NEW YORK — Pfizer and BioNTech are the primary firms to request Emergency Use Authorization from the Meals and Drug Administration in hopes of increasing the usage of its COVID-19 vaccine in youngsters ages 12 to fifteen.
At present the vaccine’s EUA is just granted for use in individuals age 16 and older.
Pfizer and BioNTech website information from Section 3 trials carried out by means of the top of March. Researchers discovered the vaccine confirmed 100% efficacy and antibody response following vaccination in youngsters as younger as 12. Greater than 2,200 adolescents had been enrolled within the trial.
The businesses additionally reported negative effects had been typically the identical as these skilled in older youngsters and adults who’re already accredited to get the vaccine. The commonest had been ache on the injection website, fatigue, headache, chills and nausea.
All youngsters concerned within the trial can be monitored for long-term safety and results for 2 years after receiving their second dose of the vaccine.
Pfizer and BioNTech stated they plan to make comparable requests to different regulatory authorities in extra international locations quickly.
The 2 firms are additionally learning the vaccine in youngsters as younger as six months.
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