After initially scoffing at a proposal made by the U.S. Food and Drug Administration (FDA) that Wuhan coronavirus (covid-19) vaccines undergo more extensive vetting to ensure their safety and effectiveness, the Trump administration is now poised to wait until after the election before launching its mass vaccination program.
The FDA's line of reasoning for the delayed rollout of Trump's Operation Warp Speed vaccines is that the public needs to better understand the agency's "science-based decision-making process that assures vaccine quality, safety and efficacy," which the FDA insists applies to "any vaccine that is authorized or approved."
In a nutshell, the FDA had warned that trying to rush Wuhan coronavirus (covid-19) vaccines to market before Nov. 3 might put members of the public at risk of serious adverse events. This is already being observed in vaccine trials as participants are developing neurological conditions, pounding headaches and other extreme, covid-like side effects.
For the past two weeks, the Trump administration remained vehemently opposed to the FDA proposal, which calls for an additional time to observe the impact of the jabs on human subjects. Trump was personally opposed to this because he wanted the vaccines to be released before Nov. 3, tweeting:
"New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!"
Something changed, however, and the president is now in agreement with the FDA that it is best to wait a little while longer to see what happens with the experimental jabs before mass distributing them by the millions.
"That two-month waiting period would make it all but certain that any vaccine couldn't be approved for use in the U.S. before the election, a target that President Trump had been aiming for," wrote Thomas M. Burton and Rebecca Ballhaus for The Wall Street Journal about the controversy surrounding the FDA proposal.
Trump, Big Pharma really wanted covid-19 vaccines to arrive before election
To be clear, the FDA was already planning to enact its proposal regardless of what the Trump administration decided. This would seem to suggest that Trump and his cabinet agreed to it simply to save face and not appear weak or powerless to change it.
The new FDA guidelines lay out the standards that any Wuhan coronavirus (covid-19) vaccine will need to meet before receiving agency approval. Following a fast-tracked FDA review, a vaccine cleared for approval would be released immediately.
"The so-called emergency-use authorization would last until the pandemic ends, after which vaccines would need the agency's standard approval to stay in use," the Journal notes.
The FDA's fast-tracked review process supposedly includes the same strict requirements as a normal lengthy review. One of these is that any vaccine up for approval must reduce the rate of Wuhan coronavirus (covid-19) infection by 50 percent or more.
The guidelines also require a two-month evaluation period, even though the FDA claims that most serious side effects associated with vaccines tend to emerge within the first six weeks after administration.
Big Pharma is upset about the decision because it means further delays for the release of their vaccine candidates. The White House has tried to go to bat for these vaccine companies, complaining that the FDA's changes are being made too late for these companies to adjust to them.
"Health authorities have expressed concern that many Americans won't take a vaccine if they are concerned it was rushed for political reasons," the Journal further warns about the delicate nature of the approval process.
More related news about the Wuhan coronavirus (covid-19) can be found at Pandemic.news.
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