HPV Vaccination during the COVID-19 Pandemic in Italy: Opportunity Loss or Incremental Cost.

OBJECTIVES: Italy was the first European country to introduce universal vaccination of adolescents, for both males and females, against Human Papilloma Virus (HPV) starting in 2017 with the NIP 2017-2019's release. However, vaccine coverage rates (VCRs) among adolescents have shown a precarious take-off since the NIP's release, and this situation worsened due to the impact of the COVID-19 pandemic in 2020. The aim of this work is to estimate the epidemiological and economic impact of drops in VCRs due to the pandemic on those generations that missed the vaccination appointment and to discuss alternative scenarios in light of the national data. METHODS: Through an analysis of the official ministerial HPV vaccination reports, a model was developed to estimate the number of 12-year-old males and females who were not vaccinated against HPV during the period 2017-2021. Based on previously published models that estimate the incidence and the economic impact of HPV-related diseases in Italy, a new model was developed to estimate the impact of the aggregated HPV VCRs achieved in Italy between 2017 and 2021. RESULTS: Overall, in 2021, 723,375 girls and 1,011,906 boys born between 2005 and 2009 were not vaccinated against HPV in Italy (42% and 52% of these cohorts, respectively). As compared with the 95% target provided by the Italian NIP, between 505,000 and 634,000 girls will not be protected against a large number of HPV-related diseases. For boys, the number of the unvaccinated population compared to the applicable target is over 615,000 in the 'best case scenario' and over 749,000 in the 'worst case scenario'. Overall, between 1.1 and 1.3 million young adolescents born between 2005 and 2009 will not be protected against HPV-related diseases over their lifetime with expected lifetime costs of non-vaccination that will be over EUR 905 million. If the 95% optimal VCRs were achieved, the model estimates a cost reduction equal to EUR 529 million, the net of the costs incurred to implement the vaccination program. CONCLUSION: Suboptimal vaccination coverage represents a missed opportunity, not only because of the increased burden of HPV-related diseases, but also in terms of economic loss. Thus, reaching national HPV immunization goals is a public health priority.

2020 Food and Drug Law Institute (FDLI) Annual Conference (October 6-8, 2020 - Virtual Meeting).

This year's annual conference of the Food and Drug Law Institute (FDLI) drew more than 700 attendees, including over 200 from the U.S. Food and Drug Administration (FDA), and featured 93 speakers. Despite being held virtually for the first time, the event offered a full agenda comprising breakout sessions, award presentations, and opportunities for networking that included postsession roundtable discussions and a sponsor virtual exhibit hall. Not surprisingly, the reality of the COVID-19 public health emergency was a recurrent and emphasized theme throughout the 3 days of the conference. This report summarizes several of the 29 breakout sessions from the event.

Association between the New COVID-19 Cases and Air Pollution with Meteorological Elements in Nine Counties of New York State.

The principal objective of this article is to assess the possible association between the number of COVID-19 infected cases and the concentrations of fine particulate matter (PM2.5) and ozone (O3), atmospheric pollutants related to people's mobility in urban areas, taking also into account the effect of meteorological conditions. We fit a generalized linear mixed model which includes spatial and temporal terms in order to detect the effect of the meteorological elements and COVID-19 infected cases on the pollutant concentrations. We consider nine counties of the state of New York which registered the highest number of COVID-19 infected cases. We implemented a Bayesian method using integrated nested Laplace approximation (INLA) with a stochastic partial differential equation (SPDE). The results emphasize that all the components used in designing the model contribute to improving the predicted values and can be included in designing similar real-world data (RWD) models. We found only a weak association between PM2.5 and ozone concentrations with COVID-19 infected cases. Records of COVID-19 infected cases and other covariates data from March to May 2020 were collected from electronic health records (EHRs) and standard RWD sources.

Innovative trial designs and analyses for vaccine clinical development.

In the past decades, the world has experienced several major virus outbreaks, e.g. West African Ebola outbreak, Zika virus in South America and most recently global coronavirus (COVID-19) pandemic. Many vaccines have been developed to prevent a variety of infectious diseases successfully. However, several infections have not been preventable so far, like COVID-19, which induces an immediate urgent need for effective vaccines. These emerging infectious diseases often pose unprecedent challenges for the global heath community as well as the conventional vaccine development paradigm. With a long and costly traditional vaccine development process, there are extensive needs in innovative vaccine trial designs and analyses, which aim to design more efficient vaccines trials. Featured with reduced development timeline, less resource consuming or improved estimate for the endpoints of interests, these more efficient trials bring effective medicine to target population in a faster and less costly way. In this paper, we will review a few vaccine trials equipped with adaptive design features, Bayesian designs that accommodate historical data borrowing, the master protocol strategy emerging during COVID-19 vaccine development, Real-World-Data (RWD) embedded trials and the correlate of protection framework and relevant research works. We will also discuss some statistical methodologies that improve the vaccine efficacy, safety and immunogenicity analyses. Innovative clinical trial designs and analyses, together with advanced research technologies and deeper understanding of the human immune system, are paving the way for the efficient development of new vaccines in the future.