FDA Will Approve COVID-19 Vaccine
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The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with
New guidelines for COVID vaccine. Prior to the new guidelines, it was recommended that everyone who is 6 months and older get at least one vaccine per year, with those in higher-0
FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.
Yesterday the Vaccine Integrity Project (VIP), a panel of leading public health and policy experts, published a viewpoint on the Food and Drug Administration's (FDA's) decision this week to issue new, more restrictive, COVID-19 vaccine recommendations via an opinion piece in the New England Journal of Medicine (NEJM).
Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter
With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.