dm+d

Unassigned

New Medicines

Respiratory syncytial virus - prevention in older adults (aged 60 years ond over)

Information

Vaccine
GlaxoSmithkline
GlaxoSmithkline

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Oct 22Filed in the EU. The EMA will start an accelerated assessment of RSV vaccine RSVPreF3 OA for older adults, with a decision expected Q3 2023 – a timeline that could allow GSK to beat rival RSV vaccine developers, including Pfizer, to the European market [5].
Jun 22GSK plans to enter talks with regulators with a view to submitting filings for approval in H2 2022 [3].
Mar 22Has fast track status in the US [2].

Category

A preventive, adjuvanted vaccine. The vaccine contains a recombinant subunit pre-fusion RSV antigen (RSVPreF3) and GSK’s AS01 adjuvant [2].
RSV is one of the common viruses that cause coughs and colds in winter. In temperate climates such as the UK, RSV occurs regularly each year, peaking over the winter. For a small number of people at risk of more severe disease, RSV infection can cause pneumonia or even death. RSV is a common cause of bronchiolitis in infants. Between Q3 2019 and Q1 2020, 3,053 confirmed RSV cases (2,903 hospitalised to lower level of care & 150 in ICU/HDU) were reported from 16 hospitals.
Respiratory syncytial virus - prevention in older adults (aged 60 years ond over)
Intramuscular

Trial or other data

Oct 22GSK announce further results from PIII trial; a single dose of RSVPreF3 provided an overall protective efficacy against RSV of 82.6%, and a 94.1% reduction in severe RSV [4].
Jun 22GSK announces its RSV vaccine met its primary outcome in the PIII trial but no specific data released. At the interim analysis, a single dose of the adjuvanted RSVPreF3 OA vaccine resulted in a statistically significant and clinically meaningful reductions in cases of lower respiratory tract disease caused by RSV in adults aged 60 years and older. GSK has previously stated that it considers an effect of 50% or more would be clinically meaningful. It is not known whether the vaccine achieved a very good response (i.e. 70%). The level of competition for the RSV opportunity means the efficacy figure may be vital. The magnitude of effect was consistent across RSV A and B strains, key secondary endpoints and in people aged 70 years and above. There were no unexpected safety concerns. GSK will continue to track patients in the trial to evaluate an annual revaccination schedule and assess the protection provided by a single dose over multiple RSV seasons [3].
May 21PIII global randomised trial (NCT04886596) initiated to investigate efficacy of a single dose of GSK´s RSVPreF3 OA investigational vaccine in adults aged 60 Years and above. The study will also assess if the vaccine is safe and induces an immune response. The study will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine. Estimated enrolment is 25,000 with primary completion date expected May 2022 [1]

ResVaxRespiratory syncytial virus - prevention

Information

ResVax
Vaccine
Not Known
Novavax

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A recombinant virus-like particle (VLP) vaccine
RSV is one of the common viruses that cause coughs and colds in winter. In temperate climates such as the UK, RSV occurs regularly each year, peaking over the winter. For a small number of people at risk of more severe disease, RSV infection can cause pneumonia or even death. RSV is a common cause of bronchiolitis in infants. Between Q3 2019 and Q1 2020, 3,053 confirmed RSV cases (2,903 hospitalised to lower level of care & 150 in ICU/HDU) were reported from 16 hospitals. [17]
Respiratory syncytial virus - prevention
Intramuscular

Respiratory syncytial virus (RSV) infection - prevention in adults

Information

Vaccine
Pfizer
Pfizer

Development and Regulatory status

Phase II Clinical Trials
None
Phase III Clinical Trials

Category

The vaccine uses crystal structure of a key viral protein to elicit immune response against respiratory syncytial virus target [1]
RSV is one of the common viruses that cause coughs and colds in winter. In temperate climates such as the UK, RSV occurs regularly each year, peaking over winter. For most people, RSV infection causes a mild respiratory illness. For a small number of people who are at risk of more severe respiratory disease, RSV infection might cause pneumonia or even death. RSV is the most common cause of bronchiolitis in infants. There were 10,941 hospital admissions due to RSV infections in 2019-20.
Respiratory syncytial virus (RSV) infection - prevention in adults
Intramuscular

