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2 doses 3 weeks apart
3rd dose for individuals ≥12 years and who have undergone solid organ transplantation, or diagnosed with conditions considered to have an equivalent level of immunocompromise
Some observational studies have suggested declining efficacy of COMIRNATY over time against symptomatic infection or against the Delta variant, while others have not. However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States. There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions. Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting.
The third booster shot will be known as "Comirnaty"
The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
www.fda.gov...
Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
The answer is "yes."
So the answer as to whether it is exactly the same is, "yes and no".
Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine
originally posted by: Ohanka
Don’t they usually test drugs on thousands of people? At least in the last stage anyway.
Seems pretty suspect to me. Pretty sure my mouthwash had more rigorous testing than this stuff.
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Sponsor:
BioNTech SE
Collaborator:
Pfizer
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : May 2, 2023
clinicaltrials.gov...
originally posted by: Phage
a reply to: HawkEyi
Correct.
Do you happen to have any information about myocarditis rates with COVID infections, btw?