FDA on COVID-19 Vaccine Boosters + Advocacy Group Pushes for Speedy FDA Approval of ALS Drug

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In this episode, Ayesha discusses the FDA’s pending decision on authorizing COVID-19 vaccine boosters for the general public. While an FDA vaccine advisory committee voted against boosters for individuals 16 years of age and older last week, the FDA is still working towards its final decision on the matter. At the same time, the advisory panel recommended offering third doses of the Pfizer COVID-19 vaccine to those 65 years and older, as well as high risk individuals. The team discussed the need for boosters in light of the Delta variant and concerns of global vaccine inequities, but agree that vaccine boosters are not out of the norm and generally to be expected at some point.

The episode also features the ALS Association’s push for rapid FDA approval of Amylyx’s investigational ALS drug. The advocacy group cites the recent speedy approval of Biogen’s Aduhelm for Alzheimer’s disease, asking the FDA why similar regulatory flexibility is not being exercised for the ALS drug that could be life-changing for many ALS patients. The editorial team discusses the impact of the rapid approval of Aduhelm, as well as COVID-19 vaccines, as potentially driving changes in regulatory timelines, as more companies and patient groups may be demanding similar speedy approvals.

Read the full articles here:

FDA Remains Mum on COVID-19 Vaccine Boosters, But Acknowledges Third Dose Improves Immunity

ALS Association Pressures FDA to Approve Amylyx Drug as Agency Cuts Phase III Trial Requirement

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