Senators urge action on Beyfortus supply as RSV threat looms

Beyfortus (nirsevimab), along with vaccines, is one of the latest weapons against RSV.

Approved on July 17, 2023, AstraZeneca and Sanofi’s Beyfortus (nirsevimab-alip) occupies a unique niche as a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor for neonates and infants. With RSV rates surging, the drug quickly fell into a shortage. The CDC and FDA recently made available more than 77,000 additional doses of Beyfortus. Meanwhile, Senate Democrats Tammy Duckworth, Kirsten Gillibrand, Ron Wyden, Ed Markey, Richard Blumenthal, Jon Ossoff, and Elizabeth Warren pushed AstraZeneca and Sanofi for action regarding the supply shortage.

Unprecedented demand

Facing criticism for the supply shortfall, Sanofi noted it had encountered “higher than anticipated demand” and said it had an “aggressive supply plan” in place to exceed past performance of pediatric vaccine launches. AstraZeneca also noted…

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Moderna leans on RSV vaccine, AI and a diversified pipeline to regain competitive edge

Moderna surged to prominence thanks to its rapid development of a competitive COVID-19 vaccine. Since the early days of the pandemic, however, the company has struggled to maintain its momentum. Year-to-date, its stock is down close to 40%, trading around $110 per share.

Adapting to COVID-19 variants

The company hopes that its development of vaccines for the XBB.1.5 COVID-19 variant will help bolster financial performance. “We are now awaiting approval to start for our updated COVID-19 vaccine applications to regulators globally,” Moderna CEO Stéphane Bancel said.

Developing a robust pipeline

Moderna CEO Stéphane Bancel has stressed in the past that Moderna is more than a COVID-19 company. “Our commercial team is also preparing for the 2024 launch of our next respiratory commercial product,” Bancel said. This product in question, a vaccine for respiratory syncytial virus (RSV) could potentially compete against products from GSK and Pfizer, among others.

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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…

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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…

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GSK wins EU nod for RSV vaccine marketing authorization application

GSK (LSE/NYSE:GSK) has won validation of the marketing authorization application from the European Medicines Agency (EMA) for its respiratory syncytial virus (RSV) vaccine candidate. GSK is pursuing authorization to use the vaccine annually in older adults.

European regulators will likely announce a final regulatory decision in the third quarter of 2023.

The vaccine candidate would be the first vaccine to protect adults 60 and older from the respiratory syncytial virus.

GSK submitted positive data from an interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase 3 study. The trial indicated that the vaccine efficacy had high overall efficacy against RSV LRTD in adults 60 and older.

In the study, the RSVPreF3 vaccine candidate demonstrated statistically significant and clinically meaningful efficacy in the target demographic.

The study involved about 25,000 participants from 17 countries.

The experimental va…

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