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Moderna Inc. said it would expand an ongoing trial of its coronavirus vaccine in children under 12 years old to gather more safety data amid worries that messenger RNA shots may trigger rare heart side effects.
“The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events,” a Moderna spokeswoman said in a statement.
Clinical trial timelines are regularly re-evaluated based on regulatory agency discussions and requests, she said, and Moderna expects to have data that would support authorization in late 2021 or early 2022. The Cambridge, Mass.-based company is discussing a proposal for a bigger trial with the U.S. Food and Drug Administration, she said.
Health care groups press for Covid vaccine mandates for frontline workers
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FDA to decide on full approval of Pfizer COVID-19 vaccine by January
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Calls mount on FDA to formally endorse Covid vaccines as Delta surges POLITICO 2 hrs ago By Lauren Gardner © Lisa Maree Williams/Getty Images A nurse administers the Pfizer vaccine to a client at the St Vincent s Covid-19 Vaccination Clinic on July 01, 2021 in Sydney, Australia.
Pressure is growing for the FDA to grant full approval to the Pfizer and Moderna Covid-19 vaccines or to at least more clearly explain to the public its decision-making process to help convince more Americans to get their shots.
Some medical experts have sounded off on social media in recent days, calling on regulators to endorse what they say the data already shows that the two vaccines by Pfizer-BioNTech and Moderna made with messenger RNA technology safely and effectively prevent severe illness, hospitalization and death from the coronavirus.