January 8th 2025
The FDA approved the addition of Guillain-Barré syndrome warnings for Abrysvo and Arexvy, citing postmarketing data suggesting an increased risk.
December 18th 2024
The addition, based on an approved update to labeling, expands to 4 the recommended vaccination options that health care professionals can offer to pregnant people.
The 2 novel vaccine candidates each combine a Sanofi licensed influenza vaccine with the Novavax adjuvanted recombinant COVID-19 vaccine.
Your daily dose of the clinical news you may have missed.
November 29th 2024
Cases and Conversations™: Applying Best Practices to Prevent Shingles in Your Practice
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New Research Suggests Cardiac Events are Prevalent in Older Adults Hospitalized with RSV
Nearly one-quarter of hospitalized adults aged 50 years and older with RSV experienced an acute cardiac event, according to results of a new study.
RSV Disease Severity Comparable to Unvaccinated COVID-19, Influenza: New Research
In adults hospitalized with RSV, odds of severe outcomes, including death, were much higher than for those admitted for, but vaccinated against, COVID-19, flu.
Pfizer: MONeT Study Topline Data Positive for Abrysvo in Adults Aged 18 to 59 Years at High Risk for RSV-LRTD
Pfizer plans to submit the phase 3 MONeT data to regulatory bodies in support of an expanded label for Abrysvo to include adults aged 18 to 59, the company said.
Vaccination of Older Adults Against RSV Could Reduce Symptomatic Cases by 1 Million per Year: Modeling Study
The study looked at the impact over 3 years but found that most of the averted burden, including more than 8000 fewer deaths, occur in the first year after vaccination.
Moderna Next-Gen mRNA COVID-19 Vaccine Meets Primary Endpoints in NextCOVE Phase 3 Trial
The mRNA bivalent vaccine candidate produced a "more robust" immune response vs Spikevax and particularly in adults over the age of 65 years, said Moderna.
Respiratory Virus Vaccines on Deck for 2024
Respiratory vaccine R & D at Moderna, Merck, and Pfizer is focused on mRNA technology, added protection for vulnerable populations, and combination shots.
Long COVID's Long Road: The Muddled Map at 4 Years
Long COVID affects approximately 20 million people in the US and that number may be conservative. Here, a snapshot, through the fog, of the route they are on.
Merck's 21-Valent Adult-Specific Pneumococcal Vaccine Accrues New Phase 3 and Real World Data
The novel 21-valent pneumococcal vaccine remains on track for the FDA PDUFA date of June 17, 2024; Merck adds this new data to the body of positive evidence.
Abrysvo Efficacy Sustained in Older Adults Through Second RSV Season
The bivalent vaccine demonstrated "durable efficacy" of more than 80% over 2 RSV seasons, according to Pfizer's report of topline findings from the RENOIR trial.
ACIP Recommends Monovalent COVID-19 Booster for Older Adults this Spring
COVID-19 hospitalizations have never fall below 6000/week, according to the ACIP; those aged 65+ have the highest inpatient rate, those aged 75+ have the highest mortality.
Of Vaccine Efficacy and COVID-19 Variants: 4 Questions
Just when the new monovalent COVID-19 vaccines were available in Sept 2023, a new variant emerged. Did the CDC get it right? What do you know about the monovalent VE?
GSK RSV Vaccine Arexvy Under FDA Priority Review for Prevention of RSV in High-Risk Adults Aged 50 to 59 Years
Approval of the application would extend the current Arexvy indication for prevention of RSV in adults aged 60 years and older; a June 2024 PDUFA date is set.
Two RSV Vaccines, One Savvy Patient who Asks, "Which One do You Recommend?"
RSV vaccines from Pfizer-BioNTech and Moderna for adults aged 60 years and older aren't that different, so which would you recommend if a patient asks?
Moderna mRNA RSV Vaccine for Adults Returns Positive Phase 3 Results
Moderna's investigational vaccine against RSV in adults showed mean efficacy of 83% against the infection and is the only mRNA technology-based RSV shot.
FDA Grants Priority Review to Merck BLA for Investigational 21-Valent Pneumococcal Vaccine
If approved the 21-valent shot would be the first pneumococcal conjugate vaccine indicated specifically for adults.
Two Vaccines Against RSV in Older Adults Approved One Month Apart: It Happened in 2023
First-ever vaccines against RSV in older adults, from GSK and Pfizer, won FDA approval in 2023. This brief slide show highlights the year's headline news about both.
Daily Dose: Coadministration of RSV and Influenza Vaccines
Why Do We Need Another Pneumococcal Vaccine?
With 3 vaccines approved against pneumococcal disease in adults, is there really the need - or the room - for 1 more? Here's what one physician thinks.
The ACIP Recommends Use for a New Vaccine: Who Needs it?
The vaccine has been available in Europe for more than 20 years; the ACIP published recommendations in November. Will any of your patients need it?
Coadministration of RSV, Influenza Vaccines Found Safe and Effective in New Study
The coadministration of RSVpreF and seasonal influenza vaccine was found to generate robust immune responses in older adults, reported authors of new study.
When it Comes to the Monovalent COVID-19 Shot, the CDC and WHO Have a Disagreement
Should the monovalent COVID-19 vaccine approved for use this respiratory virus season be given universally or to only those at high risk? There are differences of opinion.
The Exam Room's Secret Weapon for Flu Season
Physician author Terry Brenneman, MD, suggests a key difference between a great clinician and an average one, and it has to do with used car sales. Read more.
Daily Dose: Arexvy May Protect Adults Aged 50-59 Years at Increased Risk for RSV
Immune Responses to Arexvy in Adults aged 50 to 59 Years Noninferior to those in Adults aged 60 Years and Older
The comparable immune responses were observed in 50-to 59-year-olds at high risk of RSV-LRTD as well as a wider group at average risk, according to preliminary phase 3 data.
Combination Influenza/COVID-19 Vaccine Enters Phase 3 Trial, First Participant Dosed
The investigational combination vaccine against influenza and SARS-CoV-2 proved both safe and effective in recent results from a phase 1/2 trial, said Moderna.
10 Top Studies from IDWeek for Primary Care, In Case you Missed Them
IDWeek was packed with so much new science it was hard to make choices. Here we topline 10 with outcomes of interest to primary care, ICYMI.
13 Reasons Patients Give for Not Getting a COVID-19 Vaccine Booster
Reasons for not getting a COVID-19 booster ranged from worry about taking time off to believing it won't add any additional protection from infection.
How to Get Shots into Arms this Year: Patience, Persistence, and Don't Take it Personally
AAFP president-elect Steven Furr, MD, offers 3 thoughts on maximizing opportunities this year to give all necessary vaccines.
AAFP President-Elect Steven Furr, MD, Talks About Vaccination in Practice vs in Theory
Furr on COVID-19 shot: The expectation that 90% of the US population would take this new vaccine that they'd never heard of was probably not practical.
Moderna Investigational Dual Flu/COVID-19 Vaccine Shows Positive Phase 1/2 Results
The combination was found equally as effective as 2 standard influenza vaccine comparators and as the Moderna Spikevax COVID-19 booster shot.