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HomeNewsWorldGlaxoSmithKline to launch late-stage testing of syncytial virus vaccine

GlaxoSmithKline to launch late-stage testing of syncytial virus vaccine

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.

October 21, 2020 / 10:38 IST

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.

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.

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.

COVID-19 Vaccine

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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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.

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.

Reuters
first published: Oct 21, 2020 10:31 am

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