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GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≤50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…

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Moderna

Moderna’s mRESVIA Receives the US FDA’s Approval for Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.) at increased risk for RSV-associated lower…

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Viewpoints_Dr. Bill La Via

Dr. Bill La Via, Medical Director at Sanofi Shares Insights from the Findings that Support the Need of Protecting Infants from Respiratory Syncytial Virus (RSV)

Shots: Bill spoke about Respiratory Syncytial Virus and how it can severely affect infants' health Bill also talked about the 14 studies on RSV published in the Journal of Infectious Diseases (JID) The interview gives an understanding of how Sanofi’s vision to develop innovative solutions to help reduce the burden of RSV on infants, families,…

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PharmaShots Interview Jon Heinrichs of Sanofi Pasteur & Tonya Villafana of AstraZeneca Shares Insights on Nirsevimab in Healthy Infants Born at Term or Late Preterm

PharmaShots Interview: Jon Heinrichs of Sanofi Pasteur & Tonya Villafana of AstraZeneca Shares Insights on Nirsevimab in Healthy Infants Born at Term or Late Preterm

In an interview with PharmaShots, Jon Heinrichs, Associate, Vice President, and the Head of Innovation and Emerging Sciences at Sanofi Pasteur & Tonya Villafana, Vice President, Global Franchise Head, Infection at AstraZeneca share their views on the data of Nirsevimab in P-III (MELODY) trial to protect infants against Respiratory Syncytial Virus Shots: The P-III (MELODY) trial evaluates nirsevimab (50/100mg, IM) vs…

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