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Politics : Formerly About Advanced Micro Devices

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From: pocotrader9/5/2020 1:07:22 AM
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Companies developing COVID-19 vaccines planning to issue joint safety pledge: report


Tal Axelrod 3 hrs ago

A number of companies developing coronavirus vaccines intend to put forward a public pledge that they will not seek government approval unless they've concluded their shots are completely safe.A draft of the rare joint statement, reviewed by The Wall Street Journal, commits all of the companies, including Pfizer Inc., Johnson & Johnson and Moderna Inc., to ensuring that the safety of vaccinated people is their top priority. Two people familiar with the matter told the Journal that the pledge could be issued as soon as early next week.

"We believe this pledge will help ensure public confidence in the Covid-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated," the draft statement says.

The companies add that they will only apply for government emergency-use authorization or licensure of vaccines based on "substantial evidence of safety and efficacy" from phase three clinical trials that are overseen by Food and Drug Administration (FDA) guidance.



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