President Donald Trump finally has something legitimate to take credit for in his coronavirus response: A vaccine that appears poised to reach Americans in record time.
The federal government poured billions into developing and manufacturing vaccine candidates in the hopes they would prove safe and effective.
The pricey gamble appears to be paying off, with a vaccine on track to reach some Americans by the end of the year — the fastest a vaccine has ever been developed.
“Should the administration be praised for this? Absolutely,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a sharp critic of the administration’s coronavirus response.
“Donald Trump probably doesn’t know the difference between a white cell and a prison cell, but the administration got this right.”
Health experts broadly agree that the Trump administration’s national vaccine strategy was a success. The Trump administration was willing to invest in new vaccine technologies, foot the bill for large, expensive clinical studies and simultaneously pay for manufacturing vaccine candidates before it was clear they would prove effective and safe.
Trump held out the promise of a vaccine as part of his reelection strategy, but his very public bluster appears to have done very little to influence the actual process.
His real impact was in the government’s investment, experts said.Trump cheered the latest vaccine news on Twitter Monday, in the wake of Moderna joining Pfizer’s ranks in reporting stunning efficacy numbers for their vaccine candidates.
Experts now believe the first coronavirus vaccines could become available to frontline medical workers as early as December.”For those great ‘historians’, please remember that these great discoveries … all took place on my watch!” Trump tweeted.
White House spokesman Brian Morgenstern applauded Trump’s work, and took a swipe at Democrats.
The President “not only sped up the bureaucratic process, he also developed and implemented an innovative strategy to manufacture doses in advance of approval,” Morgenstern said. “
Vice President Biden, Senator Harris, and other leading Democrats have been playing politics with peoples’ lives by sowing doubts about the vaccines, and now blame those doubts on the very leader who is bringing the vaccines into existence, which is truly unconscionable.”
As the first conversations with federal health officials got underway early this year, several pharmaceutical and biotechnology companies made clear that they would need massive investments from the federal government in order to develop and manufacture a coronavirus vaccine at scale.
“The companies were willing to do it, but they made it clear there was no way they were going to do it without the investment of hundreds of millions, if not billions of dollars,” the senior federal health official said.
The investment would not only allow the companies to more rapidly develop and manufacture potential vaccines, but it would critically assuage the financial risk that corporate boards would be concerned about.
“I can’t tell you where we would be if we didn’t have Operation Warp Speed, but I can say it’s unlikely we would be where we are right now,” the official said.
Some of the technology behind the upcoming vaccines has been in the works for years.”Some of the speed had to do with the fact that actually, the scientific work, which led up to the development of these vaccines has been going on for 15 years,” said Dr.
William Schaffner, a longtime adviser to the CDC and an infectious diseases expert at Vanderbilt University, who nonetheless agreed that the administration deserved credit for the speed at which the vaccines were developed.
Rick Bright — a former Trump administration health official and current member of President-elect Joe Biden’s coronavirus transition team — said Obama administration investments in messenger RNA (mRNA) vaccine technology helped propel coronavirus vaccine development this year.
The Obama administration invested in the technology “so, when we needed them now for this crisis they were ready to run,” Bright said on ABC’s “Good Morning America” Tuesday. “
So, I’m really encouraged that the Obama investment in these new technologies is paying out now, so we can have them ready faster than we’ve ever seen.”
The mRNA technology has never been used in an approved vaccine before and is designed to produce an immune response in people who have been inoculated.
The senior federal health official acknowledged that the development of the mRNA platform helped dramatically speed the vaccine development timeline but added the massive financial injection from the federal government likely helped speed up research and development.
And even more critically, the investment in manufacturing tens of millions of vaccine doses before clinical trials were completed will speed the roll out.Experts outside the government agreed.”
They made the big gamble. They were willing to throw away hundreds of millions of doses if the vaccine were not safe or effective,” Offit said of the Trump administration.
“When we look back on this historically, we will see this as a year when a remarkable amount was achieved in a short period of time.”
