RSV Archives - Medical Design Sourcing

Legal dispute precede Pfizer’s latest FDA nod for RSV vaccine

Amid a backdrop of recent RSV vaccine approvals, GSK and Pfizer find themselves locked in a legal spat over alleged patent infringements. Both Big Pharma giants now possess the FDA’s blessing for their respective respiratory syncytial virus (RSV) vaccines. Pfizer’s recent win came with the second approval for its Abrysvo vaccine, which the company now highlights as the first FDA-approved maternal vaccine to guard infants against RSV.

In early May, GSK’s Arexvy became the first to win FDA’s blessing to protect individuals aged 60 and above from RSV complications. By the end of the month, Pfizer had won approval for Abrysvo in the same age group.

Yet, behind the scenes of these approvals, legal clouds gather. GSK has taken its grievances to a federal court in Delaware, alleging that Pfizer infringed on four of its patents related to its Arexvy vaccine. In a Reuters-posted filing, GSK claims it began work on its RSVPreF antigen in the early 2000s. In th…

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…

Moderna shares R&D updates at third annual vaccines day

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old. Efficacy fell to 37.5% in children aged 2 to 6.

As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine.

In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia.

In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermo…

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…