On May 15, President Donald Trump announced, “Vaccine or no vaccine, we’re back.
The words came mere minutes after Trump announced the public-private venture called Operation Warp Speed, which, per the Department of Health and Human Services, aims to have “substantial quantities of a safe and effective vaccine available for Americans by January 2021.”
Normally, said Lorraine Whitman and Cliff Mintz, two veteran pharmaceutical industry medical writers, it can take up to 10 years just to get a new drug or vaccine through the Food and Drug Administration’s approval process. A prospective vaccine’s clinical trials generally proceed in three phases.
In phase one, the vaccine is tested for safety in small groups of healthy people.
Phase two tests the vaccine’s efficacy by giving doses of varying sizes to the infected. “And then,” said Mintz, “you let these people out into the world and see how many develop neutralizing antibodies that are protected against the virus.”
Phase three consists of double-blind studies in large groups. “You’ll have 5,000 who will be immunized, 5,000 who won’t be,” Mintz said.
“That’s the irony of vaccine production: The only way to determine that a vaccine is actually effective is to have people get sick,” Mintz said.
Vaccines couldn’t be produced for SARS and MERS, Mintz explained, because after the initial outbreaks, there were never second waves.
“In the case of this virus,” he said, “most virologists expect a second wave because it’s so easily transmitted and so contagious.”
After phase three studies are conducted in both randomized and controlled groups, the vaccine is submitted for FDA approval. If approved, marketing can begin, followed by manufacturing and distribution.
Even after a vaccine’s been approved, the FDA can call for phase four post-marketing studies, which address concerns over sample size and representativeness.
Mintz said the coronavirus vaccine will likely undergo phase four scrutiny because of the scope of its distribution.
“The quickest vaccine I know that’s ever been developed is between four and five years,” said Mintz, who was a professor in the University of Miami’s department of microbiology and immunology before writing and consulting. Warp Speed’s goal is seven months away.
“The likelihood of a successful, safe and effective vaccine being available by January 2021, in my estimation, would be slim to none,” Mintz said.
“Now, I believe if everything hits and all the milestones are met,” he added, “I think that a vaccine available sometime towards the end of 2021, early 2022, straddles that border of possible and miraculous.”
The Operation Warp Speed architects believe this can be achieved not by skipping phases of clinical trials but by beginning mass manufacturing for dozens of potential vaccines before knowing which, if any, are safe and effective — a process known as “at risk” production.
If all goes according to plan, billions will be spent on vaccine candidates that aren’t “the one” — the idea being that once “the one” is found, it will already have been manufactured to scale to serve billions of people, saving months, maybe years in bringing the vaccine to market.
Still, the time this money may be buying isn’t cheap and there are concerns over which of Operation Warp Speed’s partners — public or private — will pay.
“I don’t know how (pharmaceutical) companies are going to have the financial wherewithal to do it,” said state Sen. Daylin Leach, whose district has GlaxoSmithKline facilities. “It can’t be feasible for 115 or more different companies to be building plants to manufacture a vaccine.”
Whitman, who spent 17 years at Pfizer, fears more than higher taxes; she worries that Operation Warp Speed could cut corners.
But Mintz said he believes in the FDA’s institutional integrity.
“There’s absolutely no way that the Food and Drug Administration is going to cut corners,” Mintz said. “I would say that only 1% of all approved drugs over the past 50 years have been taken off the market because of safety issues.”
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