Thursday, May 11, 2023

FDA Authorizes Changes that Simplify Use of Bivalent MRNA COVID-19 Vaccines

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On April 18, 2023, the Food and Drug Administration (FDA) changed the Emergency Use Authorizations (EUAs) for the Pfizer and Moderna bivalent MRNA COVID-19 vaccines. The changes will simplify vaccination for most people. 

The biggest change is that the bivalent Moderna and Pfizer COVID-19 vaccines will be used for all doses when someone gets the MRNA type vaccine.  The Pfizer monovalent and Moderna monovalent COVID-19 vaccines (also known as the original vaccines released in 2021) are no longer available. The bivalent vaccines are available to all people ages six months and older.  

Key Changes:  

  • Most people who have gotten a monovalent MRNA vaccine but not a bivalent booster, are eligible for a bivalent booster dose. Age restrictions do apply; keep reading for more information.  
  • People who are 65 or older and have gotten one dose of the bivalent COVID-19 vaccine booster may now get another dose if it has been at least 4 months since their last dose.   
  • People who are immune compromised and have already gotten a bivalent COVID-19 vaccine booster may now get another dose. Please speak with your healthcare provider about when you should get this dose.  
  • For immune compromised children between the ages of 6 months-4 years, their eligibility for additional doses will depend on which vaccine they have already gotten. Talk to their doctor about the best options for your child.  
  • If you are not a part of any of these groups of people butt have received a bivalent booster dose, you are still not eligible for another dose. The FDA will meet soon to offer more guidance.  
  • If you are still unvaccinated against COVID-19, you may now get a single dose of a bivalent MRNA vaccine.  Check with your healthcare provider to make your appointment and vaccine plan.  

Unvaccinated children may now get:

  • A two dose Moderna bivalent vaccine series. Children who qualify for this must be 6 months-5 years old.  

OR  

  • A 3 dose Pfizer bivalent vaccine series. Children who qualify for this must be between the ages of 6 months-4 years.  

OR  

  • Children who are five years old may receive either two doses of the Moderna bivalent series, or a single dose of the Pfizer bivalent series.  

Children ages 6 months through five years old who have previously gotten 1, 2, or 3 doses of a monovalent MRNA vaccine should get a dose of a bivalent MRNA vaccine. The number of bivalent doses children can get is determined by the brand of vaccine and your child’s vaccination history. 

For many people, COVID-19 infection continues to be a very real risk. You are still at great risk of getting very sick, getting long COVID, or dying from COVID-19 if: 

  • You are unvaccinated 
  • You are a child who is unvaccinated 
  • You have a disability or health condition 
  • You are pregnant (your risk is event greater if you are pregnant and unvaccinated) 
  • You live with or work in close proximity to people who are unvaccinated 

Staying up to date with your COVID-19 vaccinations is the best way to reduce the risks of COVID-19. The COVID-19 vaccine reduces the chances of becoming very sick, being hospitalized, or dying from COVID-19.  

www.SCDisabilityVaccine.org 

Contact our Vaccine Access Helpline at 1-800-787-6046. 

SC Disability Vaccine Access Network including ABLE SC AccessAbility, Disability Rights of SC, Walton Options, CDR School of Medicine Columbia, and SC Developmental Disabilities Council logos

References:  

Food and Drug Administration (2023, April 18). “Coronavirus (COVID-19) Update:  FDA Authorizes Changes to Simplify Use of Bivalent MRNA COVID-19Vaccines.”: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines

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