A Letter to the FDA from Physicians Calling for Urgent Vaccine Access

Janet Woodcock, MD
Acting Commissioner Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993

Dear Dr. Woodcock:

We are concerned physicians requesting your urgent attention in regards to protecting our youngest patients and children through access to life-saving COVID-19 vaccines. As the Omicron variant surges throughout the United States, parents and physicians continue to have no options for protecting our children under five years of age against COVID-19. With over 1,000 children under age 18 in the US dead from COVID-19 and thousands suffering from serious complications such as MIS-C, the situation could not be more dire. Moreover, we are now learning that Omicron hits babies and young children harder in their upper respiratory tract than previous variants, causing croup and bronchiolitis. This is of particular concern for the very age group that either cannot wear masks or has the most challenge wearing masks. We cannot let an entire generation of children suffer when we have a safe and effective method of protection.

We suggest two solutions to make it easier for our youngest patients and children to receive vaccines:

Solution #1

Allow providers and parents the option of joint decision-making to immunize children with off-label use of the Pfizer 10ug vaccine. This is especially true for children who are at very high risk of severe disease. The risks and benefits can be weighed by physicians and parents, but prohibiting this option as COVID spreads uncontrolled throughout our country is unethical. The Pfizer vaccine has been given to seven million children aged five to eleven in the United States, with an astounding safety profile. Moreover, 500 million doses of mRNA vaccines have been given in the U.S. and their safety has been scrutinized more than any vaccine in history. Arguably, this is one of the most widely distributed and studied vaccines before being de-escalated for administration to children. ​​No other vaccine has had such extensive dosing differences for multiple different age groups. While some families will want to wait for a lower dose, others should have the right to make this imperative choice.

Solution #2

Remove the age de-escalation barrier to vaccine approval. The de-escalation requirement is understandable in regular trials, but it is unacceptable during a raging pandemic. Removing this red tape would allow approval of Pfizer’s 3ug dose for children aged six months to two years, which trials found to be safe and effective. Delaying distribution and administration to children simply because of procedure is unethical and immoral in light of our current circumstance. As children re-enter daycare centers, preschools, and other unavoidable group settings, we all know that the number of young children infected with Omicron will soar exponentially, creating the largest health risk that kids have faced collectively throughout the entire pandemic.

The two aforementioned courses of action would be the quickest way for our children to have access to these life-saving vaccines. However, we would also urge the FDA to review and give EUA approval to the Moderna vaccine for children six months to five years as soon as possible once the data is received and the vaccine is shown to be safe and effective. It is becoming clear that the Moderna vaccine is offering better protection against variants and also severe disease. Offering this as an option to our children immediately should the submitted data show positive results is imperative.

Let’s put kids first. The general population has made their decision whether to vaccinate, mask, or socially distance. Many have been ignoring our warnings despite wave after wave of infections. Our children don’t have a choice; all they have is their parents and physicians using their every last ounce of strength, hope and perseverance to protect them from this novel virus.

Every hospitalization, medical complication, death and case of MIS-C that occurs in a child under five due to COVID-19 at this point in the pandemic is a travesty that could have been prevented. We have the technology and science to protect our children, yet we have not made their protection our number one priority. This must change immediately. We implore you. Please don’t make us wait any longer to protect our children.

