The federal government has invested billions in the development and production of vaccine candidates in the hope that they will be safe and effective. Expensive gambling seems to be paying off, with the vaccine set to reach some Americans by the end of the year – the fastest vaccine ever developed.
“Should the administration be praised for this? Absolutely,” said Dr. Paul Ofit, director of the Vaccine Training Center at 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 prison cell, but the administration has understood that correctly.”
Health experts agree that the Trump administration’s national strategy has been successful. The Trump administration was willing to invest in new vaccine technologies, pay the bills for large, expensive clinical trials, and at the same time pay for the production of vaccine candidates before it became clear that they would be effective and safe.
Trump has kept his promise of a vaccine as part of his re-election strategy, but his public outcry seems to have done very little to affect the real process. Its real impact has been in government investment, experts said.
Trump welcomed the latest news of the vaccines on Twitter on Monday after Moderna joined Pfizer, reporting stunning efficacy figures for its vaccine candidates. Experts now believe that the first vaccines against coronavirus may become available to first-line health workers as early as December.
“For those great historians, please remember that these great discoveries … all happened under my supervision!” Trump wrote on Twitter.
White House spokesman Brian Morgenstern applauded Trump’s work and swung at Democrats.
The president “not only accelerated the bureaucratic process, but also developed and implemented an innovative strategy for pre-approval dose production,” Morgenstern said. “Vice President Biden, Senator Harris and other leading Democrats are playing politics with people’s lives by sowing doubts about vaccines, and now they are blaming those doubts on the leader who created the vaccines, which is really unscrupulous.”
Since the first talks with federal health officials began earlier this year, several pharmaceutical and biotechnology companies have made it clear that they will need huge investments from the federal government to develop and produce a large-scale coronavirus vaccine.
“The companies were willing 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 health official said.
The investment will not only allow companies to develop and produce potential vaccines faster, but will critically reduce the financial risk that corporate councils 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 we’re unlikely to be where we are at the moment,” the official said.
Some of the technologies behind the upcoming vaccines have been under development for years.
“Part of the speed was due to the fact that the scientific work that led to the development of these vaccines has been going on for 15 years,” said Dr. William Schaffner, a longtime CDC advisor and infectious disease expert at Vanderbilt University. agreed that the administration deserves recognition for the speed with which vaccines have been developed.
Rick Bright, a former health official in the Trump administration and current member of President-elect Joe Biden’s transition team, said the Obama administration’s investment in mRNA vaccine technology has helped develop the coronavirus vaccine this year.
The Obama administration is investing in technology “so when we needed them now for this crisis, they were ready to launch,” Bright said on ABC’s Good Morning America on Tuesday. “So I’m really encouraged that Obama’s investment in these new technologies is paying off now so we can prepare them faster than we’ve ever seen them.”
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.
A senior federal health official acknowledged that the development of the mRNA platform has helped drastically speed up the timing of vaccine development, but added that the huge financial injection from the federal government may have helped speed up research and development. Even more critical, investing in the production of tens of millions of doses of vaccines before the completion of clinical trials will accelerate deployment.
Experts outside the government agreed.
“They made the big bet. They were willing to throw away hundreds of millions of doses if the vaccine was not safe or effective,” Ofit told the Trump administration. “When we look back in historical terms, we will look at this as a year when a remarkable amount was achieved in a short period of time.”
However, Trump committed a cardinal sin by injecting policy into the vaccination process.
He openly called for a vaccine in time to bolster his ill-fated re-election bid, fueling fear among some in the medical community and the American public. Privately and publicly, Trump called on vaccine manufacturers to speed up their development deadlines and even suggested that he try to intervene to speed up the Food and Drug Administration’s vaccination process.
“National politicians have been very avant-garde in this and have really created a very significant political framework for the whole process of developing vaccines,” Schaffner said. “That led to a lot of skepticism.”
At one point, vaccine manufacturers were apparently so concerned about the president’s perception that they released a joint letter vowing to move forward with their vaccine candidates with “high ethical standards and sound scientific principles.”
Schaffner said the message seemed to be aimed directly at the White House to say, “Sit down and shut up and let us take care of that.”
An employee familiar with the conversations between Trump and vaccine manufacturers admitted that he did not believe that his pressure had made anyone work faster. The situation was already urgent.
Moncef Slavey, scientific director of Operation Warp Speed, confirmed this in an interview with MSNBC on Monday.
“The president has never been very active,” Slavey said. “As I have said many times, we have not had interference in one way or another. And we have informed him from time to time.”
An official familiar with Trump’s appeals to vaccine manufacturers said leaders accepted the president’s appeals and attended White House meetings because they acknowledged that it was important for them to look part of the effort. They tended to give Trump an optimistic outlook when talking to him to avoid him.
They did not always avoid Trump’s temper.
When Pfizer announced – six days after election day – that its vaccine appeared to be more than 90% effective in clinical trial data, Trump unleashed it on Twitter.
“As I said a long time ago, @Pfizer and the others would only announce a vaccine after the election because they didn’t have the courage to do it before,” he wrote on Twitter.
FDA and HHS spokesmen declined to comment.
Pfizer CEO Albert Burla rejected the idea that the company was holding back the results.
“We announced it the moment we learned about it, and I have repeatedly said that the elections are an artificial timetable for us,” Burla said. “Then science brought it to us.”
Trump continued to hold out, publicly arguing with Pfizer that he had not received funds to develop his vaccine through Operation Warp Speed. However, he struck a deal worth nearly $ 2 billion for the federal government to buy millions of doses of his vaccine.
“We are committed to ensuring that our vaccine is both safe and effective before it is made available to the general public,” said Sharon Castillo, a Pfizer spokesman. “In doing so, we shared a sense of urgency and a desire to find health solutions to this pandemic that are the driving force behind Operation Warp Speed. We appreciate the help OWS provides to ensure that the vaccine is distributed to priority groups such as health workers and vulnerable . “
A difficult transition
The next big test for the federal government will be the launch into the arms of Americans. This is a complex task that is already more difficult than Trump’s refusal to step down and allow the presidential transition process to begin.
“More people can die if we don’t coordinate,” Biden said Monday. “How do we vaccinate over 300 million Americans? What’s the game’s plan? It’s a huge, huge, huge undertaking to do it.”
Health officials, including Slavey of Operation Warp Speed and Dr. Anthony Fauci of the National Institutes of Health, said contacting Biden’s transition team could help reduce any disruption to vaccine distribution plans. For now, they have no right to do so.
“Transitions are important, and if you don’t have a smooth transition, you wouldn’t optimize any effort right now,” Fauzi told CNN on Tuesday, likening it to a relay race where “you pass the baton and don’t want to slow down what you’re doing.” . “
Concerns by public health experts inside and outside the administration appear to have had little effect on the president.
He spent the day tweeting about the election results.