Pfizer Eyes FDA Authorization Granted on Its COVID Vaccine for Children Under 5 in November
Vaccine maker Pfizer aims to file an emergency authorization to Food and Drug Administration in November for its vaccine to be used by children under five. Pfizer Chief Financial Officer Frank D'Amelio had announced the recent plan of the company, according to The Hill report.
Earlier, the company announced that it expects to file in early October for emergency authorization in children ages five to 11.
D'Amelio said that they forecasted that the data for the said age group will be ready by the end of September, while data for the even younger group is seen to be prepared later in October.
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FDA on COVID Vaccines for Children
Meanwhile, FDA vaccine chief Dr. Peter Marks said that the agency will evaluate the COVID vaccines for younger children as soon as it gets its hands on the required data.
Marks said that he is very hopeful that COVID vaccines for age group five to 11 will be underway at the end of the year, according to an Associated Press News report.
Pfizer's German partner BioNTech noted that it was on track in the coming weeks to seek approval of the companies' COVID vaccine for five to 11-year-olds.
Former FDA chief Scott Gottlieb on Sunday also said that children aged five to 11 could be eligible for the Pfizer vaccine by the end of October. Gottlieb serves as one of Pfizer's board of directors.
He also noted that he has confidence in terms of the data that the company has collected. However, he acknowledged that it is still FDA's decision to make "an objective determination."
Vaccinating Children
The European Medicines Agency has approved the Pfizer COVID vaccine for 12 to 15-year-olds in May. European countries have since then moved to vaccinate children, according to a BBC News report.
Meanwhile, U.S. and Canadian regulators had started giving injections immediately after it approved the Pfizer vaccine for children 12 and older.
Forty-two percent of 12- to 17-year-olds had already received their first dose, while 32 percent had already gotten their second dose of either Pfizer or Moderna by the end of July.
The U.S. started moving to vaccinate children after infections started to jump brought by the highly transmissible Delta variant.
The Centers for Disease Control and Prevention recommends that everyone 12 years and older should get the COVID vaccine to help protect against the virus.
Children and COVID Cases
The American Academy of Pediatrics noted that children account for more than one-quarter of new weekly U.S. COVID cases.
According to a Centers for Infectious Disease Research and Policy report, around 252,000 child COVID cases were reported for the week ending September 2, which is the largest count reported for children during the pandemic.
Children accounted for 26.8 percent of reported weekly COVID cases in the U.S.
The AAP said that child cases had increased exponentially after declining in early summer. Over 750,000 cases were added between August 5 and September 2.
It also noted that hospitalization and death are still rare results of the virus in children.
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This article is owned by Latin Post
Written by: Mary Webber
WATCH: Pfizer announces timeline for child vaccinations - from ABC News