The vaccine candidate will be used to prevent lower respiratory tract diseases caused by RSV in adult patients aged 60 and above. Credit: GSK plc.

The European Medicines Agency鈥檚 (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in older adults.

The vaccine candidate will be used to prevent lower respiratory tract diseases (LRTD) caused by RSV in adult patients aged 60 and above.

Go deeper with GlobalData

  • ReportsLogo

  • ReportsLogo

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

This is the first time a vaccine candidate for the potential treatment of adult RSV patients has received a positive opinion.

If approved, 鈥檚 vaccine candidate will therefore become the first RSV vaccine candidate to protect older adults.

The European Commission (EC) is expected to make a decision on the approval by July 2023.

The CHMP鈥檚 opinion was supported by the from a pivotal Phase II AReSVi-006 (Adult Respiratory Syncytial Virus) trial.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile 鈥� free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The placebo-controlled, multi-country, randomised, observer-blind trial was designed to assess the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 OA investigational vaccine in adult patients.

The vaccine candidate demonstrated an overall efficacy of 82.6% against RSV-LRTD in adult patients.

Efficacy in older adults with at least one underlying comorbidity, such as cardiorespiratory and endocrino-metabolic conditions, was 94.6%.

Myalgia, injection site pain, arthralgia, headache and fatigue were the most frequent adverse events observed.

The RSV older adult vaccine candidate comprises a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3), along with the company鈥檚 AS01E adjuvant.

It is also under review by regulatory agencies including Japan鈥檚 Ministry of Health, Labour and Welfare and the US Food and Drug Administration.