https://sputnikglobe.com/20220202/pfizer-biontech-say-seeking-emergency-authorization-for-covid-19-vaccine-for-kids-under-5-1092670756.html
Pfizer, BioNTech Say Seeking Emergency Authorization for COVID-19 Vaccine for Kids Under 5
Pfizer, BioNTech Say Seeking Emergency Authorization for COVID-19 Vaccine for Kids Under 5
Sputnik International
WASHINGTON (Sputnik) - The pharmaceutical companies Pfizer and BioNTech said in a press release that they are seeking Emergency Use Authorization for their... 02.02.2022, Sputnik International
2022-02-02T00:52+0000
2022-02-02T00:52+0000
2022-02-02T00:52+0000
pfizer
vaccine
kids
food and drug administration (fda)
covid-19
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"Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that following a request from the US Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population," the release said on Tuesday.Pfizer and BioNTech said they expect to complete the EUA submission in the coming days, the release also said.BioNTech CEO Ugur Sahin said in the release that the vaccine has demonstrated favorable safety, tolerability and efficacy profiles in multiple clinical trials starting from five-years old.The requested EUA would authorize the first two doses of a planned three-dose primary series in the age demographic, the release said.A third vaccine dose will be needed in the future to achieve high levels of protection against current and potential future coronavirus variants, but that the EUA will give parents an opportunity to begin the vaccination series while awaiting an authorization for the third dose, Pfizer CEO Alber Bourla said.
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pfizer, vaccine, kids, food and drug administration (fda), covid-19
pfizer, vaccine, kids, food and drug administration (fda), covid-19
Pfizer, BioNTech Say Seeking Emergency Authorization for COVID-19 Vaccine for Kids Under 5
WASHINGTON (Sputnik) - The pharmaceutical companies Pfizer and BioNTech said in a press release that they are seeking Emergency Use Authorization for their COVID-19 vaccine for use in children between six-months and four-years of age.
"Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that following a request from the US Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population," the release said on Tuesday.
Pfizer and BioNTech said they expect to complete the EUA submission in the coming days, the release also said.
BioNTech CEO Ugur Sahin said in the release that the vaccine has demonstrated favorable safety, tolerability and efficacy profiles in multiple clinical trials starting from five-years old.
The requested EUA would authorize the first two doses of a planned three-dose primary series in the age demographic, the release said.
A third vaccine dose will be needed in the future to achieve high levels of protection against current and potential future coronavirus variants, but that the EUA will give parents an opportunity to begin the vaccination series while awaiting an authorization for the third dose, Pfizer CEO Alber Bourla said.
