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from: JONATHAN LEMIRE, Associated Press
Posted: 09/28/2021 / 4:23 PM CDT
Updated: 09/28/2021 / 4:28 PM CDT
FILE – In this January 22, 2021 file photo, a certified medical assistant prepares doses of the Pfizer COVID-19 vaccine at a University of Nevada vaccination center, Las Vegas. With more than 40 million doses of coronavirus vaccines available, U.S. health officials are confident that both seniors and other at-risk Americans who want a booster vaccination and parents expecting primary vaccination approval for young children will have easy access will. (AP Photo / John Locher, File)
WASHINGTON (AP) – Pfizer has submitted research to the U.S. Food and Drug Administration regarding the effectiveness of its COVID-19 vaccine in children, but vaccinations may not be available until November.
The company announced Tuesday that it had provided health officials with data from a recent study of its vaccine in children ages 5-11. Officials had previously announced that they would file an application for approval for use with the FDA in the coming weeks, leading public health experts and parents to expect the doses to be available by the end of October.
But instead of Halloween, it could fall until just before Thanksgiving, such a person familiar with the process but not authorized to discuss it publicly. However, it is possible that depending on how soon the FDA offers approval, the footage could be available earlier in November, the person said.
The drug manufacturer and its partner, BioNTech from Germany, assume that they will apply for an emergency approval of their vaccine for children between the ages of 5 and 11 “in the coming weeks”. The companies also plan to submit data to the European Medicines Agency and other regulatory authorities.
Pfizer’s two-shot vaccine is currently available to people 12 years of age and older. An estimated 100 million people in the US have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.
Pfizer tested a lower dose of the shots in children. The drug maker said last week that researchers found that the vaccine developed antibody levels to fight the coronavirus in children that were just as strong as teenagers and young adults who received regular doses.
Earlier this month, FDA chief Dr. Peter Marks of the AP that once Pfizer delivers its study results, his agency will evaluate the data “hopefully in a few weeks” to determine whether the shots are safe and effective enough for younger children.
Pfizer’s updated schedule was first published by the Wall Street Journal.
Another US vaccine manufacturer, Moderna, is also investigating its vaccinations in primary school children. Results are expected later in the year.
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