared with distal vaccination was evaluated with standard Cox models.RESULTS: We identified 2,800 pregnancies with 4vHPV exposure in specified risk windows: 919 (33%) distal, 986 (35%) peripregnancy, and 895 (32%) during pregnancy. Mean age was 22.4 years in distal and peripregnancy groups compared with 21.4 years among women vaccinated during pregnancy. Among women with distal 4vHPV exposure, 96 (10.4%) experienced a spontaneous abortion. For peripregnancy and during pregnancy exposures, spontaneous abortions occurred in 110 (11.2%) and 77 (8.6%), respectively. The risk of spontaneous abortion was not increased among women who received 4vHPV during pregnancy (adjusted hazard ratio 1.10, 95% CI 0.81-1.51) or peripregnancy 1.07 (0.81-1.41).CONCLUSION: Inadvertent 4vHPV exposure during or peripregnancy was not significantly associated with an increased risk of spontaneous abortion.

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PMID: 

Vaccine. 2018 11 12 ;36(46):7017-7024. Epub 2018 Oct 9. PMID: 30314913

Abstract Title: 

Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine – A randomized clinical trial.

Abstract: 

BACKGROUND: Limited data is available on the use of different HPV vaccines in the same subjects. We evaluated the immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent (9vHPV) and one dose of bivalent vaccine (2vHPV) administered in different order versus two doses of 9vHPV vaccine.METHODS: 371 girls and boys aged 9-10 years were randomized (1:1) to receive (I) two doses of 9vHPV or (II) a mixed schedule of 2vHPV + 9vHPV or 9vHPV + 2vHPV with a 6 month interval. Antibodies to HPV were tested by ELISA in blood samples collected one or six months post-first dose and one month post-second dose.RESULTS: Post-first dose of 9vHPV 99.4-100% of subjects were seropositive to 9 HPV types included in the vaccine. GMTs varied from 5.0 to 73.6 IU(AU)/ml depending on HPV type. Post-first dose of 2vHPV all subjects were seropositive to HPV16 and 18 (GMTs 16.7 and 11.7 IU/ml, respectively) and 50.0-76.7% were seropositive to 7 types not included in 2vHPV (GMTs varied from 0.3 to 17.5 AU/ml depending on type). Post-second dose all subjects, regardless of the study group, were seropositive to 9 HPV types included in 9vHPV. Anti-HPV16 and 18 GMTs were higher in subjects with the mixed schedule and for the other 7 HPV types higher in subjects who received two doses of 9vHPV vaccine. A higher proportion of subjects who received 2vHPVreported local or systemic adverse events than those who received 9vHPV as the first dose. Post-second dose there were no differences in reported adverse events between the two vaccines.CONCLUSIONS: The results show the mixed HPV vaccination schedules used in this study are immunogenic and have an acceptable safety profile. Although the seroprotective threshold of antibodies remains unknown the 100% seropositivity to all 9 HPV types included in 9vHPV and the increase of GMTs observed in all study groups post-second dose administration are reassuring and suggest protection might be achieved regardless of the schedule used.CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT02567955.

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PMID: 

BMJ Evid Based Med. 2019 Jan 7. Epub 2019 Jan 7. PMID: 30617051

Abstract Title: 

Ongoing inadequacy of quadrivalent HPV vaccine safety studies.

Abstract: 

[n/a]

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PMID: 

Vaccine. 2019 May 1 ;37(19):2580-2585. Epub 2019 Apr 6. PMID: 30967312

Abstract Title: 

On the contextual nature of vaccine safety monitoring: Adverse events reporting after HPV-vaccination in Denmark, 2015.

Abstract: 

BACKGROUND: In 2013-15, Denmark experienced an increase in reported suspected adverse events following vaccination (AEFI) against human papilloma virus (HPV). Dedicated centres ("One Access") were established in order to standardize management of patients who experienced medically unexplained physical symptoms after HPV vaccination. Since One Access was targeted patients with suspected AEFI after HPV vaccination, we used this opportunity to estimate completeness in AEFI reporting to the Danish Medicines Agency (DMA), and explore the topic of AEFI reporting from the perspective of physicians working at the centres to better understand health professionals' reporting behaviour.METHODS: The study consisted of a quantitative and a qualitative part. In the quantitative analysis, we used the Danish civil registry number to merge a line-list of all One Access patients referred in 2015 with total number of patients who had reported suspected serious AEFI following HPV vaccination to the DMA in the years 2009-2015. We conducted four semi-structured interviews with doctors representing three out of five regions. The Theoretical Domains Framework together with empirical data from two clinical fieldtrips guided the formation of the qualitative study.RESULTS: Among 1577 One Access patients, only 404 (26%) were reported to the DMA. We found significant regional differences in reporting completeness (p 

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PMID: 

BMJ Open. 2019 Sep 5 ;9(9):e024893. Epub 2019 Sep 5. PMID: 31492774

Abstract Title: 

Out-of-sequence DTP and measles vaccinations and child mortality in Guinea-Bissau: a reanalysis.

