June 10, 2021
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. We analyze scientific data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
We can all agree that it is of utmost importance to ensure the safety and effectiveness of the vaccines for children across age groups. There must be an appropriate and favorable balance of the benefits and risks in order to support both an EUA and licensure. We agree with the FDA’s assessment that the lower burden of disease in pediatric populations warrants more stringent criteria for safety and efficacy than for adults.
In terms of the vaccines’ safety, we agree with the FDA that in order to adequately assess risks in pre-licensure clinical trials, the safety database for each age group should be at least 1,000 vaccine recipients plus control recipients. Given the millions of children who might be vaccinated using a licensed vaccine, we think it should be studied on a sample of at least 3,000 children. In addition, the FDA’s recommended follow-up time of a median of at least 6 months after completion of the vaccination regimen is not long enough. For an adequate assessment, FDA should require that children should be followed for a minimum of 6 to 9 months – not a median that includes follow-up of less than 6-9 months.
Finally, we want to stress the importance of enrolling children from all racial and ethnic groups, including minorities who are most affected by COVID-19 in clinical trials of the vaccines. While we were happy to see that FDA encourages diversity in clinical trials, mere encouragement is not enough. Vaccines should not be granted EUA or licensure for use in populations for which they have not been tested and shown to be both safe and effective.
Please consider these points during your discussion today, in order to ensure a favorable balance of benefits and risks for vaccines among a pediatric population.