The US FDA has officially authorised the Pfizer-BioNTech COVID-19 vaccine for use in 5-11 year-old children!
Here is what you need to know…
FDA Authorised Pfizer-BioNTech Vaccine For 5-11 Yo Children!
On 29 October 2021, the US FDA officially authorised the emergency use of the Pfizer-BioNTech COVID-19 vaccine in 5-11 year-old children.
This was based on their expert panel’s earlier approval, and their own evaluation of the data from Pfizer’s paediatric clinical trial.
Here is a short summary of the US FDA’s findings on the Pfizer-BioNTech vaccine for 5-11 year-old children :
Effectiveness : Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.
Safety : The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
Now that the FDA has approved the Pfizer-BioNTech vaccine for use in 5-11 year-old children, the US Centres for Disease Control and Prevention (CDC) will look into clinical recommendations for the vaccine.
I should point out that while the Pfizer paediatric vaccine is a lower-dose, improved version of the vaccine used in adults and adolescents.
FDA Excerpts On Pfizer Vaccine Authorisation For 5-11 Yo Children
Here is a selection of excerpts from the full FDA press release on their authorisation of the Pfizer-BioNTech vaccine for use in 5-11 year-old children.
The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
The immune responses of the younger age participants were comparable to the older participants. The vaccine was 90.7% effective in preventing COVID-19.
Commonly reported side effects in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days.
Stability + Storage
The FDA also authorized a manufacturing change for the vaccine to include a formulation that uses a different buffer; buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers.
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