Emory Expert: COVID-19 Vaccine Could Be A 'Disaster' If Process Is Rushed

Caption

Dr. Walter Orenstein says a safe and effective COVID-19 vaccine could be available early next year.

Credit: Interview screenshot taken Friday, Sept. 4, 2020.

The United States must guarantee the safety and efficacy of any COVID-19 vaccine that comes to the market – and that rushing the process could prove to be a “disaster” if the science is compromised, a top Emory doctor says.

President Donald Trump last week said a coronavirus vaccine would “probably” be available in October, raising concern among scientists that the vaccine could be used as a political tool by the administration. 

In an effort to reassure the public that the process will be held to rigorous, scientific standards, the drug companies competing to develop the vaccine reportedly plan to sign a pledge this week that they will not seek government approval until the shots have been proven to be safe and effective. 

The federal government’s Operation Warp Speed aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.

Dr. Walt Orenstein, the associate director of the Emory Vaccine Center, said part of the controversy with “Warp Speed” is the question of whether there will be adequate review and assurance that whatever vaccine is released is documented to be both safe and effective.

“I think particularly given public skepticism, that we really need to have good data on safety and efficacy before we begin using it,” he said.

Orenstein said it’s far easier to look retrospectively at what should have been done than prospectively.

Health officials with the U.S. Food and Drug Administration had a similar quandary over the antiviral drug remdesivir. The trial conducted by the National Institute of Allergy and Infectious Diseases was cut short when researchers believed they found enough evidence of the drug’s benefit – that ethically the drug needed to be made available sooner than the trial’s end date.

Preliminary analysis showed the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. 

Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level, said Dr. Aneesh Mehta, the lead investigator of Emory’s remdesivir clinical trial, who emphasized the importance of understanding antivirals are in general not “silver bullets” but they work by slowly preventing the virus from making more of itself.

MORE: Antiviral Drug Remdesivir Shows Promise Against COVID-19 In Trials

Because remdesivir involves treating people who are actively ill and a vaccine is designed to protect healthy people, Orenstein said the scientific community wants demonstrated proof of safety and efficacy for the coronavirus vaccine.

“In terms of timing, it's not to say we absolutely cannot have a vaccine available by October and November,” Orenstein said. “I think the likelihood is slim for that because I think we could have a disaster if, in fact, the vaccine turned out not to be effective and particularly if it turned out to have significant safety problems.”

To demonstrate efficacy, a high enough attack rate is needed in the placebo recipients’ group to show that there is a statistically significant lower rate in vaccinees and measure that, he said.

“For example, let's say we had 15,000 vaccinees and 15,000 placebo. If we have 100 infections in the placebo and 50 in the vaccine arm that would suggest a 50 percent vaccine efficacy, a 50 percent reduction,” Orenstein said. “And that's the test. Statisticians can tell us if this is a chance phenomenon or it looks like a real phenomenon.”

FDA guidelines call for a minimum of 50% efficacy in the clinical trial. Orenstein said he believes the nation is not likely to see a COVID-9 vaccine by Election Day.

“I can't say it's impossible, but I would be extremely surprised because of the needs to collect adequate safety and adequate efficacy data,” Orenstein said. “Again, if we've got very high attack rates in the placebo or comparator arm, it may be possible. But I think the likelihood is, optimistically presuming the vaccine is safe and effective, sometime early next year.”

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Meanwhile, as federal officials eagerly anticipate a COVID-19 vaccine, Gov. Brian Kemp is tasked with preparing Georgia for vaccine distribution, state health officials said.

Centers for Disease Control and Prevention Director Robert Redfield sent a letter asking governors to fast-track permits and licenses so that vaccine distribution sites can be up and running by Nov. 1, but questions exist about whether researchers can so quickly determine a vaccine is safe and effective for fall distribution.

At roughly six months into the coronavirus pandemic, the United States has recorded more than 6 million COVID-19 cases and over 185,000 deaths.

Some worry, the rush is politically motivated. 

Michael Hokanson, a spokesman for the Georgia Department of Public Health’s North Central Health District in Macon, said plans are in place for mass vaccine distribution.

"We, like everyone involved in vaccination, are in the early stages of planning should COVID-19 vaccine be ready for distribution soon,” Hokanson said. “Locally, we do not yet have any specific details yet on what this will look like.”

Development of three different COVID-19 vaccines are already in Phase 3, in which the vaccine is given to thousands of people and tested for efficacy and safety, but the process to develop, manufacture and distribute an effective vaccine typically takes years, not months.

Emory University was one of three sites that took part in a Phase 1 study of the experimental vaccine, mRNA-1273, which was co-developed by researchers at the NIAID, part of the National Institutes of Health, and biotech company Moderna, Inc. Early results from that study found the vaccine was generally well tolerated and generated an immune response among participants.

The new larger study began July 27 and is expected to enroll about 30,000 people at more than 80 sites. Hundreds of adult volunteers 18 and older will ultimately be enrolled at three Emory University clinics: Emory Children’s Clinic, the Hope Clinic of Emory Vaccine Center, and Grady Health’s Ponce de Leon Center.

Orenstein said it’s important to remember that developing a vaccine isn’t the end goal.

“People are focusing on what do we need to get a vaccine, but once even we have a licensed vaccine, there will need to be a system to continue to evaluate efficacy,” Orenstein said. “For example, to look at issues of waning immunity and whether booster doses are needed. That will only come for after we use it and we follow it over time and measure vaccine efficacy.”