Vaccines
Test-Negative Study: RSV Vaccine May Reduce Hospitalizations and ED Visits in Adults Aged ≥60
16 Nov, 2024 | 14:18h | UTCBackground: Respiratory syncytial virus (RSV) is a significant cause of morbidity and mortality among older adults in the USA, with an estimated 100,000–160,000 RSV-associated hospitalizations annually in those aged 60 years and older. In 2023, RSV vaccines were recommended for this population, showing efficacy in clinical trials. However, real-world effectiveness data, particularly against severe outcomes like hospitalizations in high-risk groups, are limited.
Objective: To assess the real-world effectiveness of RSV vaccination against RSV-associated hospitalizations and emergency department (ED) encounters among adults aged 60 years and older during the 2023–24 RSV season in the USA.
Methods: A test-negative design analysis was conducted using data from the Virtual SARS-CoV-2, Influenza, and Other Respiratory Viruses Network (VISION), encompassing eight states. Adults aged ≥60 presenting with RSV-like illness and tested for RSV from Oct 1, 2023, to Mar 31, 2024, were included. Vaccination status was determined through electronic health records, immunization registries, and medical claims. Vaccine effectiveness (VE) was estimated by comparing the odds of vaccination among RSV-positive cases and RSV-negative controls, adjusting for age, sex, race and ethnicity, comorbidities, and geographic region.
Results: Among 28,271 hospitalizations for RSV-like illness in immunocompetent adults aged ≥60, VE against RSV-associated hospitalization was 80% (95% CI 71–85). VE against RSV-associated critical illness (ICU admission or death) was 81% (95% CI 52–92). In 8,435 hospitalizations among immunocompromised adults, VE was 73% (95% CI 48–85) against RSV-associated hospitalization. Among 36,521 ED encounters in immunocompetent adults, VE against RSV-associated ED visits was 77% (95% CI 70–83). VE estimates were consistent across age groups and vaccine products.
Conclusions: RSV vaccination effectively prevented RSV-associated hospitalizations and ED visits among adults aged ≥60 during the first season post-approval, including those at highest risk due to advanced age or immunocompromise.
Implications for Practice: These findings support recommending RSV vaccination for adults aged ≥60 to reduce severe RSV-related morbidity and mortality. Clinicians should consider advising eligible patients to receive the RSV vaccine to prevent hospitalizations and critical illness.
Study Strengths and Limitations: Strengths include a large, geographically diverse cohort and integrated medical, laboratory, and vaccination data, allowing robust VE estimates across subgroups. Limitations involve potential misclassification of vaccination status, residual confounding, and reliance on clinician-directed RSV testing, which may introduce bias.
Future Research: Further studies are needed to evaluate the duration of vaccine protection over multiple RSV seasons and to assess VE in other high-risk populations and settings.
Cohort Study: Lower Risk of Cardiovascular Complications in Post–COVID-19 Vaccine Myocarditis Compared to Conventional Etiologies
7 Sep, 2024 | 20:36h | UTCStudy Design and Population: This French nationwide cohort study included 4,635 individuals aged 12-49 hospitalized for myocarditis between December 2020 and June 2022. The cohort was divided into three groups: 558 patients with post–COVID-19 mRNA vaccine myocarditis, 298 with post–COVID-19 infection myocarditis, and 3,779 with conventional myocarditis.
Main Findings: At 18 months of follow-up, the frequency of cardiovascular events was significantly lower in the postvaccine myocarditis group (5.7%) compared to conventional myocarditis (13.2%) with a weighted hazard ratio (wHR) of 0.55 (95% CI, 0.36-0.86). Hospital readmission for myopericarditis occurred in 3.2% of postvaccine cases, 4.0% of post–COVID-19 cases, and 5.8% of conventional cases. The all-cause mortality rate was 0.2% for postvaccine myocarditis, 1.3% for post–COVID-19 myocarditis, and 1.3% for conventional myocarditis.
Implications for Practice: Postvaccine myocarditis patients, primarily young males, experience fewer complications compared to conventional myocarditis, but long-term follow-up is still needed. These findings should guide future mRNA vaccine recommendations and clinical management for myocarditis patients.
