Officials at the White House had the same question. So why did the FDA add 18 days to the side-effects check? In his book “Warp Speed,” Paul Mango, former HHS deputy chief of staff for policy who was intimately involved with the vaccine effort, reports that vaccine developers understood the earlier guidance to mean trials would only be required to monitor for adverse events for, at most, 42 days after the second dose.īiden’s COVID head: ‘God gave us two arms’ to get double vaccinations The House report fails to mention that these new guidelines - submitted to the White House and HSS on September 21 - revised earlier June 2020 guidelines that stated the “safety evaluation of COVID-19 vaccines … should be no different than for other preventive vaccines for infectious diseases.” Former HHS deputy chief of staff for policy Paul Mango said he never heard Trump ask for the vaccine to be released before Election Day. The agency would now require a median follow-up of 60 days after the vaccine shots to check for adverse side effects. The delay followed a curious FDA decision to toughen its standards for COVID vaccine safety review (effectiveness guidelines were unchanged). Eleven days later, it filed a vaccine emergency use authorization request - the first in the US - that was granted on December 11. Instead, on November 9, six days after the presidential election, Pfizer announced that its COVID-19 vaccine candidate was 90% effective. Pfizer’s trials were moving faster than expected and he predicted the company would likely have results by the end of October.įive days later, on “Face the Nation,” Bourla said there was more than a 60% chance Pfizer would know results by the end of October. 9, 2020, Pfizer CEO Albert Bourla announced on the “Today” show that Pfizer had joined a pledge with other pharmaceutical companies to follow FDA guidance and to only request a vaccine emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study. Pfizer CEO Albert Bourla pledged to only request a vaccine emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study. ![]() We know from interviews that vaccine trials were proceeding faster than anticipated and that an announcement about vaccine efficacy was possible by the end of October 2020 with authorization soon to follow. In reality, it was Trump opponents who undermined public confidence, resulting in new FDA guidelines that delayed vaccine availability and likely cost lives. Stephen Hahn to the commission on which it is based, reveal these assertions are misleading, politically motivated distortions. ![]() ![]() Graeme Jennings/APīut the report, and the testimony of former FDA Commissioner Dr. Stephen Hahn said Trump administration officials pressed him to speed up vaccine authorization even after the election. It claims that the administration’s actions “resulted in damaging consequences for the coronavirus response” by undermining public confidence in the vaccine. Last month, in a congressional report provocatively titled “ A ‘Knife Fight’ with the FDA: The Trump White House’s Relentless Attacks on FDA’s Coronavirus Response,” the House Select Subcommittee on the Coronavirus Crisis alleged that Trump administration officials “blocked FDA from issuing guidance on coronavirus vaccine authorizations for weeks in an attempt to ensure that the first vaccine could be authorized before the 2020 presidential election.” ![]() But one victim is clear: Americans’ trust in their government and public health experts.ĭemocrats are trying to deflect blame for this scandal by claiming the inverse: that the Trump administration undermined public trust by irresponsibly trying to “rush” the vaccine for political gain. We may never know how much damage was done in the name of politics. Yet it’s become increasingly clear that the FDA put the brakes on the vaccine at the 11th hour, delaying its authorization because Democrats - worried it would help Donald Trump’s 2020 re-election prospects - undermined public confidence in the vaccine development efforts. Scientist who tried to squash Wuhan theory gets more cash to study virusesįor every week we didn’t have a COVID-19 vaccine, more people died, more children were kept out of school, and more damage was done to society. Norwegian Cruise Line eliminating COVID-19 testing, masking, vaccination requirements Multiple Massachusetts colleges extend mask mandates indefinitelyĬhinese artist turns COVID tests into art to represent pandemic life in China
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