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The federal government has invested billions in the development and manufacture of candidate vaccines in the hope that they would prove to be safe and effective. The costly gamble appears to be paying off, with a vaccine on track to reach some Americans by the end of the year – the fastest vaccine ever developed.
“Should the administration be commended for that? 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 response to the coronavirus. “Donald Trump probably doesn’t know the difference between a white cell and a jail cell, but the administration got it right.”
Health experts widely agree that the Trump administration’s national vaccination strategy has been a success. The Trump administration was willing to invest in new vaccine technologies, foot the bill for large and expensive clinical studies, and simultaneously pay for the manufacture of vaccine candidates before it was clear that they would prove to be effective and safe. .
Trump kept the vaccine promise as part of his re-election strategy, but his very public boast appears to have done very little to influence the actual process. Its real impact was on government investment, experts said.
Trump applauded the latest vaccine news on Twitter on Monday, following Moderna joining the ranks of Pfizer to report astonishing efficacy figures for their vaccine candidates. Experts now believe the first coronavirus vaccines could be available to frontline medical workers as early as December.
“For these great” historians “, remember that these great discoveries … all took place under my supervision!” Trump tweeted.
White House spokesman Brian Morgenstern applauded Trump’s work and swept Democrats aside.
The president “not only accelerated the bureaucratic process, he also developed and implemented an innovative strategy to manufacture doses before approval,” Morgenstern said. “Vice President Biden, Senator Harris and other leading Democrats have played politics with people’s lives by casting doubts on vaccines, and now attribute those doubts to the very leader who makes vaccines exist,” which is really unacceptable. ”
First investments
As the first conversations with federal health officials began earlier this year, several pharmaceutical and biotech companies made it clear that they would need massive investments from the federal government to develop and manufacture a vaccine against large-scale coronavirus.
“The companies were prepared to do it, but they made it clear that there was no way to do it without investing hundreds of millions, if not billions of dollars,” the senior federal official said. health.
This investment would not only allow companies to develop and manufacture potential vaccines faster, but it would critically mitigate the financial risk that would be of concern to boards of directors.
“I can’t tell you where we would be if we didn’t have Operation Warp Speed, but I can say that it is unlikely that we would be where we are now,” said the official.
Some of the technology behind upcoming vaccines has been around for years.
“Part of the speed was due to the fact that, in fact, the scientific work that led to the development of these vaccines has been going on for 15 years,” said Dr William Schaffner, longtime CDC adviser and expert in infectious diseases at Vanderbilt University, which nonetheless recognized that the administration deserved praise for the speed at which vaccines have been developed.
Rick Bright – former Trump administration health official and current member of President-elect Joe Biden’s coronavirus transition team – said the Obama administration’s investments in messenger RNA vaccine technology (mRNA ) helped propel the development of the coronavirus vaccine this year.
The Obama administration invested in technology “so when we needed them now for this crisis, they were up and running,” Bright said on ABC’s “Good Morning America” Tuesday. “So I’m really encouraged that Obama’s investment in these new technologies is paying off now, so we can get 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 had significantly accelerated the vaccine development timeline, but added that the massive financial injection from the federal government had likely helped accelerate research and Development. And even more critically, investing in manufacturing tens of millions of doses of vaccine before clinical trials are over will speed deployment.
Experts from outside the government agreed.
“They made the big bet. They were prepared to throw away hundreds of millions of doses if the vaccine wasn’t safe or effective,” Offit said of the Trump administration. “When we look back on this historically, we will see this as a year where a remarkable amount has been achieved in a short period of time.”
Presidential pressure
Trump, however, committed a cardinal sin by injecting politics into the vaccination process.
He openly called for a vaccine in time to support his ill-fated re-election bid, sparking fear among some in the medical community and the American public. Privately and publicly, Trump has called on vaccine makers to speed up their development timelines and even suggested he might try to intervene to speed up the Food and Drug Administration’s vaccine clearance process.
“National politicians have been very much forward in this area and have really created a very substantial political veneer over the whole process of vaccine development,” Schaffner said. “It had the effect of creating enormous skepticism.”
At one point, vaccine makers were apparently so concerned with the perception the President was creating that they issued a joint letter committing to move forward with their vaccine candidates “to high ethical standards and principles. solid scientists ”.
Schaffner said the message seemed to be aimed squarely at the White House to say, “Sit down and shut up and let us take care of that.”
An official familiar with calls between Trump and the vaccine makers admitted they didn’t think his pressure made anyone work faster. The situation was already urgent.
Moncef Slaoui, the scientific manager of Operation Warp Speed, said so in an interview with MSNBC on Monday.
“The president has never been very actively involved,” Slaoui said. “As I have said on several occasions, we 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 manufacturers said executives have responded to the president’s calls and attended meetings at the White House because they recognize it is important for them to be part of the effort. They tended to give Trump an optimistic outlook when speaking to him so as not to criticize him.
They haven’t always shied away from Trump’s temper.
When Pfizer announced – six days after polling day – that its vaccine appeared to be over 90% effective in clinical trial data, Trump went wild on Twitter.
“As I have said for a long time, @Pfizer and the others would not announce a vaccine until after the election because they hadn’t had the courage to do it before,” Trump tweeted.
Spokesmen for the FDA and HHS declined to comment.
Pfizer chief executive Albert Bourla dismissed the idea that the company had withheld its results.
“We announced it at the time we learned about it, and I have said on several occasions that the election was an artificial calendar for us,” Bourla said. “That’s when science brought it to us.”
Trump continued to complain and publicly scold Pfizer for pointing out that the company had not received funding to develop its vaccine as part of Operation Warp Speed. He did, however, sign a nearly $ 2 billion deal for the federal government to purchase millions of doses of his vaccine.
“We are continuously committed to ensuring that our vaccine is both safe and effective before it is made available to the general public,” said Sharon Castillo, a spokesperson for Pfizer. “In doing so, we shared the sense of urgency and the will to find healthcare solutions to this pandemic, which has been the driving force behind Operation Warp Speed.” We appreciate the assistance provided by OWS to ensure vaccine distribution to priority populations. such as healthcare workers and the vulnerable. “
A delicate transition
The next big test for the federal government will be hugging Americans. 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 are at risk of dying if we don’t coordinate,” Biden said Monday. “How do you get over 300 million Americans vaccinated? What’s the game plan? It’s a huge, huge, huge undertaking to get there.”
Health officials including Slaoui of Operation Warp Speed and Dr Anthony Fauci of the National Institute of Health both said making contact with Biden’s transition team could help limit any disruption. vaccine distribution plans. So far, they are not allowed to do this.
“Transitions are important, and if you don’t have a smooth transition, you wouldn’t be maximizing the effort you’re currently making,” Fauci told CNN Tuesday, likening it to a relay race where “you spend the day. relay. and you don’t want to slow down what you’re doing. “
These concerns of 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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