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.
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 TrumpDHS to label white supremacists as the ‘most persistent and lethal threat’ to the US: report Buttigieg slams Trump over comments on fallen soldiers: ‘He must think we’re all suckers’ White House tells federal agencies to cancel ‘divisive’ racial sensitivity training: report 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 SchumerCompanies developing COVID-19 vaccines planning to issue joint safety pledge: report Schumer calls for accountability in Daniel Prude death in Rochester Top Democrats press Trump to sanction Russian individuals over 2020 election interference efforts 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 FauciCompanies developing COVID-19 vaccines planning to issue joint safety pledge: report Overnight Health Care: White House denies Trump has embraced ‘herd immunity’ strategy on COVID-19 | Penn State doctor: About a third of tested athletes with COVID-19 had heart inflammation | Fauci says Midwestern states should be on alert this Labor Day Scott Atlas is a needed voice of wisdom and reason on the Coronavirus Taskforce MORE, the nation’s leading infectious disease expert, said on CNN on Thursday.
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