January 2023 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in January 2023 for investigational products in development.
Diagnosis & Disease Information
Updated Booster Shots, Not Original COVID-19 Vaccines, Should Be Standard: FDA Panel
Committee members also weighed a proposal to streamline the dosing schedule for COVID-19 vaccines by turning them into annual shots
Bivalent Vaccine Provides Added Protection Against BA.5, XBB/XBB.1.5
Additional protection against symptomatic infection provided for people who had previously received monovalent vaccine doses
MPR Weekly Dose Podcast #145
Pfizer-BioNTech bivalent vaccine under investigation; Trial evaluating HIV prevention vaccine discontinued; Early detection sepsis test cleared; Trial results for RSV-associated disease vaccine; Combo Tx for HCC recurrence shows promise.
Lack of Efficacy Ends Trial Evaluating Janssen’s HIV Vaccine Candidate
The decision to discontinue the study was made based on an analysis from an independent data and safety monitoring board.
Safety Signal in Seniors Prompts Investigation of Bivalent COVID-19 Vaccine
The preliminary safety signal was identified by the CDC’s Vaccine Safety Datalink.
Overall Increase Seen in COVID-19 Vaccine Acceptance Globally
Vaccine hesitancy varied considerably; 12.1% of vaccinated individuals hesitant about booster doses
Adacel Approved for Use During Pregnancy to Prevent Pertussis in Infants
The approval was based on a re-analysis of data from on observational study of Tdap vaccine effectiveness in the US.
FDA to Review 20-Valent Pneumococcal Conjugate Vaccine for Pediatric Use
The 20vPnC vaccine consists of capsular polysaccharide conjugates for the 13 serotypes included in Prevnar 13, along with 7 additional serotypes that cause invasive pneumococcal disease.
No Increase in Adverse Events Seen With COVID-19 Vaccination After MIS-C
Minor adverse events seen in 48.6 percent of patients, most often arm soreness and/or fatigue
