With Pfizer-BioNTech’s submission for Emergency Use Authorization for their COVID-19 vaccine for children aged 5-11, CDC and the White House have issued guidance local health departments (LHDs) can use to prepare to administer COVID-19 vaccines to this age group. On October 20, the Biden Administration announced that they have secured enough vaccines to vaccinate the 28 million children between the ages of 5 and 11 in the U.S. and are planning to make sure the vaccines are available at thousands of sites throughout the country. HHS will release a new public education campaign about the benefits of the vaccine and risks of COVID-19 for children and will work with trusted messengers and organizations to release the message.
On October 14, CDC released a Pediatric COVID-19 Vaccination Operational Planning Guide which focuses on key differences between an adult and adolescent vaccination program and one designed for younger children. The guide is based on current assumptions and will be updated as more information is available. The full guide can be found here, but listed below are some of the high-level considerations from the guide for LHDs as they prepare to vaccinate this population.
- The vaccine formulation for 5–11 year-olds will have a new product configuration code, new packaging, new preparation, and a new drug code. Preliminary differences can be seen here. Minimum orders for the launch will be 300 doses but will decrease to 100 doses in subsequent weeks.
- To avoid any confusion, no orders of Pfizer adult vaccines will be shipped during the pediatric launch. This is expected to only last for a few days.
- Sites should be ready to administer vaccines to this population as early as the first week of November.
- Begin to plan your ordering strategy and identify priority locations and providers now. Vaccination providers that are most likely to vaccinate pediatric populations should be prioritized. Ensuring equitable access should also be prioritized in site selection. Sites that will be participating in the first weeks of launch should be able to vaccinate a large volume of children and utilize all doses ordered.
- Communicate with the pharmacies and Vaccines for Children (VFC) providers in your jurisdiction to determine which are planning to vaccinate this population. Ensure they have appropriate training, access to the immunization information system, are aware of VAERS reporting requirements, and anything else needed to immediately start providing vaccines once recommended. Ensure that they are enrolled and report their supply to VaccineFinder so they will be displayed as a vaccination site on vaccines.gov. Encourage providers to offer COVID-19, flu, and any other needed routine immunizations at the same visit.
- Consider how you will reach any special populations such as tribal nations, rural and frontier areas, and children with disabilities or special healthcare needs. If there are any tribal nations within your jurisdiction, reach out to them to ensure their involvement in planning efforts. Consider working with schools to hold school-located clinics.
- Begin working on a communications plan to promote COVID-19 vaccines for those under 12. Plan to address concerns parents in your communities may have and ensure providers also know how to address these concerns. Partner with trusted organizations and messengers in your jurisdiction to help promote the safety and efficacy of these vaccines.
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to convene on October 26 to review and vote on Pfizer-BioNTech’s EUA application for their 5–11 year-old vaccine. Pending FDA’s decisions, the Advisory Committee on Immunization Practices (ACIP) is scheduled to convene on November 2 and 3 to discuss recommendations and guidelines for the administration of COVID-19 vaccine to the 5–11 year-old population. CDC will continue to update its guidance as new information and recommendations are released.