Following an analysis of safety and effectiveness data, the Food and Drug Administration (FDA) on July 8 granted full approval of the Pfizer-BioNTech COVID-19 vaccine for use in individuals ages 12 to 15.
FDA authorized the vaccine for emergency use in this age group in May 2021 and granted full approval for use in those 16 and older in August 2021. The vaccine remains available under emergency use authorization (EUA) for people 6 months and older and as a booster dose.
FDA Authorizes Pharmacists to Prescribe Paxlovid
FDA on July 6 revised the EUA for Paxlovid, an antiviral authorized to treat patients with mild to moderate COVID-19 and at high risk of developing severe disease, to allow state-licensed pharmacists to prescribe the drug, with some limitations.
While state-licensed pharmacists at Test-to-Treat sites already are authorized to prescribe Paxlovid, the revised EUA allows community pharmacies not participating in the Test-to-Treat program the option to offer this service to patients.
Paxlovid must be taken within five days of symptom onset. FDA encourages patients first to consider seeking care from their regular health care provider or at a local Test-to-Treat site. Patients who have tested positive for COVID-19 and seek to determine their eligibility for receiving Paxlovid through a state-licensed pharmacist must provide electronic or printed health records that are less than 12 months old, including their most recent laboratory blood work for the pharmacist to review for kidney or liver problems. Alternatively, pharmacists may consult the patient’s health care provider for this information.
Patients also must provide a list of medications, including over-the-counter medications, they are taking, so the pharmacist can screen for drugs that have potentially serious interactions with Paxlovid.
State-licensed pharmacists should refer patients to a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, in the event that:
- there is insufficient information to assess renal and hepatic function;
- there is insufficient information to assess for a potential drug interaction;
- other medications must be modified due to a potential drug interaction; or
- Paxlovid is not an appropriate therapeutic option based on the current fact sheet for health care providers or due to potential drug interactions that cannot be monitored.
FDA Extends COVID-19 Test Expiration Dates
FDA has extended the expiration dates for InBios International Inc. SCoV-2 Ag Detect Rapid Self-Tests and SD Biosensor Inc. Pilot COVID-19 At-Home Tests. Using additional data from the manufacturer, FDA extended the test’s shelf life from 10 to 13 months.
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.