June 10 testimony before FDA’s Vaccines and Related Biological Products Advisory Committee

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Arnold Monto, M.D., Acting Chair
Vaccines and Related Biological Products Advisory Committee
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993

RE: Docket No. FDA- 2021-N-0458; for Vaccines and Related Biological Products Advisory Committee

Good afternoon. My name is Nissa Shaffi, and I am representing the National Consumers League (NCL). I have no conflicts of interests regarding today’s remarks.

The National Consumers League was founded in 1899, by the renowned social reformer Florence Kelley. General Secretary Kelley’s support of vaccinations played a key part in mitigating a critical smallpox outbreak towards the end of the 19^th century, and her stalwart advocacy for immunizations has informed NCL’s bedrock principles for vaccine education, confidence, and safety.

122 years later, we are honored to persist in our pursuit to advance vaccines as vital public health interventions, and we extend our gratitude to the Vaccines and Related Biological Products Advisory Committee for the opportunity to present comment during this public hearing session.

Emergency Use Authorization (EUA)

NCL appreciates that the FDA recognizes that Emergency Use Authorization is not intended to replace the rigor of full approval, and that randomized clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment.

The diligent review and public engagement that went into the EUA process for the COVID-19 vaccines currently available have helped our nation reach key milestones in immunizations.

As our adult populations have benefitted from these critical public health efforts, we are energized to extend that momentum towards our youngest citizens. Through our education and outreach of consumers, we support FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine via an EUA to help prevent the spread of the virus in pediatric populations.

Safety and Effectiveness

We have great trust in the FDA’s safety monitoring systems and call on the Agency to perform ongoing post-market surveillance to ensure the vaccine’s continued safety and efficacy.

As we’ve observed with recent vaccine safety concerns, consumers rely heavily on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine. We call on the FDA to continue to sustain its robust interagency collaboration as we endeavor to vaccinate the nation.

Pediatric Population Vaccine Uptake

Although children are at a lower risk of COVID-19 compared to adults, and tend to experience milder symptoms, pediatric populations now account for 22% of new COVID cases, compared to 3% last year. As with adults, children and adolescents with underlying chronic health conditions are at higher risk for COVID-19-related hospitalization and death.

The absence of a vaccine for pediatric populations will lead to continuing transmission that will consistently put children at risk for infection.

Furthermore, vaccine uptake for routine pediatric immunizations have declined dramatically during the pandemic. It is essential for public health officials, advocates, and parents to ensure that children are up to date with their vaccines, and that children eligible for the COVID-19 vaccine receive their shots. Data shows that the COVID-19 vaccine currently available for children ages 12-15 is safe and effective, and has been recommended to be co-administered along with routine pediatric vaccinations.

Health Disparities

While COVID-19 has impacted the entire country, it has largely devastated communities of color. Children of color, specifically Black and Hispanic youth, have been especially vulnerable. This has been even more apparent with the prevalence of Multisystem inflammatory syndrome in children, a rare but serious COVID-19-associated condition, that has been observed in children 1- 14 years of age, 64% of which were reported to be Black or Hispanic.

To achieve meaningful herd immunity, we will need to ensure that children have access to a safe and effective COVID-19 vaccine, and also consider the unique disparities that children of color experience in the face of the pandemic.

Thank you to the Committee for your consideration of our views on this important public health issue. 

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League