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

Rochelle Walensky, MD, MPH

Director, Centers for Disease Control 

Dear Dr. Walensky:

We are concerned physicians urgently requesting your immediate action to protect our youngest patients and children by providing access to life-saving COVID-19 vaccines. This is a life-threatening emergency affecting the youngest and most vulnerable members of our society and should be treated as such.

Nearly 250 doctors called on the FDA to cut the red tape to vaccinate our children in a letter sent on January 20, 2022. Today, we send this letter to you to urge the same. Please use your power to expedite vaccine access to children under age five: today, by removing the prohibition of off-label use from the vaccine provider agreement, and in the future, through any mechanism at your disposal.

We respectfully ask that you use your power to allow providers and parents the option of joint decision-making to immunize children with off-label use of any fully-approved SARS-CoV-2 vaccine (including the currently fully FDA-approved Pfizer vaccine, Comirnaty). The CDC’s vaccine provider agreement is the only barrier to off-label use of Comirnaty and lacks legal precedent (Lanphier & Fyfe, 2021). You could cut that red tape with a simple press release today.

The Omicron variant is surging through the United States. Parents and physicians have no sustainable options for protecting children under five. COVID-19 has killed more than one thousand American children, more than 400 of those under the age of five. Thousands more suffer from serious complications such as MIS-C. The situation could not be more dire. It is now clear that Omicron hits babies and young children harder, causing croup and bronchiolitis. Furthermore, long COVID, which can have debilitating neurocognitive and physical effects, is still being studied and may be common in children. The vaccine likely prevents severe illness and long term harm in these vulnerable children. ​Immediate access to vaccines is critically urgent for children, especially those who are at high risk of severe disease.

You have the power to prevent unnecessary suffering among an entire generation of children by paving the way for use of a readily available, safe, and effective method of protection against this deadly virus. Pfizer’s ongoing clinical trial has proven that lower doses are safe in children under five. Its safety profile has been demonstrated through administration in eight million children aged five to eleven in the United States alone. More than 500 million doses of mRNA vaccines have been safely given in the U.S. Physicians in other countries have safely administered thousands of doses of Comirnaty to children using off label prescribing. This is one of the most widely distributed and studied vaccines before age de-escalation.

Physicians and parents can weigh the risks–just like they do for other drugs that pediatricians prescribe off-label for children. Physicians determine appropriate dosing for more dangerous medications with less data regularly. While some families will want to wait for more data, others should have the right to choose protection now based on shared decision-making with their physicians.

 At this stage of the pandemic, with increased morbidity and mortality from the Omicron variant, we beg you to put kids first. The general population has the freedom to make individual decisions whether to vaccinate, mask, or socially distance. Our children do not have a choice. Please use any tools at your disposal to prioritize the protection of children. The CDC alone has the power to amend the vaccine provider agreement and allow off-label use.

