To those with power to make change,

We are concerned physicians requesting your urgent attention in regards to protecting our youngest patients and children through access to life saving COVID-19 vaccinations. As the Omicron variant continues to spread exponentially throughout the United States, parents and physicians continue to have no options for protecting our children under 5 years of age against COVID-19. With over 1000 children under age 18 in the US dead from COVID 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 toddlers harder than previous variants- tragically, the very age group that cannot wear masks for protection. 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 the Pfizer 10ug vaccine off label. 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 seems unethical. The Pfizer vaccine has been given to 8 million children aged 5-11 in the United States alone with an astounding safety profile. Moreover, 9 billion doses of mRNA vaccines have been given worldwide and their safety has been scrutinized more than any vaccine in history. There is no other vaccine that has been so widely distributed and studied before being de-escalated for administration to children. There is also no other vaccine that has 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 for the 3ug dose for children aged 6mo-2years, which the Pfizer trials found to be safe and effective. Delaying distribution and administration to toddlers simply because of procedure is morally unacceptable in light of our current circumstance. As children re-enter daycare centers, preschools, and other unavoidable group settings this week, 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 6mo-6years 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 5 due to COVID 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 absolute number one priority. This must change immediately. We implore you. Please don’t make us wait any longer to protect them.