Stepping Up or Stepping Back: FDA Roles in Producing and Shaping Knowledge of Pediatric Covid-19 Vaccines

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This article refers to:

E-Cigarettes and the Multiple Responsibilities of the FDA

This article is referred to by:

E-Cigarettes, the FDA, Public Health, and Harm Reduction: A Response to the Open Peer Commentaries

Notes

1 At the time of writing (July 2022) the Covid-19 vaccines from Moderna for those under age 18 and Pfizer BioNTech (here forward referred to as “Pfizer”) for those under age 16 remain under EUA. Pfizer and Moderna Covid-19 vaccines for adults have received full FDA approval in the form of an approved biologics license application (FDA 2022).

2 Particularly policies regarding nonpharmaceutical interventions (NPIs) to mitigate transmission in daycares, schools, transportation, and other public settings that would reduce Covid-19 risks to children.

3 For the Pfizer EUA application the FDA only agreed to review following the trial extending to include third dose data (Tufekci 2022), and FDA asked both Pfizer and Moderna to expand enrollment in the clinical trials for younger children (Stolberg, LaFraniere, and Weiland 2021).

4 Note that while we are suggesting FDA deference to the authority of the CDC on some matters, on others CDC deference to FDA authority may be most appropriate. For example, once the FDA fully approved BLAs for adult Covid-19 vaccines, FDA regulations, and medical, legal, and ethical norms, would allow them to be used off-label in populations for whom vaccines were not yet authorized or approved. However, the CDC took the unusual step to prohibit off-label use that may have been outside its typical scope (see Lanphier and Fyfe 2021).

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Funding

The author(s) reported there is no funding associated with the work featured in this article.