FDA asking COVID-19 vaccine developers for two months of safety data, raising doubts about approval by Election Day

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The Food and Drug Administration (FDA) wants coronavirus vaccine developers to submit two months of safety data before applying for emergency approval, circumventing the White House, which has expressed concerns about the stringent requirements.

The FDA, in documents posted online Tuesday, advised drugmakers conducting COVID-19 vaccine clinical trials to monitor patients for at least two months to assess potential negative effects from their candidates.

President Trump has recently called those steps a “political move” that would surely mean a vaccine is not approved by Election Day. Continue reading.

At Wacky Press Conference Trump Bullies Reporter Wearing Mask

President Donald Trump late Monday morning announced he would hold a press conference, but after a late start and minutes in it became clear it was yet another campaign-style stream-of-consciousness rally devoid of facts and filled with lies.

Both MSNBC and CNN were not airing the “press conference” minutes after it began.

After Trump’s 20 minutes or so of angry grumbling, and disgruntled attacks on Vice President Joe Biden and Senator Kamala Harris, his Democratic opponents, Trump ended his remarks before taking reporters questions by saying, “Happy Labor Day, everybody.” Continue reading.

Gerald Ford Rushed Out a Vaccine. It Was a Fiasco.

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Trump should keep that in mind as he pushes for a coronavirus shot.

Last week, news arrived that President Trump had lurched into what may be his most reckless obsession yet: His administration would probably seek an “emergency use authorization” for a Covid-19 vaccine long before some scientists believe it would be safe to do so.

A spokesman for the Department of Health and Human Services immediately addressed the obvious suspicion: “Talk of an ‘October surprise’”— an attempt to manufacture good news just before the November election — “is a lurid Resistance fantasy.”

As he does often, however, the president proudly admitted to the exact thing his underling insisted was inconceivable. Continue reading.

Trump’s Vaccine Can’t Be Trusted

If a vaccine comes out before the election, there are very good reasons not to take it.

True to the president’s word—or threat, perhaps—the United States government is preparing to roll out a COVID-19 vaccine on, or before, Nov. 1, even though none of the more than 150 vaccines in the research pipeline worldwide have completed Phase 3 safety and efficacy clinical trials. In its mad sprint to Election Day, the White House has funneled billions of dollars into drug companies and ordered government agencies to execute their public health duties at breakneck speeds that defy credulity. Like most experts closely watching these developments, I have no confidence that a safe, effective vaccine will be ready for use by Halloween. Worse, I can no longer recommend that anyone retain faith in any public health pronouncements issued by government agencies.

State and territorial governors across America have received a letter dated Aug. 27 from the director of the Centers for Disease Control and Prevention (CDC), Robert Redfield, instructing them to grant facilities and licensing to a private contractor, McKesson Co., for mass immunizations. “CDC urgently requests your assistance in expediting applications for these distribution facilities,” Redfield wrote, “and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”

With that mass vaccination date less than 58 days away—and, surely not coincidentally, two days before the national elections—states must scramble to submit their immunization scheme to the CDC for approval by Oct. 1. This must cover everything from logistics and personnel to public education and recruitment. The pace required here is astounding, dramatically more rapid than any prior drug or vaccine rollout in history. Though officials insist no corners are being cut, the timetable is simply too short for full safety analysis of any vaccine. Continue reading.