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Coronavirus Vaccine Makers Preparing Joint Statement on Safety, Standards

Coronavirus Vaccine Makers Preparing Joint Statement on Safety, Standards

A nurse gives a volunteer an injection as part of a study for a possible COVID-19 vaccine in Binghamton, N.Y. (Hans Pennink/AP)

By    |   Friday, 04 September 2020 10:48 PM EDT

The three drug companies developing vaccines for COVID-19 are considering issuing a joint public statement that they will not seek emergency governmental approval until there is “substantial evidence of safety and efficacy” of their inoculations, The Wall Street Journal is reporting.

The move comes as vaccines are reportedly being readied for regulatory review as early as October and Democrats raise fears the Trump administration is pressuring the Food and Drug Administration to approve them.

The companies, including Pfizer, Johnson & Johnson and Moderna, could issue the statement as soon as early next week, the Journal said, citing two unidentified sources “familiar with the matter.”

“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.

A Gallup poll release in early August said more than one-third of Americans, 35%, would not get the vaccine if it was “available right now.”

Of that, 47% of Republicans said they would get the vaccine while 81% of Democrats would.

Large clinical trials of at 30,000 people already are underway or scheduled to start soon.

The Centers For Disease Control and Prevention, expected to be involved in the distribution of the vaccines, last week notified states to be ready for launch by November. An meeting to be convened by the FDA of outside experts to discuss the vaccines has been scheduled for late October.

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The three drug companies developing vaccines for COVID-19 are considering issuing a joint public statement that they will not seek emergency governmental approval until there is "substantial evidence of safety and efficacy" of their inoculations, The Wall...
covid, vaccine, drug manufacturers, statement
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2020-48-04
Friday, 04 September 2020 10:48 PM
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