Western States Scientific Safety Review Workgroup Finds Pfizer-BioNTech and Moderna Vaccines Safe and Effective for Children as Young as 6 Months Old

SACRAMENTO – The Western States Scientific Safety Review Workgroup today completed its review of the federal process and has unanimously concluded that the Pfizer-BioNTech and Moderna vaccines are safe and effective for children as young as 6 months old. The Workgroup provided its confirmation to the Governors of California, Nevada, Oregon and Washington this afternoon.

The Moderna two-dose vaccine series and the Pfizer three-dose vaccine series are now available to children as young as 6 months old. On Friday, June 17, the U.S. Food and Drug Administration (FDA) authorized the use of the vaccines in children as young as 6 months old, and the CDC affirmed that decision on Saturday. The Workgroup reviewed the federal decisions on Saturday and affirmed them today.

The Workgroup thoroughly reviewed safety and efficacy data for the vaccines. The Workgroup found that completion of either vaccine series produced antibody levels similar to those achieved in individuals aged 16-25 years. Observed vaccine reactions among infants aged 6-12 months and children aged 1 through 5 years were consistent with reactions to other vaccines routinely recommended for these age groups.

The Workgroup concluded that the benefits of completing either vaccine series substantially outweigh any known or likely risks. Immunization can be expected to reduce the numbers of COVID-19-related serious illnesses, hospitalizations, and deaths in young children while facilitating their participation in normal educational, social and recreational activities.

Washington, Oregon, and Nevada joined California’s COVID-19 Scientific Safety Review Workgroup in October 2020. The Workgroup, made up of nationally-acclaimed scientists with expertise in immunization and public health, has concurrently and independently reviewed the FDA’s actions related to COVID-19 vaccines. It will continue to evaluate other COVID-19 vaccines as they go through the federal process.

“Vaccines are safe, effective, and widely accessible – we’re strongly encouraging parents to protect their kids from COVID-19 with these vaccines, and California has pre-ordered nearly 400,000 doses that can be administered at the more than 8,500 vaccine sites throughout the state.” California Governor Gavin Newsom Said.

California Health and Human Services Agency Secretary, Dr. Mark Ghaly, and Director of the California Department of Public Health (CDPH) and State Public Health Officer, Dr. Tomás J. Aragón, issued a joint statement supporting the recommendation by the Western States Scientific Safety Review Workgroup, the U.S. Centers for Disease Control (CDC), the American Academy of Pediatrics, and the Federal Food and Drug Administration (FDA) to grant emergency use authorization (EUA) of the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as 6 months.

“Vaccination for children aged 6 months and older is an important tool to protect against COVID-19 and ensures our communities can now have whole family protection against this deadly virus. Along with other routine children’s vaccinations, we recommend infants and children 6 months and older complete their primary COVID-19 vaccination series and stay up to date on all recommended childhood vaccines, including COVID-19.

“Although our youth are resilient, COVID-19 hospitalizations for children under 4 years old were five times higher during the Omicron surge than during Delta, and one in five children hospitalized with COVID-19 were also admitted to the ICU. COVID-19 has become one of the top five leading causes of death in children and vaccines make these deaths preventable. Studies have shown that getting our children vaccinated is the safest way to protect them from the worst outcomes of COVID-19, including hospitalization, long COVID, Multisystem Inflammatory Syndrome in Children (MIS-C), and death. Getting everyone in our homes and communities vaccinated reduces the chances for the virus to spread to those we love most.”

Clinical trials involving thousands of infants and toddlers 6 months and older firmly show that the COVID-19 vaccines are safe and effective in this population.

The authorization will add young children aged 6 months through 4 years old to those eligible to get a Pfizer vaccine (ages 5-17 are already eligible), and children and adolescents aged 6 months through 17 years old to get a Moderna vaccine.

In alignment with California’s SMARTER Plan, the state is operationally ready to immediately begin administering vaccines for infants and toddlers aged 6 months and older this week. To find a vaccine, visit myturn.ca.gov or call 1-833-422-4255. Parents can also talk to their child’s health care provider, or visit Vaccinate All 58 to learn more about the safe and effective vaccines available for all Californians aged 6 months and older.