Sincerely,

Katherine Matthias, DO
Sheyla Villena, MD
Katya Shpilberg, MD
Stephanie Maximous, MD, MS
Katherine Gartin, MD
Sonia Hegde DO MPH
Joan Pelletier, DO, FAAP
Katherine Luce, MD
Joanna Mattis, MD, PhD
Melissa Kivitz-Krantzow, MD
Melissa Orkin, MD
Mehak Swami, DO
Heather R. Saavedra, MD
Samya Mohammad, DO
Archana Chander, MD
Subin Sharma, MD
Robert Montero, MD, FAAP
Caitlin M. Nicotra, DO
Saira Adeel, MD
Asma Khalid, MS, MD
Christian Faulkenberry, MD
Saira Alimohamed, MD
Sonia Hovelson, MD
Anne Chmilewski, MD
Sonya Gabrielian, MD, MPH
Inessa Fishman, MD
Julie Gutman, MD
Ramona Ataya-Dakour, MD
Ramzi Dakour, MD
Shweta J. Bhatt MD
Huma Rana, MD, MPH
Alissa Kahn, MD
Amanda R Howland, MD
Sugandha Landy, MD
Rochelle Schieb, MD
Melissa AH Gener, MD, FCAP
Julia Mustillo, MD
Yoo Mee Shin, MD
Jamie Osman-Wager, MD, MPH
Rachel Kornik, MD
Krysta Koepke, MD
Kathleen D. Keeffe Hough, MD
Lauren Stern, MD
Susan Yuditskaya, MD
Marsha Chenoweth, MD, FAAP, FAPA
Faith Galderisi, DO
Uma S. Levy, MD
Pamela D. Portnoy-Saitta, DO
Jennifer Kaufman, MD
Jessica Rachel Starr, MD
Jennifer Youngblood, MD
Riabianca Garcia, MD
Kelsey Alexander, MD
Hillary Roth, MD
Connie Lee, MD
Lily Mei, MD
Sohni Dean, MD
Milan Mulye, MD
Brittany Chan, MD
Kalindi Parikh, MD
Zara Oakes, MD
Alpa Patel Shah, DO, FAAP
Asma Chattha, MBBS
Kirsten Steffner, MD
Fiana Klein, DO
Lauren Azevedo, MS, DO, FAAP
Angela Griffin MD
Dana L Hartwigsen, DO
Gloria Choi, MD
Sarah Ditch, MD
Etsegenet Tizazu, MD
Zahra Syed, MD
Sasha Shapiro, MD
Whitney Bossert, MD
Shelileah Newman, MD
Emily Paprocki, DO
Jasmine Bauknight, MD
Sarah E Lichtenstein, MD
Catherine Krafft, MD
Maryam Hosseini, MD
Lubaba Kobaisy, MD
Summer Barlow, MD
Dr. Kimberly Nowak, DO
Nicole LeBoeuf, MD, MPH
Sara Schroder, MD
Eugenia Kim DO
Arielle Bauer, MD
Sharon Paige, MD, PhD
Alexandra Downing, DO
Vidya Pai, MD
Lingmin He, MD
Christina Hernandez, MD
Richelle Stillwagon, MD
Kavit Shah, MD
Kathleen Pencek, MD
Sara Szkola, MD
Peter Mustillo, MD, FAAAAI, FAAP
Yuliya Gatina, DO
Leah Delumpa, DO
Daphna Shiffeldrim, MD
Elizabeth Bukowy, DO
Kristen Wendorf, MD
Julianne Hesterberg, MD
Maria Ximena Kiely, MD, MPH
Michelle Park, MD
Christina Blum, MD
Amber Sobuto, DO
Lisa R Allen, MD, FACS
Hilary Anderson, MD
Priyanka Gimbel, MD
Jennifer Foster, MD
Sarah Prinzi, MD
Emily Torell, MD, MPH
Jessica Meznarich, MD
Dana Johnson, MD
Andrea Stitgen, MD
Ashley Keilman, MD
Briana Riemer, MD
Tiffiny Hron, MD, FACS
Kate Waldeck, MD, FAAP
Tricia Thomson, MD