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

Sincerely,

Katya Shpilberg, MD
Sharon Paige, MD, PhD
Zahra Syed, MD
Joanne Angiello, MD
Valerie Grant, MD, MS
Kaitlin Bowers, DO
Ashley Tatum, DO
Anisha Shetty, MD
Katherine Matthias, DO
Victoria Min, MD
Ryan Hensley, MD
Jiean Joseph Heifetz-Li, DMD MPH
Teresa Fu, MD
Meenal Sharkey, MD, FACEP, FAAEM
Eve Bloomgarden, MD
Kyle Robertson, DO
Erin Syverson MD
Maria Vintimilla, MD
Sasha Shapiro, MD
Melissa AH Gener, MD
Monica Gomberg, MD
Kerry Jurges, MD
Arthi Venkat, MD
Meghann McManus, DO, MPH
Audra Ryan-Shepard, MD MPH
Rita Silva-Leu, DO
Julia Mustillo, MD
Peter Mustillo, MD
Ritika Arora, MD
Ashley Fuller, MD
Riesa Klapproth, MD
Amanda R Howland, MD
Jamie Osman-Wager, MD MPH
Rachel Lieberman, MD
Alpa Patel Shah, DO, FAAP
Kavit Shah, MD
Kelli Williams, MD, MPH
Alissa Kahn, MD
Dashima Carthen, MD
Rebecca Karp, MD
Wanny Tam, MD MPH
Sara Sakamoto, MD
Jennifer Kaufman, MD
Christine Drower, MD
George Karp, MD
Monisha Das Ireland, M.D
Ashley Keilman, MD
John Calvin Ireland, DO
Megan Griff, MD
Elizabeth Stephens, DO
Johana Oviedo, MD, MPH
Erin Cordero, MD
Sonya Gabrielian, MD, MPH
Lynda Tang, MD
Elizabeth Levacy Foley, DO
Jessica Rachel Starr, MD
Robin Kalish, MD MPH
Stella Cai, MD
Eva Martin, MD
Alexis Dallara-Marsh, MD
Jennifer Kung, MD
Rachel Cymerman, MD
Milan Mulye, MD
Carol Lee, MD
Monica Hahn MD MPH MS
Sharmina Zaidi, MBBS MS
Meagan Roenker, MD
Shelene Stine, MD, MPH
Ashley Crimmins, MD
Melissa W. Braveman, MD, FAAP
Holland Patterson, MD
Rose Tress Quinn, MD
Noa Hughes, MD
Nicole Lacasse, MD, MPH
Allie Robbins, MD
Summer Barlow, MD
Laura Young, MD
Meredith Renda, MD
Lynsey Owen, MD, FACOG
Lynn Chacko, MD
Cathleen Adam’s, MD
David Tischfield, MD, PhD
Robin Daugherty, MD
Archana A. Parikh, MD
Bushra Rizvi, MD
Stephanie Maximous, MD, MS
Anne Mattingly, MD
Katie Fulcher, DO
Melissa Orkin, MD
Elizabeth Feldman, MD
Aarti Gaglani, MD
Elizabeth Brem, MD
Stephanie Camaglia Reznick, MD
Jennifer Kannan, MD
Rebecca Roediger, MD
Michelle Aucoin, MD
Kristen Johnson, MD
Valentina Dehghan-Bernabe, MD
Johny Kuttab, MD
Reshma Thadani, MD
Janice LB Byrne, MD
Risa Skibell MD, PhD, MBA
Jamie Hutton, MD
Dana Shanis, MD
Yuliya Gatina, DO
Cindy Cedillo, MD
Charles Chester, MD
Marina Khrizman, DO
Ralph Chester, MD
Marisa Nadas, MD
Anne Nguyen, MD
Richelle Stillwagon, MD
Kelly Fradin, MD
Holly MacCallum, MD
Nicholas Parziale, MD
Holly MacCallum, MD
Kirsten Steffner, MD
Kathryn Jacobe, MD, FAAFP, IBCLC
Kathryn DAVIS, MD, MPH
María Ximena Traa Kiely, MD, MPH
Melissa A. Tribuzio, MD
Karen Rembold, MD
Elizabeth Weedin, DO
Patricia Notario, MD
Amy Voelker, MD, FAAP
Amanda Bristol Swanson, MD
Sara Szkola, MD
Joanna Fried, MD
Adrienne D. Mishkin, MD, MPH, MS
Molly Groose, MD, MS
Bianka Soria-Olmos, DO
Aashima Bansal, MD
Kate Buzzi, MD
Mary McHugh, DO
Joel Alan Badeaux, MD, MPH
Catherine Scott, MD
Sara Jordan, MD
Jaclyn Vargas, MD
Sarah Volz, DO, MS
Raul N Lara, MD
Judy Felgenhauer, MD
Francesca Khani, MD
Shweta Bhatt, MD
Nicole Nassif, MD
Phoebe Danziger, MD
Priya Chandan, MD, PhD, MPH
Matthew Adamkin, MD
Stephanie Tarracciano, DO
Pai Liu, MD
Katherine Luce, MD
Meghan Tozzi, MD
Scheherezada Urban McCarthy, MD, FACE
Sara Rostanski, MD
Aniesa Slack, MD
Emily Hogeland, MD
Sara Dawn O’Dell, DO
Amanda Salter, MD
Kim Harvey, MD, FAAP
Elizabeth Bukowy, DO
Sara Oberhelman-Eaton, MD, CLC, FAAFP
Sonia Hegde, DO, MPH
Evelyn Angulo, MD
Sudha Dubey, MD, MPH
Jessica Ogorchock-Congilosi, MD
Randaline Barnett, MD
Nicholas Figueroa, MD
Louisa Howard, MD, MA
Mrudula Gadani, MD
Victoria Jewell-Mahler, MD, FAAP
Robin Gaus, MD
Megan Zilla, MD, PhD
Electra Foster, MD
Patrick Foster, MD
Laura Marrs, MD
Hali Pearce, DO
Summer Barlow, MD
Sarah Prebil, MD
Ephat Russcol, MD
Scheherezada Urban McCarthy, MD, FACE
Marina Khrizman, DO
Electra Foster, MD
Patrick Foster, MD
Sudha Dubey, MD, MPH
Aimee Kahn, MD, MPH
Melissa Braveman, MD
Anisha Shetty, MD
Shipra Gupta, MD
Hillary Roth, MD
Kirsten Steffner, MD
Sara Oberhelman-Eaton, MD, CLC, FAAFP
Kelly D. Berchou, MD
Andrea Orr, MD, FAAP
Joanna Fried, MD
Karen J Parsell, MD
Kristen Wendorf, MD, MS
Jennifer Kaufman, MD
Johny Kuttab, MD, FACC, FSCAI
Kristle Lynch, MD
Tara Karp, DO

Sources:
Lanphier E, Fyfe S. Pediatric Off-Label Use of Covid-19 Vaccines: Ethical and Legal Considerations. Hastings Cent Rep. 2021;51(6):27-32. doi:10.1002/hast.1296