The regimens were well-tolerated as evident by the comparable incidence of local and systemic reactions among all treatment arms. No grade 4 adverse events or death were reported.
The researchers estimated that in HIV-uninfected children aged 1 to 59 months in 2015 there were 294,000 pneumococcal deaths and 29,500 Hib deaths.
The authors note that in recent years, a social movement of public health vaccine opposition has been growing in the United States, with an increase in measles outbreaks.
The researchers found that women who underwent index screening mammography were more likely than unscreened women to later undergo Papanicolaou test (odds ratio, 1.49), bone mass measurement (odds ratio, 1.70), and influenza vaccine (odds ratio, 1.45).
In this Phase 3, open-label, randomized, controlled multicenter study, a total of 865 patients were randomized to receive one of the following vaccine regimens: (1) the first RZV dose and PPSV23 together on Day 0 and the second dose of RZV at Month 2 (N=432); or (2) PPSV23 on Day 0 and then first RZV dose at Month 2 with the second RZV dose at Month 4 (N=433; control group).
"All found higher proportions seroprotected (definition varied by study) in younger age groups (ages varied by study) at 15 days post-vaccination but similar seroprotection at 30 days," the study authors reported.
The study authors reported that the rate of AIS in the 12 months following vaccination was 7.8 per 100,000 person-years at risk (95% CI: 4.8, 10.9) in patients who received the vaccine versus 6.8 (95% CI: 1.3, 12.2) in those who did not.
Specifically, the types the vaccine protects against are HPV 16, 18, 31, 33, 45, 52, 58 (which cause ~90% of cervical cancer cases worldwide), and types 6 and 11 which case genital warts.
Of the 2500 cases of hepatitis A infection reported between January 2017 and April 2018, 68% were among persons who reported drug use (injection and non-injection), homelessness, or both.
The researchers found that mandatory influenza vaccination requirements for HCP increased from 37.1% in 2013 to 61.4% in 2017 among all responding hospitals.
The researchers found that 50,157 reports were received by VAERS after DTaP vaccination; 87.7% reported concomitant administration of other vaccines and 11.2% of reports were serious.
The final guidance clarifies that drugs developed for inhalational anthrax prophylaxis can rely on evidence from animal studies (the Animal Rule) to support approval when the criteria under the Animal Rule have been met.
Between October 20, 2017 and February 20, 2018, the Vaccine Adverse Event Reporting System (VAERS) received 155 reports involving RZV, with 13 (8%) involving an administrative error.
The authors found that vaccination rates varied between 1.5% and 42.4% at the 6 institutions assessed and that 21.3% of eligible patients at the University of Colorado received HZV prior to the intervention.
PCV13, marketed as Prevnar 13, was evaluated in a test-negative case-control study in real-world conditions where patients were administered pneumococcal vaccination as advised by their healthcare providers.
Provider-verified vaccination records obtained from a pilot study conducted in 14-29-year-old patients were utilized to determine the sensitivity and specificity of the self/parent-reported vaccination data.
Dr Vincent also states that target groups should be considered in vaccine development and adds, "It is generally thought that the best target group would be girls and boys aged 9-13, preferably before sexual debut, similar to the HPV vaccination program."
The authors concluded, "There is high-certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and young women aged 15 to 26," while also indicated that future studies should have long-term follow-up.
There are currently no approved treatments or vaccines available for chikungunya, a virus transmitted through mosquito bites.
The researchers found that even relatively low-efficacy influenza vaccines can have a high impact, especially with optimal distribution across age groups. In order to minimize mortality and DALYs, the optimal distribution of the vaccine uptake shifts toward the elderly as vaccine efficacy declines.
The sBLA included clinical data from a Phase 4 study that enrolled nearly 2000 children and assessed the safety and immunogenicity of the 0.5mL dose.
The Breakthrough designation was based on data from Phase 2 studies which assessed the safety and efficacy of the vaccine in this patient population.
MF59 adjuvanted, quadrivalent influenza vaccine (aQIV) was found to be more efficacious in preventing influenza than a non-adjuvanted conventional influenza vaccine in children aged 6 through 23 months.