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Less than a year to develop a COVID vaccine – here’s why you shouldn’t be alarmed
November 25, 2020 9.27pm AED
I’m a clinical trials geek. I keep hearing people talk about the seven to ten years it takes to make a vaccine and how dangerous speeding this up might be. The word that keeps popping up is “rushed”, and it is making the average person nervous about vaccine safety. So, as a clinical trials doctor, I am going to tell you what I do for most of those ten years – and it is not very much.
I’m not lazy. I submit grants, have them rejected, resubmit them, wait for review, resubmit them somewhere else, sometimes in a loop of doom. When I am lucky enough to get trials funded, I then spend months on submitting to ethics boards. I wait for regulators, deal with personnel changes at the drugs company and a “change of focus” away from my trials, and eventually, if I am very lucky, I spend time setting up trials: finding sites, training sites, panicking because recruitment is poor, finding more sites. I then usually have more regulatory issues and, finally, if my big pot of luck is not used up, I might have a viable therapy – or not.
At this point, it might get delayed because of questions over profitability or any number of other obstacles. I’m not even going to go into the years it normally takes to get the “preclinical” studies, the ones before the human trials, done.
Ten years to develop a vaccine is a bad thing
So next time somebody expresses concern at the astonishing speed the vaccine trials have happened at, point out to them that ten years isn’t a good thing, it’s a bad thing. It’s not ten years because that is safe, it’s ten hard years of battling indifference, commercial imperatives, luck and red tape. It represents barriers in the process that we have now proved are “easy” to overcome. You just need unlimited cash, some clever and highly motivated people, all the world’s trial infrastructure, an almost unlimited pool of altruistic, wonderful trial volunteers and some sensible regulators.
With all of this and the clock ticking on a global pandemic killing people by the second, it turns out we can do amazing things. The vaccine trials have been nothing short of a miracle. A revolution in how we do trials that when you think about it is perhaps not that surprising given our ability to innovate when we really need to.
And we really need to – necessity being the mother of invention. Safety has not been compromised. All trials have been through the correct “phases” or process of any normal drug or vaccine. Hundreds of thousands of the very best of us volunteered and had an experimental vaccine. The world watched so closely that when a single person fell ill, we were all debating it.
To date, there has not been a single associated death related to COVID vaccines and only a handful of potentially serious events. Just imagine watching everybody in a small city for six months and reporting every single heart attack, stroke, neurological condition or anything that might be judged serious. How astonishing is this? It has been a triumph of medical science.
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None of this is to downplay the challenges still ahead. It is also not to say vaccines are without safety questions still to be answered. It has been, however, a triumph of good process and great people. I am confident that when regulators pore over the safety and efficacy data, closely followed by every interested scientist in the world, that vaccines will only be used if their benefits clearly outweigh the risks – and you should be confident too.
Misha Ketchell
Editor
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Why does it take so long to make a vaccine?
It’s a tortuous path, with regulatory hurdles at multiple points along the way
By Felice J. Freyer Globe Staff,
Updated May 15, 2020, 9:33 a.m.32
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Most said a coronavirus vaccine won’t be on the market for a year or two.
That’s because vaccine development normally follows a tortuous path intended to make sure the drug works and won’t cause harm. The process wends from identifying a vaccine candidate, to testing it in the laboratory and in people, and then to manufacturing it, with regulatory hurdles at multiple points along the way. With the coronavirus, drug makers, researchers, and public-private partnerships are racing down that path as fast as they can.
“Historically, vaccine development for a new virus not previously seen by the human species would take decades,” said Dr. Dan Barouch, head of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, who is working on a coronavirus vaccine with Johnson & Johnson.
But humanity cannot wait decades now. The urgent demand for a COVID-19 vaccine is “probably greater than the demand for any other vaccine in human history,” he said. “For COVID-19, there is extreme pressure to go as fast as possible.”
Still, Barouch added, for every person who asks why it’s taking so long, there’s one asking whether it’s dangerous to rush the process. “In my opinion the process can be accelerated dramatically without increasing the risk to patients,” he said.
To speed things up, numerous companies are working on parallel tracks, exploring different types of vaccines; if one candidate fails, others will still move forward. Steps that would normally occur sequentially are being done simultaneously. And drug makers are taking the huge risk of manufacturing large quantities of vaccine even before they know whether it will ever be approved for sale.
Read the rest of the article here:
https://www.bostonglobe.com/2020/05/15/nation/why-does-it-take-so-long-make-vaccine/
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