Vaccines

The FDA has approved Pfizer-BioNTech's 2026-2027 Comirnaty XFG formula, an updated COVID-19 vaccine targeting the XFG variant, for adults 65 and older and for individuals ages five through 64 with at least one high-risk underlying condition.

The phase 3 priMe trial found the investigational vaccine did not demonstrate noninferiority for preventing tuberculosis infection, though the study authors cited surrogate end point and exposure-imbalance issues that complicate interpretation.

The US childhood vaccine schedule was the big news this month with the presidential executive order making changes to it as well as the latest Centers for Disease Control and Prevention kindergarten immunization numbers for the 2025-2026 year. Learn more about the news with clinician commentary and how it might impact patient care.

The latest national numbers show a decrease in vaccination rates, along with a spike in the number of immunization exemptions, leading to an increase in the number of cases for vaccine-preventable diseases such as measles.

President Trump signed an order spacing the timing of immunizations, limiting the number of vaccines, and changing the MMR vaccine by separating it into 3 single-antigen vaccines.

The FDA has approved Moderna's influenza vaccine and set a Prescription Drug User Fee Act (PDUFA) date for Merck's RSV immunization product for expansion for a second season.

Investigational mRNA influenza vaccine prompts broader immune response than conventional vaccines, with activity against multiple strains.

An FDA advisory committee voted unanimously to recommend mRNA-1010 for approval, after the Agency initially refused to review the application and HHS cancelled contracts supporting mRNA vaccine development.

Two new complementary initiatives from CIDRAP’s Vaccine Integrity Project and The Evidence Collective aim to evaluate and improve US vaccine policymaking, governance, and public trust amid ongoing changes to the nation's immunization infrastructure.

There were a number of FDA approvals in recent weeks. Here is a listing of the approvals including the news reports and review of the phase 3 study data.

An investigational dual vaccine against Lassa fever and rabies demonstrates promise against priority target plaguing West Africa.

The FDA has approved an expanded indication for Merck's Capvaxive, allowing its use in children and adolescents aged 2 to 17 years with chronic medical conditions that increase their risk of pneumococcal disease following completion of a primary pneumococcal vaccination series.

New data on flu vaccine for children counter the contention that a lack of contemporaneous randomized data justifies its removal from recommended annual immunizations.

Modeling of the ACIP recommendation to replace universal birth-dose HepB vaccination with vaccination based on "shared decision" and maternal status shows substantially more maternal screening or vaccinating infants of unscreened mothers will be necessary to mitigate increase in infections.

Editor-in-Chief Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS, discusses how a coalition of major medical professional societies needed to step in to sue the federal government after sweeping changes to US vaccine policy under Health and Human Services Secretary Robert F. Kennedy Jr. reshaped the CDC’s vaccine advisory process. The medical organizations argued that the evidence-based foundations of public health recommendations had been compromised.

In this month's column, we talk to leaders from professional medical organizations about the revised Advisory Committee on Immunization Practices charter as well as commentary about the Centers for Disease Control and Prevention’s suppression of COVID-19 vaccine data.

In this month's column, a federal district court struck down the

The agency’s acting director took the unusual step of withholding the publication of the study findings in the Morbidity and Mortality Weekly Report, which showed the vaccine was protective against hospitalization and emergency department visits.

Results from a large population-based study found that receiving influenza and pertussis vaccines on the same day during pregnancy does not increase the risk of adverse maternal, birth, or neonatal outcomes compared with pertussis vaccination alone.

Study ascertains vaccination status of children hospitalized for Bordetella pertussis infections and assesses diagnostic value of testing modalities.

This week, read about omadacycline as an oral treatment option for Mycobacterium abscessus pulmonary disease, combining immunotherapy with antifungals for fungal infections, this year's Peggy Lillis Foundation's C diff meeting, and more.

This week, read about a new COVID variant, the test and treat paradigm model for hepatitis C, and a mission around bringing Americans with Ebola back to the US.

A phase 3 trial of an investigational Lyme disease vaccine from Pfizer Inc. and Valneva SE demonstrated more than 70% efficacy, signaling potential progress toward the first approved human vaccine for the disease. Pfizer is planning to move forward with regulatory submissions for potential approval.

This week, read about the DOTs trial, the latest measles numbers, the World Health Organization's new targets for antibiotic development, and more.

In this month's column, we look at the leadership change at CDC, an amicus brief supporting the AAP's lawsuit against HHS changes to the pediatric vaccine schedule, and potential clinical repercussions around the reports the federal government is considering removing the COVID-19 vaccine from the market.