The US Food and Drug Administration (FDA) has approved for the first time a vaccine against the respiratory disease respiratory syncytial virus (RSV), which kills thousands of Americans each year. The new vaccine, called Arexvy, needs one more final approval for public use by the U.S. Centers for Disease Control and Prevention.
First RSV vaccine approved
Head of the FDA Center for Biological Evaluation and Research, Dr. “The approval of the first RSV vaccine today is an important public health achievement to prevent a life-threatening disease,” said Peter Marks, in a statement about the Arexvy vaccine developed by GlaxoSmithKline (GSK) against the RSV virus.
Adults aged 60 and over who are at higher risk of contracting this disease will be able to receive GSK’s vaccine following CDC’s final approval. According to the phase III clinical trial data of the vaccine, it is stated that its effectiveness in reducing symptomatic infection in adults aged 60 and over is 82.6 percent, and it is 94.1 percent effective against aggravation of the disease. In addition, it is reported that the side effects of the vaccine are mostly “mild or moderate” and last only a few days.
RSV primarily causes cold-like symptoms in adults, but in some cases can cause severe illness and severe effects up to hospitalization. RSV can be fatal for young children, the elderly, and people with underlying health conditions such as asthma. When the condition worsens, it can lead to bronchiolitis or lung inflammation.
Thousands of people die every year
According to the CDC, RSV kills 100-300 children under the age of five and 6,000-10,000 adults over the age of 65 in the United States each year. On the other hand, hospitalizations due to RSV are estimated to be between 60,000 and 120,000 in the United States. The development of RSV vaccine technology took nearly 60 years, according to the published report, and initial trials in the 1960s had unintended consequences.
Other pharmaceutical companies competing for approval of the RSC vaccine include Pfizer, Moderna and Bavarian Nordic. According to reports, the market size of RSV vaccines is expected to reach $10 billion by 2030.
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