Reference: Semenzato L. et al. (2024). Long-term Prognosis of Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2, or Conventional Etiologies. JAMA, Online. DOI: http://doi.org/10.1001/jama.2024.16380
Link: https://jamanetwork.com/journals/jama/fullarticle/2822933
Phase 3 RCT: Butantan-DV Dengue Vaccine is Safe and Shows 67.3% Efficacy Over 3.7 Years in Participants Aged 2–59 Years – Lancet Infect Dis
10 Aug, 2024 | 20:23h | UTCStudy Design and Population: This double-blind, randomized, placebo-controlled, phase 3 trial conducted in Brazil evaluated the efficacy and safety of the Butantan-dengue vaccine (Butantan-DV) in 16,235 healthy participants aged 2–59 years. Participants, who had not previously received a dengue vaccine, were randomly assigned to receive either a single dose of Butantan-DV or a placebo and were followed up for an average of 3.7 years.
Main Findings: The study found that Butantan-DV demonstrated 67.3% efficacy against virologically confirmed dengue (VCD) caused by any dengue virus serotype, with no cases of VCD caused by DENV-3 or DENV-4. The proportions of serious adverse events were similar between the vaccine and placebo groups, indicating that the vaccine was generally well tolerated.
Implications for Practice: The results support the potential of the Butantan-DV vaccine as an effective intervention for preventing symptomatic dengue, particularly from DENV-1 and DENV-2, across a broad age range regardless of dengue serostatus. Continued development and monitoring are warranted to confirm long-term efficacy and safety.
Phase 2 Trial | Maternal GBS6 vaccine shows promise in infant group B strep prevention
21 Jul, 2023 | 13:34h | UTCCommentary: Maternal strep B vaccine slashes risk of infection among infants – CIDRAP
RCT | Single-Dose VLA1553 Chikungunya vaccine shows high immunogenicity and seems safe
23 Jun, 2023 | 13:38h | UTCNews Release: First phase 3 trial of a chikungunya vaccine candidate finds it is generally safe and provokes an immune response – The Lancet
Commentary on Twitter
New: First phase 3 trial of a chikungunya vaccine candidate finds it is generally safe and provokes an immune response. https://t.co/YSzV5oxXRc pic.twitter.com/rGL7A5eLAr
— The Lancet (@TheLancet) June 13, 2023
RCT | NmCV-5 pentavalent meningococcal vaccine shows non-inferiority to quadrivalent MenACWY-D in Mali and Gambia
30 May, 2023 | 11:46h | UTC
Commentary on Twitter
Original Article: Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia https://t.co/RScQOr5IWS#InfectiousDisease pic.twitter.com/jA6d92QlK2
— NEJM (@NEJM) May 26, 2023
RCT | Optimizing the timing of whooping cough immunization in mums through investigating pertussis vaccination in pregnancy
16 May, 2023 | 14:49h | UTC
RCT | Investigational 4-Antigen Staphylococcus aureus vaccine fails to prevent infections in spinal surgery
12 May, 2023 | 13:12h | UTC
Commentary on Twitter
Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STRIVE Randomized Clinical Trial
✅ Just Accepted
🔓 Open Access
🔗 https://t.co/eFVufc7rzi pic.twitter.com/XdylTWa66v— Clinical Infectious Diseases (@CIDJournal) May 3, 2023
FDA approves first Respiratory Syncytial Virus (RSV) vaccine
11 May, 2023 | 12:15h | UTCFDA Approves First Respiratory Syncytial Virus (RSV) Vaccine – U.S. Food & Drug Administration
Commentary: US FDA Approves First-Ever RSV Vaccine – Health Policy Watch
M-A | Association of SARS-CoV-2 vaccination or infection with Bell palsy
10 May, 2023 | 16:03h | UTC
RCT | Maternal RSVpreF vaccination protects infants from severe RSV illness
10 Apr, 2023 | 13:56h | UTCBivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: Vaccination during pregnancy could prevent RSV illness in infants – Charité – Universitätsmedizin Berlin
Commentary on Twitter
In a phase 3 trial, adults (≥60 years of age) received one 120-μg dose of RSVpreF vaccine or placebo. Vaccine efficacy against RSV-associated lower respiratory tract illness was 67 to 86%. https://t.co/R9u77iWjF9 pic.twitter.com/iPU8VAMQ9M