Dr. Valerie Grant, MD, MS
Jill C. Anderson, MD
Christy Harvey, MD
Robin Kalish, MD, MPH
Kristi Moore, MD
Kristi Smith, DO
Leena Pawar, MD
Priya Simoes, MD
Victoria Min, MD
Ghada Harsouni, MD
Teresa Fu, MD
Pia Chatterjee, MD
Mary Abel, MD
Pakhadi Buddhadev, MD
Emily Gladstone, DO
Dr. Jennifer Harmon, MD, PHD
Lukas Gladstone, DO
Elizabeth Richardson, DO
Shaunna Lyon, MD, FAAP
Marina Khrizman, DO
Erica Katz, MD
Heather Siefkes, MD
Judy Lin, MD
Anisha Shetty, MD
Rachel Rosenstein, MD, PhD
Kenneth Lieuw, MD, PhD
Bibhav Acharya, MD; Associate Professor
Ameena Ahmed, MD, MPH
Roshen Mathew, MD
Violette Hong, MD
Shikha Jain, MD, FACP
Allison Lippert Boatman, MD
Lara Marsh, MD
Angela Vrooman, DO
Kirsten Koch, MD
Amy Wysocki, MD
Kathryn Tegeder, MD
Emilie Padfield, MD
Erika Nealey, MD
Jennifer Mills, MD, FACP, FHM
Stephanie Camaglia Reznick, MD
Teri T. Bates, CPNP
Sayani Tewari, MD
Fariha Hussain, MD
Jennifer Osborne, MD
Eva Martin, MD
Kendra Joy Jackson, MD
Jennifer Belasco, MD, MS
Joanna Fried, MD
Sarah Nelson-Taylor, MD, PhD
Dr. Rachel Sidwell, MD, FAAP
Jennifer Kannan, MD
Jacqueline Kannan, MD
Kelly Fradin, MD
Heather Lawsky-Scheer, MD
Joyce Zmuda, MD, FAAP
Robyn Steinacher, DO
Sarah Van Camp, DO
Ashley Crimmins, MD
Michelle Myers, MD
Teresa Nodal, MD
Shelene Stine, MD, MPH
Nicholas Stine, MD
Lisa Wray, MD
Alrick Drummond, MD, FAAP
Tiffany Moadel, MD
Laura D. Romano, DO
Jill Moore, MD
Janet Perlman, MD, MPH
Patricia Wells, MD, FAAP
Sarah Abdulhamid, MD
Catherine Krafft, MD
Kathleen Pedersen, MD
Katrina Willie-Musoma, MD, FAAP
Andrea Orr, MD, FAAP
Vibha Murthy, MD
Milan Mulye, MD, FAAP
Reshma Ajmere, MD
David Mattos, MD
Valentina Dehghan-Bernabe, MD
Phoebe Danziger, MD
Rosabelle McConkey, MD
Amy Voelker, MD, FAAP
Aimee Kahn, MD, MPH
Nancy Uythoven, MD, FAAP
Alexandra C. Villasante Fricke, MD
Sohni Dean, MD
Hyunjung Stella Shin, MD
Perel Schneid, DO
Kristen A. Romanelli, DO
Scott Penney, MD
Kevin Kannan, MD
Rishi Gaiha, MD
Aditi Stanton, MD
Danelle Stabel, DO
Erin Syverson, MD
Laura Young, MD
Connie Cheng, MD
WanWan Xu, MD
Teresa Ku-Borden, MD
Kimberly Ponton, MD
Joanna Chin, MD
Monica Hahn, MD, MPH, MS
Anil Goklaney, MD
Stephanie Tarnacki, MD
Nicole Lacasse, MD, MPH
Sarin Prakobwanakit, MD
Noor Tarabishy, MD
Rebekah Diamond, MD
Sarah Kureshi MD, MPH
Rachel Cymerman, MD
Ritu Jain Viswanath, MD
Purab Viswanath, MD
Sara Casile, DO
Catherine Feaga, DO
Deepthi Reddy, MD
Kelli Williams MD, MPH, Associate Professor
Jami Zaretsky, MD
Nicole Boczek, PhD
Sarah Volz, DO
