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11.28.22 – GSK is Cordially Inviting You to Participate in a Live Webinar Speaker Program Featuring Disease Education and Vaccine Information For Meningococcal Serogroup B.

The purpose of the program is to provide disease education on Meningococcal Serogroup B, Including meningococcal B vaccination and the advisory Committee on Immunization Practices (ACIP) recommendations.

December 1st –  1:15 PM EST – Meningococcal Serogroup B – Disease Education and Vaccine Information with Dr. Jennifer Coren

December 7th – 12:15 PM EST – Meningococcal Serogroup B – Disease Education and Vaccine Information with Dr. Francisco Murphy

December 14th – 3:15 PM EST – Meningococcal Serogroup B – Disease Education and Vaccine Information with Dr. Jaime Fergie

11.14.22 – Sanofi, GSK Crash The COVID-19 Vaccine Party Late With a World-First Nod For Their Next Gen Booster

After months of review at European regulators’ desks, GSK and Sanofi have scored a world-first nod to enter the COVID-19 vaccine market in Europe with their pandemic booster VidPrevtyn Beta.

Thursday, the European Commission signed off on the Sanofi-GSK booster to augment protection against COVID-19 in adults ages 18 and up, making VidPrevtyn the first next-gen, protein-based adjuvanted COVID-19 vaccine approved in Europe.

Wedding a beta antigen with GSK’s pandemic adjuvant, VidPrevtyn is designed to offer “broad protection against multiple variants” of the coronavirus, the partners said in a release. The shot can be used as an adjunct in adults who’ve already received primary vaccination with mRNA or adenoviral COVID shots.

11.7.22 – With FD Decision Penciled In For May, GSK Powers Ahead In RSV Race with Pfizer  

The last few weeks have seen GSK and Pfizer locked in a neck-and-neck race to see which company can get their respiratory syncytial virus (RSV) vaccine to market first. Now, it looks like the British Big Pharma may have the edge in the U.S., securing priority review status from the FDA and an estimated decision date of May 3.

The company backed up its approval application with data from the AReSVi-006 phase 3 trial, which showed high overall vaccine efficacy against RSV lower respiratory tract disease in adults aged 60 years and older. The study of 25,000 people linked a single dose of the vaccine candidate to overall efficacy of 82.6%.

“The world has been waiting more than 50 years for an RSV vaccine, so this is a very significant scientific achievement,” GSK CEO Emma Walmsley said on a third-quarter earnings call this morning. 

11.2.22 –  UPDATE: Pfizer’s phase 3 maternal RSV vaccine trial hits an interim review, prompting early stop and race to FDA  

Pfizer has halted a pivotal trial of its respiratory syncytial virus (RSV) vaccine candidate early for efficacy, positioning the Big Pharma to file for approval by the end of the year. But with the study only meeting one of its two primary endpoints, the top-line result leaves scope to question how Pfizer will fare against AstraZeneca and Sanofi’s rival antibody.

At the preplanned interim efficacy analysis, Pfizer linked the administration of its bivalent RSV prefusion vaccine candidate RSVpreF, also known as PF-06928316, during pregnancy to a significant reduction in the rate of severe medically attended lower respiratory tract illness (MA-LRTI) in newborns. The efficacy against severe MA-LRTI was 81.8% through the first 90 days of life, falling to 69.4% over the six-month follow-up period.