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    FDA Approves First RSV Vaccine for Adults Aged 50 and Up

    Top News 4 Mins Read

    The FDA as of late has not been known for their honesty with the American people. Now, another vaccine is approved, and I’m betting the number of people who take it will be significantly lower due to the Covid debacle.

    The U.S. Food and Drug Administration (FDA) has recently approved the first vaccine for respiratory syncytial virus (RSV) aimed at adults as young as 50 who are considered at high risk for severe RSV complications. This decision by the FDA marks the first time an RSV vaccine has been greenlit for this specific age group, offering new preventative measures against the virus.

    Global pharmaceutical giant GSK initiated the request for this age group expansion in February. Their data indicated that the immune response in adults from the age of 50 was similar to older groups. GSK plans further trials to examine the vaccine’s efficacy in adults aged 18 to 49, with results anticipated later this year.

    This development follows approvals for RSV vaccines by other companies like Pfizer and Moderna, which currently cater to adults over 60. Pfizer has also shared plans to extend its vaccine studies to younger adults, based on encouraging study outcomes.

    Before GSK’s vaccine becomes widely available to those aged 50 to 59, it requires the endorsement of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices. Their recommendation, potentially coming in upcoming meetings, is crucial for facilitating insurance coverage for the vaccine.

    The CDC committee had previously noted potential public health benefits of vaccinating adults in their 50s against RSV. This age group, though younger than the traditionally targeted over-60 cohort, often faces increased risks from RSV due to existing health conditions such as COPD or heart failure. These underlying issues can exacerbate the effects of RSV, making vaccination a strategic preventive measure.

    Dr. Phil Dormitzer, GSK’s Senior Vice President and Global Head of Vaccines Research and Development, mentioned that the vaccine has shown comparable safety outcomes in the 50 to 59 age group as in older adults, though some side effects were slightly more pronounced, likely due to stronger immune responses.

    A significant concern that the CDC panel has been monitoring is the occurrence of Guillain-Barré syndrome, a rare neurological disorder, following vaccination. So far, the data indicates a low incidence rate of about 1.5 cases per million doses. No concerning trends have been observed in the 50 to 59 age group regarding this syndrome, reassuring public health officials.

    The CDC is also contemplating the necessity and timing of booster doses for RSV. According to Dormitzer, GSK is preparing to present more findings on potential boosters, which could be spaced as much as three years apart. This approach suggests that the duration of immunity provided by the vaccine could extend well beyond a single RSV season, possibly eliminating the need for annual vaccinations.

    Since the public has not done well with the Covid boosters, they have a lot of selling to do to earn the trust of the people once again.

    Major Points

    • The FDA has approved GSK’s RSV vaccine for adults aged 50 and older, expanding the eligible age group for the first time.
    • GSK plans further trials for adults aged 18 to 49, with results expected later this year, while Pfizer and Moderna are also conducting similar studies.
    • The vaccine’s wider availability hinges on the endorsement of the CDC’s Advisory Committee on Immunization Practices, which influences insurance coverage.
    • The CDC noted the vaccine could be particularly beneficial for adults in their 50s who have pre-existing conditions that heighten RSV risks.
    • Discussions are ongoing about the necessity and timing of booster shots, with the potential for the immunity from the vaccine to last beyond a single season.

    Charles William III – Reprinted with permission of Whatfinger News

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