February 10, 2022, 2:21 p.m. News Staff — As the COVID-19 pandemic enters its third year, family physicians continue to face challenges such as limited supplies of test kits and treatments, shifting guidance on isolation and quarantine recommendations, changes in mask mandates and other issues that can affect patient care.
Fortunately, there are also reasons for family physicians to be optimistic. Recently, the FDA granted emergency use authorizations for two antiviral medications — Paxlovid (manufactured by Pfizer Inc.) and molnupiravir (manufactured by Merck Sharp & Dohme Corp.) — for the treatment of mild to moderate COVID-19.
The agency has also expanded the use of remdesivir (also known as Veklury) for outpatients and pediatric patients with mild to moderate COVID-19. At the same time, however, authorizations for some monoclonal antibody treatments have been revised based on data that suggests they are ineffective against the omicron variant of the disease.
To provide members with the latest evidence and information on these treatment options and other key updates, the AAFP will host a Virtual Town Hall, “COVID-19 Therapeutics: Evidence, Access and Misinformation,” on Feb. 16 from 7 to 8 p.m. CT. All AAFP members are invited to attend.
The event will be moderated by AAFP President Sterling Ransone, Jr., M.D.; Alexis “Alex” Vosooney, M.D., chair of the Academy’s Commission on Health of the Public and Science; and Julie Wood, M.D., M.P.H., the Academy’s senior vice president for Research, Science and Health of the Public.
After completing the event, attendees will be able to describe the latest evidence and information for recently approved therapeutics for COVID-19, evaluate the risk and benefits of prescribing the new therapeutics to patients when supplies are limited, and develop strategies to address patient questions and misinformation about COVID-19 treatments and prevention.
The COVID-19 Virtual Town Hall comes amid several new developments for COVID-19 vaccines.
On Feb. 4, the CDC endorsed a unanimous recommendation from its Advisory Committee on Immunization Practices to allow use of the Moderna COVID-19 vaccine in patients 18 years and older. The endorsement followed a Jan. 31 decision from the FDA to approve the vaccine.
The ACIP recommendation has been reviewed and approved by the AAFP.
The approved Moderna vaccine will be marketed as Spikevax, and has the same formulation as the Moderna vaccine that received an emergency use authorization in December 2020. It is administered as a primary series of two doses, with the second dose given one month after the first dose. It is also authorized as a heterologous, or “mix and match,” single booster dose for individuals 18 and older following completion of primary vaccination with a different COVID-19 vaccine.
On Feb. 1, in response to a request from the FDA, Pfizer Inc. and BioNTech SE initiated a rolling submission that seeks to amend the current EUA of the Pfizer-BioNTech COVID-19 vaccine to include children ages 6 months through 4 years. The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 15 to discuss the submission.
The application, if approved, would authorize the first two 3-microgram doses of a planned three-dose primary series in this age group. Data on a third dose given at least eight weeks after completing the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of the requested EUA amendment.