[ad_1]
Silver Spring, Maryland, January 3, 2022 /PRNewswire/-Today, the U.S. Food and Drug Administration revised the Pfizer-BioNTech Emergency Use Authorization (EUA) for the COVID-19 vaccine to:
- Expand the range of single booster doses to be used by individuals between 12 and 15 years of age.
- Reduce the time between the completion of the initial Pfizer-BioNTech COVID-19 vaccine and the booster dose to at least five months.
- The third primary series of doses is allowed for certain immune-compromised children between 5 and 11 years of age.
“Throughout the pandemic, as the virus that causes COVID-19 continues to evolve, the FDA needs to adapt quickly, which means using the best available science to make informed decisions while taking into account the health and safety of the American public. “Acting FDA Commissioner Janet Woodcock, MD “With the current wave of omicron variants, we must continue to take effective, life-saving preventive measures, such as primary vaccinations and boosters, wearing masks, and maintaining social distance to effectively combat COVID-19.”
What you need to know:
Boosters are now authorized for people 12 years and older
Today’s action expands the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine to individuals under 12 years of age.
- The agency has determined that the protective health benefits of a single booster dose of Pfizer’s BioNTech COVID-19 vaccine against COVID-19 and possible related serious consequences (including hospitalization and death) exceed the potential risks for individuals 12 to 15 years old .
- FDA reviewed Israel, Including safety data from more than 6,300 individuals aged 12 to 15 who received a booster dose at least 5 months after completing the main two-dose vaccine series.
- These additional data allow the FDA to reassess the benefits and risks of boosters in young adolescents in the face of the current surge in COVID-19 cases.
- The data shows that there are no new safety issues after boosting immunization in this population. To date, no new cases of myocarditis or pericarditis have been reported among these people.
For people 12 years and older, the reinforce interval is updated to five months
The FDA also authorized the use of a single booster dose…
The full story on Benzinga.com
[ad_2]
Source link