Respiratory syncytial virus (RSV) infection - prevention in infants by immunisation to pregnant women

Information

Vaccine
Pfizer
Pfizer

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

The vaccine uses crystal structure of a key viral protein to elicit immune response against respiratory syncytial virus target [1]
RSV is one of the common viruses that cause coughs and colds in winter. In temperate climates such as the UK, RSV occurs regularly each year, peaking over winter. For most people, RSV infection causes a mild respiratory illness. For a small number of people who are at risk of more severe respiratory disease, RSV infection might cause pneumonia or even death. RSV is the most common cause of bronchiolitis in infants. There were 10,941 hospital admissions due to RSV infections in 2019-20.
Respiratory syncytial virus (RSV) infection - prevention in infants by immunisation to pregnant women
Intramuscular

Respiratory syncytial virus infection - prevention in adults aged 60 and over

Information

Vaccine
Janssen
Janssen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Respiratory syncytial virus (RSV) fusion (F) protein fusion (F) protein recombinant nanoparticle vaccine (adjuvanted)
RSV is one of the common viruses that cause coughs and colds in winter. In temperate climates such as the UK, RSV occurs regularly each year, peaking over the winter. For a small number of people at risk of more severe disease, RSV infection can cause pneumonia or even death. RSV is a common cause of bronchiolitis in infants. Between Q3 2019 and Q1 2020, 3,053 confirmed RSV cases (2,903 hospitalised to lower level of care & 150 in ICU/HDU) were reported from 16 hospitals [1].
Respiratory syncytial virus infection - prevention in adults aged 60 and over
Intramuscular

Respiratory syncytial virus infection prevention

Information

Vaccine
Bavarian Nordic
Bavarian Nordic

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

MVA-BN® RSV is a universal vaccine candidate designed to induce protective immune responses against both RSV subtypes (A & B) [1]
RSV is one of the common viruses that cause coughs and colds in winter. In temperate climates such as the UK, RSV occurs regularly each year, peaking over the winter. For a small number of people at risk of more severe disease, RSV infection can cause pneumonia or even death. RSV is a common cause of bronchiolitis in infants. Between Q3 2019 and Q1 2020, 3,053 confirmed RSV cases (2,903 hospitalised to lower level of care & 150 in ICU/HDU) were reported from 16 hospitals. [5]
Respiratory syncytial virus infection prevention
Intramuscular

Respiratory syncytial virus infection prophylaxis in pregnant woman population to prevent illness in infants during first months of life by transfer of maternal antibodies

Information

Vaccine
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 22Development discontinued [8].

Category

Respiratory syncytial virus (RSV) recombinant subunit pre-fusion antigen (RSVPreF3)
RSV is one of the common viruses that cause coughs and colds in winter. In temperate climates such as the UK, RSV occurs regularly each year, peaking over winter. For most people, RSV infection causes a mild respiratory illness. For a small number of people who are at risk of more severe respiratory disease, RSV infection might cause pneumonia or even death. RSV is the most common cause of bronchiolitis in infants. There were 10,941 hospital admissions due to RSV infections in 2019-20 [2,3].
Respiratory syncytial virus infection prophylaxis in pregnant woman population to prevent illness in infants during first months of life by transfer of maternal antibodies
Intramuscular

Trial or other data

Feb 22GSK announces that, further to the voluntary pause announced on February 18th, the company has decided to stop enrolment and vaccination in trials evaluating its potential RSV maternal vaccine candidate in pregnant women (NCT04605159, NCT04980391, NCT05229068). Further analysis to better understand safety data from these trials is ongoing, and the relevant regulatory authorities have been informed. This decision does not impact the ongoing AReSVi 006 phase III trial (NCT04886596) for RSV in older adults [7].