2023-01-18| Trials & Approvals

Moderna Welcomes Phase 3 Win For RSV Vaccine

by Joy Lin
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Moderna’s RSV vaccine, mRNA-135 has met its primary endpoints in the ConquerRSV Phase 3 pivotal efficacy trial, announced by the company. Based on the positive results, the Cambridge, Massachusetts-based company intends to file for regulatory approval in the first half of 2023 for its mRNA shot as a prophylaxis against respiratory syncytial virus (RSV). 

Related Article: CDC Warns Of “Tripledemic” Winter Amid Rising Flu And RSV Cases

The Rise in RSV Infections

RSV is a common childhood illness that typically causes cold-like symptoms. RSV infections have seen a huge increase in prevalence across the US even before the winter season. The rise has been attributed to the easing of COVID-19 masking and social distancing policies, which have allowed more people to go out. 

This has also led to children who have not been exposed to the virus before to become infected. While symptoms are usually mild, it could lead to serious infections especially in infants and younger children, or complicate existing conditions, such as asthma, in older children. Adults get it too, and while most cases are mild, older adults and the immunocompromised could experience severe symptoms.

According to the CDC, RSV accounts for around 2.1 million outpatient visits and 58,000 hospitalizations in the US each year. And that’s only the statistics for children under five years of age.

Moderna’s RSV Vaccine Showed 83.7% Efficacy In Older Adults

mRNA-1345 is an RSV vaccine consisting of a single mRNA sequence that encodes for a surface glycoprotein on the virus. The surface protein is necessary for infection as it helps the virus enter host cells. The vaccine uses the same lipid nano particles (LNPs) as in the Moderna COVID-19 vaccines. 

In the global ConquerRSV trial in adults 60 years or older, mRNA-1345 demonstrated a vaccine efficacy of 83.7% against RSV-related lower respiratory tract disease, which is defined by two or more symptoms in older adults. 

The shot was found to be well-tolerated, with no safety concerns identified by the independent Data and Safety Monitoring Board (DSMB). The most common reported side effects in the mRNA-1345 group were injection site pain, fatigue, headache, muscle pain and joint pain. 

The trial is ongoing, and an updated safety analysis will be provided for the regulatory submission. Moderna will also submit the data for peer review and present it at an upcoming scientific meeting. 

Besides ConquerRSV, Moderna is advancing mRNA-1345 in four other ongoing trials that evaluate the shot in pediatric populations and in combination with other shots for influenza and COVID-19. 

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