A Letter from Scientists Calling for Urgent Vaccine Access

Janet Woodcock, MD 

Acting Commissioner Food and Drug Administration 10903

New Hampshire Avenue Silver Spring, MD 20993

Rochelle Walensky, MD, MPH

Director Centers for Disease Control and Prevention

1600 Clifton Road, Atlanta, Georgia 30333

Dear Dr. Woodcock and Dr. Walensky:

We are scientists calling on our leaders at the FDA and the CDC to work together to urgently make COVID-19 vaccines accessible to children under 5. You delivered life-saving vaccines to adults in record time. Now, we need you to allow us to protect our youngest citizens immediately. mRNA vaccines are safe and effective in hundreds of millions of people. Data has shown that the 10 ug dose of the Pfizer vaccine is safe and effective in 8 million children aged 5-11. Data demonstrates the need for protection for the youngest children. Now is the time to make the policies follow the science. Make the ethical choice to give equal access to vaccines for children under 5.

The need for vaccination access for children under 5 is urgent. Nearly one million children tested positive for COVID-19 in the week ending Jan 13, 2022. This is of particular concern for this youngest age group who have no means of protection, no access to vaccines and no ability to wear masks that fit properly. The surge of childhood and infant hospitalizations with this Omicron wave makes it clear that this disease is not always mild for the youngest patients.  

The risks inherent in delaying access to vaccination for children aged 6 months to 5 years old far outweigh any potential risks for granting access. 

1. MIS-C: Throughout the pandemic, one of the greatest risks to young children has been Multisystem Inflammatory Syndrome (MIS C). Vaccines protect children from MIS C.

2. Data from people 16 years old and older shows that COVID-19 infection poses a much higher risk of any acute or long term adverse effect (ie: myocarditis and pericarditis) when compared to any risks associated with vaccination, even at the highest Pfizer dose. 

3.  Adverse neurological consequences are associated with pediatric COVID-19. Reports show encephalitis can occur post COVID-19 infection. Access to the vaccine could prevent these symptoms. 

4.  Evidence shows an association between COVID-19 infection and subsequent development of diabetes in children. 

5.  COVID-19 vaccination is proving to be effective in preventing  ‘long COVID’ in older cohorts. This is likely to be true for the youngest children as well. 

6.  Vaccination reduces infections, which reduces chances for the virus to mutate into more dangerous variants. We need access to the vaccines for everyone who is willing. 

The social and economic burdens for delaying access to vaccines for children under 5 are significant. 59% of children under age 5 require nonparental care, with 62% of those children attending center based care. These facilities are often disrupted because of Covid outbreaks amongst children who do not yet have vaccine access. If healthcare workers do not have childcare, they cannot work. Granting access to COVID-19 vaccines to children under 5 will alleviate a burden on the health care system. 

 There are pathways to expand access to vaccines. We are confident that you can find a way to expand access to COVID-19 vaccines safely to protect children under 5. As scientists, we recognize that when problems are identified, appropriate solutions should be presented. We believe the following potential solutions are pathways to address vaccine access: 

1. Removing age de-escalation requirements for both Pfizer and Moderna vaccines would allow age groups to move forward where data shows a vaccine dose is effective and safe. 

2. We ask that the CDC remove off-label restrictions for FDA approved COVID-19 vaccines and work with the FDA to give potential dose recommendations for younger patients based on the available data, which would empower pediatricians to provide protection to their youngest patients. 

3. Current data from clinical trials is sufficient to show safety and efficacy of a 3 ug Pfizer Covid-19 vaccine dose for babies from 6 months to 2 years of age. Protecting children who are unable to wear masks should be the highest priority. It is unethical to deny protection for them until the correct dose is identified for the 2-5 year-old cohort. 

 You have the power to save babies and young children from severe COVID-19, MIS-C, long-COVID, and potential long term damage to tissues that this virus may cause. We cannot let millions of children suffer the consequences of COVID-19 when we have a safe and effective method of protection. Every severe COVID-19 symptom that occurs in a child under 5 could be prevented by working to make necessary changes to current policy. COVID-19 Vaccines must be available to children under 5 immediately. 

Sincerely,

● Emily Bates, PhD, Associate Professor, Department of Pediatrics, University of Colorado Medical Campus, Aurora, CO

● Judith Liebman, MS electrical engineering and computer science, head of nuclear science image processing and controls at Lawrence Livermore National Laboratory.

