The EUA process affords the FDA other flexibility to make the vaccine available sooner. For example, a fully licensed vaccine might require months of stability testing, since the vaccine might sit on the shelf of a distributor or doctor’s office for six months or longer. But for the Covid emergency, the EUA allows the FDA to act without some of this testing, since these vaccines are intended to be delivered to patients quickly.
The EUA process also allows the FDA to require more data as a condition of authorization. Active collection of benefit and risk information should be required, for example through connecting vaccine records with data from secure electronic medical-record or insurance-claim databases to assess outcomes.
We also reject the idea that the FDA’s professional staff can be cowed by outside influences. Beneath all the political rhetoric, the process for developing Covid vaccines has been rigorous. The FDA has prescribed an extensive process for meeting its vaccine EUA standards, including a public assessment by independent experts. The FDA also announced that it will soon articulate its standards for emergency authorization in guidance.
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