Pfizer said it will wait for its data on a three-dose series of its vaccine because it ''may provide a higher level of protection in this age group.''
Review of Pfizer formulation is delayed as FDA waits for more data
A bottle of Pfizer-BioNTech COVID-19 vaccine is pictured at a vaccine clinic at the A. Ray Olpin Student Union at the University of Utah in Salt Lake City on Thursday, Jan. 20, 2022. | Kristin Murphy, Deseret News Need for third dose still being studied A decision on whether COVID-19 vaccinations should be approved for children as young as 6 months old has been postponed by the federal Food and Drug Administration, likely until mid-April. The Utah Department of Health had expected to receive the first shipment of 23,000 scaled-down doses of the Pfizer COVID-19 vaccine as soon as Feb. 21, and had plans to quickly distribute the shots to local health departments, doctors and pharmacies around the state. But Friday, the CDC announced regulators would wait for the results of an ongoing study of the effects of a third dose of vaccine in children under 5 years old, rather than fast-track approval for a two-dose regime based on earlier data showing that failed to produce a strong enough immune response.
The company said it will wait until it has more data on a third dose.
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The vaccine maker and regulator will wait for data on a third shot, expected in April.

Delay ahead for Pfizers COVID-19 vaccine for kids younger than 5

09:06pm, Friday, 11'th Feb 2022 The Columbian
WASHINGTON (AP) U.S. regulators on Friday put the brakes on their push to speed Pfizer''s COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.
The vaccine for kids under five is expected to be a three-dose vaccine.

Pfizer postpones FDA request for vaccine for kids under 5

09:00pm, Friday, 11'th Feb 2022 Arutz Sheva (Israel National News)
Pfizer-BioNTech is postponing its rolling application to the Food and Drug Administration (FDA) to expand the use of its two-dose COVID-19 vaccine for children ages 6 months to 4 years, NBC News reported on Friday. The move means that vaccines for this age group will not be available in the coming weeks. (Israel National News'' North American desk is keeping you updated until the start of Shabbat in New York. The time posted automatically on all Israel National News articles, however, is Israeli time.)
Delay is a setback for parents eager to get their kids but vaccinated, but critical to get more data on third dose, FDA vaccine chief says.

Pfizer, BioNTech delay FDA application for young kids'' COVID-19 vaccine

08:41pm, Friday, 11'th Feb 2022 United Press International
Pfizer and BioNTech said Friday they are delaying a Food and Drug Administration application for COVID-19 vaccines for kids 6 months to 4 years old.

Delay ahead for Pfizers COVID-19 vaccine for children under age 5

08:33pm, Friday, 11'th Feb 2022 Albert Lea Tribune
WASHINGTON U.S. regulators on Friday put the brakes on their push to speed Pfizers COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available. The Food and Drug Administration had urged Pfizer and its partner BioNTech to apply for authorization of extra-low doses of its vaccine for the [] The post Delay ahead for Pfizers COVID-19 vaccine for children under age 5 appeared first on Albert Lea Tribune .
A US decision on Pfizer and BioNTech''s COVID-19 vaccine for children 6 months through 4 years of age has been postponed for at least two months after the Food and Drug Administration said it needed more data. The FDA had planned to make a decision on the vaccine based on early trial data because of wh
FDA says more data needed on how well 3rd doses work in this age group, creating uncertainty over when the shots will be okayed for young children
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