COVID-19 Vaccine Booster Shots & COMIRNATY Info Sheets
/COVID-19 Vaccine Booster Shots
Updated August 20, 2021
When can I get the booster?
The goal is for people to start receiving a COVID-19 booster shot 8 months after an individual's second dose of an mRNA vaccine, either COMIRNATY (Pfizer-BioNTech) or Moderna. The booster shots will be available starting September 20, 2021.
Who will be the first people to get a booster dose?
The first people eligible for a booster dose are those who were fully vaccinated earliest in the vaccination rollout, including many health care providers, residents of nursing homes/long-term care facilities, and other older adults.
Why is the U.S. waiting to start offering vaccine boosters?
While the COVID vaccines have been highly effective, COVID-19 constantly evolves. Experts are looking at all available data to understand how well the vaccines are working, including how new variants like Delta affect vaccine effectiveness.
I received the J&J COVID-19 Vaccine. Do I need a booster shot?
Yes, it is likely. However, because the J&J vaccine was given in the US later than the mRNA vaccines, there is not enough data yet to confirm a decision. The U.S. Department of Health and Human Services (HSS) will keep the public informed with a timely plan for J&J booster shots.
If we need a booster dose, does that mean that the vaccines aren’t working?
No. COVID-19 vaccines are working very well and continue to protect against severe illness, hospitalization, and death. However, with the Delta variant, public health experts are starting to see reduced protection against mild and moderate disease. For that reason, HHS is planning for a booster shot so vaccinated people maintain protection over the coming months.
What’s the difference between a booster dose and an additional dose?
People who are moderately or severely immunocompromised sometimes don't produce enough protection. An additional dose of the vaccine can sometimes help build more antibodies against the disease. CDC recommends for these people to receive an additional (third) dose of an mRNA COVID-19 vaccine at least 28 days after the completion of the initial 2-dose mRNA COVID-19 vaccine series.
A booster dose is another dose of a vaccine given to someone who has built enough protection after vaccination, but then that protection has decreased over time (waning immunity).
For more information, please visit:
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html
COMIRNATY COVID-19 Vaccine Receives Full U.S. FDA Approval For Individuals 16 Years and Older
On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved COMIRNATY (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted FDA approval.
Indication & Authorized Use
COMIRNATY is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12 through 15 years, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
FDA authorized the Pfizer-BioNTech COVID-19 Vaccine, which has the same formulation as COMIRNATY, in the U.S under Emergency Use Authorization (EUA) since December 11, 2020, and is still currently under EUA to:
prevent COVID-19 in individuals 12 years of age and older, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
An individual may be offered either COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19.
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