Moderna's mRNA RSV vaccine for seniors receives FDA approval.
Moderna becomes the third vaccine approved by the FDA for people aged 60 and older to combat RSV, and the first to be an mRNA vaccine among them. This makes it Moderna's second product to receive approval, following their COVID-19 vaccine. There are other vaccines from GSK and Pfizer that have also been approved for this age group. Additionally, there's an RSV vaccine available for pregnant women that can protect infants during birth, alongside a preventive antibody designed to prevent severe illness in babies.
The RSV virus is widespread globally, with around 64 million cases reported yearly, according to the National Institute of Allergy and Infectious Diseases. Even though most people experience mild symptoms and recover within a few weeks, the virus can be particularly harmful for older adults, young children, and those with preexisting health issues. Roughly 60,000 to 160,000 seniors are hospitalized for RSV annually, and between 6,000 to 10,000 deaths occur each year, according to the US Centers for Disease Control and Prevention.
The symptoms of RSV often mimic those of a common cold, including a stuffy nose, cough, fever, sneezing, wheezing, and reduced appetite. However, RSV infections can evolve into more severe illnesses like pneumonia, especially for those with underlying heart or lung conditions or those whose immune systems are compromised.
The latest data from Moderna shows that their RSV vaccine demonstrated an 83.7% efficiency in preventing lower respiratory tract infections up to four months after being administered. This information is based on clinical trials involving 37,000 participants from 22 countries. A subsequent analysis demonstrated continued protection for almost nine months. No severe safety concerns arose within the trial, with the most common side effects being localized pain from the shot, headaches, and fatigue.
The chief executive officer of Moderna, Stéphane Bancel, expressed their satisfaction in the FDA's approval: “We're proud to receive FDA approval for our second product, mRESVIA. This demonstrates the flexibility and effectiveness of our mRNA platform. The mRESVIA vaccine shields older adults from the severe consequences that can result from RSV infection. It is also the first mRNA vaccine to be approved for a disease other than COVID-19. Our ongoing dedication is to enhance global public health by tackling infectious diseases effectively."
At the moment, the CDC advises only the use of the other two available RSV vaccines for adults aged 60 and above, requiring doctors to guide seniors on whether they should receive the shots. However, on the 26th of June, an independent committee of vaccine advisers will convene to consider if Moderna's vaccine is to be recommended. Following this, the CDC will announce the final recommendations for using the vaccine.
Moderna predicts that their RSV vaccine will be made available to eligible populations in the US in time for the 2024-2025 RSV season, which commonly occurs in fall to winter.
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Moderna's mRNA RSV vaccine will be their second product approved by regulatory bodies, following the COVID-19 vaccine. The approved RSV vaccine from Moderna offers protection against severe consequences of RSV infection in older adults.
