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The Texas Department of State Health Services (DSHS) is alerting COVID-19 vaccine providers that the U.S. Food and Drug Administration (FDA) yesterday released new guidelines associated with the Johnson & Johnson/Janssen (J&J) COVID-19 vaccine. Citing the risk of thrombosis with thrombocytopenia syndrome (TTS), the FDA now limits the use of the J&J vaccine to the following groups:

• Individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate.
• Individuals 18 years of age and older who elect to receive the J&J COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.

TTS is a condition of rare and potentially life-threatening blood clots in combination with low levels of blood platelets. According to the FDA, symptoms of TTS would show approximately one to two weeks after receiving the J&J COVID-19 vaccine.  In making the determination to limit the authorized use of the J&J COVID-19 Vaccine, the FDA considered the availability of other COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS. However, when other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate for an individual or if that individual chooses to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine, the FDA has determined that the benefits of the vaccine for the prevention of COVID-19 outweigh the risks.

J&J- Fact Sheet for Recipients and Caregivers 

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The Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer or the Moderna COVID-19 vaccines for individuals 50 years and older and certain immunocompromised individuals. Following this, the Centers for Disease Control and Prevention (CDC) has updated its clinical recommendations to include the following:  

• A second booster dose of the Pfizer or Moderna COVID-19 vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. 
• A second booster dose of the Pfizer COVID-19 vaccine may be administered to certain immunocompromised individuals (see below) 12 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. 
• A second booster dose of the Moderna COVID-19 Vaccine may be administered to certain immunocompromised individuals 18 years of age and older at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine.
• In addition, adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least 4 months ago may now receive a second booster dose using an mRNA COVID-19 vaccine. 

Immunocompromised individuals include people with a range of conditions.  A full list of conditions can be found on CDC’s website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.  

Individuals who are immunocompromised or 50 years of age and older may discuss with their health care provider whether getting a second booster dose is appropriate for them. If their health care provider is not at a site administering vaccines, these individuals can self-attest and receive the second booster dose wherever vaccines are offered.

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• CDC clarified existing guidance to confirm that those who previously received an mRNA COVID-19 vaccine (Pfizer or Moderna) should receive a total of 4 doses: a primary series of 3 doses of an mRNA vaccine, plus 1 booster dose of an mRNA vaccine (4th dose). 
• People who received the Johnson & Johnson COVID-19 vaccine should receive a total of 3 doses: 1 J&J dose, followed by 1 additional mRNA dose at least 28 days later, then 1 booster dose at least 2 months after the 2nd (additional) dose. mRNA vaccines are preferred for the booster.
• People who received a 3-dose mRNA COVID-19 vaccination series should receive the booster dose 3 months after the primary series (instead of 5 months after the primary series).

For all CDC COVID-19 vaccine interim clinical considerations updates, please visit CDC Interim COVID-19 Vaccine Clinical Recommendations.

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 Today, the Food and Drug Administration and the Centers for Disease Control and Prevention shortened the Moderna booster dose interval time to 5 months. Individuals who received the Moderna COVID-19 vaccine as their primary series can now receive a single booster dose 5 months after completing the primary series. 

 Current Vaccine Fact Sheets:

 Pfizer COVID-19 vaccine 5-11 years of age EUA Fact Sheet for Recipients and Caregivers 

 Pfizer COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers  
Moderna COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers 

 J&J/Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers 

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 CDC has authorized:

• Moderately or severely immunocompromised children 5-11 years of age are now recommended to receive an additional dose of the Pfizer vaccine 28 days after their second dose. A booster dose is not authorized for children in this age group at this time.

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 CDC panel endorses Pfizer and BioNTech’s Covid booster shots for 12- to 15-year-olds

The CDC’s vaccine advisory panel on Wednesday endorsed 13-1 third shots of Pfizer and BioNTech’s Covid for adolescents ages 12 to 15 at least five months from their second shot as omicron cases surged across the U.S.

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The CDC updated their vaccination recommendations to include a single booster dose for 16-year and 17-year-olds at least 6 months after completing their primary Pfizer COVID-19 vaccination series.     

Important to note, at this time only the Pfizer COVID-19 vaccine is authorized and recommended for adolescents 16-17 years old.

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 CDC Recommends Pfizer COVID-19 Vaccine for Ages 5-11

On October 19th, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow for the use of the Pfizer COVID-19 vaccine in individuals 5 to 11 years of age.

On November 2nd, Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices unanimously recommended that children in that age range be vaccinated against COVID-19 with the Pfizer vaccine. CDC Director, Dr. Rochelle Walensky, has endorsed that recommendation.

For additional information:

https://www.dshs.texas.gov/coronavirus/immunize/vaccine-faqs.aspx#children

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No problem! You can still get the vaccine for free.  When you arrive for your appointment, you'll simply check the "uninsured" section on our form when you're completing your paperwork. 

Yes. We'd be happy to provide your second dose, as long as it's the same brand of vaccine as your first dose!

PeopleFirst Pharmacy

2501 E Hebron Pkwy

Carrollton, TX 75010

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Email us at  covid19@trinityapothecary.com