A Letter to the FDA from Health Care Workers Urging Prompt Data Review

Robert Califf, MD, Commissioner
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993

Peter Marks, MD, PHD, Director, Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993

Dear Dr. Califf and Dr. Marks:

We are the people who stand on the frontlines of the pandemic.  We are the ones who comfort a parent while their once healthy child now fights to live.  We are the ones who hold a patient’s hand, unable to do anything more, as they slip away after a valiant fight on a ventilator.  We are the ones who encourage our patients to push themselves in rehab so they can grasp at some semblance of the life they had before they got long COVID.  We are the ones analyzing the data and seeing disturbing health trends for those who have been infected.  We are the ones who welcome patients into our offices, hoping they aren’t carrying a virus that we might bring home to our own loved ones. 

We are exhausted.  We are seeing the real life impact of COVID.  We know that the pandemic is not over, even if we wish it were.  And we know that children are vulnerable, that COVID hurts children, and that they are owed the life-saving vaccines accessible to everyone else.

This is why we ask that you make no delays in reviewing Moderna’s data once it is submitted.  Furthermore, discussion of the <6 vaccine data must be prioritized over discussions pertaining to boosters and older age groups.  We ask that the FDA acts with the same urgency on its timeline as it did with other age groups, which typically ranged from 17-20 days between submission and approval. Anything different would be unethical, unscientific and unacceptable.

With nearly 500 children under the age of five in the United States dead from COVID, thousands suffering from MIS-C, and an ever-evolving recognition of COVID-induced neuroinflammation, myocarditis, and long COVID in children, there must be no further delay.  We cannot continue to standby and allow preventable death and disability in the most vulnerable members of society.  

We have witnessed remarkable achievements when our leaders have acted urgently.  Adults have been eligible for COVID vaccines for almost a year and a half, and children over five have been eligible for at least six months.  Young children have waited long enough and deserve the same as the rest of the population.  Please do not fail our youngest at this critical time.  Review Moderna’s data for children under 5 as soon as it is available.

Sincerely,