Lessons learned from the COVID-19 pandemic for improved influenza control.

The World Health Organization noted that COVID-19 vaccination programmes could be leveraged to deliver influenza vaccination. In 2008, the International Federation of Pharmaceutical Manufacturers and Associations' (IFPMA) Influenza Vaccine Supply International Task Force (IVS) developed a survey method using the number of influenza vaccine doses distributed globally to estimate vaccination coverage rates. Seven hundred and ninety-seven million doses were distributed in 2021, representing a 205% increase over the 262 million doses distributed in 2004, exceeding the number of doses distributed during and after the 2009-2010 influenza pandemic. The most obvious explanation for the global increase is the enabling of critical elements of the vaccine ecosystem by decision-makers during the COVID-19 pandemic to reinforce implementation of influenza vaccination programs. Most of the improvements in performance of influenza programs during the COVID-19 pandemic can be classified in four categories: 1) promoting vaccination using tailored approaches for specific populations; 2) improving convenient access to influenza vaccines in COVID-safe settings; 3) improving reimbursement of seasonal influenza vaccination for priority groups; 4) maintaining the timing of vaccination to the autumn. In spite of the increase in rates of seasonal influenza vaccines distributed during the COVID-19 pandemic, globally, the rate of influenza dose distribution is sub-optimal, and a considerable proportion of the influenza infections remains preventable. To sustain the benefits from increased uptake of influenza vaccines, governments need to sustain the efforts made during the COVID-19 pandemic, and a number of global policy endeavours should be undertaken, including developing a clear global roadmap for achieving influenza control objectives, adopted by a WHA resolution, in line with the strategic objective 3 of the Global Influenza Strategy 2030, embedded in the Immunization Agenda 2030 (IA2030).

Pre-marketing authorisation submission assessments in Europe.

The publication of the European Directive 2001/20/EC on the implementation of good clinical practice in trials has far-reaching consequences on the type of data to be submitted for evaluation by the competent authorities and ethics committees, in order to initiate a clinical trial with one or more site(s) in Europe. The ensuing commission guidelines and guidance provided by Member States at the time of national implementation describe the content of an application for a 'clinical trial authorisation' and its maintenance. This review discusses some of the implications for pharmaceutical companies submitting requests for clinical trial authorisations.

DNA microarray screening of differential gene expression in bone marrow samples from AML, non-AML patients and AML cell lines.

This study used cDNA microarray technology to compare gene expression profiles in acute myeloblastic leukaemia (AML) with cDNA dot-blot and real time PCR analysis of cDNA transcripts to confirm array data. Patient AML marrow samples and AML cell lines were compared with normal/non-AML samples. Screening revealed five particular genes to be significantly differentially expressed across the sample groups. The migration-inhibitory factor-related-proteins 8 and 14 (MRP-8 and MRP-14) genes, the products of which inhibit cell migration and differentiation were the most highly expressed in non-malignant cells. The high-mobility-group-protein gene (HMG-1) was up regulated in leukaemic samples and cell lines, which may be associated with aggressive disease. Also upregulated in malignant samples were genes encoding c-myc and glutathione-S-transferase pi (GSTP), the latter implicated in chemotherapy resistance. Faulty expression of such genes may contribute to the pathogenesis of AML and resistance to treatment.