Health GSK to launch late-stage testing of syncytial virus vaccine

08:35  21 october  2020
08:35  21 october  2020 Source:   reuters.com

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World’s largest vaccine makers to begin testing on people in US with eye on rollout in early 2021.

The launch of phase 1 and 2 trials represent an "important stage and another step towards the development of a potential vaccine to help us beat A protein-based vaccine owned by Sanofi and used to treat influenza was paired with a GSK -developed add-on, known as an adjuvant, that boosts

A GSK logo is seen on a flag at a GSK research centre in Stevenage © Reuters/PETER NICHOLLS A GSK logo is seen on a flag at a GSK research centre in Stevenage FRANKFURT (Reuters) - GlaxoSmithKline said it would move its experimental vaccine against the respiratory syncytial virus (RSV), a cause of pneumonia in toddlers and the elderly, into the final stage of testing, encouraged by mid-stage trial results.

RSV vaccine development has been fraught with setbacks for decades but the pharma industry is gearing up to bring a first inoculation to market over the next few years.

The area is a key growth opportunity for GSK, as it seeks to offset declining sales of its blockbuster lung drug Advair due to generic competition.

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GSK and Sanofi plan to combine drugs they each produce in a bid to create an effective solution to stop the virus in its tracks. The vaccine will be developed by Sanofi and GSK aim to start early clinical trials later this year and hope regulatory approval might be possible later next year. UK-based GSK 's

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GSK said a Phase I/II trial with about 1,000 healthy adults aged 60-80 showed that the vaccine prompted a "robust" increase in antibodies and immune cells one month after injection, indicating a stimulated immune system.

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A separate product, designed to give pregnant women the ability to confer immunity to their unborn children, led to high levels of protective neutralising antibodies in non-pregnant healthy woman taking part in a Phase I/II trial.

GSK said Phase III studies, with the potential to produce data for regulatory approval, would likely start over the coming months.

The vaccines were well-tolerated with side effects including injection-site pain and headache, GSK added.

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GlaxoSmithKline CEO calls coronavirus vaccine partnership with Sanofi an 'unprecedented collaboration'. GlaxoSmithKline CEO Emma Walmsley told Jim Cramer that GSK 's new Covid-19 vaccine Clinical trials are scheduled to begin later this year. The global count of coronavirus cases

Respiratory Syncytial Virus Infections. Biological: RSV_PreF3 Vaccine ( GSK 3844766A) adjuvanted with AS01B Drug: Placebo. Phase I, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK 's Respiratory Syncytial Virus (RSV) Vaccine GSK 3844766A in Japanese Subjects

Companies including Johnson & , Sanofi and Moderna are competing to get a vaccine approved against RSV, which globally leads to about 3 million hospital stays for children under five per year. Swedish Orphan Biovitrum's Synagis, a monthly shot, is currently the only preventive treatment against RSV in high-risk infants. Sanofi and partner AstraZeneca are working on longer-acting nirsevimab, which could be given once per cold season to that group, if approved.

GSK is also conducting early-stage studies of an RSV vaccine for children and plans to publish results some time between Oct. 26-29 for a subgroup of children which already had some exposure to the virus.

(Reporting by Ludwig Burger. Editing by Jane Merriman)

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