— NEJM (@NEJM) April 5, 2023
RCT | RSVpreF vaccine successfully prevents RSV-associated respiratory illness in seniors
10 Apr, 2023 | 13:54h | UTCEfficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults – New England Journal of Medicine (link to abstract – $ for full-text)
FDA panel endorses 2 RSV vaccines for older adults, but flag at potential increased risk of Guillain-Barre
8 Mar, 2023 | 14:27h | UTCPfizer vaccine:
In close vote, FDA advisers recommend Pfizer RSV vaccine for those 60 and older – CIDRAP
GSK’s vaccine:
FDA panel recommends GSK’s RSV vaccine for ages 60 and up – CIDRAP
FDA advisors recommend GSK’s RSV vaccine for older adults, but flag potential safety risks – CNBC
See also: Rare neurological condition is ‘important potential risk’ of Pfizer’s RSV vaccine, FDA says – CNN
Phase 2b RCT | Ad26.RSV.preF–Respiratory Syncytial Virus preF protein vaccine is immunogenic in older adults
17 Feb, 2023 | 13:30h | UTCSummary: A phase 2b clinical trial evaluated the Ad26.RSV.preF–RSV preF protein vaccine’s efficacy, immunogenicity, and safety in preventing RSV-mediated lower respiratory tract disease in adults aged 65 years and older. The vaccine was effective in preventing the disease and immunogenic, as demonstrated by the increase in RSV A2 neutralizing antibody titers after vaccination. The vaccine was associated with higher rates of adverse events than the placebo, but most were of mild to moderate severity. The trial concluded that Ad26.RSV.preF–RSV preF protein vaccine was effective in preventing RSV-mediated lower respiratory tract disease in older adults.*
Article: Efficacy and Safety of an Ad26.RSV.preF–RSV preF Protein Vaccine in Older Adults – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: Ad26.RSV.preF-RSV preF Protein Vaccine Immunogenic in Seniors – HealthDay
*Note: This summary was created through the collaboration of a medical editor and ChatGPT.
RCT | Respiratory Syncytial Virus prefusion F protein vaccine provides protection for older adults
17 Feb, 2023 | 13:32h | UTCSummary: A phase 2b clinical trial evaluated the Ad26.RSV.preF–RSV preF protein vaccine in adults aged 65 years and older. The vaccine was effective and immunogenic, as demonstrated by the increase in RSV A2 neutralizing antibody titers after vaccination. The vaccine was associated with higher rates of adverse events than the placebo, but most were of mild to moderate severity.*
Article: Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
Respiratory syncytial virus causes clinically significant illness in children and adults. In a placebo-controlled trial, a prefusion stabilized F protein vaccine led to an 83% lower risk of RSV infection. https://t.co/aU9BV0LXBU pic.twitter.com/0zy1hu0VH6
— NEJM (@NEJM) February 15, 2023
*Note: This summary was created through the collaboration of a medical editor and ChatGPT.
RCT | Evaluation of BNT162b2 Covid-19 vaccine in children younger than 5 years of age
17 Feb, 2023 | 13:27h | UTCSummary: The study was a combined phase 2-3 clinical trial that aimed to determine whether the BNT162b2 vaccine was safe, could elicit an immune response and was effective in preventing COVID-19 in healthy children. The trial was conducted on children aged 6 months to 11 years, with the findings presented for the 6 months to 4 years age group. The results indicated that the vaccine was safe, immunogenic, and effective in reducing the risk of symptomatic COVID-19 by 73.2% in children aged 6 months to 4 years. The vaccine was well-tolerated, and the side effects were mainly mild to moderate. The incidence of fever was similar among those who received the vaccine or a placebo.*
Article: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age – New England Journal of Medicine (link to abstract – $ for full-text)
*Note: This summary was created through the collaboration of a medical editor and ChatGPT.
