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During the second and last debate before the Nov. 3 election, President Donald Trump insisted — again — that a coronavirus vaccine will be ready “within weeks.”
But according to scientific experts, there’s no way that’s happening, at least not with a vaccine that has proven safe and effective through appropriately timed clinical trials.
“There is absolutely *NO* vaccine coming in just ‘a few weeks,’” epidemiologist Dr. Eric Feigl-Ding, a senior fellow at the Federation of American Scientists in Washington D.C., and chief health economist for Microclinic International, said on Twitter during the presidential debate.
“If for some hellish reason Trump WH tries to rush a vaccine tomorrow or this coming week — it would be reckless and against all scientific standards for establishing efficacy and safety,” he continued.
The process to develop, test and distribute a vaccine, no matter the disease involved, usually takes years to accomplish. But Trump said he doesn’t think his own health officials, who have presented a different timeline, are “counting on the military the way I do.”
“We have Operation Warp Speed, the military is going to distribute the vaccine,” Trump said during the debate.
When debate host Kristen Welker of NBC asked the president if his claims on the vaccine timelines were a “guarantee,” Trump said, “no.”
“It’s not a guarantee but it will be by the end of the year,” he responded.
Operation Warp Speed, a public–private partnership initiated by the Trump administration, was designed “to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021,” according to the U.S. Department of Health and Human Services.
A fact sheet on the initiative says, “rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally.”
“This increases the financial risk, but not the product risk,” the sheet reads.
But experts have a different take.
In the ongoing randomized, placebo-controlled clinical trials, participants are randomly assigned to either receive a vaccine candidate or a placebo.
“There is no specified time frame to determine efficacy. What drives the time frame is how frequently disease occurs in those who receive the study vaccine compared to those who receive the placebo vaccine,” William Moss, executive director of Johns Hopkins’ International Vaccine Access Center, told CBS News in September. “During a pandemic this can happen faster than in a non-pandemic situation.”
But if there wasn’t a pandemic, phase 3 trials — the last step before a vaccine is approved for public use — could last at least two to three years, Moss added. Only then would manufacturing of the vaccine begin after data review is complete.
“When the president comes out and says, ‘by a very special day, we might have a vaccine,’ the whole thing blows up,” Ashish Jha, dean of the Brown School of Public Health, said at a COVID-19 session at the STAT Health Tech Summit in September. “In some ways, we’ve got to get the politicians to shut up and let the scientists talk about this and drive this process.”
Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said if the U.S. “wanted to take the chance of hurting a lot of people or giving them something that doesn’t work,” it could release a vaccine under the proposed expedited timeline, according CBS News. “We could start doing this, you know, next week if we wanted to. But that’s not the way it works.”
Vaccine developers have also come out to ensure public confidence in a vaccine.
In a “historic pledge,” nine biopharmaceutical companies vowed to ensure that the COVID-19 vaccines they develop are safe and effective before submitting them for approval to federal health officials, McClatchy News previously reported.
An infectious diseases and immunization expert at Vanderbilt University in Nashville told USA Today the joint pledge is “unprecedented.”
“I’ve only been doing vaccines for 40 years and I’ve never heard of anything like this before,” Dr. William Schaffner told the outlet. “Having the companies themselves issue this statement I think will offer some reassurance. Not completely, but some reassurance to the medical profession.”