Rachel Thomas, DO
Leigh Bragg, MD
WanWan Xu, MD
Janice Man, MD
Kathryn Davis, MD, MPH
Leyat Tal, MD
Laura Herzig, MD
Evelyn Angulo, MD
Lynn Ngo, DO
Scheherezada Urban McCarthy, MD, FACE
Nina Patel, MD
Priya Pillutla, MD
Zoe Aron, MD
Mallory Alcala, DO
Nina Nanda Vadecha, MD
Saul Hymes, MD, FAAP; Associate Division Chief of Pediatric Infectious Diseases
Neha Kumar, MD
Monika Goyal, MD, MSCE
Dr Audra Ryan-Shepard, MD MPH
Samantha Deming-Berr, DO, MPH
Robyn George, MD
Leslie Lane, MD
Katherine Ready, MD
Andrea Zepeda, MD
Gianina Best, MD
Scheherezada Urban McCarthy, MD, FACE
Michele M. Walsh, MD
Scott Zucker, MD
Bianca Jacobs, MD
Deborah Steinbaum, MD, MPH
Heather Shafi, MD, FAAP
Sabrina Young, DO
Leah Jordan, MD, Fellow Physician in Neonatal-Perinatal Medicine
Jennifer Young, DO
Nicole Miniuk, MS, FNP-BC
Sophia Patel, MD
Dr. Molly R. Falasco, MD
Kathryn S. Sutton, MD
Katherine Baldwin, MD
Risa Skibell, MD, PhD, MBA
Bethany Sabol, MD
Alisa Khan, MD, MPH
Jennifer Swingle, DO
Stephanie Cone, MD
Renée Betancourt, MD
Elise Bender, MD
Ryan Heinrich, RN
Phoebe Olhava, MD
Emily Hamburg-Shields, MD, PhD
Zeva Daniela Herzog, MD
Melissa W. Braveman, MD, FAAP
Heidi Schmidt, MD, MS
Rebecca N. Thompson, MD, MSc
Kerry Jurges, MD
Lindsey Stephens, MD
Stephanie Salinas Gallagher, MD
Amanda Kiely Bicket, MD, MSE
Kam Lam, MD, MPH, MS
Sara Szkola, MD
Johny Kuttab, MD, FACC, FSCAI
Carly Zapata, MD, MPH
Whitney Hunt, MD, FAAP
Aditi M. Kapil, MD FACS
Jennifer Cotton, MD, Assistant Professor of Emergency Medicine
Kate Hoppock, DO
Joanne Angiello, MD
Kathryn Heim, MD
Jennifer Kung, MD
Sudha Dubey, MD, MPH
Ashley Fuller, MD
Arun Gurunathan, MD
Eric Sincoff, DO
Sarah Lupu, MD
Matthew N. Fournier, MD
John P Okerblom, MD
Christine Lee, MD, CLC
Heather Kapperman, MD, MS
Maaria Syed, MD
Insiyah Gomberawalla, MD
Alex Cutler, MD
Adam Janicki, MD
Shawn Brickner, MD
Anna Pesok, MD
Sara McLaughlin, MD, PhD
Amanda Carpenter, MD
Christopher Ashton, MD, FAAP
Alyssa Valenti, MD
Jennifer McNulty, MD
Jamie Hutton, MD
Gaby Aguilera Nunez, MD
Emily Breidbart, MD
Erin W. McLeod, MD
Manile Dastagir, DO
Rebecca Brafman, MD
Amy Becker, MD
Erin Hanft, MD
Emanuela Cimpeanu, MD
Shira Yun, MD
Noel Torres Jr, MD, FAAP
Eliza Hutchinson, MD
Sylvia Lee, MD
Julia Selezneva, MD, MS
Shauyene Hsieh, MD
Kimberly Bloom-Feshbach, MD
Jessica Anglin, MD, FAAP
Fauzia Shaikh, MD
Anusha Viswanathan, MD
Samantha Auman, MD
Melissa S Hughes, MD
Dana Raml, MD
Mollie M, Cecil, MD
Jamila Fletcher, MD
Joyce Hairston, MD, MS

