Vaccines

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.

Despite the funding being terminated, the company said data from its phase 1/2 study of its investigational vaccine, mRNA-1018, demonstrated positive interim results.

The World Health Organization (WHO) says the previously predominant LP81 variant has been declining, and that the NB181 strain, which is a variant under monitoring, is increasing.

Following a positive safety review, Vaxart advances its needle-free, room-temperature stable oral vaccine candidate with government-backed funding and a year-long follow-up study.

In a joint announcement, the leaders of the NIH, HHS, and FDA, made comments about this CDC immunization removal.

With this news, Sanofi's immunization becomes the only MenACWY vaccine that can help protect individuals 6 weeks of age and older, with no upper age limit.

The FDA committee advisors are recommending the monovalent JN1-lineage-based COVID-19 vaccines preferentially using the LP81 strain.

The company made the decision after the FDA requested more vaccine data for the mRNA-1083 vaccine. Moderna plans to resubmit their Biologics License Application (BLA) for the vaccine later this year.

FDA leadership says they expect more testing for COVID-19 vaccines and that they generate antibody titers in people in order for vaccines to be considered for approval.

The company's Nuvaxovid vaccine is the only recombinant protein-based, non-mRNA COVID-19 immunization available in the US.

Regulatory action follows reports of serious adverse events during use in elderly individuals; vaccine remains authorized for younger age groups in the US and Europe with over 40,000 doses administered globally.

In a large study, Moderna’s investigational vaccine, mRNA-1083, was shown to have noninferiority to other vaccines, and had an acceptable tolerability and safety profile.

The company had requested approval for its mRNA-1083 combination vaccine last year. With this setback, the company is now looking at 2026 for approval.

Despite political restructuring and funding cuts, the NIH’s Generation Gold Standard vaccine platform offers a promising solution for pandemic preparedness and global health resilience.

The agencies are calling for sustained investments in immunization efforts in the midst of increasing case numbers rising for diseases such as whooping cough, measles, and others.

US cases already surged 210% in 2025, while ECDC reported a 786% increase in Europe, with 35,212 cases in 2024.

After delays in the review of the COVID-19 vaccine—which missed its April 1 review deadline—the agency has requested new data.

The University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) announced its initiative that will look to ensure reliable vaccine data and information is available to the public and medical community.

Ninety-four percent of cases were tied to 10 outbreaks, Texas leading with 624 cases, while Michigan and Montana reported the first outbreaks since 2019 and 1990, respectively.

Study of 400,000 pediatric records shows vaccine’s effectiveness in preventing Long COVID during Delta and Omicron waves.

ACIP provides recommendations on meningococcal vaccines, RSV vaccination for at-risk adults, and chikungunya vaccines for travelers and laboratory workers, while also addressing safety concerns and potential expansions of use for each.

CDC maintains low public health risk despite more cases, the first reported death, and accelerated vaccine development to enhance pandemic preparedness.