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The agency released tighter standards for emergency coronavirus vaccine approval on Tuesday, almost certainly spoiling President Donald Trump's plan to have the jab rolled out for the public before Americans head to the polls on November 3. The White House had complained the new guidelines would unacceptably delay the much-anticipated vaccine and attempted to prevent their release for two weeks.
The new recommendations, which are not legally binding, strongly encourage manufacturers to follow patients for at least two months after their last jab in order to monitor any late-appearing adverse effects. They also advocate ensuring the immune response does not wear off rapidly, and potentially observing how inoculated patients respond to virus exposure. With Phase III trials ongoing for four of the vaccine candidates and a fifth set to enter Phase III this month, the recommended monitoring period would push approval into December - even if clinical trials concluded this week and no side-effects cropped up.
In addition to the extended monitoring period, manufacturers are advised to document five cases of severe Covid-19 infection in trial participants who received the placebo, ensuring participants' continued health isn't merely a product of their belief that they have been vaccinated.
The New York Times speculated that the guidelines had finally been released in response to a marked decline in public confidence in the jab, which many fear will be rushed, unsafe, or ineffective. A whopping two-thirds of Americans polled last month were unwilling to participate in the first round of immunizations, with a quarter saying they'd never get it and 44 percent adopting a "wait and see" approach.
That fraction has grown steadily over the last few months as Republicans and Democrats turned the vaccine into a political football. The FDA itself was accused of taking a political stance by billionaire vaccine evangelist Bill Gates, whose money is bankrolling the development and future manufacture of six vaccine candidates.
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Comment: What most people fail to realize, especially the mainstream media, is that the vast majority of QAnon followers are harmless basement dwelling conspiracy enthusiasts, not dangerous militia members. Like with most things, this Facebook ban is about controlling the narrative, not about any clear and present threat to people's safety. This unlike Antifa and BLM, which have not been banned from any platforms.
Twitter, as could be expected, is divided on the issue: