GSK to Submit Older Adult RSV Vaccine Candidate to FDA in 2022

The decision comes after the company announced positive phase 3 data for the combination vaccine candidate in adults aged 60 years and older.

Unpublished interim analysis data show GSK’s respiratory syntactical virus (RSV) vaccine candidate achieved pre-specified efficacy marks in its phase 3 pivotal trial, the company reported Monday.

Now, GSK intends to submit the candidate, which would be designated for adults ≥60 years old, for potential approval with the US Food and Drug Administration (FDA) later this year.

The RSV vaccine candidate from GSK is an antigen of subunit prefusion RSV F glycoprotein plus proprietary adjuvant AS01. Investigators believe this combination may help against the natural decline of immunity to RSV observed in older adults.

The candidate is being assessed in the phase 3 AReSVi 006 phase 3 trial, a randomized, placebo-controlled, observer-blinded study assessing single-dose efficacy in approximately 25,000 adults aged ≥60 years old from 17 countries. Investigators reported in a previous immunogenicity trial that the vaccine induced “strong humoral and cellular immune responses” retained by patients ≥6 months post-vaccination readout.

GSK announced Monday their interim analysis, as reviewed by an independent data monitoring committee, showed their primary efficacy endpoint was exceeded in AReSVi 006, without any unexpected safety outcomes.

While the data is to be published and reported at an upcoming medical meeting, the company stated their vaccine candidate is the first of its kind to show “statistically significant and clinically meaningful efficacy” in adults ≥60 years old. Additionally, they stated a consistent benefit was observed across both RSV subtypes A and B, as well as in adults aged ≥70 years old.

In a statement accompanying the interim data announcement, GSK chief scientific officer and president of research & development Hal Barron, MD, called the data indicative of “exceptional protection for older adults from the serious consequences of RSV infection.”

“RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalizations and more than 24,000 deaths worldwide each year,” Barron said. “Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”