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COVID-19 VACCINE

COVID-19 VACCINE

 

Which vaccines have been FDA approved for COVID-19?

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The FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. As of August 23, 2021, the FDA has issued full approval of the Pfizer-BioNTech vaccine for ages 16+.

The previously issued Emergency Use Authorizations (EUA) for the Pfizer-BioNTech vaccine for those ages 12 to 15 and third doses for the immunocompromised, as well as EUAs for COVID-19 vaccines manufactured by Moderna and Johnson & Johnson’s Janssen, remain in effect. An EUA gives the FDA authority to allow unapproved medical products to be used in emergencies when no approved alternatives are available. Other COVID-19 vaccines are in development and will be reviewed by the FDA under EUA.

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Who qualifies for a booster shot?

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Following guidelines set by ACIP and the CDC all individuals who are over the age of 18 are eligible to receive a Moderna or Pfizer-BioNTech COVID-19 booster shot at least six months after their primary two-dose vaccination series.

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The FDA and CDC also authorized the administration of a booster dose of the Pfizer-BioNTech vaccine for patients ages 16-17 years, six months after receiving the second dose of their primary COVID-19 vaccination series.

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Eligible individuals do not need to receive a booster shot that matches the formulation of their primary series. If individuals choose a booster dose that differs from their primary vaccine series, the manufacturers recommend individuals should check with their health care provider regarding the timing of the booster dose.

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Additionally, individuals who are 18 years and old and received the Johnson & Johnson (Janssen) COVID- 19 vaccine may receive a single booster does of Johnson & Johnson (Janssen), Moderna, or Pfizer-BioNTech COVID-19 vaccine at least two months after receiving their primary vaccination.

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Patients who received a Johnson & Johnson (Janssen) COVID-19 vaccine and prefer to receive a Johnson & Johnson (Janssen) booster are encouraged to contact their primary care provider for best next steps or refer to vaccines.gov for more information.

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