● Nicole Boczek, PhD, Genetics

● Jessica Fielder, MS Physics, Lecturer Faculty Physics and Astronomy San Francisco State University

● Stefanie N. Kairs, MS

● Rebecca Spencer, MD/PhD, Department of Anesthesia, Concord Hospital

● Christian Mosimann, PhD; Pediatrics/Developmental Biology, Johnson Chair, Associate Professor Department of Pediatrics, University of Colorado Anschutz Medical Campus

● Lisa Powell, Principal Scientist

● Genevieve Metzger, PhD, Bioinformatics, Research Project Specialist, Pacific Northwest Research Institute

● Carolyn Martineau, PhD, Senior Instructor, DePaul University Department of Biological Sciences

● Rebecca Cook, PhD, Immunology

● Alexa Burger, PhD, Pediatrics/Developmental Biology, Associate Professor

Department of Pediatrics, University of Colorado Anschutz Medical Campus

● Jennifer A. Alexander, PhD, Program Associate, English Language Programs,

The Graduate School and Linguistics,, Northwestern University

● Rachel Kammeyer, MA, CCC-SLP

● Jessica Head, DVM

● Samanth Schwartz, PhD, Department of Pharmacology Post doctoral Researcher, University of Colorado Anschutz Medical Campus

● Catarina Vales, PhD, Research Scientist, Carnegie Mellon University

● Hristo Paskov, PhD

● Sarah Verrill, DVM

● Kimberly Pool, DVM

● Aaron Strauss, M.Eng., Computer Science

● Rachel Cox, MS, CGC

● J. Garrecht Metzger, PhD

● Tila Franca, MS BioMedical Eng

● Alison Brinkman, OTR/L CKTP

● Misty L Lambert, BS, DVM, Associate Veterinarian

● Paulo Carvalho, PhD, Research Scientist, Carnegie Mellon University

● Daniela Mauler, DVM, CCRP, Diplomate European College of Veterinary Neurology

● Rachel Sellen, MS, RDN

● Anna Fisher, PhD, Developmental Psychology

● Amanda Harmon, MSW, LCSW

● Matthew Miller, MS, Mechanical Engineering, Applications Engineer II, Arconic, Inc.

● Erin Kenzie, PhD, Senior Research Associate, Oregon Rural Practice-based Research Network, Oregon Health & Science University

● Sierra Schupbach, third year medical student

● Sarah Crosby, PhD

● Liliana B Cruz. MBA, Pharmacist & Chemist

● Megan Gregory, Ph.D.

● Emma Rukhotskiy, PhD, Community and Prevention Research

● Tiffany Colglazier, DVM

● Christine James, PhD

● Chelsey Rae Calhoun, DVM

● Siân Burman, DVM

● Heather M. Wiedrick, DVM

● Laura Van de Grift, DVM

● Kaitlin Stanmyer, DVM

● Angela Cadwell, DVM

● Tracy A. Wight, DVM

● Teresa D. Bragg, VMD

● Danelle Griswold, DVM

● Erica Lachenauer, DVM, PhD Veterinary Resident at Rutgers University

● Caitlin Trebelhorn, DVM

● Tyler Hether, PhD

● Laura Smiley, DVM

● Marissa Sallee, DVM

● Taryn Lindbeck, DVM

● MacKenzie Pellin, DVM, DACVIM, DACVR, Assistant Professor of Veterinary Oncology, University of Wisconsin-Madison

● Rebecca Kohnken, DVM, PhD

● Angela Bosco-Lauth, PhD, DVM

● Theresa Hamilton, DVM

● Alissa A. Kirchhoff, MS, DVM

● Rita Johnson, DVM, MPH

● Kelsey Legendre, DVM, MS, DACVP, Veterinary Clinical Pathologist

● Lisa Langs Rund, DVM, DACVIM

● Dayna Willems, DVM

● Nicholas Colglazier, BS

● Kaila Helmer, DVM

● Sara Sammons, DVM, MS, Diplomate of the American College of Veterinary Internal Medicine

● Laura Case, PhD, Assistant Professor Department of Anesthesiology, University of California San Diego

● Alisha Bretz, DVM

● Steffani Klittich, DVM

● Margaux Bennett, PhD

● Lauren Barkley, DVM

● Nicole Fay, PhD, Director of Pharmacology, Clinical & Nonclinical Development, Nutcracker Therapeutics

● Kathryn Raymond, DVM

● Gina Lee Finney, DVM, MBA, CHPV

● Jill Mitchell, PhD, LCSW, OSW-C

● Amy Hoover, DVM

● Katharina Horton, DVM

● Elise Geldon, VMD, Owner, Liberty Falls Veterinary Clinic

● Lori Flanagan, DVM

● Kelly Lemkul, DVM

● Meredith C. Owen, DVM

● Sarah Smith, DVM

● Rebecca Jasinski, DVM

● Molly Wilson, MS, Director of Student Recruitment, College of Agriculture and Life Sciences, Virginia Tech

● Mari Childs, DVM

● Bari Morris, DVM, DACVECC

● Justin Lemkul, PhD, Biochemistry, Assistant Professor Department of Biochemistry, Virginia Tech

● Rebecca Coll, DVM

● Anna Austin, VMD

● Natalie Geuli, MSc

● Anna Goldberg, DVM

● Stacey M. Sood, DVM, MPH

● Caleb Doll, PhD, Assistant Research Professor, Dept of Pediatrics, Anschutz Medical Campus

