• AAFP Approves Recommendations on Updated COVID-19 Vaccines

    Sept. 15, 2023, News Staff — The AAFP approved federal actions that allow the broad use of updated COVID-19 vaccines made by Pfizer/BioNTech and Moderna to target specific strains of the virus that causes the disease.

    The Academy’s Commission on Health of the Public and Science began an expedited evidence review this week after the FDA approved the vaccines for children and adults ages 12 years older and authorized them for emergency use in children ages 6 months to 11 years, and the CDC recommended them for people 6 months and older. Board Chair Sterling Ransone, M.D., FAAFP, accepted the commission’s recommendation to approve the agencies’ actions on Sept. 14.

    Updated Vaccine Recommendations

    Under the FDA’s guidelines,

    • people ages 5 years and older, regardless of previous vaccination, are eligible for a single dose of an updated mRNA COVID-19 vaccine at least two months after the last dose of any COVID-19 vaccine;
    • people ages 6 months through 4 years who have previously been vaccinated against COVID-19 are eligible for one or two doses of an updated mRNA COVID-19 vaccine (with timing and number of doses dependent on the previous COVID-19 vaccine received); and 
    • unvaccinated people ages 6 months through 4 years are eligible for three doses of the updated Pfizer-BioNTech COVID-19 vaccine or two doses of the updated authorized Moderna COVID-19 vaccine.

    The bivalent Moderna and Pfizer/BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

    The CDC has also posted updated COVID-19 vaccine recommendations along with additional guidance on use of the vaccines in people who are moderately or severely immunocompromised.

    The updated vaccines are monovalent or “single-target” mRNA vaccines. They are each administered in a single dose and include a component designed to protect against XBB 1.5, an omicron subvariant of the virus. Although XBB 1.5 is no longer the most common strain in circulation, substantial evidence suggests the vaccines will provide good protection against it, as well as against BA.2.86, another omicron subvariant that has raised concern.

    “Ample data from previous iterations of the vaccine show that it is safe,” Jay Lee, M.D., M.P.H., FAAFP, a member of the AAFP board of directors and chief medical officer with Share Our Selves, a federally qualified health center in Costa Mesa, Calif., told TheHealthy.com.

    “Getting the vaccine is among the most effective ways to prevent serious illness now that people aren’t routinely wearing masks or avoiding large crowds,” he said. “We know that people who have been vaccinated or have had COVID-19 in the past do better and are less likely to become seriously ill or die.”

    The application for an updated non-mRNA vaccine from Novavax was still pending with the FDA as of Sept. 12.  However, the recommendation from the Advisory Committee on Immunization Practices that the CDC accepted covers monovalent XBB-containing COVID-19 vaccines that could be authorized in coming months. 

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    Fair and Equitable Vaccine Access

    The updated COVID-19 vaccines, which may be available as soon as this week, will be covered by most public and private insurance plans because they are recommended by the ACIP, but an estimated 25 million to 30 million adult Americans do not have health insurance. Because the COVID-19 public health emergency expired in May, there has been concern that some adults without health insurance may have to pay out of pocket for the vaccines, which cost $120 to $130.

    “We are concerned that transitioning the COVID-19 vaccine to the commercial market will create financial and operational challenges for physicians that will impact access to and utilization of COVID-19 vaccines,” the AAFP told HHS in a Sept. 7 letter. To maximize COVID-19 vaccination this fall, the letter urged the administration to

    • ensure that distribution processes, payment rates and manufacturing buy-back programs enable primary care practices to offer COVID-19 vaccines; and
    • facilitate timely, equitable access to vaccines for uninsured adults through the CDC’s new Bridge Access Program.

    This advocacy is informed by meeting the AAFP had over the summer with vaccine manufacturers and other stakeholders to learn about the commercial packaging, storage and handling of the updated COVID-19 vaccines. The letter noted that “while some things have improved (single-dose vials), there remain unique challenges to acquiring, storing and furnishing COVID-19 vaccines for the upcoming year.”

    Family Physicians Tout Vaccination Benefits

    Several family physicians shared advice on talking with patients and administering the updated vaccines, either alone or in conjunction with other immunizations.

    AAFP President Tochi Iroku-Malize, M.D., M.P.H., M.B.A., FAAFP, who is the senior vice president and chair of the family medicine service line for Northwell Health in New York, told CNN she will encourage patients to schedule vaccination as soon as possible.

    “Your exposure to the virus does not depend on when you schedule your vaccine,” said Iroku-Malize. “The virus is not waiting for you to go get your vaccine. So get the vaccine now, as soon as you’re able.”

    Marcus Plescia, M.D., M.P.H., of Charlotte, N.C., a family physician and chief medical officer for the Association of State and Territorial Health Officials, noted that the vaccines could prove especially beneficial for certain patient populations.  

    “This vaccine is really important, particularly for people at high risk for severe COVID-19, such as older people and those who have underlying medical problems,” Plescia said.

    And Ransone, who is also the physician practice director at Riverside Fishing Bay Family Practice in Deltaville, Va., told Scripps National News he would make the updated vaccines part of a larger effort to protect older patients against a wide range of respiratory diseases.

    “For most of my patients over 60 these days, I’m recommending that they get their flu shot, that they get their updated COVID booster and that they get an RSV vaccine,” Ransone said, “so it’s a big three this year.”

    Family physicians are encouraged to visit the Academy’s COVID-19 webpage for the latest on COVID-19 vaccines, treatment options and educational activities.