Vaccines

Spikevax and mNEXSPIKE authorized for older adults and high-risk individuals; experts emphasize protection against severe COVID-19 outcomes.

New authorization limits shots to adults ≥65 and individuals with underlying health conditions, with ACIP set to review guidance and insurance coverage implications.

From chikungunya setbacks to COVID-19 booster guidance and childhood vaccine safety initiatives, here are the top regulatory and research developments this summer.

The American College of Cardiology is providing recommendations on the influenza, COVID-19, RSV vaccinations and others.

Regulators cite four new serious adverse event reports, halting US distribution while global access efforts continue.

New data show consistent late-summer and winter surges, reinforcing the need for seasonal vaccine timing and focused protection for high-risk groups.

The renewed federal panel aims to improve vaccine oversight and restore public trust amid declining immunization rates and ongoing concerns about vaccine ingredients.

After a three-month review, the FDA and EMA have cleared continued use of IXCHIQ in adults 60+, adding new safety warnings for elderly individuals with chronic conditions.

Low vaccine uptake, immunity gaps, and new antiviral data raise alarms ahead of a potential late-summer surge.

Study reveals notable sex-based disparities in liver complication risk among adults with cirrhosis, particularly in nonviral cases.

In a continuing trend from the last several years, a record number of families are opting out of vaccines.

Vinay Prasad’s, MD, MPH, short tenure marked by tough regulatory decisions and political pushback; the Trump administration has not yet named a successor for the CBER director role.

This comes after the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) made the recommendation to remove the vaccine preservative.

First author Jacek Skarbinski, MD, offers insights on new data published last week showing how this population can benefit from continued vaccination.

A large study looked at booster uptake and effectiveness among US adults who received chemotherapy or immunotherapy.

New format eliminates reconstitution step, offering greater convenience for providers and supporting expanded access for at-risk adults.

New research finds no link between aluminum in vaccines and autism, asthma, or other health conditions, strengthening the case for vaccine safety.

The company said it expects to have its updated mRNA-1273 (Spikevax) vaccine available for these eligible populations in the US for the next respiratory virus season.

Results from Invivyd’s pemivibart (Pemgarda) phase 3 trial show it had a significant PrEP effect during the 6-month on-drug period for both immunocompromised and immunocompetent populations.

New epidemiologic data, vaccine effectiveness, and safety assessments guide a move from universal to targeted vaccination recommendations for the 2025–26 season.

The philanthropic organization plans to provide the gift over the next 5 years, and is in contrast with what is happening with US vaccine funding to the organization as well as the country's changing immunization policies.

Single-dose, nonvaccine antiviral shows significant seasonal prophylactic efficacy and favorable safety profile in over 5000 healthy adults.

Gilead’s Yeztugo, a long-acting HIV capsid inhibitor, shows 96 to 100% efficacy in phase 3 trials and aims to expand access worldwide through regulatory filings and support programs.

A ValuePenguin poll of more than 2000 adults highlights partisan divides, persistent myths, and concerns over vaccine access, with 41% fearing skepticism could hinder immunization efforts.

In an early release of his letter for the Summer issue, Editor-in-Chief Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS, discusses the recent changes to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), and where professional societies must step in and lead with research data and clinical guidance in the absence of experienced committee members.

The federal agency approved the company’s mRNA-1345 (mRESVIA) vaccine for people who are between the ages of 18 to 59 years.

Phase 3 results show immune response and tolerability in adults 65 and older, following phase 2 findings.

The replacement of all 17 ACIP members sparks concern among medical experts and prompts calls for Senate investigation.

Full committee removal raises concerns over vaccine policy stability and scientific independence.

The company's vaccine, mRNA-1283, becomes the first approval under the new federal guidelines.