On Monday, May 10, 2021, the Food & Drug Administration (FDA) announced they are amending the emergency use authorization (EUA) for Pfizer/BioNTech’s COVID-19 mRNA vaccine to include adolescents age 12 to 15. On Wednesday, May 12, this EUA expansion was affirmed 14-0 (with one recusal) by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), the final step to offering the vaccine to the public under the new EUA guidelines.
Non-grandfathered health plans, whether insured or self-funded, must provide no-cost coverage of the vaccine for this new age group within 15 business days. During the public health emergency declaration, this no-cost coverage must be available in- or out-of-network. Once the public health emergency ends, cost-sharing can be applied out-of-network only if there is adequate in-network access to the vaccine. At this time, the federal government has been paying for all vaccines, so the only costs charged have been for administration of the vaccine.
The previous Pfizer/BioNTech vaccine EUA issued December 11, 2020, was approved for individuals age 16+. Pfizer has begun the process to request full approval of the vaccine
IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.
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