Politics Trump’s vaccine promises meet reality
States prepare for their own vaccine safety reviews amid worries about Trump’s influence on the FDA
It's not yet clear whether the states would seek to block distribution of a vaccine they deem unsafe or ineffective, or just broadcast those concerns far and wide.New York, California, Michigan, West Virginia, Washington D.C. and potentially a handful of others are in the early stages of creating independent panels to review vaccine data as it becomes available – although it’s not yet clear whether all these states would seek to block distribution of a vaccine they deem unsafe or ineffective, or just to broadcast those concerns.
President Trump’s optimistic promises that a vaccine forwould be ready either before the election or by the end of the year seem increasingly unlikely to be fulfilled.
In a Wednesday interview with the Journal of the American Medical Association,adjusted pushed back the administration’s timeline for when a vaccine would be ready.
“Could be January, could be later. We don’t know,” Fauci, the leading expert on infectious diseases on the president’s coronavirus task force, said.
In early October, shortly after he was treated for his own COVID-19 infection at Walter Reed Medical Center, Trump repeatedly said on the campaign trail that"vaccines are coming momentarily." But when pharmaceutical manufacturer Pfizer announced on Oct. 16 that it would delay applying to the Food and Drug Administration for emergency authorization to distribute the vaccine it was developing, Trump softened his declarations, saying a vaccine would be coming “within weeks.”
USA TODAY's experts say securing a COVID vaccine in record time could be easy. Distributing it won't be.
Our panel of experts expect at least one COVID-19 vaccine will be approved in the coming months. Then things could really get complicated.Overall, hopefulness was the theme of USA TODAY's vaccine panel this month. After five months, the panel's countdown clock to a widely available vaccine skipped forward another hour, to 8 a.m.
On a corporate earnings call on Tuesday, Pfizer revealed that it had so far been unable to conduct an analysis of a Phase 3 clinical trail to determine whether its vaccine is safe and effective,Without that analysis, the FDA will not grant an emergency use authorization.
“I can tell you our decision at FDA will not be made on any other criteria than the science and data associated with these clinical trials,” FDA director Stephen Hahn toldin September.
He was responding to accusations from the president days earlier that the FDA had been coopted by the “deep state,” delaying the release of a vaccine so as to hurt his reelection chances.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!
You Can Now Get a COVID-19 Vaccine in China. That Might Not Be a Good Thing
In China, an unofficial vaccine rollout is gathering pace despite the warnings of international public health experts . In September, state-owned SinoPharm revealed that hundreds of thousands of Chinese had already taken its experimental COVID-19 vaccines as part of a state initiative to protect frontline health workers and officials traveling to high-risk nations. In the eastern manufacturing hub of Yiwu this week, hundreds of people queued for a $60 dose of the CoronaVac vaccine made by private firm SinoVac.Read more: ‘We Will Share Our Vaccine with the World.— Donald J. Trump (@realDonaldTrump)
The clash prompted Health and Human Services Secretary and Trump loyalistto seek to have the FDA director replaced, .
But Trump’s assertion that a vaccine could be ready by Nov. 3 was always improbable. While “Operation Warp Speed” has made notable initial progress in the production of a vaccine, reality has set in over recent weeks, as manufacturers like AstraZeneca and Johnson & Johnson were forced to pause their vaccine trials after participants became ill.
Such setbacks are common in vaccine development and don’t necessarily mean that the compound being tested caused the illness, but researchers have to investigate to rule it out.
Debate transcript: Trump, Biden final presidential debate moderated by Kristen Welker
Here is the full transcript of the final presidential debate between President Donald Trump and former Vice President Joe Biden, moderated by Kristen Welker in Nashville on Oct. 22, 2020. Headers have been added for ease of reading. © Mario Tama, Getty Images People are pictured watching the final debate between President Donald Trump and Democratic presidential nominee Joe Biden at The Abbey in West Hollywood, California. [0:00] Welker: A very good evening to both of you. This debate will cover six major topics.
Video: Hillary Clinton 'sick to my stomach' over possible second Trump term (FOX News)
Health experts have always known that the odds were long that vaccine could be available for the public by the end of the year. When he testified before Congress in mid-September, Centers for Disease Control and Prevention director Robert Redfield said a vaccine would not be widely available until late spring or early summer next year.
“If you’re asking me when it is going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at late second quarter, third quarter 2021,” Redfield said, a prediction that Trump felt it.
“I think he made a mistake when he said that,” Trump said at a testy White House press conference the next day. “It’s just incorrect information and I called him and he didn’t tell me that and I think he got the message maybe confused, maybe it was stated incorrectly.”
Trump’s optimism rests on his plan to enlist the U.S. military to distribute the vaccine, which in turn assumes that a safe and effective product is available.
The FDA and CDC Promised Transparency in the Vaccine Approval Process. Here's How Congress Can Hold Them to It
Senators Maggie Hassan and Lisa Murkowski introduced the SAVE Act to ensure that the CDC and FDA follow through with the transparency they committed to around vaccine approval process.While we all hope to get potential vaccines reviewed, produced and distributed as quickly as possible, we can’t sacrifice safety and efficacy for speed. It is also critically important that the public has confidence in the federal government’s vaccine review process, which includes assurances that the Food and Drug Administration (FDA) has followed the necessary protocols to ensure vaccine safety and effectiveness.
“We have a vaccine that’s coming, it’s ready,” Trump said during the. “It’s going to be announced within weeks, and it’s going to be delivered. We have Operation Warp Speed, which is the military, is going to distribute the vaccine.”
But Trump’s own military officials may not be on board with this plan.
“Our best military assessment is that there is sufficient U.S. commercial transportation capacity to fully support vaccine distribution,” Charles Pritchard, a spokesman for the Department of Defense, saidin late September. “There should be no need for a large commitment of DOD units or personnel to support the nationwide distribution of vaccines.”
To date, COVID-19 has killed more than 228,000 Americans and infected more than 8.9 people in the U.S. The pandemic is worsening, with new cases rising across the country by 41 percent over the last 14 days. Over the last 24 hours alone, 81,457 new cases and 1,016 deaths from COVID-19 were reported in the U.S.
Phase 3 vaccine trials are ongoing, and it is conceivable that a company could approach the FDA in the weeks following the election seeking emergency use authorization. Even so, that doesn’t mean a vaccine will be granted approval before the end of the year, or that, if it is, it will be available to most Americans until after the “” Trump’s opponent, Joe Biden, says is coming.
Donald Trump made many promises in 2016 and early in his term. Which has he kept and what is he still working on?
Trump has kept a number of pledges, including tax cuts and conservative judges. But not on others such as bringing back coal and replacing Obamacare."Unlike so many who came before me, I keep my promises," Trump said during his State of the Union speech this year.
Read more from Yahoo News:
Do you trust FDA on COVID-19 vaccines? States and a Black medical group form review boards for second opinion .
Five states and an Black medical group say they’ll conduct independent verification of any COVID-19 vaccines that are approved by FDA.These review panels, which began popping up last month, are meant to instill public confidence and counter the political pall cast over COVID-19 vaccine development and approval. In recent weeks, faith has improved in the FDA's commitment to base COVID-19 vaccines decisions in science, but the growing number of oversight groups seek to add another layer of trust.