Moderna’s vaccine for children aged 12 to 18 towards the ok all over the world

After Pfizer-BioNTech is given the green light, Moderna could soon get approval for teenagers between 12 and 18 years of age. mRna Covid vaccine. The biotechnology company announced that it has applied for authorization to the United States Food and Drug Administration (FDA) for use in this age group, after applications filed in recent days with the European Medicines Agency (EMA) and the Public Health Agency of Canada (PHAC). The data sent to the regulatory authorities is based on the results of the TeenCove Phase 2/3 Clinical Study, in which the serum has been shown to be safe and highly effective in boys.

In the clinical trial, which involved 3,732 adolescents between the ages of 12 and 17 divided into two groups (in a 2: 1 ratio) who respectively received two doses of the mRna vaccine (mRNA-1273) or placebo, no cases of Covid-19 were observed in the vaccinated group (about 2,500 adolescents), indicating 100% efficacy in comparison with the placebo group, in which 4 cases of Covid-19 were instead recorded. The study also stated that protection was achieved with a single dose equal to 93% from any form of symptomatic disease starting from 14 days after administration.

As for the safety profile, the vaccine was well tolerated, with no reporting of significant adverse events. Most of the side effects were mild or moderate in severity. The most common local reaction was injection site pain, while headache, fatigue, muscle aches and chills were reported as the most frequent systemic effects. “All study participants – Moderna underlines in a note – they are monitored for 12 months after the second dose to evaluate long-term protection and safety ”.

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The company also plans to send the trial data to other regulatory authorities globally to apply for authorization for use in this age group after approval already obtained in individuals aged 18 and over by health agencies in the US, Canada, Israel, the European Union, the United Kingdom, Switzerland , Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea, Botswana, the Emergency Use Listing (EUL) and the World Health Organization (WHO). “We will be submitting the authorization request soon at regulatory agencies around the world for this population of a younger age – said Stéphane Bancel, CEO of Moderna -. We are encouraged that our vaccine was highly effective in adolescents”.

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