On Sunday, Pfizer CEO Albert Bourla said that Pfizer plans to submit very soon its COVID-19 vaccination data for 5–11-year-olds will be ready to be assessed by the U.S. Food and Drug Administration (FDA). It means the doses could be available for kids later this Autumn after primary data proposed that the jab produces a robust immune response in children.
Albert Bourla told ABC’s “This Week with George Stephanopoulos” that he thinks they’re going to submit that child vaccine data any day, so it is a query of days, not weeks and months, and then it is up to the U.S. public health protection agency to be able to analyze the data and determine about its approval. Moreover, Bourla said the pharmaceutical firm is ready to begin manufacturing the jab immediately.
NEW: Pfizer is ready to ask the FDA for authorization to use its Covid-19 vaccine in children 5-11 “within days,” Pfizer CEO Albert Bourla told ABC.
— Ana Cabrera (@AnaCabrera) September 26, 2021
Earlier in this week, Pfizer Inc. released initial trial data, which hasn’t still been assessed, that found kids dosage, that’s “one-third of the dose given to adults,” is safe and effective enough among 5-11-year-olds.
Pfizer Chief Executive said that if U.S. regulators authorize it, they’d be ready with their production to deliver that new vaccine formulation because the kid’s jab is a different formulation.
At present, only twelve-year-olds and above can get protected against the lethal virus with a Pfizer-made vaccine. However, Janssen and Moderna-made vaccines are only approved for elders aged 18 and up.
Children Make Up A big Number Of Reported U.S. COVID-19 Cases
The data proposed the jab evoked an immune response in children alike to that of fully inoculated sixteen to twenty-five-year-olds in spite of the smaller dose, and also similar minor side-effects like fever, fatigue, pain at the injection spot, and chills.
On Sunday, the former U.S Commissioner of the FDA, Dr. Scott Gottlieb, former FDA head, who also serves on Pfizer’s board, said that he anticipates the FDA’s assessment of the Pfizer child vaccine data to take approximately 4-6 weeks, putting the timeline for potential authorization somewhere between Halloween and mid of November.
According to an “American Academy of Pediatrics (AAP) assessment of U.S. CDC data as of 22nd September,” about 13M children under eighteen, which accounts for 55% of twelve-to-seventeen-year-olds, are partially vaccinated. In the meantime, Bourla restated that he anticipates annual COVID vaccine doses for almost everyone might be needed down the road.
Furthermore, earlier in this month, United States General Dr. Vivek Murthy said that the administration is prepared to process that data speedily as soon as the drug company submits it.
According to the AAP, approximately 5.5M coronavirus cases have been reported in children as of 16th September. Children account for slightly over 15 percent of all American COVID cases, but cases have been remarkably increasing among kids in the past months because of the spread of the highly contagious Delta variant.
Moreover, AAP reports children’s infections to account for 25.7 percent of the total reported in the week of 9-16th September. Unfortunately, the total number of cases in children since the pandemic hit increased by nine percent only in the period of fourteen days, between September 2-16.