Home Health News President Donald Trump says COVID-19 vaccines are coming 'momentarily.' Scientists say they're not. – USA TODAY

President Donald Trump says COVID-19 vaccines are coming 'momentarily.' Scientists say they're not. – USA TODAY

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Jordan Culver

Elizabeth Weise

Karen Weintraub
 
| USA TODAY

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Coronavirus: How vaccines are developed and tested

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.

President Donald Trump, back at the White House days after being diagnosed with COVID-19, said vaccines in the fight against the coronavirus pandemic are coming “momentarily.” 

Doctors and scientists have repeatedly refuted that claim. 

Trump, speaking in a video posted to Twitter after leaving the Walter Reed National Military Medical Center on Monday, said he felt “better than 20 years ago” after praising the medicines and equipment involved in his treatment. Earlier in the day, he said people shouldn’t be afraid of COVID-19, and said, “Maybe I’m immune, I don’t know,” during Monday night’s video. 

In the video, Trump also said, “The vaccines are coming momentarily.” 

For a COVID-19 vaccine to become available in the United States, it would first have to gather enough data from Phase 3 clinical trials to be able to prove to the Food and Drug Administration that it was safe, effective and provided immunity to the virus.

Data, data and more data: Will make a coronavirus vaccine safe, USA TODAY’s vaccine panel says

At that point, the FDA would ask its external review committee, the Vaccines and Related Biological Products Advisory Committee, if it concurred. Only then could the agency issue either an Emergency Use Authorization or continue through the full licensing process to issue a license for the vaccine. 

Dr. Paul Pottinger, an infectious disease professor at the University of Washington School of Medicine, said he’s hopeful there will be good news soon on current ongoing trials, but it’s his understanding a “robust supply” of a safe vaccine available for public use will not be available for “many, many months.” 

“Remember, there’s always that delay between when we know something is safe and effective and when it is then available to be generally deployed,” he said. “But, there will not be a safe, generally effective, generally deployable vaccine any moment, I’m very confident of that.” 

On Sept. 16, CDC Director Robert Redfield said that even once a vaccine was approved, only limited amounts would initially be available. The general American public, he anticipated, will not be able to get it and “get back to our regular life” until next summer or fall. Trump later said Redfield misspoke. 

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Four candidate vaccines are being tested in Phase 3 trials. Each involves at least 30,000 people each, half of whom will get the active vaccine and half a placebo. 

Dr. Stephen Hahn, head of the FDA, has repeatedly said he would not approve a vaccine until it has been shown to be safe and effective. He has also said there might be an intermediate endpoint — short of the completion of a 30,000-person trial — that could meet his standards for a so-called emergency use authorization.

Early approval can be issued only during a federal health emergency.

‘Outright egregious’: Scientists outraged by White House appointees’ meddling with coronavirus information

The fastest vaccine ever developed took four years. Work on a COVID-19 vaccine has been happening at a much faster pace, thanks to advances in technology, research on similar but much smaller coronavirus outbreaks, a concerted effort by the companies, and federal support.

Public health officials, testifying before Congress on Sept. 30, said politics is not influencing the development of a COVID-19 vaccine. 

Both government and independent researchers provide strong oversight of vaccine development, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University and a former FDA commissioner.

Trump: CDC Director Robert Redfield ‘confused’ about coronavirus vaccine, mask efficacy

“This is not an easy process to disrupt just because somebody says something about it,” he said at the time. “It does undermine confidence, though.”

The CDC, in a planning document detailing how how states and local public health programs should plan and prepare for the release of one or more COVID-19 vaccines, said “limited doses” of a vaccine might be available by early November.

The document added planners should assume that by January 2021, “significantly more COVID-19 vaccine may be available for distribution.” 

It’s going to be a while: When will children get a COVID-19 vaccine?

Dr. Otto Yang at the University of California-Los Angeles doesn’t see approval before the new year.

“I really don’t think we can have safety data that is good enough until at least winter (three to four months of trial data). Shorter than that is too little time, no matter what the results show,” said Yang, a professor of medicine and associate chief of infectious diseases at UCLA’s David Geffen School of Medicine.

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