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FDA Announces Approval and Authorization of Updated COVID-19 Vaccines

On September 11, 2023, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. These actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc., which have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

https://www.cdc.gov/media/releases/2023/s0419-covid-vaccines.html

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Updated Pfizer 2023-24 EUA Fact Sheet: https://www.fda.gov/media/167212/download

Updated Moderna 2023-24 EUA Fact Sheet:  https://www.fda.gov/media/167209/download

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Authorization

 The CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option to receive an additional COVID-19 vaccine dose.  

CDC’s Advisory Committee on Immunization Practices (ACIP) met on Wednesday, April 19th to discuss these COVID-19 vaccine recommendation changes, and the associated implications and implementation. Although there was no vote at this meeting, ACIP members expressed their support for these recommendations.  

These changes include:  

• CDC’s new recommendations allow an additional updated (bivalent) vaccine dose for adults ages 65 years and older and additional doses for people who are immunocompromised. This allows more flexibility for healthcare providers to administer additional doses to immunocompromised patients as needed.  
• Monovalent (original) COVID-19 mRNA COVID-19 vaccines will no longer be recommended for use in the United States. 
• CDC recommends that everyone ages 6 years and older receive an updated (bivalent) mRNA COVID-19 vaccine, regardless of whether they previously completed their (monovalent) primary series.  
• Individuals ages 6 years and older who have already received an updated mRNA vaccine do not need to take any action unless they are 65 years or older or immunocompromised. 
• For young children, multiple doses continue to be recommended and will vary by age, vaccine, and which vaccines were previously received. 

https://www.cdc.gov/media/releases/2023/s0419-covid-vaccines.html

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Updated Pfizer EUA Fact Sheet: https://www.fda.gov/media/167212/download

Updated Moderna EUA Fact Sheet:  https://www.fda.gov/media/167209/download

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Authorization

Today, CDC’s Director Rochelle P. Walensky, M.D., M.P.H., signed a decision memo allowing Novavax monovalent COVID-19 boosters for adults.

This action gives people ages 18 years and older the option to receive a Novavax monovalent booster instead of an updated (bivalent) Pfizer-BioNTech or Moderna booster if they have completed primary series vaccination but have not previously received a COVID-19 booster—and if they cannot or will not receive mRNA vaccines.

Who can receive the Novavax as a Booster?

A first booster dose to the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: 

• individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, 
• individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine because they would otherwise not receive a booster dose of a COVID-19 vaccine. 

Some may be unable to receive an mRNA vaccine as a result of an allergy to a component of an mRNA COVID-19 vaccine, or as a result of a history of a severe allergic reaction (such as anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine, or a lack of availability of an mRNA vaccine. People ages 18 and older may also choose to receive a Novavax monovalent booster if they are unwilling to receive mRNA vaccines, and would otherwise not receive a booster dose.

https://www.cdc.gov/media/releases/2022/s1019-novavax.html

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Updated Novavax EUA Fact Sheet:  https://www.fda.gov/media/159898/download

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Most vaccines are covered at no charge if you have insurance.  If you do NOT have insurance, you can visit www.vaccines.gov to search for locations that offer no cost vaccines.  Narrow your search to look for Bridge Access Program locations if you are uninsured. 

PeopleFirst Pharmacy

2501 E Hebron Pkwy

Carrollton, TX 75010

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Email us at  covid19@trinityapothecary.com