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Value of an in-depth analysis of unpublished data on the safety of influenza vaccines in pregnant women.

ABSTRACT: Unpublished data can sometimes provide valuable information on the safety of biologic products.We assessed information potentially available from regulatory authorities, manufacturers, and public health agencies. We explored 4 recently established vaccine registries, reviewed package inserts from 99 influenza vaccines, and contacted vaccine manufacturers and regulatory agencies for data on influenza vaccine safety in pregnant women.The vaccine registries did not have sufficient data to analyze and there are problems with the quality of the information. The majority of package inserts provided no product-specific safety information for pregnant women, especially in less developed countries. The majority of available data come from reports gathered from passive adverse event reporting systems in the general population and reports of women enrolled in clinical trials of influenza vaccines who became pregnant at various times before or after receiving influenza vaccine. The information was not collected in a systematic manner, there are inconsistencies in the follow up of pregnant women and the available information about pregnancy outcomes. Considerable resources would be needed to systematically identify all of the information, try to obtain missing follow up information, and conduct analyses. There would be substantial limitations to any attempt to conduct a systematic analysis.The value of trying to analyze unpublished data on the safety of influenza vaccine in pregnancy is limited and would require considerable resources to thoroughly investigate. Expanding efforts to identify and review unpublished data regarding the safety of influenza vaccines in pregnancy is not likely to produce information of high scientific value or information that could not be identified from publications and other publically available data.

SUBMITTER: Halsey NA

PROVIDER: S-EPMC5647814 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Value of an in-depth analysis of unpublished data on the safety of influenza vaccines in pregnant women.

Halsey Neal A NA Proveaux Tina T

Vaccine 20170927 45

<h4>Background</h4>Unpublished data can sometimes provide valuable information on the safety of biologic products.<h4>Methods</h4>We assessed information potentially available from regulatory authorities, manufacturers, and public health agencies. We explored 4 recently established vaccine registries, reviewed package inserts from 99 influenza vaccines, and contacted vaccine manufacturers and regulatory agencies for data on influenza vaccine safety in pregnant women.<h4>Results</h4>The vaccine r ...[more]

PMID: 28958812

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Project description:BACKGROUND:Maternal immunization is an effective strategy to protect pregnant women and their infants from vaccine-preventable diseases. Despite the recommendation of maternal influenza and more recently pertussis immunization in Australia, uptake of these vaccines has been suboptimal. A midwife delivered immunization program for pregnant women at the Women's and Children's Hospital in South Australia commenced in April 2015. Monitoring the uptake of the current funded vaccine programs for pregnant women is limited. The study aimed to estimate maternal vaccine uptake and assess factors associated with influenza and pertussis vaccine uptake among pregnant women. METHODS:This prospective study was undertaken between November 2014 and July 2016 at the Women's and Children's Hospital. Following consent, demographic details and vaccination history for South Australian pregnant women who attended the antenatal clinic were collected. A standardised self-reported survey was completed during pregnancy with a follow up telephone interview at 8-10 weeks post-delivery. RESULTS:205 women consented and completed the self-reported survey. Of the 180 pregnant women who completed the study, 76% and 81% received maternal influenza and pertussis vaccines respectively. The adjusted odds of women receiving maternal vaccines during pregnancy were significantly higher for women delivering after the implementation of the midwife delivered program compared with women who delivered babies prior to the program for both pertussis vaccination (AOR 21.17, 95% CI 6.14-72.95; p<0.001) and influenza vaccination (AOR 5.95, 95% CI 2.13-16.61, p<0.001). Women receiving a recommendation from a health care provider and first time mothers were significantly more likely to receive influenza vaccination during pregnancy. CONCLUSIONS:High uptake of influenza and pertussis vaccines during pregnancy can be attained with health care provider recommendation and inclusion of maternal immunization as part of standard antenatal care. A midwife delivered maternal immunization program is a promising approach to improve maternal vaccine uptake by pregnant women.

Project description:IntroductionPregnant women and infants are at risk of severe influenza and pertussis infection. Inactivated influenza vaccine (IIV) and diphtheria-tetanus-acellular pertussis vaccine (dTpa) are recommended during pregnancy to protect both mothers and infants. In Australia, uptake is not routinely monitored but coverage appears sub-optimal. Evidence on the safety of combined antenatal IIV and dTpa is fragmented or deficient, and there remain knowledge gaps of population-level vaccine effectiveness. We aim to establish a large, population-based, multi-jurisdictional cohort of mother-infant pairs to measure the uptake, safety and effectiveness of antenatal IIV and dTpa vaccines in three Australian jurisdictions. This is a first step toward assessing the impact of antenatal vaccination programmes in Australia, which can then inform government policy with respect to future strategies in national vaccination programmes. METHODS AND ANALYSIS: 'Links2HealthierBubs' is an observational, population-based, retrospective cohort study established through probabilistic record linkage of administrative health data. The cohort includes births between 2012 and 2017 (~607 605 mother-infant pairs) in jurisdictions with population-level antenatal vaccination and health outcome data (Western Australia, Queensland and the Northern Territory). Perinatal data will be the reference frame to identify the cohort. Jurisdictional vaccination registers will identify antenatal vaccination status and the gestational timing of vaccination. Information on maternal, fetal and child health outcomes will be obtained from hospitalisation and emergency department records, notifiable diseases databases, developmental anomalies databases, birth and mortality registers.Ethics and disseminationEthical approval was obtained from the Western Australian Department of Health, Curtin University, the Menzies School of Health Research, the Royal Brisbane and Women's Hospital, and the West Australian Aboriginal Health Ethics Committees. Research findings will be disseminated in peer-reviewed journals, at scientific meetings, and may be incorporated into communication materials for public health agencies and the public.

Project description:BackgroundPregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed.MethodsWe conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185).We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period.Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus.ResultsWe identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included.Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy.The most frequent exposure was to AS03 adjuvant in the context of A/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03) - corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

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Value of an in-depth analysis of unpublished data on the safety of influenza vaccines in pregnant women.

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Value of an in-depth analysis of unpublished data on the safety of influenza vaccines in pregnant women.

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