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USFDA grants fast track designation for GSK Neisseria gonorrhoeae investigational vaccine

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-06-27T13:30:33+05:30  |  Updated On 27 Jun 2023 1:30 PM IST
USFDA grants fast track designation for GSK Neisseria gonorrhoeae investigational vaccine
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Gonorrhoea is a sexually transmitted infection caused by a bacterium called Neisseria gonorrhoeae.

London: GSK plc announced today the US Food and Drug Administration (FDA) has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine (NgG). The vaccine candidate is currently in an ongoing Phase II trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of age, considered at risk of gonorrhoea.

Fast Track designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with unmet medical needs.

Gonorrhoea is the second most prevalent bacterial sexually transmitted infection (STI) worldwide, with an estimated 82 million new cases globally each year. In the US, rates of reported gonorrhoea have increased 118% from 2009 to 2021, resulting in 710,151 cases being reported to the US Centers for Disease Control and Prevention (CDC) in 2021.

Phil Dormitzer, Global Head of Vaccines R&D, GSK, said, “We welcome the FDA's decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection. With a high and growing incidence, gonorrhoea is a major concern for sexual and reproductive health around the globe. This designation recognises the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a ‘high priority’ pathogen by the World Health Organisation.”

Antimicrobial resistance (AMR) to gonorrhoea has increased over the past 80 years, rendering many classes of antibiotics used to treat the disease ineffective. Vaccines can play a critical role in the fight against AMR by helping prevent bacterial, viral and other infections. At this time, there are no gonorrhoea vaccines approved anywhere in the world.

Read also: Japan approves GSK shingles vaccine Shingrix for at risk adults aged 18 and over



GSKGSK newsUSFDAneisseria gonorrhoeae investigational vaccine
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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