Pfizer Inc. and Biotech SEสมัครสมาชิก SLOTXOsaid on Tuesday they had begun filing data with the US regulators. Their vaccine was approved for Emergency Use (EUA) in children under 5 years of age, despite clinical trial results of children 2 to 4 years of age with weaker immune responses than expected.
Both companies revealed that they have begun filing information. After receiving a request from the US Food and Drug Administration (FDA) to address the urgent health needs of this age group.
The FDA said that the advisory committee which consists of external experts will meet on February 15 to consider and approve the petition.
The two companies are asking the FDA to green light their vaccine as a two-dose vaccine, however, Pfizer CEO Albert Burla. stated in the statement that The company believes a third dose of the vaccine will be necessary. "To achieve a high level of protection against various mutants now and in the future"
"If two doses are approved, parents will have the opportunity to begin vaccinating their children with COVID-19 while awaiting approval for the third dose," Burla said.
Both companies are expected to submit complete information. To obtain emergency approval for the 2-dose formulation in the next few days. and then followed by the needle injection data 3.
Pfizer and Biotech The 3 mcg vaccination is being tested in children of this age group. It was downgraded from 10 micrograms for children 5-11 years old and 30 micrograms for children 12 years and older.
in december Pfizer said it is revamping its clinical trials for the three-dose version of the vaccine as a result of the reduced-dose two-dose trial. It was found to induce immune responses in young children aged 2 to 4, less than that in individuals aged 16 to 25.
It is against children aged 6 months to 24 months who produce the same immune response as those aged 16 to 25.
If the FDA and the US Centers for Disease Control and Prevention Approval of Pfizer-BioEntech's request The coronavirus vaccine for young children is expected to be available at the end of February.
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