November 12, 2018 – Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine – A randomized clinical trial (full text) “A higher proportion of subjects who received 2vHPV reported local or systemic adverse events than those who received 9vHPV as the first dose. Post-second dose there were no differences in reported adverse events between the two vaccines.”

November 12, 2018 – The choice of analytical methodology can alter conclusions regarding herd effects of paediatric pneumococcal vaccination programmes (full text)

• Funding: This work was supported by GlaxoSmithKline Biologicals SA which paid for all costs associated with the development and publication of this manuscript.

• Disclosures: JYP, CAT, and CJC are employees and hold shares of the GSK group of companies.
• WPH was an employee of the GSK group of companies at the time this analysis was conceived and reports receiving financial support from the GSK group of companies.
• WPH is also patent co-holder for PCV13 but receives no royalties as per industry practice.
• KB received consulting fees from the GSK group of companies for the work under consideration for publication.

October 10, 2018 – Optimizing the utilization of aluminum adjuvants in vaccines: you might just get what you want “Stabilizers such as sorbitol and glycerol can affect the adsorptive capacity of AH for proteins, but they do not appear to affect adsorption at the low concentrations that are typically used in vaccines. However, the effect of stabilizers on the adsorptive strength has not been thoroughly determined. … Preclinical studies should be conducted to determine the minimum dose of aluminum adjuvant that induces a maximal immune response. … Our expectation is that the potency of aluminum adjuvants will continue to be exceeded by alternative approaches in preclinical and clinical studies, but there needs to be a vaccine-specific evaluation of how much enhancement is enough, in addition to how much reactogenicity is acceptable.”

October 8, 2018 – Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women “374 pregnant and 225 nonpregnant women were vaccinated. Severe local or systemic reactions or “any” fever were uncommon (≤3% for both groups). Moderate/severe injection-site pain was significantly higher in pregnant (17.9%) versus nonpregnant (11.1%) women, but did not prompt a healthcare visit. Proportions of other moderate/severe or any severe reactions were not significantly higher in pregnant compared to nonpregnant women. Moderate/severe (including pain) and severe reactions were not significantly higher in pregnant women receiving repeat versus first-time Tdap.”

Potential conflicts of interest

• KME was on a Data and Safety Monitoring Board for a Novartis funded influenza vaccine in children and received research funding for studies of Group B streptococcus vaccine in pregnant women produced by Novartis.
• GKS is on a Data and Safety Monitoring Board for a GlaxoSmithKline funded RSV vaccine study in pregnant women. She has received research funding for studies of Group B streptococcus vaccine in pregnant women produced by Novartis and for RSV vaccine in pregnant women produced by Novavax.
• KBF has received research funding for studies of Group B Streptococcus vaccine in pregnant women produced by Novartis and for RSV and CMV surveillance among pregnant women and their infants by Pfizer and Regeneron.
• EBW has received funding from CSL, GlaxoSmithKline, Merck, Novartis, Novavax, and Pfizer to conduct clinical research studies. He has received support from Novartis as a member of a Data Safety Monitoring Board and from Merck as a consultant. The other authors report no conflict of interest.”

October 9, 2018 – Cell culture-derived influenza vaccines in the severe 2017–2018 epidemic season: a step towards improved influenza vaccine effectiveness “With BARDA support, two vaccines licensed in the US are produced in cell culture: recombinant influenza vaccine (RIV, Flublok™) manufactured in insect cells and inactivated mammalian cell-grown vaccine (ccIIV, Flucelvax™). Quadrivalent ccIIV (ccIIV4) vaccine for the 2017–2018 influenza season was produced using an A(H3N2) seed virus propagated exclusively in cell culture and therefore lacking egg adaptative changes.”

October 8, 2018 – Reporting and evaluating influenza virus surveillance data: An argument for incidence by single year of age “The Institute also stressed the need to further our ‘‘understanding of the mechanisms that underlie the role of immunologic imprinting and the effect of serial influenza exposure and vaccination on vaccine efficacy.” Accomplishing this lofty goal however, will require modernization of the way that surveillance data is reported, as we have outlined above.”

October 8, 2018 – Transcriptome profiling in blood before and after hepatitis B vaccination shows significant differences in gene expression between responders and non-responders “In conclusion, our study has shown that immune-related gene expression signatures differ between responders and nonresponders after Engerix-B vaccination with a peak response at day 3 in the responder group and a delayed and suppressed response at day 7 in the non-responder group. Our data also suggest that the immune status before vaccination may influence the response to vaccines. Additional studies, preferentially using a similar hypothesis-free approach, are required to confirm this observation. Finally, a more holistic and system biology-based approach will be necessary to provide a predictive framework of classifiers to distinguish responders from non-responders.”

October 4, 2018 – Raman spectroscopy-based identification of toxoid vaccine products “An increasing global demand has led to the need to reduce time and cost of manufacturing. The evolving concepts for QC and the upcoming threat of falsification of biomedicines define a new need for methods that allow the fast and reliable identification of vaccines. … Vaccines used for prophylaxis of infectious diseases range among the eldest and most complex biomedicines. Today, a remarkable number of them still consist of mixtures of attenuated microorganisms or detoxified virulence factors that induce protective immune memory, i.e., either opsonizing or neutralizing antibody responses. The microbial antigens contained in a vaccine are often poorly immunogenic, such as inactivated toxins and are, therefore, provided together with adjuvants that augment the immune response. The most common adjuvants are poorly soluble aluminium salt-containing gels that adsorb the antigens, thereby forming a suspension.

October 1, 2018 – Measles: is a new vaccine approach needed? “In 2012, the US Centers for Disease Control and Prevention proposed a third-dose measles, mumps, and rubella vaccine. In Europe, the question arises whether a third or even a fourth-dose vaccine should be proposed to health-care workers, and whether re-vaccinating them every 5 years could ensure sufficient vaccination coverage against new strains. … We are confronted with measles epidemics and outbreaks that affect immunised people and in which the B3 and the D8 strains are involved. Immunological research should be done to ensure vaccine effectiveness against this B3 strain, routine re-vaccination should be proposed to health-care workers, and ring vaccination could limit the dissemination of outbreaks.”

October 1, 2019 – Non-live pentavalent vaccines after live measles vaccine may increase mortality “Second, the findings are consistent with previous studies suggesting higher mortality when DTP-containing vaccine is received with or after MV. Third, the point estimates of the excess mortality among the children receiving Penta on the date of visit became stronger when the follow-up period was shortened and effects less likely to be diluted by vaccinations during follow-up. Fourth, while there was no indication of sex-differential treatment, the potential negative effect of providing Penta after MV was particular pronounced for girls, who have been shown to have higher mortality after DTPvaccination in previous studies.

September 18, 2018 –Impact of history of febrile convulsions on the risk difference of febrile convulsions with the tetravalent measles–mumps–rubella–varicella vaccine: Post-hoc exploratory analysis of results from a matched-cohort study “Conclusions The results of this assumption-based analysis suggest that the risk of FC following a first dose of MMRV could be lowered by administering the tetravalent vaccine to children with no personal or family history of FC, and vaccinating children with a personal or family history of FC with separate but concomitant MMR+V vaccines.”