COVID-19, RESPIRATORY SYNCYTIAL VIRUS (RSV), AND INFLUENZA VACCINATION UPDATES 09/27/2023

Date: 09/27/23

As you may recall, in the Fall of 2022 we experienced the ‘tripledemic’, with historic cases of respiratory infections due to COVID-19, influenza (flu), and RSV. To prepare for the fall and winter seasons upon us, review the vaccination recommendations for COVID-19, flu, and RSV.

COVID-19*

The current, up to date COVID-19 vaccine is a bivalent vaccine consisting of the original virus strain and the omicron virus strain. In June, the Vaccines and Related Biological Products Advisory Committee recommended that the 2023-2024 COVID-19 vaccine formulation be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. Pfizer, Janssen, and Moderna are currently in process of updating their current formulations, with plans to have the vaccine available by late September, early October¹.

The recommendations below are as of September 2023 for COVID-19 vaccination²:

Bivalent Vaccination

Status	Manufacturer	Vaccine Dose
Unvaccinated	Moderna/Pfizer	1 dose now
1 or more doses of monovalent vaccine	Moderna/Pfizer	1 dose 8 weeks after previous dose
At least 1 dose of bivalent vaccine	Moderna/Pfizer	No further dose *If ≥65 years 1 dose 4 months after 1st bivalent dose

The below table summarizes the COVID-19 vaccinations needed to ensure your patients are up to date.

Age/Status	Vaccine Dose
≥6 years old	1 updated Pfizer or Moderna vaccine
6 months to age 5	Pfizer: 6 months to 4 years old get 3 COVID-19 vaccine doses, including at least 1 updated COVID-19 dose 5 years old get at least 1 updated COVID-19 vaccine dose Moderna: 2 vaccine doses, including at least 1 updated COVID-19 vaccine dose
≥65 years old	May receive a 2nd dose of Pfizer or Moderna vaccine
Unable to receive mRNA vaccine	Novavax COVID-19 vaccine doses approved for the age group
Johnson & Johnson/Janssen vaccine	1 updated vaccine dose Pfizer/Moderna

Influenza

Patients can now schedule appointments to receive their flu shot for the 2023-2024 season with their primary care provider or at their local pharmacies. A change this season is the Advisory Committee on Immunization Practices (ACIP) has recommended that people with an egg allergy may receive any flu vaccine (egg-based or non-egg-based) that is appropriate for their age and other comorbidities³.

RSV

Three new medications have received FDA approval for pediatric and adult populations for protection against RSV. The first is Abrysvo™, an RSV vaccine. It is approved for prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older⁴. In clinical studies there was an 85.7% reduction of RSV with lower respiratory tract disease in individuals with greater than or equal to three symptoms (see table below). Second is Arexvy®, another RSV vaccine, approved for prevention of lower respiratory infection caused by RSV in individuals aged 60 and older⁵. In the clinical trials, it had an 82.6% overall efficacy against RSV, and a 94.6% efficacy against RSV in individuals with at least one comorbidity. There was a 66.7% reduction of RSV with lower respiratory tract disease in individuals with greater than or equal to two symptoms. Third is Beyfortus™ (nirvsevimab-alip), a monoclonal antibody. It is indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season^6,7. The safety and efficacy of this medication was supported by three clinical trials where it was shown to reduce chances of severe infection requiring medical attention by 75%.

New RSV Medications

Drug Name	FDA Indication	Dose	Adverse Effects
Abrysvo4	≥60 years old for prevention of lower respiratory tract disease caused by RSV Pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age	IM injection x1	Injection site reactions, fever, diarrhea, fatigue, headache, pain
Arexvy5	≥60 years old for prevention of lower respiratory tract infection caused by RSV	IM injection x1	Injection site reactions, fever, fatigue, pain
Beyfortus6,7	CDC/ACIP approved recommendation: Neonates and infants <8 months, born during – or entering – their first RSV season. For a small group of children between the ages of 8 and 19 months who are at increased risk of severe RSV disease, such as children who are severely immunocompromised, a dose is recommended in their second season	First RSV season Neonates and infants <5kg: 50mg Neonates and infants ≥ 5kg: 100mg Second RSV season Children up to 24 months who remain at risk: 200mg	Injection site reactions, rash

Note: This information is accurate as of September 15, 2023. For additional updates, please visit the ACIP/FDA websites.

*Please note these are clinical recommendations. The Illinois Department of Healthcare and Family Services (HFS) is currently reviewing provider payment guidance.

References

1. Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023. Accessed August 14, 2023.
2. Stay Up to Date with COVID-19 Vaccines. Accessed September 14, 2023.
3. 2023-2024 CDC Flu Vaccination Recommendations Adopted. Accessed August 10, 2023.
4. Abrysvo. Accessed August 14, 2023.
5. Arexvy. Accessed August 12, 2023.
6. Beyfortus. Accessed August 12, 2023.
7. CDC Recommends a Powerful New Tool to Protect Infants from the Leading Cause of Hospitalization. Accessed August 15, 2023.