Moderna, the COVID-19 vaccine giant, has seen great results from mRNA-1345, a trial investigational respiratory syncytial virus (RSV) vaccine.
The vaccine has shown effectiveness by 83.7 percent against the virus, as shown with two or more symptoms in adults. Among the participants, the mRNA-1345 vaccine was mostly well-endured and showed no safety complications by the Data and Safety Monitoring Board (DSMB). With positive results, Moderna is to propose the vaccine for regulatory approval in 2023.
Moderna, an American pharmaceutical and biotechnology company known for its mRNA vaccines, revealed positive results with its RSV Phase 3 efficacy trial with mRNA-1345. The DSMB showed great vaccine efficacy against RSV-associated lower respiratory tract disease (RSV-LRTD).
"Today's results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older. These data are encouraging, and represent the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform after, Spikevax, our COVID-19 vaccine. We look forward to publishing the full data set and sharing the results at an upcoming infectious disease medical conference," said Moderna's Chief Executive Officer Stéphane Bancel.
"Respiratory diseases are a major public health priority given they have a significant health impact and are a leading cause of hospitalization. For these reasons, in addition to our mRNA-1345 RSV vaccine candidate, we are committed to developing a portfolio of respiratory mRNA vaccines to target the most significant viruses causing respiratory disease, including COVID-19, influenza, and human metapneumovirus."
What did the trial find?
The trial was randomized and double-blinded, and also placebo-controlled, with more than 37,000 adults over the age of 60 in 22 different countries. The analysis was built upon 20 cases of RSV-LRTD with three or more symptoms, of which 17 cases were observed in the placebo group compared to three cases observed in the mRNA-1345 group.
The analysis also included 64 cases of RSV-LRTD with two or more symptoms, where 55 cases occurred in the placebo group and 9 cases occurred in the mRNA-1345 group.
"RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities," said principal investigator for the study sites in Bangladesh and Professor, Department of International Health, Director, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University Abdullah Baqui.
This continuing study will resume monitoring for safety and efficacy. Most mild or moderate adverse reactions of the vaccine were pain in the injection site, fatigue, headache, myalgia, and arthralgia.
"This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas."
What is RSV?
RSV, or respiratory syncytial virus, is a respiratory virus that causes symptoms similar to cold or flu. Some individuals can recover in a couple of weeks, but it can also be severe for others, especially for infants and the elderly. In the United States, RSV is one of the most frequent cause of bronchiolitis and pneumonia in infants under the age of one.
The virus can be transmitted by contacting an infected person, getting virus droplets in your eyes, nose, or mouth. You can also catch RSV by surface-touching. The virus is usually contagious for around three to eight days, but for infants and those who are immune-compromised can continue to shed the virus for around four weeks.