Abstract: 

OBJECTIVES: To assess whether the sequence of diphtheria-tetanus-pertussis vaccine (DTP) and measles vaccine (MV) was associated with child survival in a dataset previously used to assess non-specific effects of vaccines with no consideration of vaccination sequence.DESIGN: Prospective cohort study analysed using the landmark approach.SETTING: Bandim Health Project's Health and Demographic Surveillance System covering 100 village clusters in rural Guinea-Bissau. The recommended vaccination schedule was BCG and oral polio vaccine (OPV) at birth, DTP and OPV at 6, 10 and 14 weeks, MV at 9 months and booster DTP and OPV at 18 months of age.PARTICIPANTS: Children aged 9-17 months (main analysis) and 18-35 months (secondary analysis: age of booster DTP) with vaccination status assessed between April 1991 and April 1996.METHODS: Survival during the 6 months after assessing vaccination status was compared by vaccination sequence in Cox-proportional hazards models with age as underlying time. Analyses were stratified by sex and village cluster.MAIN OUTCOME MEASURE: Mortality rate ratio (MRR) for out-of-sequence vaccinations compared with in-sequence vaccinations.RESULTS: Among children aged 9-17 months, 60% of observations (3574/5937) were from children who had received both MV and DTP. Among these, 1590 observations were classified as in-sequence vaccinations (last DTP before MV), and 1984 observations were out-of-sequence vaccinations (1491: MV with DTP and 493: MV before DTP). Out-of-sequence vaccinations were associated with higher mortality than in-sequence vaccinations (MRR 2.10, 95% CI 1.07 to 4.11); the MRR was 2.30 (95% CI 1.15 to 4.58) for MV with DTP and 1.45 (95% CI 0.50 to 4.22) for DTP after MV. Associations were similar for boys and girls (p=0.77). Between 18 and 35 months the mortality rate increased among children vaccinated in-sequence and the differential effect of out-of-sequence vaccinations disappeared.CONCLUSION: Out-of-sequence vaccinations may increase child mortality. Hence, sequence of vaccinations should be considered when planning vaccination programmes or introducing new vaccines into the current vaccination schedule.

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PMID: 

MMWR Morb Mortal Wkly Rep. 2019 Aug 16 ;68(32):698-702. Epub 2019 Aug 16. PMID: 31415491

Abstract Title: 

Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices.

Abstract: 

Vaccination against human papillomavirus (HPV) is recommended to prevent new HPV infections and HPV-associated diseases, including some cancers. The Advisory Committee on Immunization Practices (ACIP)* routinely recommends HPV vaccination at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up vaccination has been recommended since 2006 for females through age 26 years, and since 2011 for males through age 21 years and certain special populations through age 26 years. This report updates ACIP catch-up HPV vaccination recommendations and guidance published in 2014, 2015, and 2016 (1-3). Routine recommendations for vaccination of adolescents have not changed. In June 2019, ACIP recommended catch-up HPV vaccination for all persons through age 26 years. ACIP did not recommend catch-up vaccination for all adults aged 27 through 45 years, but recognized that some persons who are not adequately vaccinated might be at risk for new HPV infection and might benefit from vaccination in this age range; therefore, ACIP recommended shared clinical decision-making regarding potential HPV vaccination for these persons.

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PMID: 

JAMA Pediatr. 2019 Sep 3. Epub 2019 Sep 3. PMID: 31479099

Abstract Title: 

Government Role in Regulating Vaccine Misinformation on Social Media Platforms.

Abstract: 

[n/a]

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PMID: 

Lancet. 2019 Sep 14 ;394(10202):915-916. PMID: 31526731

Abstract Title: 

Polio vaccination controversy in Pakistan.

Abstract: 

[n/a]

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PMID: 

Vaccine. 2019 Sep 16 ;37(39):5877-5885. Epub 2019 Aug 20. PMID: 31443993

Abstract Title: 

The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged≥50 years: A randomized trial.

Abstract: 

BACKGROUND: This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged≥50 years.METHODS: In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed.RESULTS: VRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.CONCLUSIONS: Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.

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PMID: 

Vaccine. 2019 Sep 16 ;37(39):5807-5811. Epub 2019 Aug 22. PMID: 31445771

Abstract Title: 

Comparison of vaccine effectiveness against influenza hospitalization of cell-based and egg-based influenza vaccines, 2017-2018.

Abstract: 

Egg-based influenza vaccines could be less effective than cell-based vaccine due to adaptive mutations acquired for growth. We conducted a test-negative case-control study at Kaiser Permanente Southern California to assess vaccine effectiveness (VE) against hospitalization for laboratory-confirmed influenza during 2017-2018. Among the 1186 cases and 6946 controls, 74% and 59%, respectively, were ages ≥ 65 years. For any influenza, the adjusted relative VE of cell-based vaccine versus egg-based vaccines was 43% (95% CI: -45% to 77%) for patients ages 

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