Recombinant IAV H1N1 (A/Ohio/UR06-0091/2007) Hemagglutinin (a.a. 1-528) [His]

Influenza A viruses cause acute respiratory infections in swine that result in significant economic losses for global pig production. Currently, three different subtypes of influenza A viruses of swine (IAV-S) co-circulate worldwide: H1N1, H3N2, and H1N2. However, the origin, genetic background and antigenic properties of those IAV-S vary considerably from region to region. Pigs could also have a role in the adaptation of avian influenza A viruses to humans and other mammalian hosts, either as intermediate hosts in which avian influenza viruses may adapt to humans, or as a "mixing vessel" in which influenza viruses from various origins may reassort, generating novel progeny viruses capable of replicating and spreading among humans. These potential roles highlight the importance of controlling influenza A viruses in pigs. Vaccination is currently the main tool to control IAV-S. Vaccines containing whole inactivated virus (WIV) with adjuvant have been traditionally used to generate highly specific antibodies against hemagglutinin (HA), the main antigenic protein. WIV vaccines are safe and protect against antigenically identical or very similar strains in the absence of maternally derived antibodies (MDAs). Yet, their efficacy is reduced against heterologous strains, or in presence of MDAs. Moreover, vaccine-associated enhanced respiratory disease (VAERD) has been described in pigs vaccinated with WIV vaccines and challenged with heterologous strains in the US. This, together with the increasingly complex epidemiology of SIVs, illustrates the need to explore new vaccination technologies and strategies. Currently, there are two different non-inactivated vaccines commercialized for swine in the US: an RNA vector vaccine expressing the HA of a H3N2 cluster IV, and a bivalent modified live vaccine (MLV) containing H1N2 gamma-clade and H3N2 cluster IV. In addition, recombinant-protein vaccines, DNA vector vaccines and alternative attenuation technologies are being explored, but none of these new technologies has yet reached the market. The aim of this article is to provide a thorough review of the current epidemiological scenario of IAV-S, the challenges faced in the control of IAV-S infection and the tools being explored to overcome those challenges.

Background: Pregnant women and infants are known as high risk groups for influenza. WHO recommend pregnant women be vaccinated with inactivated influenza vaccine. In Japan, some municipalities started to give subsidy to encourage pregnant women to receive a shot on their own accord, which has made the introduction of seasonal antepartum maternal vaccination program (AMVP) into the routine vaccination list a current topic in health policy and has raised the need to evaluate the value for money of such possibility. Methods: We conducted a cost-effectiveness analysis to evaluate the efficiency of conducting AMVP in Japan. A decision tree model was adopted taking into consideration the duration of single-year vaccine effectiveness for infants and for mothers. The program targeted pregnant women aged 20-49 years old at or over 12 weeks gestation during October 1 through March 30. Estimated probabilities of treatments received due to influenza for pregnant/postpartum women or their infants varied by calendar time, vaccination status, and/or gestational age. Incremental cost-effectiveness ratio (ICER) compared with current no-AMVP from societal perspective was calculated. Transition probabilities, utility weights to estimate quality-adjusted life year (QALY), and disease treatment costs were either calculated or extracted from literature. Costs per vaccination was assumed at (sic)3,529/US$32.1. Results: AMVP reduces disease treatment costs, while the reduction cannot offset the vaccination cost. Incremental QALYs were at 0.00009, among them 84.2% were from infants. ICER was (sic)7,779,356/US$7 0,721 per QALY gained. One-way sensitivity analyses revealed that vaccine effectiveness for infant and costs per shot were the two main key variables affecting the ICER. Conclusion: We found that vaccinating pregnant women with influenza vaccine to prevent unvaccinated infants and pregnant/postpartum women from influenza-associated disease in Japan can be cost-effective from societal perspective, under the WHO-suggested "cost-effective" criteria (1-3 times of GDP). (C) 2020 Elsevier Ltd. All rights reserved.