Recommended adult immunization schedule, United States, 2023
13 Feb, 2023 | 13:06h | UTCRecommended Adult Immunization Schedule, United States, 2023 – Annals of Internal Medicine
Commentary: Recommended 2023 Adult Immunization Schedule Published – HealthDay
Commentary on Twitter
The 2023 #ACIP schedule is out now with important changes to #COVID19 and pneumococcal vaccines, including recommendations for adults who have previously received PCV13 and PPSV23: https://t.co/QeErLZJFuZ pic.twitter.com/BR6aa1kNKi
— Annals of Int Med (@AnnalsofIM) February 10, 2023
Updated child and adolescent immunization schedule, United States, 2023
13 Feb, 2023 | 13:05h | UTCChild and Adolescent Immunization Schedule by Age – Centers for Diseases Control and Prevention
See also: Recommended Childhood and Adolescent Immunization Schedule: United States, 2023 – Pediatrics
Commentary: Immunization Schedule for Children, Teens Updated for 2023 – HealthDay
US infant pertussis incidence trends before and after implementation of the maternal Tdap vaccine
13 Feb, 2023 | 12:38h | UTCUS Infant Pertussis Incidence Trends Before and After Implementation of the Maternal Tetanus, Diphtheria, and Pertussis Vaccine – JAMA Pediatrics (free for a limited period)
Commentary: Maternal Tdap Vaccination Protects Youngest Infants From Pertussis – HealthDay
Commentary on Twitter
Study findings suggest that maternal #Tdap vaccination is associated with a reduction in #pertussis among infants younger than 2 months, the strategy’s target age group. https://t.co/a5h3z2zXY2
— JAMA Pediatrics (@JAMAPediatrics) February 7, 2023
Guillain–Barré syndrome following influenza vaccination: a 15-year nationwide population-based case–control study
10 Feb, 2023 | 13:35h | UTCCommentary: Influenza vaccination increases risk of Guillain-Barre syndrome within one month – Medical Dialogues
Case-control study | Effectiveness of a Meningococcal Group B vaccine (4CMenB) in children
9 Feb, 2023 | 13:59h | UTCCommentaries:
NEJM: Effectiveness of pediatric meningococcal B vaccine – MedicalResearch.com
4CMenB Vaccination Effective Against Invasive Meningococcal Disease in Children Under 5 – HealthDay
Commentary on Twitter
In this case–control study of all meningococcal cases in Spain between 2015 and 2019, full vaccination with meningococcal serogroup B vaccine was 76% effective in preventing meningococcal diseases. https://t.co/MMNDjX1g66 pic.twitter.com/bcbywfr8N3
— NEJM (@NEJM) February 5, 2023
Cohort Study | Outcomes of Meningococcal B disease in children after implementation of routine 4CMenB vaccination
9 Feb, 2023 | 13:57h | UTC
Commentary on Twitter
Cases of MenB disease in vaccine-eligible children declined after #4CMenB implementation in England, but morbidity in vaccinated and unvaccinated children remained unchanged
New study by @ShamezLadhani & colleagues @UKHSA: https://t.co/4BkIBvsFJs pic.twitter.com/lUxIUCjW47
— The Lancet Child & Adolescent Health (@LancetChildAdol) February 1, 2023
Case-control study | Estimation of vaccine effectiveness of CoronaVac and BNT162b2 in patients with SARS-CoV-2 Omicron
6 Feb, 2023 | 13:32h | UTC
Commentary on Twitter
The CoronaVac and BNT162b2 (Pfizer) vaccines were effective against severe outcomes due to Omicron (74-77%), but protection among older individuals in Hong Kong was more likely to wane 6 months after the second dose; boosters can bring effectiveness >90%. https://t.co/kqgwryJ1kT
— JAMA Network Open (@JAMANetworkOpen) February 3, 2023
The next generation of coronavirus vaccines: a graphical guide
3 Feb, 2023 | 14:18h | UTCThe next generation of coronavirus vaccines: a graphical guide – Nature
WHO updates recommendations on HPV vaccination schedule
9 Jan, 2023 | 14:57h | UTCNews Release: WHO updates recommendations on HPV vaccination schedule – World Health Organization
Guideline: Human papillomavirus vaccines: WHO position paper, December 2022 – World Health Organization
Commentaries:
WHO supports 1-dose HPV vaccine strategy – CIDRAP
Commentary on Twitter
🆕 WHO has revised its recommendations on possible schedules for human papillomavirus (#HPV) vaccines & now recommends:
👉1 or 2-doses for girls & women aged 9-20
👉2 doses with a 6-month interval for women 21+https://t.co/m0KZyH6sPR pic.twitter.com/W4PeS4raV9— World Health Organization (WHO) (@WHO) December 21, 2022