This Vaccines issue on "Confidence in Vaccines" provides sound evidence through multiple perspectives of life-saving impacts when vaccination programs are effectively implemented in a population. Yet ...there remain challenges to achieving this impact, including scientific, medical, manufacturing, policy-related and logistical issues. Additionally, socio-cultural, religious and political agendas can come into play, taking public health hostage and sometimes allowing the circulation of myths regarding vaccination. All of these challenges play a role in public confidence in vaccines and vaccination. What we trust, we embrace. What we do not trust, we do not embrace.
Involving patients in the development of medicines and vaccines should result in benefits to patients. The vaccine recipient is usually a healthy person. We describe the rationale and implementation ...of a vaccine company's initiative to encourage employees to identify with patients of the conditions prevented by the vaccines they help to produce.
The Voice of the Patient ("VoP"), begun in 2014, is an educational programme directed at the 16,000 employees of a global vaccine company. It engages employees through an understanding that they are all "vaccine patients", and that they can make a difference by considering the impact of decisions made in their day to day work.
The initiative includes presentations about vaccine-preventable diseases, global live webcasts with experts and patients, employee visits to healthcare facilities in developing countries, and the production of patient-focused sections in research publications.
In a 2017 employee survey, 90% of respondents said they know how their daily work impacts patients and they demonstrate focus on patients. We believe this is preliminary evidence that, by supporting employee awareness of the impact of their individual roles, VoP could be a model for a type of initiative that will contribute to industry's continuing evolution towards more patient-centred healthcare.
•There is an individual approach to vaccination across the 16 European countries.•Most countries prioritise paediatric immunisation (set targets, monitor coverage).•Additional measures to improve ...vaccine coverage in all age groups are needed.•Harmonisation in target setting and data collection was proposed (European Vaccine Action Plan 2015–2020).•EVAP 2015–2020 proposition has been adopted but not yet implemented to date.
Vaccine policy, decision processes and outcomes vary widely across Europe. The objective was to map these factors across 16 European countries by assessing (A) national vaccination strategy and implementation, (B) attributes of healthcare vaccination systems, and (C) outcomes of universal mass vaccination (UMV) as a measure of how successful the vaccination policy is.A.Eleven countries use standardised assessment frameworks to inform vaccine recommendations. Only Sweden horizon scans new technologies, uses standard assessments, systematic literature and health economic reviews, and publishes its decision rationale. Time from European marketing authorisation to UMV implementation varies despite these standard frameworks. Paediatric UMV recommendations (generally government-funded) are relatively comparable, however only influenza vaccine is widely recommended for adults.B.Fourteen countries aim to report annually on national vaccine coverage rates (VCRs), as well as have target VCRs per vaccine across different age groups. Ten countries use either electronic immunisation records or a centralised registry for childhood vaccinations, and seven for other age group vaccinations.C.National VCRs for infant (primary diphtheria tetanus pertussis (DTP)), adolescent (human papillomavirus (HPV)) and older adult (seasonal influenza) UMV programmes found ranges of: 89.1% to 98.2% for DTP-containing vaccines, 5% to 85.9% for HPV vaccination, and 4.3% to 71.6% for influenza vaccine. Regarding reported disease incidence, a wide range was found across countries for measles, mumps and rubella (in children), and hepatitis B and invasive pneumococcal disease (in all ages).These findings reflect an individual approach to vaccination by country. High VCRs can be achieved, particularly for paediatric vaccinations, despite different approaches, targets and reporting systems; these are not replicated in vaccines for other age groups in the same country. Additional measures to improve VCRs across all age groups are needed and could benefit from greater harmonisation in target setting, vaccination data collection and sharing across EU countries.
A randomized controlled trial was performed in infants undergoing routine immunization in North Hertfordshire. Ninety-six children received a single dose of inactivated polio vaccine, followed by two ...doses of live attenuated oral polio vaccine and 97 children received three doses of live attenuated oral polio vaccine at 2, 3 and 4 months of age. Blood samples were taken by study nurses 6 weeks after vaccination and stool samples were collected by parents weekly for 4 weeks after each dose of vaccine. Follow-up was completed for 92 of 96 (96%) children in the combined schedule group and 92 of 97 (95%) in the control group. After vaccination the proportions of children with detectable antibody to poliovirus serotypes 1, 2 and 3 were high and similar between groups and geometric mean titers (95% confidence interval) to poliovirus types 1, 2 and 3 were 264 (200 to 347), 375 (311 to 450) and 189 (144 to 250) in the combined schedule group and 369 (290 to 469), 401 (321 to 498) and 206 (145 to 293) in the live vaccine group, respectively. The only significant difference between groups in rates of viral excretion was observed after the second dose of live attenuated oral polio vaccine, when excretion of type 3 poliovirus was reduced in those children who had received piror inactivated polio vaccine (P = 0.05). This study suggests that, compared with the current schedule, a combined schedule of inactivated and live polivaccines is likely to produce equivalent individual protection against poliomyelitis and is unlikely to substantially alter circulation of poliovirus in the community. Becuase the risk of vaccine-associated polio-myelitis is greatest after the first dose of poliovaccine, this schedule could also reduce the risk to vaccine recipients.
Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of ...children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12–14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.
The safety, immunogenicity, and immunologic priming of 2 dosages (2 μg or 10 μg) of a meningococcal C oligosaccharide-CRM197 conjugate vaccine was evaluated in 114 infants vaccinated at ages 2, 3, ...and 4 months. Antibody persistence and response to boosting with 10 μg of meningococcal C polysaccharide were assessed. The meningococcal conjugate vaccine produced fewer local reactions than concurrent routine immunizations. Total serogroup C-specific immunoglobulin geometric mean concentration (GMC) increased from 0.3 μg/mL before vaccination to 13.1 μg/mL at age 5 months. Serum bactericidal antibody (SBA) geometric mean titers (GMTs) rose from < 1:4 to 1:1057 at 5 months and fell by 14 months to 1: 19. Following boosting, anti-C-specific immunoglobulin GMC rose to 15.9 μg/mL and SBA GMT to 1:495. Antibody responses in the 10-μg dose cohort were significantly higher at 5 months (P < .01) than in the 2-μg dose cohort but were lower after polysaccharide boosting (P = .02). This meningococcal conjugate vaccine was well tolerated and immunogenic and induced immunologic memory in infants.
The development of effective vaccines against serogroup B meningococci is of great public health importance. We assessed a novel genetically engineered vaccine containing six meningococcal class 1 ...(PorA) outer membrane proteins representing 80% of prevalent strains in the UK. 103 infants were given the meningococcal vaccine at ages 2, 3 and 4 months with routine infant immunisations, with a fourth dose at 12–18 months. The vaccine was well tolerated. Three doses evoked good immune responses to two of six meningococcal strains expressing PorA proteins contained in the vaccine. Following a fourth dose, larger bactericidal responses to all six strains were observed, suggesting that the initial course had primed memory lymphocytes and revaccination stimulated a booster response. This hexavalent PorA meningococcal vaccine was safe and evoked encouraging immune responses in infants. Vaccines of this type warrant further development and evaluation.
We conducted a phase 3 randomized controlled trial looking at the immunogenicity and safety of a novel combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid ...conjugate vaccine, Hib-MenC-TT in a 2-, 3-, and 4-month primary infant immunization schedule. SBA MenC titers ≥1:8 and anti-PRP concentrations ≥0.15 μg/mL were measured in 99.2% and 100%, respectively, of the infants receiving Hib-MenC-TT.
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