In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The authorization was based on trial data that showed the vaccine was safe, well-tolerated and induced robust immune responses among children in this age group; side effects were generally mild to moderate. Amid concerns of the rare adverse event of myocarditis in children and adolescents following vaccination with mRNA vaccines, the FDA conducted its own benefit-risk analysis that showed the benefit of vaccination outweighs the risk of myocarditis. The editorial team discussed the positive trial data, the importance of vaccinating kids amid rising infections among younger children, as well as vaccine hesitancy among parents.
The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD). The implant is surgically placed in the eye and injected with Genentech’s anti-VEGFA monoclonal antibody ranibizumab for continuous delivery. Compared with the current standard of care of near-monthly intravitreal anti-VEGF injections, the ocular implant only has to be refilled every six months. The team discussed the convenience of the device, but also potential patient hesitancy over the surgery for its implantation.
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