The US FDA Authorizes The Pfizer-BioNTech Vaccine For Young Kids
As anticipated, the US FDA (Food & Drug Administration) approved EUA (Emergency Use Authorization) for the Covid-19 vaccine co-produced by BioNTech & Pfizer for children of age group of 5-11. One-third of the dosage administered to adults will be given to children. There are around 28 million children belonging to this age group in the United States.
It will be transferred to the vaccine advisory group of the US CDC (Centers for Disease Control & Prevention) for further discussion. They are planning to organize a meeting on 02/11/2021 & 03/11/2021.
In the reports composed earlier this week for the imminent advisory panel meeting, the Pfizer-BioNTech vaccine for young kids showed 90.7% efficacy in children belonging to this age group. Out of the 2200 children who participated in the study, 1500 got the active shot. Just 19 children were tested positive for Covid-19 in the whole group. Among the 3 vaccinated children who were infected with SARS-CoV-2, mild symptoms like headache, sore throat, and cough were observed. The rest of the 16 children were not vaccinated and showed more symptoms, including 10 children who showed signs of fever. No mortality orsevere conditions were noted in both groups. Moreover, there were no conditions like myocarditis, which has been seen in older adolescent groups predominantly in males.
The FDA’s Acting Commissioner, Janet Woodcock expressed in a statement that as a physician & a mother, she knows that children, school staff, caregivers, and parents have been longing for today’s approval. Vaccinating children of the age group of 5-11 for inducing immunity against Covid-19 infections will help us bring one step closer to achieving normalcy. Rigorous & comprehensive assessment of data associated with the effectiveness & safety of the vaccine will help ensure guardians & parents that this shot meets their high standards.
If the CDC team authorizes the first Covid-19 shot for children, it might be available to children belonging to the age group 5-11 by the start of November 2021. Pfizer-BioNTech vaccines for adults were administered 21 days post the first jab.
Storage is another major difference between the actual formulation and the Covid-19 shot for children. This dose can be stored in a refrigerator for about ten weeks.
Approximately 9% of all the Covid-19 positive cases in the United States were children belonging to this age group. FDA’s clinical deputy director, Doran Fink from the department of vaccines & related products, claimed that they account for almost 40% of all the Covid-19 pediatric cases. The incidence rate for children of this age group is near the highest of any age group.
For children belonging to the age group of 5-11 and below, MIS-C (Multisystem Inflammatory Syndrome) is the most severe form of Covid-19. So far, over 5000 children have been detected positive for this condition. MIS-C usually happens when various organs become inflamed, including the gastrointestinal organs, eyes, skin, brain, kidneys, lungs, or heart.
As of 17/10/2021, 146 mortalities associated with Covid-19 were reported in children belonging to the age group 5-11 and 691 mortalities in children below the age of 18 in the United States. The Biden administration has the 1st 15 million doses ready to be used once it is approved and has got sufficient vaccines to innoculate all 28 children belonging to the age group of 5-11.
Out of other questions, the CDC advisory team has a choice of suggesting the Pfizer-BioNTech vaccine for children who are highly susceptible to Covid-19 infection as healthy children are less probable to get a serious illness or show any signs of disease. CDC has found some underlying medical conditions that group these children into the high-risk category. These comprise neurological disorders, chronic lung disease, and obesity. The CDC revealed that the most prevalent underlying medical condition observed in Covid-19 positive children was lung disease, mainly asthma.
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