‘ Trump, however, committed a cardinal sin by injecting politics into the vaccine process. He openly clamored for a vaccine in time to bolster his ill-fated reelection bid, igniting fear among some in the medical community and the American public.
Privately and publicly, Trump called on vaccine makers to speed up their development timelines and even suggested he may try to intervene to speed up the Food and Drug Administration’s vaccine authorization process.
“The national politicians have been very much out front in this and have really created a very substantial political veneer over the entire vaccine development process,” Schaffner said.
“That has had an effect of creating a terrific amount of skepticism.”At one point, vaccine makers were apparently so concerned about the perception the President was creating that they released a joint letter vowing to move forward with their vaccine candidates under “high ethical standards and sound scientific principles.”
Schaffner said that message appeared to be aimed squarely at the White House to say: “Sit down and shut up and let us take care of this.”One official familiar with the calls between Trump and the vaccine makers conceded they did not believe his pressure prompted anyone to work faster.
The situation was already urgent.Moncef Slaoui, the scientific head of Operation Warp Speed, affirmed as much in a Monday MSNBC interview.”The President has never been very actively involved,” Slaoui, said. “
As I said many times, we have had no interference one way or the other. And we have informed him from time to time.
“The official familiar with Trump’s calls to vaccine makers said the executives took the President’s calls and attended meetings at the White House because they recognized it was important for them to appear a part of the effort.
They tended to give Trump an optimistic outlook when they spoke to him in order to avoid him lashing out.They didn’t always avoid Trump’s temper.
When Pfizer announced — six days after Election Day — that its vaccine appeared more than 90% effective in clinical trial data, Trump unleashed on Twitter.
“As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before,” Trump tweeted.
The furious President also called FDA Commissioner Stephen Hahn and Health and Human Services Secretary Alex Azar, demanding to know why the information wasn’t made public before the election and accusing Pfizer of trying to undermine him, according to a White House official.
FDA and HHS spokespeople declined to comment.Pfizer’s chief executive Albert Bourla dismissed the notion that the company had been holding back results.
“We announced it the moment we learned about it, and I said multiple times the election for us is an artificial timeline,” Bourla said. “This is when science brought it to us.”
In a Tuesday interview with The New York Times, Bourla added: “I knew very well, because I had spoken to the President, that he would like to see it earlier, but I didn’t receive any pressure, per se, on me to do something that is not appropriate.”
Trump has kept up his griping, publicly scolding Pfizer for pointing out that the company didn’t receive funds to develop its vaccine through Operation Warp Speed.
It did, however, ink a nearly $2 billion deal for the federal government to purchase millions of doses of its vaccine.
“We have made an unwavering commitment to ensure that our vaccine is both safe and effective before it is made available to the general public,” said Sharon Castillo, a Pfizer spokeswoman.
“In doing so, we have shared the sense of urgency and the drive to find health care solutions to this pandemic that have been the engine behind Operation Warp Speed.
We appreciate the assistance that OWS is providing to ensure the vaccine is distributed to priority populations like health care workers and the vulnerable.”
A tricky transition
The next big test for the federal government will be getting shots into Americans’ arms.
It’s a complicated task already made more difficult by Trump’s refusal to concede and allow the presidential transition process to begin.”More people may die if we don’t coordinate,” Biden said Monday.
“How do we get over 300 million Americans vaccinated? What’s the game plan? It’s a huge, huge, huge undertaking to get it done.”Health officials including Operation Warp Speed’s Slaoui and the National Institute of Health’s Dr.
Anthony Fauci have both said that making contact with Biden’s transition team could help limit any disruption to vaccine distribution plans. So far, they are not allowed to do so.
“Transitions are important, and if you don’t have a smooth transition, you would not optimize whatever efforts you’re doing right now,” Fauci said on CNN Tuesday, likening it to a relay race where “you’re passing the baton and you don’t want to slow down what you’re doing.
“Those concerns from public health experts inside and outside the administration appear to have had little impact on the President.He spent the day tweeting about the election results.
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