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The US Food and Drug Administration has approved another vaccine to help protect the elderly The same virus of the respiratory system, known as RSV. The shot, made by Moderna and marketed under the name mResvia, could be another weapon in the country's RSV arsenal come fall.
Moderna's shot is the third RSV vaccine to get the green light for people 60 and older and the first mRNA vaccine among them. It is the company's second product to receive FDA approval behind its Covid-19 vaccine.
Other FDA-approved RSV vaccines are: Made by GSK And Pfizer. There is also RSV vaccine For pregnant women and children in the US, there are preventable postpartum and a Protective antibodies It can be given to prevent serious illness in children.
The virus is ubiquitous and usually causes a mild infection. Worldwide, approximately 64 million people are infected with RSV each year National Institute of Allergy and Infectious Diseases.
Most people with RSV feel like they have the flu, and they usually get better within a few weeks, but the virus can be especially dangerous for the elderly. Small children and people with chronic health problems. Depending on the severity of the disease, between 60,000 and 160,000 older adults are hospitalized with RSV each year, and between 6,000 and 10,000 die. US Centers for Disease Control and Prevention.
Symptoms of RSV can include runny nose, cough, fever, sneezing, wheezing, and loss of appetite, but infection can develop into pneumonia or worsen breathing problems such as asthma or COPD.
as if single year, Millions of people are hospitalized with lower respiratory tract infections caused by RSV. In older people with chronic heart or lung disease and people with weakened immune systems, RSV can turn into pneumonia or kill them.
Moderna said Friday Approval of the RSV vaccine is based on clinical trial data, even four months after a person receives the vaccine. The vaccine It had 83.7% effectiveness in preventing lower respiratory tract infections. Trials of the vaccine involved 37,000 adults in 22 countries.
Moderna's long-term analysis showed that the vaccine provided continued protection for nearly nine months after vaccination. The company said there were no serious safety concerns from the test; The most common side effects are 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,” said Stefan Bansel, CEO of Moderna. News release. “mRESVIA protects the elderly from the serious consequences of RSV infection, and is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, save time on vaccinations and reduce the risk of administration errors. This approval marks the first time an mRNA vaccine has been approved for a disease other than Covid-19.” At mRESVIA, we continue to deliver to patients by addressing the global public health risks associated with infectious diseases.
The CDC recommends two doses of RSV vaccine approved for adults 60 and older using shared clinical decision-making, which means seniors should discuss with their doctor whether they should get the vaccine.
The agency's independent vaccine advisory committee is considering recommending the Modena vaccine at its June 26 meeting. The CDC makes the final decision to recommend the vaccine and provides guidance to doctors on how it should be used.
Moderna said it expects the vaccine to be available to eligible groups in the U.S. for the 2024-25 RSV season, which typically begins in the fall and peaks in the winter.