Wednesday, February 28, 2024

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    FDA Approves First RSV Vaccine for Adults 60 and Older: GSK’s Single-Dose Shot Shows Strong Efficacy

    The vaccine demonstrated remarkable efficacy in late-stage clinical trials.

    In a historic milestone, the Food and Drug Administration (FDA) has granted approval for the world’s first respiratory syncytial virus (RSV) vaccine, designed specifically for adults aged 60 and older. This significant breakthrough comes after decades of research and development efforts, marking a crucial step forward in addressing RSV, a virus that has posed a long-standing health threat.

    The journey to develop an RSV vaccine began nearly six decades ago when researchers first embarked on this challenging endeavor. Now, the fruits of their labor have culminated in the approval of GSK’s single-dose RSV vaccine, a development that promises to revolutionize healthcare for older adults.

    In late-stage clinical trials, GSK’s RSV vaccine demonstrated remarkable efficacy, reducing the risk of symptomatic illness by an impressive 83% and severe illness by an astounding 94%. This extraordinary level of protection holds immense promise in safeguarding older adults against the severe consequences of RSV infection.

    However, before the vaccine becomes available to the public, it awaits a crucial recommendation from the Centers for Disease Control and Prevention (CDC). Once this recommendation is in place, manufacturing of vaccine doses will proceed, with the goal of having the shots ready for distribution in the fall. Specific production figures have not been disclosed at this time.

    RSV, although typically resulting in mild lower respiratory illness for healthy adults, can take a severe and life-threatening course in certain cases, leading to pneumonia or bronchiolitis, which inflames airways and obstructs them with mucus. Notably, older individuals and infants are particularly vulnerable to the devastating effects of RSV. In the United States alone, RSV claims the lives of up to 10,000 individuals aged 65 and older and up to 300 children under the age of 5 each year.

    RSV typically exhibits a seasonal pattern, with cases peaking between late December and mid-February. However, in the previous year, cases began to surge during the summer as individuals gradually abandoned pandemic precautions.

    One crucial aspect highlighted by GSK is the vaccine’s lasting protection, which has been observed to persist for at least six months. This durability is essential, ensuring that individuals receive timely vaccinations well in advance of the next RSV season, typically occurring in late fall and winter.

    Moreover, GSK’s data suggests that it is safe to administer the RSV vaccine concurrently with a standard flu shot, providing a convenient means of enhancing protection against multiple respiratory illnesses. However, ongoing research is exploring whether the vaccine can be administered alongside high-dose or adjuvanted flu vaccines, both of which are recommended by the CDC for older adults.

    As part of its ongoing commitment to safety, GSK will continue to monitor the vaccine’s performance and safety over the next two RSV seasons, further enhancing our understanding of its effectiveness and potential side effects. Reported side effects thus far have included injection site pain, fatigue, and muscle pain.

    The FDA’s approval process for GSK’s RSV vaccine proceeded based on its safety and efficacy, with an advisory panel voting 10-2 in favor of approval. The advisory panel’s unanimous recommendation underscores the vaccine’s potential to make a substantial impact on public health.

    Looking ahead, a second RSV vaccine designed for older adults, developed by Pfizer, is awaiting FDA approval later this month. While there are concerns about the adequacy of RSV infection rates in Pfizer’s trial, the vaccine received a 7-4 vote in favor of recommendation by the FDA advisory panel based on safety and efficacy. Pfizer has been asked by the FDA to conduct a study on the risk of Guillain-Barré syndrome after the vaccine’s approval.

    Pfizer’s vaccine also underwent testing for use in pregnant individuals to protect infants from RSV, with the FDA reviewing this data for a decision expected in August. Although GSK is not planning further studies on pregnant individuals, it is conducting research among individuals aged 50 to 59, with a focus on those with underlying health conditions. Data from this study is anticipated to become available after July.

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