Vaccines

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.

A district court judge has ruled against the current administration's vaccine policies and throws into jeopardy this week’s Advisory Committee on Immunization Practices meetings that were scheduled to discuss COVID-19 vaccines.

A phase 3 clinical trial found the Butantan-DV tetravalent dengue vaccine provided 80.5% protection against severe dengue with warning signs over 5 years and prevented hospitalizations among vaccinated participants.

This week, read about tapering vancomycin for 2 weeks after a 2-week standard dose treatment of Clostridioides difficile, phage-antibiotic combinations, another episode from our vaccine roundtable, and more.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted for a trivalent vaccine composition for use in the US, protecting against influenza A (H1N1 and H3N2) and influenza B (Victoria lineage).

The rate of HBV vaccination of newborns in the US has declined by over 10% in the past 2 years, reversing decades of increasing coverage.

This week, read about the latest measles numbers, a risk assessment and antibiotic treatment of GAS pharyngitis, an analysis of ceftolozane-tazobactam over aminoglycosides/polymyxins for resistant P aeruginosa, and more.

The FDA’s biologics center faces another leadership shake-up as Vinay Prasad, MD, MPH, plans an exit in April, leaving questions over vaccine rules and gene-therapy approvals.

Moderna has cleared a major regulatory milestone in Europe after the EMA’s CHMP recommended approval of mRNA-1083 (mCOMBRIAX), the world’s first combined influenza and COVID-19 vaccine for adults aged 50 and older.