Companies developing COVID-19 vaccines planning to issue joint safety pledge

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.

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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. 

The resolution marks an unusual joint commitment among a string of competitors who are racing against the clock and each other to be the first to bring a COVID-19 vaccine to market.

However, polling shows that many Americans are skeptical of the efficacy of a vaccine in part due to concerns over the speedy timetable and worries that President TrumpDonald John TrumpBiden leads Trump by 36 points nationally among Latinos: poll Trump dismisses climate change role in fires, says Newsom needs to manage forest better Jimmy Kimmel hits Trump for rallies while hosting Emmy Awards MORE is pushing for a vaccine to be released early to boost his reelection bid.

The Centers for Disease Control and Prevention asked state governors last week to fast track applications for building permits for vaccine distribution sites that would be up and running in early November, around the same time as Election Day. 

“Too much of the evidence points to the Trump administration pressuring the [Food and Drug Administration] to approve a vaccine by Election Day to boost the President’s re-election campaign,” Senate Minority Leader Charles SchumerChuck SchumerRepublican senator says plans to confirm justice before election 'completely consistent with the precedent' Video of Lindsey Graham arguing against nominating a Supreme Court justice in an election year goes viral Graham signals support for confirming a Supreme Court nominee this year MORE (D-N.Y.) said in a statement this week referencing a report from The Washington Post addressing the concerns. “All Americans want a safe and effective vaccine as soon as possible, but if these important life and death decisions appear political, it will only undermine Americans’ confidence in a vaccine and prolong the pandemic.”

Officials have sought to allay those concerns, with the FDA vowing to not approve a vaccine unless it is proven to be 50 percent effective compared with a placebo.

“I mean I will look at the data and I would assume and I’m pretty sure it’s going to be the case that a vaccine would not be approved for the American public unless it was indeed both safe and effective. And I keep emphasizing both safe and effective. If that’s the case ... I would not hesitate for a moment to take the vaccine myself and recommend it for my family,” Anthony FauciAnthony FauciNorth Carolina couple married 50 years dies minutes apart of coronavirus holding hands As virus pummels US, Europe sees its own spike Democratic chairman says White House blocked FDA commissioner from testifying MORE, the nation’s leading infectious disease expert, said on CNN on Thursday.