select search filters
briefings
roundups & rapid reactions
before the headlines
Fiona fox's blog
A press release from GSK announces the phase III trial results for their respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.
Dr Christopher Green, Associate Clinical Professor & Consultant Physician in Infectious Diseases, University of Birmingham, said:
“RSV has been a target for vaccine development since the virus was first discovered in the 1950s. The first vaccines developed in the 1960s used a formalin-inactivated version of the virus as a vaccine design, which had also been used as a method to generate vaccines against other viruses at that time. However, the formalin-inactivated RSV (FI-RSV) vaccine when given to infants in the 1960s resulted in significant harm to many of the youngest recipients when they were infected with the real virus later that year, and two sadly died. Much work was needed to understand why this happened before RSV vaccine research could resume. The FI-RSV vaccine appeared to prime an immune response to the real virus that was harmful in the youngest infants who had little/no previous exposure and natural immunity, unlike the older children and adults. Nonetheless, RSV vaccine development has always been an especially difficult and sensitive problem for this reason and many others that were less related to safety. We have not used formalin-inactivation as a way of making vaccines for use in humans for over 50 years but for RSV even today new RSV vaccine candidates undergo careful animal testing that includes RSV infection before the vaccine can be considered for testing in humans.
“In the elderly, the age-related changes mean natural RSV immunity built up and maintained by a lifetime of RSV exposure becomes less capable of protection, and severe RSV infection (that is infection/inflammation in the lower respiratory tract) becomes more common and this causes a similar disease burden to seasonal influenza. A vaccine to prevent severe disease is greatly needed for both infants and the elderly, and this has been a major global health priority for decades. There is still no licensed RSV vaccine for any age groups but advances in structural biology and other vaccine designs have been making real progress in this field.
“The news in this press release represents a huge achievement after such a long time, and we await the full publication with great interest. From the limited information in this press release, the trial data should hopefully be robust and sufficiently powered. There will be many details to look at when the full scientific publication is available, and a large trial was needed to pick out significant differences in the rates of severe infection between those who received the vaccine and those who did not. The fact that vaccine protection was effective for both RSV subtypes is good and not a surprise given the vaccine antigen or protein is shared between them.”
Prof Adam Finn, Professor of Paediatrics, University of Bristol, said:
“Following on from results press released by Pfizer in August and data presented by Janssen at an RSV meeting in Belfast in September, these new results from GSK add to the sense that more than one highly effective vaccine to prevent serious respiratory illnesses caused by this virus in elderly people are well this side of the horizon. We are all hoping and expecting to hear more detail about these studies very soon but on the face of it, these are very encouraging results. Respiratory infections are a major cause of serious illness and death in old people and cause massive pressure on the NHS in the wintertime. With effective vaccines to prevent pneumonia caused by viruses like SARS CoV2, influenza and RSV as well as bacterial lung infections, the stage is set for further radical improvements in this area of preventative medicine in the near future.”
Declared interests
Dr Christopher Green has worked has worked on vaccine trials involving UK government, charities and pharmaceutical companies including AstraZeneca, GSK, Pfizer, Valenva, Janssen, Novavax, CureVac and Moderna.
Prof Adam Finn: “Research funding from Pfizer, GSK, Sanofi, Janssen, Valneva as well as UK government and charities. Consultancy for companies developing vaccines against whooping cough, hepatitis, norovirus and other infections.”