For Glaxo, FDA approval increases key vaccine Shingrix's reach

 In response to the coronavirus pandemic knocking Shingrix off its juggernaut course, GlaxoSmithKline plans a “relaunch” to get the rising star vaccine back on its upward trajectory.

Now, that effort has received a boost as the FDA on Monday approved the shingles vaccine in adults age 18 and older who are immunocompromed and thus are at a greater risk of developing the viral condition that causes a painful rash with blisters.

The go-ahead opens a up a new population for Shingrix, which gained its initial FDA nod in October 2017 for those aged 50 and older. 

The FDA issued the approval based on studies examining the safety and efficacy of Shingrix in adults who had undergone stem cell transplant and those undergoing treatment for hematological malignancies. 

Investigators also collected data from adults who were immunodeficient or immunosuppressed due to disease or therapy, including patients with HIV, solid tumors or renal transplants. For those in this category, Shingrix becomes the first shingles vaccine approved for use.

The blessing comes 11 months after Europe sanctioned Shingrix for use in adults who are at increased risk of shingles. And it comes as GSK attempts to get Shingrix back on track after pandemic shutdowns disrupted the important rollout.

Last year, the blockbuster vaccine posted a 10% sales increase to $2.8 billion. In 2019 as uptake increased, Shingrix sales doubled.

Earlier in the pandemic, the CDC instructed people to not get another vaccination within two weeks of receiving a COVID-19 shot. In all, millions of vaccines were missed during the pandemic, researchers have found.

https://www.fiercepharma.com/vaccines/as-glaxosmithkline-works-to-get-shingrix-back-track-fda-approval-increases-key-vaccine-s