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Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.

ABSTRACT: INTRODUCTION:A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season. METHODS:We conducted a case-control study over three influenza seasons (2012-13, 2013-14, 2014-15) in the Vaccine Safety Datalink (VSD). Cases (women with SAB) and controls (women with live births) were matched on VSD site, date of last menstrual period, age group, and influenza vaccination status in the previous influenza season. Of 1908 presumptive cases identified from the electronic record, 1236 were included in the main analysis. Administration of IIV was documented in several risk windows, including 1-28, 29-56, and >56?days before the SAB date. RESULTS:Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1-28?day risk window and SAB (adjusted odds ratio (aOR) 0.9; 95% confidence interval (CI) 0.6-1.5). The season-specific aOR ranged from 0.5 to 1.7 with all CIs including the null value of 1.0. Similarly, no association was found among women who were not vaccinated in the previous season; the season-specific aOR in the 1-28?day risk window ranged from 0.6 to 0.7 and the 95% CI included 1.0 in each season. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception. CONCLUSION:During these seasons we found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester.

SUBMITTER: Donahue JG

PROVIDER: S-EPMC6906603 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.

Donahue James G JG Kieke Burney A BA King Jennifer P JP Mascola Maria A MA Shimabukuro Tom T TT DeStefano Frank F Hanson Kayla E KE McClure David L DL Olaiya Oluwatosin O Glanz Jason M JM Hechter Rulin C RC Irving Stephanie A SA Jackson Lisa A LA Klein Nicola P NP Naleway Allison L AL Weintraub Eric S ES Belongia Edward A EA

Vaccine 20190917 44

<h4>Introduction</h4>A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season.<h4>Methods</h4>We conducted a case-control study over three influenza seasons (2012-13, 2013-14, ...[more]

PMID: 31540812

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Project description:BACKGROUND: Neuraminidase inhibitors (NAIs) such as oseltamivir (O) and zanamivir (Z) play a central role in the control of influenza infections. However, the emergence and dissemination of antiviral resistance threaten the efficacy of this intervention and advocate for innovative therapeutic strategies. The objective of this study was to evaluate in mice the efficacy of O-Z combination compared to that of monotherapy, for the treatment of experimental infections with influenza A(H1N1)pdm09 viruses. METHODS: Recombinant A(H1N1)pdm09 wild-type (WT) and O-resistant H275Y NA mutant viruses were generated by reverse genetics. Groups of twelve C57BL/6 mice were inoculated intranasally with saline, the WT or H275Y viruses. To mimic the clinical condition, infected mice were treated 48h p.i. with either saline, O by gavage, Z intranasally, or an O-Z combination, twice daily for 5 days. Weight loss and mortality were monitored for 14 days. On day 4 p.i., four mice were sacrificed to determine lung viral titers (LVT) by plaque assay in ST6GalI-MDCK cells. RESULTS: In mice infected with the WT virus, treatment with Z or O-Z resulted in 100% survival, vs 50% for the O group and 12.5% for the untreated group. Z monotherapy also led to a significant reduction in weight loss compared to O as well as lower LVT (5.7E^6 vs 1.7E^7 PFU mL, respectively). Intermediate values were observed for the O-Z combination. In the H275Y group, the efficacy of O-Z was comparable to that of Z and significantly higher than that of O in terms of survival (85.7% and 100% vs 12.5%, respectively), weight loss and LVT (5.4E^6 and 3.5E^6 vs 2.8E^8 PFU/mL, respectively). The evaluation of these treatments in mice infected with influenza A(H3N2) is in progress. CONCLUSIONS: Z monotherapy had greater efficacy than O in mice infected with A(H1N1)pdm09. O-Z bitherapy conferred no significant advantage over Z monotherapy. Development of new molecules and synergistic combined therapies are a necessity.

Dataset Information

Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.

Publications

Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.

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