Infovac-France survey in pediatric vaccinology: How does it compare with the literature?

BACKGROUND: Immunization is experienced as painful and may be responsible for needle fear and noncompliance. There are rare evidence-based methods to reduce pain and improve comfort during immunization. There are no French immunization guidelines summarizing the good practices, based on recent studies. This study focused on the methods used by physicians and how they compared with those validated by clinical trials. METHODS: An online questionnaire was sent to the practitioners from the Infovac network, and a PubMed bibliographic search was conducted. RESULTS: Almost 2000 doctors responded to this survey. Purging the needle was a habit in 77.9% of them and aspiration before injection in 21.1%. Only one-quarter of the responding doctors injected in the deltoid muscle between 15 and 24 months, and some injected in the buttocks at any age. Half of the physicians vaccinated infants in their parent's arms, children were seated with half of the pediatricians and only one-third of the general practitioners (GPs), and teenagers were seated when vaccinated by three-quarters of the doctors. Anesthetic creams were used by 46.6% of the physicians, mostly by pediatricians (61.9%), and for infants. Breastfeeding was suggested by three-quarters of the physicians for infants under 4 months of age, and sugared solutions were used by 55.5% of the pediatricians and 32.3% of the GPs. Half of the doctors used rocking and cuddling for babies under 24 months of age and toys between 11 and 24 months. CONCLUSION: Many methods are available to distract and improve comfort during immunization. Physicians should choose those they prefer, adjusting for the child's age. There should be French guidelines for immunization techniques, based to the latest clinical surveys, to help improve immunization practice.

Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO.

Direct at line monitoring of live virus particles in commercial manufacturing of vaccines is challenging due to their small size. Detection of malformed or damaged virions with reduced potency is rate-limited by release potency assays with long turnaround times. Thus, preempting batch failures caused by out of specification potency results is almost impossible. Much needed are in-process tools that can monitor and detect compromised viral particles in live-virus vaccines (LVVs) manufacturing based on changes in their biophysical properties to provide timely measures to rectify process stresses leading to such damage. Using ERVEBO, MSD's Ebola virus vaccine as an example, here we describe a flow virometry assay that can quickly detect damaged virus particles and provide mechanistic insight into process parameters contributing to the damage. Furthermore, we describe a 24-h high throughput infectivity assay that can be used to correlate damaged particles directly to loss in viral infectivity (potency) in-process. Collectively, we provide a set of innovative tools to enable rapid process development, process monitoring, and control strategy implementation in large scale LVV manufacturing.

The Quest for a Truly Universal Influenza Vaccine.

There is an unmet public health need for a universal influenza vaccine (UIV) to provide broad and durable protection from influenza virus infections. The identification of broadly protective antibodies and cross-reactive T cells directed to influenza viral targets present a promising prospect for the development of a UIV. Multiple targets for cross-protection have been identified in the stalk and head of hemagglutinin (HA) to develop a UIV. Recently, neuraminidase (NA) has received significant attention as a critical component for increasing the breadth of protection. The HA stalk-based approaches have shown promising results of broader protection in animal studies, and their feasibility in humans are being evaluated in clinical trials. Mucosal immune responses and cross-reactive T cell immunity across influenza A and B viruses intrinsic to live attenuated influenza vaccine (LAIV) have emerged as essential features to be incorporated into a UIV. Complementing the weakness of the stand-alone approaches, prime-boost vaccination combining HA stalk, and LAIV is under clinical evaluation, with the aim to increase the efficacy and broaden the spectrum of protection. Preexisting immunity in humans established by prior exposure to influenza viruses may affect the hierarchy and magnitude of immune responses elicited by an influenza vaccine, limiting the interpretation of preclinical data based on naive animals, necessitating human challenge studies. A consensus is yet to be achieved on the spectrum of protection, efficacy, target population, and duration of protection to define a "universal" vaccine. This review discusses the recent advancements in the development of UIVs, rationales behind cross-protection and vaccine designs, and challenges faced in obtaining balanced protection potency, a wide spectrum of protection, and safety relevant to UIVs.