Yesterday, VRBPAC— FDA’s external scientific committee— met to discuss the latest clinical trial data for RSV vaccines. This is a big deal beca

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2023-03-16 22:30:06

Yesterday, VRBPAC— FDA’s external scientific committee— met to discuss the latest clinical trial data for RSV vaccines. This is a big deal because it could be the first RSV vaccine to market— something we’ve been waiting on for decades. (Literally since the 1960s, with the first RSV vaccine candidates ending in terrible failure among kids.)

The purpose of this meeting was to discuss the safety and efficacy of the vaccines. Some of the safety data was tight, so keep this post in your back pocket. We smell misinformation brewing.

Both Pfizer and GlaxoSmithKline (GSK) are applying for licenses. Their RSV vaccines are for adults over the age of 60. Both are one dose vaccines given in preparation for winter season.

GSK (vaccine name: Arexvy) uses an adjuvant (called AS01E)—an ingredient that helps the vaccine create a stronger immune response and is shown to give longer immune responses.

Pfizer (vaccine name: Abrysvo) has no adjuvant. Everyone has already had an RSV infection in their life, so by just giving the protein, they can activate memory cells from previous infections to do all the work. Adjuvants usually give more symptoms too, so including one was not worthwhile in Pfizer’s judgment. (Pfizer didn’t see any benefit when it examined adjuvants).