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Tozinameran - COVID-19 mRNA vaccine can now
be used in adolescents aged 12 to 15 years.
In a momentous step to fight against the ongoing COVID-19 pandemic, the Food and Drug Administration (FDA) had authorized the emergency use of COVID-19 vaccine (tozinameran) in individuals aged 12 to 15 years on 10th May 2021. This step is in revision to the emergency use authorization (EUA) original declaration on 11 Dec 2020 for its management in people aged 16 years and older.
As per the Centers for Disease Control and Prevention (CDC), about 1.5 million people with COVID-19 infection were reported in the age group of 11 to 17 years from 1 March 2020 to 30 April 2021. As compared to adults, children and adolescents usually have a milder infection. The COVID-19 vaccine is administered in two doses at an interval of 3 weeks, the same dosage and dosing schedule in people aged 16 years or more.
This COVID-19 vaccine has fulfilled the statutory norms to revise the EUA, along with known and potential advantages of this vaccine overshadowing the known and potential risks in individuals of 12 years of age and more, favoring the vaccine’s use in this age group. The safety data was assessed in 2,260 adolescents aged 12 -15 years enrolled in the randomized controlled clinical trial. The vaccine was used in 1,131 individuals and saline placebo in 1,129 individuals. To determine the safety after the second dose, more than half of the participants had a follow-up of a minimum of 2 months.
Injection site pain, fever, fatigue, headache, chills, muscle, and joint pain were commonly reported adverse effects which lasted for 1 to 3 days. It should be noted that the adverse events vary from person to person and some may not even experience any adverse events. It is advisable that people with a known history of a serious allergic reaction, comprising anaphylaxis to any constituent of the vaccine should not be given this vaccine.
In terms of effectiveness, a comparison of immune responses to the
vaccine in 190 individuals aged 12-15 years was made with 170 individuals aged
16-25 years. As found, the immune response of adolescents was non-inferior than
individuals aged 16-25 years. Seven days following the second dose, an
investigation of cases of COVID-19 in adolescents resulted in 100%
effectiveness of this vaccine. To ensure the timely identification of safety
issues, the safety of the vaccine will
be regularly monitored.
FDA
Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
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