9/2/2025 UPDATE

Pfizer and BioNTech’s updated COVID-19 vaccine, COMIRNATY® LP.8.1, has received FDA approval for the upcoming season. This vaccine targets the LP.8.1 sublineage of SARS-CoV-2, aligning with current FDA guidance to better match circulating strains.

Who Can Get the Vaccine?

The vaccine is approved for:

• Adults aged 65 and older
• Individuals aged 5 through 64 who have at least one underlying condition that increases their risk for severe COVID-19.

NOTE:  

• Patients do not need to provide documentation (e.g., doctor’s notes or medical records) to confirm their condition.  They can self-attest to having a qualifying condition when receiving the vaccine.  This policy is designed to reduce barriers and ensure easier access for those at higher risk.
• Patients can receive the flu vaccine and the COVID-19 vaccine during the same appointment. This is a common clinical practice and can be more convenient than scheduling separate visits

7/2/2025 UPDATE

Pathways remains dedicated to staying informed of immunization news. For the 2025-2026 Immunization Season, Pathways will continue to administer pre-filled 0.5-mL syringe of FluLaval Quadrivalent – an inactivated Influenza Vaccine recommended for ages 6 Months+ with no thimerosal. 

For patients 65 years and older, Fluad will be administered, unless FluLaval is requested. Fluad is a pre-filled 0.5-mL syringe of Quadrivalent Influenza Vaccine recommended for ages 65 Years+ with no thimerosal.

Pathways will continue to offer COVID-19 Pfizer vaccines as in past seasons. Though we do not anticipate a disruption in insurance coverage, further review of insurance coverage for COVID-19 Pfizer vaccines is being conducted. 

Please review the ACIP vote and information re: Flu & COVID-19 vaccines from last week’s Meeting.  

Influenza vaccines 2025–26 recommendations:  

ACIP voted (6 yes, 1 abstain) to reaffirm recommendations for the 2025–26 influenza season for routine annual influenza vaccination of all people age 6 months and older who do not have contraindications.  In three separate votes, ACIP voted (5 yes, 1 no, 1 abstain) that seasonal influenza vaccines should be provided only in single dose formulations that are free of thimerosal as a preservative for (1) children age 18 years and younger, (2) pregnant women, and (3) all adults.  The 2025–26 influenza vaccines will include a new A/H3N2 strain and the same A/H1N1 and B/Victoria strains as the previous season. All U.S. seasonal influenza vaccines marketed for 2025–26 will be trivalent. Product options will include live attenuated influenza vaccine (FluMist, AstraZeneca) for self- or caregiver-administration.

COVID-19 vaccines (information only, no vote taken)

COVID-19 disease burden:  COVID-19 continues to cause hospitalizations and death in the United States. CDC’s preliminary estimates from October 1, 2024, through June 7, 2025, indicate COVID-19 resulted in 9.8–16.1 million illnesses, 2.4–3.8 million outpatient visits, 270,000–440,000 hospitalizations, and 32,000–51,000 deaths. Long COVID also continues to be a significant public health issue. In 2023, 8.4% of adults and 1.4% of children reported having had long COVID.

COVID-19-associated hospitalizations from July 2024 through June 2025 were highest among adults age 75 years and older. Strikingly, rates of hospitalization in infants younger than age 6 months (268/100,000) were comparable to those among adults age 65 through 74 years (266/100,000). While most hospitalized adults had at least one underlying medical condition, 71% of hospitalized children younger than age 6 months and 54% of children age 6 through 23 months had no identified underlying medical condition before hospitalization. Half (50%) of SARS-CoV-2-positive pregnant women hospitalized from April 2024 through March 2025 with COVID-19 symptoms on admission had no underlying medical conditions. Approximately 1 in 4 hospitalized children younger than age 18 years required ICU admission. During 2024–25, 89% of COVID-19 vaccine-eligible children and adolescents hospitalized with COVID-19 had not received the most recently recommended COVID-19 vaccine. Similarly, most adults hospitalized with COVID-19 had received no COVID-19 vaccine since July 2023. COVID-19-related mortality decreased in 2024–25 compared to previous seasons. More than 75% of deaths occurred in adults age 75 years and older.

Vaccine coverage and effectiveness:  COVID-19 vaccination coverage for older adults improved in 2024–25 compared to previous seasons, but overall coverage remains below previous years in all age groups. Coverage was estimated at 47%, 43%, and 23% for people age 75 years or older, 65 through 74 years, and 18 through 64 years, respectively. Approximately 13% of children age 6 months through 17 years were up to date with COVID-19 vaccination in April 2025. CDC presented data from several surveillance systems demonstrating the benefits of an in-season COVID-19 vaccination in reducing emergency department/urgent care visits in children, hospitalization in infants younger than age 5 months whose mothers were vaccinated, and both types of events in adults.  

Vaccine safety:  Extensive monitoring continues to support the overall safety of COVID-19 vaccines. Most reported adverse events are similar to those seen with other vaccines. An increased risk of myocarditis and pericarditis was seen after mRNA COVID-19 vaccination among adolescent and young adult males, most often after the second monovalent or first booster dose of mRNA COVID-19 vaccine. CDC follow-up studies show that 90% people for whom this adverse event was reported had fully or probably fully recovered by 1 year after vaccination. On June 25, FDA revised the package inserts for Comirnaty (Pfizer) and Spikevax (Moderna) regarding this rare adverse event. See accompanying story in this issue.
 The majority (70%) of COVID-19 vaccine reports to the Vaccine Adverse Events Reporting System (VAERS) in children younger than age 12 years were vaccine administration errors likely due to the complexity of the recommendations. Multiple studies of COVID-19 vaccination in pregnant women showed no increased risk in maternal, pregnancy, or infant outcomes

More HERE:  CDC: ACIP Presentation Slides: June 25–26 Meeting web page

Next meeting:  The next scheduled ACIP meeting will be held October 22–23, 2025, although the ACIP Meeting Information web page notes that additional meetings may be held in September or October. Information about past and future ACIP meetings may be found on the ACIP website.   

6/23/2025 UPDATE

Advisory Committee on Immunization Practices (ACIP) 
ACIP Meeting Information – 6/25 & 6/26 

At a glance:

• The ACIP holds three regular meetings each year to review scientific data and vote on vaccine recommendations. Additional meetings may be held as needed.
• Meetings are open to the public via live webcast.

ACIP Meeting this week:  https://www.cdc.gov/acip/meetings/index.html

AGENDA:  https://www.cdc.gov/acip/downloads/agendas/draft-posted-2025-06-23.pdf