- On Tuesday, Pfizer and BioNTech revealed that they had submitted an application to the US Food and Drug Administration (FDA) for approval of a booster dose.
- Only 28 percent of children aged 5 to 11 years — roughly 8.2 million – are completely vaccinated, according to data from the US Centers for Disease Control and Prevention.
- In October, Pfizer and BioNTech’s first two-dose COVID-19 vaccine for children aged 5 to 11 was approved in the United States.
Pfizer Inc PFE.N, and also BioNTech SE BNTX.O announced on Tuesday that they had submitted an application to the US Food and Drug Administration (FDA) for approval of a booster dose of their COVID-19 vaccination for children aged 5 to 11 years.
Earlier this month, the businesses announced that the third dose of their shot boosted protection against the original coronavirus version and the Omicron variation among youngsters in the age group in a mid-to-late stage study.
It’s unclear how much of a request is in the age range for a third vaccine dosage. According to the US Centers for Disease Control and Prevention data, only 28% of children aged 5 to 11 years – around 8.2 million – are fully vaccinated.
There has also been considerable criticism regarding the need for boosters in younger children, considering the age group’s lower risk of serious infection and hospitalization.
Pfizer and BioNTech have submitted a request for FDA approval of a 10-microgram booster dose for children aged 5 to 11. A 30-microgram dosage of the vaccination is given to adults.
In October, the first two-dose COVID-19 shot from Pfizer and BioNTech was approved in the United States for children aged 5 to 11.
IN JANUARY, the US Food and Drug Administration (FDA) authorized a third dosage of the businesses’ COVID-19 vaccination for youngsters aged 12 to 15 years old. The agency has also approved a booster shot for immunocompromised youngsters aged 5 to 11 years.
Moderna Inc MRNA.O, a competitor, is currently awaiting a ruling from US regulators on using its principal COVID-19 series in children under the age of 18.
By the end of April, it aims to submit an application to the FDA for approval of its COVID-19 vaccination for children aged six months to five years.
Source: Global News
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