Pfizer and BioNTech have applied to amend the FDA emergency use authorization (EUA) for their COVID-19 vaccine to include children ages 6 months to 4 years old.
The application is for authorization of the first two three-microgram doses in a planned three-dose primary series. In the coming months, Pfizer and BioNTech will submit data on a third dose, given eight weeks after completion of the second dose. The three-microgram dose is smaller than the 10-microgram dose for children ages 5 to 11, authorized in October 2021, and the 30-microgram dose currently given to individuals ages 12 and older.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Feb. 15 to discuss this request. Meeting materials will be available two days in advance.
ACIP Recommends Moderna Vaccine for Adults
Meanwhile, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices on Feb. 4 recommended the Moderna COVID-19 vaccine for individuals 18 and older. This comes a week after the Food and Drug Administration (FDA) granted the vaccine full approval.
Medicare to Cover Over-the-Counter COVID-19 Tests
The Centers for Medicare & Medicaid Services (CMS) announced Feb. 3 that enrollees in Medicare and Medicare Advantage can access over-the-counter COVID-19 tests at no cost.
Beneficiaries can access up to eight FDA-authorized or -approved tests each month at no cost through eligible pharmacies and participating entities, which will receive payment directly from Medicare. CMS anticipates the initiative will begin in early spring.
The agency has released an FAQ document with more information.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.