● Lindsay Franz-Waltsak, DVM, Veterinarian, Oxford Animal Hospital

● Rachael E Carpenter, DVM, Clinical Instructor, Anesthesiology, Virginia-Maryland College of Veterinary Medicine

● Lucinda Dixon, DVM, Assistant Professor of Anatomy, Lincoln Memorial University College of Veterinary Medicine

● Kimberly Scutchfield, DVM

● Jordan Frank, M.Sc, P.Geo

● Elisabeth Hamilton, PhD, Assistant Professor of Biology SUNY OCC

● Lauren Blackwelder, DVM

● Jackelyn L. Snyder, DVM Associate Veterinarian, Hagyard Equine Medical Institute

● Yamilee Jacques, MD, Internal Medicine

● Yamilee Jacques, MD, Internal Medicine

● Tiffany Carpenetti, PhD, Associate Professor of Anatomy, Via College of Osteopathic Medicine

● Kristen James, DVM, associate veterinarian Driggs Veterinary Clinic, Driggs ID

● Elana Frankenthal, DVM. Madison, WI

● Jean Rinkowski, PT, DPT, CSCS

● Suzanne DiNello-Schleicher, VMD

● Katherine Jameson, PhD

● Amy Crutchfield, DVM

● Jennifer Fraser Bandy, MS, DVM, Medical Director Valley Veterinary Clinic

● Hilary Lucero, DVM

● Mehjabeen Hossain, PhD Candidate, Department of Bimolecular Sciences, University of Mississippi

● Rachel Lawrence, DVM, DACVPM

● Kathleen Coda, DVM, Research Animal Resources, University of Minnesota

● Dr. Lauren Culler, Ph.D., Biology, Assistant Professor, Department of Environmental Studies, Dartmouth College

● Jenette Knepley, DVM

● Lauren Auverset van Gerwen, PhD, Assistant Professor of Communication, University of Louisiana at Lafayette

● Rosana Granja-Segovia, MSc, DVM

● Amanda Webb, BS, MS

● Carole Scherling, PhD, Neuroscience

● Joshua Bowers, DO, Emergency Medicine Physician

● Laura DeWitt-Oates, BS

● Suruchi Schock, PhD, Scientist

● Anne M. Arnhym, RN, MS, CPNP, UCSF Benioff Children’s Hospital

● Megan Burger, PhD, Postdoctoral Fellow MIT

● Casey Theriot, PhD, Associate Professor at NC State University College of Veterinary Medicine

● Elisa Crisci, PhD, DVM, MSc, Assistant Professor of Virology, Department of Population Health and Pathobiology, College of Veterinary Medicine, NCSU

● Erin Stern, PhD, London School of Hygiene and Tropical Medicine

● Simone Rosenblum, MS Public Policy

● Emily Coyle, PhD, Developmental Psychology, Associate Professor and Chair, Department of Psychology, Saint Martin's University, Lacey, WA

● Eva P Karasmanis, PhD, Cellular and Molecular Medicine, Postoctoral Fellow, University of California, San Diego

● Erin Golden, PhD, Director of Undergraduate Research & Creative Activities, University of Colorado Denver

● Ross M. Kedl, PhD, Professor Department of Immunology and microbiology, University of Colorado Anschutz Medical Campus

● Kirsten Howley, PhD

● Carolyn Fisher, PhD, Biochemistry, Analytical Chemist at the Forensic Science Center at LLNL

● Aryaman Shalizi, PhD, Senior Scientist, Genomics and Functional Screening, Synthego

● Michelle Breitwisch, PharmD, MS Clinical Pharmacist

● Kelly Jean Craig, PhD, Deputy Chief Science Officer Evidence-Based Practice, IBM Watson Health

● Elyse Miller, BS, MPH

● Jesse Richardson-Jones, PhD

● Amy Larson Gordon, PhD, Scientist II, Skyhawk Therapeutics, Waltham, MA

● Linden Higgins, PhD, Faculty of Biology, University of Vermont

● Nathan Monson, BS, DVM

● Megan Zilla, MD PhD, PGY-4 Pathology Resident, UPMC

● Jessica Deckman, Senior Scientific Connect Director- Team Lead

● Heather Bowling, PhD

● Lee Dolat, PhD

● Abigail Tadenev, PhD, The Jackson Laboratory

● Anzi Hu, PhD

● Kathy Hart, PhD, LSU

● Nikki Bush, PhD, RD

● Shelley Halpain, PhD

● Christina Morcos, MSN, Family Nurse Practitioner, Clinical Nurse Specialist, RN

● Kiersten McFague, PA-C, MMS in cardiac and critical care

● Matthew Taliaferro, PhD, Assistant Professor, Department of Biochemistry and Molecular Genetics, University of Colorado Anschutz Medical Campus

● Jeffrey Tran, MS Physics

● Sarah Ivan, BS, MPP