Virus World

US biotech company Moderna on Tuesday announced positive interim trial results for its vaccine against respiratory syncytial virus (RSV) in adults over the age of 60. There are no jabs currently available for the virus, which is a top cause of lower respiratory diseases, commonly leading to bronchiolitis in children and pneumonia in the elderly. However numerous vaccines and treatments are under development, most notably by Moderna's rival COVID-19 vaccine maker Pfizer. Moderna's vaccine was found to be nearly 84 percent effective against RSV-linked diseases in Phase III trials—the final stage of human testing—the firm said in a statement. The trial of the vaccine, which uses the new mRNA technology from Moderna's COVID jab, involves some 37,000 adults over 60 in 22 countries including the United States.

The company released the findings of an interim analysis, which has not been peer-reviewed. In the placebo group, there were 55 cases of RSV-linked lower respiratory tract disease with at least two symptoms, compared to nine in the group that received the vaccine, it said. The vaccine had no serious side effects, the company added. Moderna plans to apply for regulatory approval for the vaccine in the US, Europe and other regions in the coming months. This could make it available for the RSV season in the Northern Hemisphere's winter this year, Moderna's chief medical officer Paul Burton told AFP. The company is also testing the vaccine for use in children, but those trials are still at the first phase.

'Good news'

In high-income countries, RSV caused 5.2 million cases of severe disease among adults over 60 in 2019, Moderna said. Up to 30,000 elderly patients die every year in G7 countries due to the virus, Burton added. He said that the number of doses required for Moderna's vaccine was yet to determined. The positive results come after Pfizer announced in December that its own RSV vaccine for over-60s was granted priority review status by the US Food and Drug Administration. The previous month, Pfizer said another of its RSV vaccines, which is given to pregnant mothers, was effective at protecting newborns. Also in November, the European Union approved a preventative treatment which works similarly to a vaccine made by AstraZeneca and Sanofi which has been shown to prevent severe illness from RSV in infants. When asked about other RSV vaccines being developed by Moderna's rivals, Burton said "it's good news". "The public has gone seven decades with nothing" to fight the virus, and soon could have multiple options, he said. Moderna is also looking at whether the RSV jab can be combined with COVID and even influenza vaccines, after soaring cases of all three in recent months was dubbed a "tripledemic".

Moderna's Press Release:

https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx 

Moderna receives FDA Fast Track designation for Respiratory Syncytial Virus (RSV) vaccine (mRNA-1345), its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than 60 years of age.  “We are pursuing an mRNA RSV vaccine to protect the most vulnerable populations – young children and older adults,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are studying mRNA-1345 in these populations in an ongoing clinical trial and we look forward to sharing data when available. The Fast Track designation for older adults underscores the urgent need for a vaccine against RSV. With our investments in science and manufacturing, we have taken eleven infectious disease vaccines into human clinical trials. We have accelerated research and development of our infectious disease therapeutic area and we will continue to advance our mRNA vaccines into new areas of high unmet need.” Respiratory syncytial virus is a common respiratory virus that generally causes cold-like symptoms. In the United States and areas with similar climates, RSV infections occur primarily during fall, winter, and spring. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV is the most common cause of bronchiolitis and pneumonia in children younger than one year of age in the United States and can result in pneumonia and respiratory distress in older adults. According to the U.S. Centers for Disease Control and Prevention, in the United States, RSV leads each year, on average, to approximately 58,000 hospitalizations among children younger than five years old, 177,000 hospitalizations among adults 65 years and older and 14,000 deaths among adults 65 years and older. There is no approved vaccine available today for RSV.

Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and that fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. The Company previously received Fast Track designation for its COVID-19 vaccine candidate, Zika vaccine candidate (mRNA-1893), methylmalonic acidemia (MMA) (mRNA-3704) and propionic acidemia (PA) (mRNA-3927) programs.

The Phase 1 study of mRNA-1345 to evaluate the tolerability and reactogenicity of mRNA-1345 in younger adults, older adults and children is ongoing. All four cohorts of younger adults (ages 18-49 years) are fully enrolled. Dosing in the older adult cohort (ages 65-79 years) is ongoing. The age range of toddlers in this de-escalation Phase 1 study is 12-59 months. The Company shared the first interim analysis of the Phase 1 study of mRNA-1345, through 1-month post-vaccination, of the younger adult cohorts at its annual Vaccines Day on April 14, 2021. Results showed the vaccine candidate generated a geometric mean rise in neutralizing antibodies relative to baseline of at least 11-fold. The Company also intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. Moderna owns worldwide commercial rights to mRNA-1345.

About mRNA-1345

mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. RSV is the leading cause of respiratory illness in young children. Older adults (65+) are at high risk for severe RSV infections. mRNA-1345 uses the same lipid nanoparticle (LNP) as Moderna’s authorized COVID-19 vaccine and contains optimized protein and codon sequences....