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23rd June 2023
The UK should introduce routine vaccination for respiratory syncytial virus (RSV) to protect babies and older adults, the Joint Committee on Vaccination and Immunisation (JCVI) has recommended.
It has made the early recommendations after reviewing several vaccines currently in development to allow sufficient lead time for the Government to get a policy and programme in place, a statement said.
The committee said there was a significant burden of RSV illness in the UK population and ‘unmet public health need which has a considerable impact on NHS services during the winter months’.
A series of meetings have been held by the committee this year to review the efficacy, safety and duration of protection of the new vaccines that are being developed.
Modelling has also been done by the London School of Hygiene and Tropical Medicine on the impact and cost effectiveness of potential immunisation strategies, the committee said.
One potential vaccine developed by Sanofi and AstraZeneca – long acting monoclonal medicine Beyfortus (nirsevimab) for passive immunisation against RSV infection and disease in infants – was licensed by the European Commission and and UK regulators in November.
Pfizer has also developed a bivalent RSV maternal vaccine which has undergone clinical trials and has a potential licensing timeline in 2023, the committee said.
There was no preference whether a maternal vaccination or a passive immunisation programme should be chosen to protect babies and both should be considered.
But a year-round vaccination programme would ensure high uptake and would be less complex and resource intensive to deliver than seasonal immunisation, the JCVI advised.
For the over-75s there are currently three vaccine products in development by GSK, Pfizer and Moderna which are due to be licensed this year or early 2024, all of which should be considered, the committee said.
An RSV vaccine programme for adults aged 75 years and above could also be cost effective with the committee favouring a one-off campaign with an initial offer covering several age groups followed by a routine programme for those turning 75 years old.
‘In summary, JCVI advises that a RSV immunisation programme, that is cost effective, should be developed for both infants and older adults,’ it said.
‘A fuller statement providing more detail on the evidence considered and the key discussions and conclusions of the committee will be published alongside the minutes of the June meeting,’ it added.
‘The committee will continue to keep its advice under review as further evidence emerges and will update its advice when appropriate.’
JCVI joint committee chair Professor Sir Andrew Pollard said: ‘The JCVI recognises that there is a significant burden of respiratory syncytial virus (RSV) illness in the UK population, which has a considerable impact on the NHS during winter.
‘The Committee has issued a rapid short statement advising that a RSV immunisation programme that is cost effective should be developed for both infant and older adults. The statement has been published to enable engagement with stakeholders, with a final statement issued to Ministers later this summer to inform a policy decision.’
28th April 2023
RSV infection leads to a global high morbidity and mortality burden in children aged 0-60 months. Moreover, the greatest risk for hospitalisation occurs during the first 6 months of life. In a recent study, RSV-associated acute respiratory infection, led to the hospitalisation of one in every 56 healthy term-born infants. Whether maternal vaccination can reduce such RSV-related infection in newborns and infants remains uncertain.
In the present, randomised, double-blind, phase 3 trial, pregnant women received a single dose vaccine or placebo, between weeks 24 and 36. The two primary efficacy endpoints were severe RSV-associated lower respiratory tract illness and medically attended, less severe illness. Assessment of these outcomes took place at 90 and 180 days after birth. A lower boundary of the confidence interval > 20% was the success criterion for vaccine efficacy.
Maternal vaccination and RSV-associated infections
Overall, 7358 women received either the vaccine (3682) or placebo. There were 6 cases of severe RSV in the vaccinated group and 33 in the placebo arm within 90 days of birth (vaccine efficacy = 81.8% 99.5% CI 40.6% – 96.3%). Within 180 days, the vaccine efficacy against severe infection was 69.4% (97.58% CI 44.3 – 84.1%). In contrast, vaccine efficacy was only 57.1% (99.5% CI 14.7 – 79.8) against less severe disease and did not meet the criteria for success.
Adverse events were similar in all groups within 1 month after injection or within 1 month after birth.
2nd February 2023
Moderna has announced that mRNA-1345, its investigational vaccine, met its primary endpoint and demonstrated a high vaccine efficacy against RSV-associated lower respiratory tract disease and which was defined by two or more, as well as three or more, symptoms.
