The FDA says that it will no longer approve Covid vaccines without clinical trials for the general population. Instead, it will only approve COVID-19 vaccines for:
- Adults aged 65 and older.
- Individuals aged 6 months and older with at least one high-risk condition (e.g., asthma, diabetes, cancer, obesity).
This was announced in a New England Journal of Medicine publication by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research. It means that no approval for the general population unless there are clinical trials, not emergency use authorizations.
This does not mean that the current vaccines will be removed from the childhood vaccine schedule. That is determined by the CDC so as of now, the COVID-19 vaccine is still on the CDC’s recommended schedule for children as young as 6 months.
At the very least, it will mean shots going forward will need full approval but based on the way that the Novavax vaccine was approved last week based on truly shit trials, we shouldn’t get that excited yet. The standards for trials must go up at the same time as the requirement.
