Although respiratory syncytial virus (RSV) is a very common infection in newborns and children under one year of age, older people can also get it. It is precisely in those over 60 years of age that the GSK pharmaceutical vaccine seems to be effective, which could reduce the risk of developing the infection in a serious way.
The data provided by the pharmaceutical company based on a phase III clinical study, and which will be presented at the IDWeek 2022 congress, indicate that the RSV vaccine could help reduce the risk of severe disease by 94.1% and, overall, it appears to be 82.6% effective.
This lower respiratory tract RSV vaccine success rate was defined when patients had at least two lower respiratory tract signs, or when it was considered severe by the investigator and confirmed by the external committee. In addition, people who had pre-existing comorbidities, such as underlying cardiorespiratory and endocrine-metabolic diseases, and were between 70 and 79 years old, the vaccine efficacy rate was 93.8%.
This vaccine could be the first approved against RSV
The vaccine in question contains a recombinant RSV pre-fusion glycoprotein F antigen (RSVPreF3) that has been combined with AS01E, an adjuvant proprietary to GSK. This drug could become the first approved worldwide against respiratory syncytial virus.
Headache, pain at the injection site, or fatigue were the most common side effects in patients who received the RSV vaccine
“These are truly exceptional results given that today RSV remains one of the leading infectious diseases without a vaccine, despite more than 60 years of research. We believe that with the high efficacy of the vaccine that has been demonstrated in this pivotal trial, our vaccine candidate has the potential to help significantly reduce the global burden of RSV-associated disease in older adults, including those at higher risk due to their age or underlying comorbidities,” explains Tony Wood, Chief GSK Scientific Officer.
Regarding the safety of the vaccine, something very important with a view to its marketing, GSK’s vaccine against RSV of the lower respiratory tract was well tolerated with a favorable safety profile. Side effects observed in the trials were mild to moderate but transient. Among the most common were fatigue, pain at the injection site, headache and myalgia (pain in the area of the muscle where the drug was injected).
Based on all these successful results of the phase III study in which some 25,000 people from 17 countries have participated, including Spain, where 1,087 people have participated in 16 centers in Catalonia, the Valencian Community, Galicia and Madrid, and in the absence of completing the studies, the pharmaceutical developer believes that the presentation of the drug to the regulatory agencies could be carried out in the second half of this year 2022.
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