FDA approves Moderna’s mRNA RSV vaccine for older adults

The US Food and Drug Administration has approved another vaccine to help protect older people from respiratory syncytial virus, known as RSV. The shot, made by Moderna and sold under the name of mResvia, could be another tool in the country’s RSV arsenal in the fall.

Moderna’s shot is the third RSV vaccine for people 60 and older that’s gotten the green light from the FDA and the first mRNA vaccine among them. It’s the company’s second product to receive FDA approval, behind its Covid-19 vaccine.

The other FDA-approved RSV vaccines are made by GSK and Pfizer. There’s also an RSV vaccine for pregnant people in the US that can protect an infant after birth and a preventive antibody that can be given to prevent serious illness in babies.

The virus is ubiquitous and typically causes mild infection. Globally, about 64 million people get sick with RSV each year, according to the National Institute of Allergy and Infectious Diseases.

Many people who get RSV feel like they have a cold, and they will typically recover in a few weeks, but the virus can be particularly dangerous for older people, young children and people with underlying health conditions. Depending on how bad the season is, between 60,000 and 160,000 older adults are hospitalized with RSV every year, and between 6,000 and 10,000 die, according to the US Centers for Disease Control and Prevention.

RSV symptoms can include a runny nose, cough, fever, sneezing, wheezing and a decreased appetite, but an infection can also turn into pneumonia or make underlying breathing problems like asthma or COPD worse.

In a single year, millions of people are sent to the hospital with a lower respiratory tract infection that started with RSV. Seniors who have underlying heart problems or lung diseases and those with suppressed immune systems are at the highest risk that RSV could turn into pneumonia or kill them.

Moderna said Friday that approval of its RSV vaccine was based on clinical trial data showing that even about four months after someone gets the shot, the vaccine had an 83.7% efficacy at preventing lower respiratory tract disease. The vaccine trials involved 37,000 adults in 22 countries.

Moderna says a longer-term analysis showed that the vaccine provided continued protection nearly nine months after vaccination. The company said there were no serious safety concerns identified in the trial, and the most common problems were pain at the injection site, headache and fatigue.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.”

The CDC recommends the two other approved RSV vaccines for adults 60 and older using shared clinical decision-making, meaning seniors should discuss with their doctor whether they should get the shot.

The agency’s independent committee of vaccine advisers will consider at its meeting June 26 whether Moderna’s vaccine should be recommended. The CDC makes the final determination on whether to recommend the vaccine and gives doctors guidance on how it should be used.

Moderna said it expects that its vaccine will be available for eligible groups in the US in time for the 2024-25 RSV season, which typically starts in the fall and peaks in the winter.

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