The U.S. Food and Drug Administration (FDA) says the likely benefits of giving the Pfizer COVID-19 vaccine to five to eleven-year-olds outweigh the risk of rare cases of heart inflammation.
According to the Associated Press and Bloomberg, the FDA gave the assessment on Friday concerning the provision of two shots of a ten-microgram dose to the age group which would be a third of what was given to people 12 years and older.
In a staff report, the regulator said that in most scenarios analysed, the vaccine’s capacity to prevent hospitalizations and deaths likely exceeds the risk of adverse outcomes such as the heart condition myocarditis.
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet Tuesday to evaluate data and hear presentations from the company and health officials. The committee will then make a recommendation on whether to grant authorization.
If approval is granted, the U.S. Centers for Disease Control and Prevention could begin vaccinating five to eleven year olds from as early as next month.
In the report published just days before the committee vote on Tuesday, the FDA however did not explicitly say emergency authorization for the younger age group should be given.