respiratory syncytial virus Archives - Medical Design Sourcing

An overview of the RSV vaccine landscape: What comes after GSK’s approval of Arexvy?

[Peter Hansen/Adobe Stock]

GSK (NYSE:GSK) has secured FDA approval for its respiratory syncytial virus (RSV) vaccine Arexvy, marking a significant milestone in the RSV vaccine landscape. RSV is common and usually results in mild infections, but can be dangerous in the immunocompromised as well as in younger and older populations.

The GSK vaccine targets adults aged 60 and older. In clinical studies, the single-dose vaccine demonstrated strong efficacy in preventing lower-respiratory tract infections and more severe diseases. In a phase 3 study published in NEJM with a median follow-up of 6.7 months, the vaccine efficacy against RT-PCR-confirmed RSV-related lower respiratory tract disease was 82.6%.

Efficacy against severe RSV-related lower respiratory tract disease was higher at 94.1% while efficacy against RSV-related acute respiratory infection was 71.7%. The most commonly reported side effects of Arexv…

An overview of the RSV vaccine candidate landscape in early 2023

[RSV image from NIAID]

Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk.

Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956. A year later, the pediatrician and virologist Robert M. Chanock linked RSV to respiratory infections in children. Attempts to develop a vaccine for the virus soon followed.

Despite numerous attempts beginning in the 1960s, an FDA-approved RSV vaccine has remained elusive until recently. Out front is GSK’s (NYSE:GSK) RSV vaccine for adults aged 60 and older, which has won the backing of an FDA advisory panel. Close behind is Pfizer’s (NYSE:PFE) single-dose vaccine for the same a…

Icosavax shares positive early results for VLP vaccine candidate against RSV

The biopharma Icosavax (Nasdaq:ICVX) has announced positive topline interim results from its Phase 1/1b clinical trial of IVX-121, a vaccine candidate with a prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen.

The Phase 1 portion of the study enrolled 90 healthy young adults between 18 and 45. The Phase 1b portion included 130 healthy adults aged 60 to 75.

IVX-121 had a robust immunologic response to RSV. In addition, Icosovax noted that the vaccine candidate achieved comparable Geometric Mean Titer (GMT) levels at Day 28 in both age groups.

Seattle-based Icosavax noted that the vaccine candidate had a favorable tolerability profile with no vaccine-related serious adverse events.

“Importantly, we believe these Phase 1/1b data provide initial validation of our underlying VLP technology. They also reaffirm our strategy to combine multiple pathogen targets in one vaccine,” said Adam Simpson, CEO of Icosavax, in a news release. “As plann…

Agenus and GSK tout positive Phase 3 data for RSV vaccine

Immuno-oncology firm Agenus (Nasdaq:AGEN) and its partner GSK (NYSE:GSK) have announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 Phase 3 trial of an experimental respiratory syncytial virus (RSV) vaccine.

RSV infects most children before the age of 2. Some 75,000 to 125,000 children are hospitalized as a result of the virus annually, according to data from the National Institute of Allergy and Infectious Diseases.

But RSV can also pose a risk to older adults, especially those with chronic conditions, as the CDC noted.

The Agenus and GSK study focused on adults at least 60 years of age.

The analysis of the Phase 3 trial was the first to show a statistically significant and clinically meaningful efficacy in older adults.

Agenus and GSK note that the AReSVi 006 study exceeded its primary endpoint without observing any unexpected safety concerns.

The companies hope to file regulatory sub…

Nirsevimab offers significant protection against RSV in infants in Phase 3 trial

AstraZeneca’s (LON:AZN) and Sanofi’s (Nasdaq:SNY) nirsevimab had 75% efficacy against lower respiratory tract infections resulting from rr (RSV) in a Phase 3 study.

There are currently few treatment options for lower respiratory tract infections stemming from RSV. Two antivirals, palivizumab and ribavirin, are available, while new vaccines are currently authorized.

RSV is the most common cause of lower respiratory tract infections in infants.

AstraZeneca has announced that the immunostimulant nirsevimab is the first potential therapy that could offer sustained protection for an entire RSV season with a single dose.

In the placebo-controlled MELODY Phase 3 trial, nirsevimab had 74.5% efficacy against medically-attended lower respiratory tract infections from RSV in healthy infants.

The Phase 3 study was recently featured in NEJM. Another article in the same journal focused on nirsevimab’s safety profile in the MEDLEY Phase 2/3 study, c…

GSK halts Phase 3 RSV maternal vaccine candidate program

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that it has chosen to stop enrollment and vaccination of studies testing its respiratory syncytial virus (RSV) maternal vaccine candidate in women.

The company had announced a voluntary pause of the trials NCT04605159, NCT04980391 and NCT05229068 on February 18.

GSK did not elaborate on the reason for halting the trials.

GSK’s AReSVi 006 Phase 3 trial (NCT04886596) for RSV older adults 60 years and older is ongoing.

GSK shares were down 2.25% to $41.72 in mid-day trading.

Vaccine makers have attempted in vain to create a vaccine for RSV, which CDC links to 14,000 deaths in adults aged 65 years or older annually.

Several companies have RSV vaccine candidates, including Moderna (NASDAQ:MRNA) and Janssen (NYSE:JNJ).

Janssen begins Phase 3 study for RSV vaccine in adults 60 and older

After recently sharing positive Phase 2b data related to its experimental respiratory syncytial virus (RSV) vaccine in seniors, Janssen (NYSE: JNJ) has launched a Phase 3 study of the vaccine.

RSV is common and contributes to serious respiratory illnesses, including pneumonia in the elderly. The virus infects approximately 64 million people annually.

The global EVERGREEN study will enroll roughly 23,000 adults 60 years of age and older.

“Positive data from our first RSV vaccine efficacy study and the initiation of the Phase 3 EVERGREEN study are crucial milestones in the clinical development of our investigational RSV adult vaccine, which has the potential to safely and effectively prevent lower respiratory tract disease caused by RSV in older adults,” said Dr. Penny Heaton, global therapeutic area head, vaccines at Janssen Research & Development.

Currently, no vaccines are available for RSV, although several are in development.

FD…

Moderna wins FDA fast track designation for RSV vaccine

COVID-19 vaccine pioneer Moderna (NSDQ:MRNA) is aiming to develop one of the first mRNA-based vaccines against respiratory syncytial virus (RSV).

Now, the FDA has granted fast track designation for mRNA-1345, an experimental single-dose mRNA RSV vaccine in adults 60 and older.

Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), GlaxoSmithKline (LON:GSK), Novavax (NSDQ:NVAX) and Bavarian Nordic (CPH:BAVA) are also developing RSV vaccines. None of those, however, use a mRNA platform.

RSV generally causes mild cold-like symptoms, according to the CDC, but can lead to serious illness in infants and the elderly. In infants, RSV frequently leads to pneumonia and another type of respiratory tract infection known as bronchiolitis.

Cambrdige, Mass.–Moderna hopes to ultimately win regulatory approval to use the mRNA-1345 vaccine to “protect the most vulnerable populations – young children and older adults,” said Stéphane Bancel, CEO of Moderna, in a statem…