Moderna Expands Child Vaccination Trials to Get More Safety Data

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Posted on: Tuesday, July 27, 2021 – 9:50 AM | Last update: Tuesday, July 27, 2021 – 9:50 AM

Moderna Inc said it will expand a trial of its coronavirus vaccine in children under 12 to collect more safety information, amid concerns that doses of its messenger RNA (MRNA) could cause rare heart side effects. .

“The goal is to develop a broader safety database that increases the likelihood that the rarest cases will be discovered,” a Moderna spokeswoman said in a statement.

The spokeswoman explained that trial timelines are subject to regular reassessment based on discussions and requests from the regulatory agency, but Moderna currently expects to obtain data that supports the license to use the vaccine at the end of this year 2021 or the beginning of next year 2022.

She added that the company is actively discussing a proposal to conduct a larger trial with the US Food and Drug Administration.

The move comes in the wake of reports of young people suffering from carditis and endocarditis after being vaccinated with the two vaccines, Moderna and Pfizer, which rely on messenger RNA technology.







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