The U.S. Food and Drug Administration has granted full approval for Moderna’s COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years who are at increased risk of the disease. This vaccine was previously available for paediatric populations under emergency use authorization. Moderna anticipates making its updated vaccine available for the eligible U.S. population for the upcoming 2025-26 respiratory virus season.
Health Secretary Robert F. Kennedy Jr. had asserted in May that routine COVID-19 vaccinations for healthy children and healthy pregnant women are no longer recommended. However, the U.S. Centres for Disease Control and Prevention (CDC) maintains that vaccinations remain a viable option for healthy children when parents and healthcare providers agree on the necessity. The agency has also recommended updated COVID vaccines for everyone aged six months and older, adhering to the guidance from its panel of external experts.
Kennedy has been a controversial figure, having promoted skepticism about vaccine safety, which contrasts with evidence and research from numerous scientific bodies. Under his leadership, the CDC faced significant changes, including the dismissal of all 17 members of the Advisory Committee on Immunization Practices, which advises on vaccine policy. Kennedy replaced these members with seven others, including individuals who have previously spoken against vaccinations.
In related news, the FDA also approved gradual dosing for Lilly’s Alzheimer’s drug, Kisunla, which was aimed at minimizing the risk of a specific type of brain swelling known as ARIA-E associated with the treatment. This drug has been designed to help clear an Alzheimer’s-related protein, beta-amyloid, from the brain and was initially approved for adults with early-stage Alzheimer’s. The approval of Kisunla’s new dosing strategy is expected to provide healthcare professionals with better options for discussing treatment benefits and risks with their patients.
-Raja Aditya
