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Highlights
- There are several vaccine developers that have launched COVID-19 vaccine for adults and now conducting trials to test the vaccine in kids.
- COVID-19 vaccine for children aged 12 year and older have received emergency use approval from the regulatory authorities.
- Pfizer-BioNTech has submitted data from the Phase 2/3 clinical study of their COVID-19 vaccine in children 5 to <12 years to the US FDA.
As of now, only children aged 12 year and older can get their COVID-19 jab but it is anticipated that the vaccine for younger group could be available soon. With the highly contagious emerging variant of coronavirus taking a grip and schools are reopening, parents are eagerly waiting for COVID-19 vaccine for all age group kids to have the protection against deadly disease.
Vaccines for children are identical to the vaccine that are made for adults, but they are given at a different kid-sized doses. For identifying the right amount of dose, clinical trials are being conducted encompassing children of varying age groups.
For instance, Pfizer Inc is conducting separate COVID-19 vaccine clinical trials in age groups of 5-11 years, 2 to <5 years, and 6 months to <2 years children. All age groups are being administered the similar vaccine, but the dose of the vaccine might be different. Typically, the younger the age group, the smaller the dose of the vaccine.
There are several vaccine developers that have launched COVID-19 vaccine for adults and now few are conducting clinical trials to test vaccine in kids.
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Source: © Sedovukr | Megapixl.com
In this backdrop, let us discuss the latest developments in COVID-19 vaccine for children-
Pfizer-BioNTech submit data of COVID-19 vaccine in Children
On 28 September 2021, Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) disclosed that the companies have submitted data from the Phase 2/3 clinical study of their COVID-19 vaccine in children 5 to <12 years of age to the US Food and Drug Administration (FDA).
The companies disclosed that a formal submission to request emergency use authorization (EUA) for COVID-19 vaccine in children 5 to <12 years is anticipated to follow in the coming weeks.
On 20 September 2021, the companies disclosed top-line results from the clinical trial conducted in the participants 5 to 11 years of age. The results from the trial demonstrated that the vaccine was well-tolerated and exhibited robust neutralizing antibody responses.
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Moderna’s COVID-19 vaccine for Adolescents
In May 2021, Moderna disclosed that its COVID-19 vaccine has met its primary immunogenicity endpoint with consistent safety and tolerability as shown in the Phase 3 COVE study in adults (12-<18 years).
In July 2021, the Company announced that European Medicines Agency’s (EMA) Committee adopted a positive opinion recommending marketing authorization for Spikevax (Moderna’s COVID-19 vaccine) to include adolescents 12 years of age and older. Recently, the Health Canada has approved Moderna’s COVID-19 vaccine for individuals 12 years of age and older.
Moreover, the Company is also conducting the KidCOVE study, Phase 2/3 trial of mRNA-1273 in children aged 6 months to <12 years.
Novavax COVID-19 vaccine
Biotech company Novavax Inc. (NASDAQ: NVAX) is conducting clinical trial of its COVID-19 on children of 12 to 17 years of age with its partner Serum Institute of India Pvt Ltd (SII).
According to several media report, recently, Serum Institute of India has obtained permission to conduct clinical study of Novavax COVID-19 vaccine in children aged 7-11 years. According to reports, Covovax, the Novavax vaccine manufactured by SII, could be available for authorisation for use in kids as early as January or February 2022.
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