The ConquerRSV trial is a randomised, double-blind trial, designed to evaluate the safety and tolerability of the mRNA-1345 vaccine. The study sought to demonstrate the efficacy of a single vaccine dose in the prevention of a first episode of RSV-associated lower respiratory tract disease when compared to placebo, 14 days after vaccination, through to 12 months. In a site dedicated to the study, individuals are invited to screen for inclusion, highlighting how in the US alone, the virus causes 14,000 annual deaths.
ConquerRSV was reported to have recruited more than 37,000 adults 60 years of age and older. The study’s primary efficacy endpoints were based on two definitions of RSV-lower respiratory tract disease with either two or three or more symptoms.
According to Moderna, the efficacy of the vaccine was 83.7% (95% CI 66.1 – 92.2%, p < 0.0001) against RVS-associated disease as defined by two or more symptoms. The reported interim analysis was based on a total of 64 cases, 55 of which occurred in those given placebo. In addition, there were 20 cases of RSV-associated lower respiratory tract infections where patients presented with 3 or more symptoms, of which only 3 occurred in patients given the vaccine. This gave a vaccine efficacy of 82.4% (95% CI 34.8 to 95.3%, p = 0.0078) against RSV-associated disease with 3 or more symptoms.
An analysis of safety data showed that mRNA-1345 was well tolerated and there were no safety concerns identified, although this will continue to be monitored as the trial progresses. Commonly reported adverse effects were generally mild to moderate in severity e.g., injection site pain, fatigue, headache, myalgia and arthralgia. In fact, only 4% of systemic adverse reactions reported for the vaccine were grade 3 or higher (i.e., severe) and overall, there were only 3.2% of localised adverse reactions, at grade 3 or above.
Moderna also announced that these findings will be submitted for publication and presented at an upcoming conference and hope to submit all the data for regulatory approval in the first half of 2023.
19th October 2022
RSV vaccine candidate, RSVPreF3, manufactured by GSK, provided a high overall efficacy in a phase 3 trial among older adults.
Respiratory syncytial virus (RSV) is one of the common viruses that cause coughs and colds and causes severe respiratory illnesses in infants and older adults who frequently require hospitalisation.
The condition creates a severe disease burden upon sufferers and the global number of hospital admissions for RSV-acute respiratory infections (ARI) in older adults has been estimated at 336,000, leading to an estimated 14 000 in-hospital-related deaths.
Currently, no RSV vaccine has been approved although in September 2022, it was reported that Pfizer was ready to file for FDA approval of its candidate RVS vaccine.
GSK’s randomised, placebo-controlled trial was designed to evaluate the efficacy of the RSVPreF3 at preventing lower respiratory tract disease (LRTD) caused by RSV in adults ≥ 60 years of age following a single dose of the vaccine.
GSK announced preliminary findings from the study in June 2022, including that the vaccine showed statistically significant and clinically meaningful efficacy in adults aged 60 years and above. The current findings have yet to be published in a peer-reviewed article.
RSV vaccine results
The findings show that among those assigned to RSVPreF3 there were seven lower respiratory tract RVS cases compared to 40 in the placebo group, giving an overall vaccine efficacy of 82.6% (96.95% CI, 57.9 – 94.1, p < 0.0001). The vaccine also demonstrated a high efficacy against both type A (84.6%) and type B (80.9%) RVS.
In addition, there was a consistently high vaccine efficacy across a range of pre-specified secondary endpoints. For example, among those with a severe lower respiratory tract infection, there was only one case in the RSV vaccine group compared to 17 in the placebo arm, giving an efficacy of 94.1% (95% CI, 62.4 – 99.9, p < 0.0001). Among patients with pre-existing comorbidities, such as underlying cardiorespiratory and endocrino-metabolic conditions, vaccine efficacy was 94.6% (95% CI, 65.9 – 99.9) and 93.8% (95% CI, 60.2-99.9) in adults aged 70-79 years.
Among patients with RSV confirmed acute respiratory infections, vaccine efficacy whilst lower, was still high with an overall efficacy of 71.7% and again, this was similar for type A (71.9%) and type B (70.6%).
The RSV vaccine was also well tolerated with observed solicited adverse events typically mild-to-moderate in severity and transient, with the most frequent being injection site pain, fatigue, myalgia, and headache.
The company expects to undertake regulatory submissions based on the phase III data in the second half of 2022.