The Breakthrough designation follows an FDA examination of results from a Phase 2 randomized, double-blind trial which evaluated the safety and immunogenicity of the treatment in adults aged 60 to 64 years.
Compared with control practices over time, the active choice intervention correlated with a significant 9.5% increase in vaccination rates, in adjusted analyses. Similar increases were seen in vaccination rates across times of the day.
According to the Centers for Disease Control and Prevention (CDC), the 2017-2018 flu season was one of the most severe - excluding pandemics - on record.
The researchers found that coverage increased for 1 or more dose of HPV vaccine (60.4 to 65.5%), 1 or more dose of meningococcal conjugate vaccine (MenACWY; 82.2 to 85.1%), and 2 or more doses of MenACWY (39.1 to 44.3%) from 2016 to 2017.
Best practices and recommendations for the appropriate storage and handling of vaccines provided by the CDC.
"Education about herd immunity and local vaccination coverage could be a useful tool for increasing willingness to vaccinate, generating benefits both to individuals and communities," the authors write.
The strongest protection against CIN2+ was among women who had received at least 3 vaccine doses and had received their first dose at age 14 to 17 years (RR, 0.52) or age 18 to 20 years (RR, 0.65). In women 21 years or older at the time of first dose.
For this study, researchers investigated the incidence of primary ovarian insufficiency incidence and estimated risk for POI after vaccination with human papillomavirus, Tdap, influenza and meningococcal conjugate using Kaiser Permanente Northwest electronic health records from 2006 to 2014.
Currently, the Advisory Committee on Immunization Practices (ACIP) recommends pregnant women receive the Tdap vaccination to prevent pertussis infection.
The researchers, after adjusting for potential confounding factors, found that RA patients who received the influenza vaccine had reduced risk of hospitalization for septicemia, bacteremia, or viremia.
No significant risks were seen in exploratory analyses of individual autoimmune disorders, including Bell's palsy, optic neuritis, and Graves' disease.
Doctors tried an unorthodox approach - injecting each tumor with Gardasil, the HPV vaccine. The result: All the tumors completely and rapidly disappeared.
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.
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.
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.