Aniesa Slack, MD
Anthony Strickland, MD, FASAM
Eliana Cardozo, DO
Elizabeth Elmschig, MD MPH
Elizabeth Qin, MD PhD
Carmen Kilpatrick, MD
Kyle Gillis, MD
Dana Gal, MD
Juliet Morgan MD
Heather Felton, MD
Honora Burnett, MD MPP
Eleanor Woodward, MD
Stephanie C. Gardner, MD
Allie Schwartz, MD
Olivia Choi, MD, PhD
Kenneth Pettersen, MD, MPH
Sarah Michael, DO, MS
Leslie Finkel, MD
Bushra Rizvi, MD
Eve Bloomgarden, MD
Christine Drower, MD
Stephanie Li, MD
Aedan S. Olaso, MD, FACP
Bao Huynh, MD
Meghna Joshi, MD
Maura Dunfey Hwang, DO
Anna Rempel, MD
Kendra Reith, MD
Shelly Gruenbacher, MD
Kaitlin Bowers, DO
April Barnado, MD, MSCI
Ashley Burkholder, DO
Natasha Boydstun, DO
Kathryn Fick, MD
Megan Kirch, MD
Loren Gavaghan, MD
Melissa Zegar, DO
Laura Davids, MD
Ashley Tatum, DO
Angela Weyand, MD
Andrea Censullo, MD
Jami A Maxson, MD
Raelene Walker, MD, FAAP
Abigail VW Kumral, MD
Eneida Nemecek, MD, MS, MBA
Andrea Edlow, MD, MSc
Julie Childers, MD, PhD
Joseph Yaroch, MD
Anika Nelson, MD
Marit Knutson, MD
Carly Zapata, MD, MPH
Joseph S. Thomas, MD
Nicholas Johnson, MD
Carol Lee, MD
Karen Rembold, MD
Meagan Roenker, MD
Matthew Molloy, MD, MPH
Laura Young, MD
Megan H Pesch, MD, MS
Amber M Tyler, MD
Heather Schlott, MD
Anna Jesus, MD
Katie Fulcher, DO
Kristen Marrone, MD
Ralph L Chester, MD
Charles Chester MD
Brett L. Arron, MD, FASA
Irène Mathieu, MD
Peter P. Scalise III, MD, FACC
Serwa Ertl, MD
Chrisanna Dobrowolski, MD, MS
Bradley DeNardo, MD
Kristen Johnson, MD
Reshma Thadani, MD
Magdalene Brooke, MD
Risa Skibell, MD, PhD, MBA
Jamie Osman-Wager, MD MPH
Elizabeth Marsicano, MD
Cindy Cedillo, MD
Farid Jalali, MD
Audrey Stanton, DO, MPH, FACEP
Janienne Kondrich, MD
Yamilee Jacques, MD, Internal Medicine
Kathryn Jacobe, MD, FAAFP, IBCLC
Michelle Murray MD FAAP
Melissa A. Tribuzio, MD
Christine Martín, MD MPH
Bianka Soria-Olmos, DO
Danielle Bius, MD
Catherine Scott, MD
Shruti Gandhi, MD
Judy Felgenhauer, MD
Katherine Luce, MD
Emily Hogeland, MD
Kim Harvey, MD, FAAP
Amy Cho, MD, MBA, FACEP
Amanda Wallace, MD
Katherine Baldwin, MD
Michelle Tang, MD
Jessica Carani, MD
Sarah Wiersma, MD
Monica Selak, MD
Ruchita Amin, MD
Theodore E. Dushane, PhD, MD
Electra Foster, MD

Randaline Barnett, MD
Nicholas Figueroa, MD
Kimberly Ponton, MD
Louisa Howard, MD, MA
Kristen Poston, DNP, NP-C
Mrudula Gadani, MD
Fatima Ahmad, MD
Megan Zilla, MD, PhD
Laura Simon, MD
Mark Sorrentino MD, MS
Laura Marrs, MD
Summer Barlow, MD
Emily Fisher, MD
Patrick Foster, MD
Jane Lyons, MD
Jessica Lemke, MD
Jeffrey Landy, MD
Jacquelyn Smith, DO
Heather Felton, MD, FAAP
Lindsey Healy, MD