PERSPECTIVE FROM THE 19TH HOLE: This is the title I chose for my personal blog, which is meant to give me an outlet for one of my favorite crafts – writing – plus to use an image from my favorite sport, golf. Out of college, my first job was as a reporter for the Daily Astorian in Astoria, Oregon, and I went on from there to practice writing in all of my professional positions, including as press secretary in Washington, D.C. for a Democrat Congressman from Oregon, as an Oregon state government manager in Salem and Portland, as press secretary for Oregon’s last Republican governor (Vic Atiyeh), and as a private sector lobbyist. This blog also allows me to link another favorite pastime – politics and the art of developing public policy – to what I write.
It doesn’t take prescience to know that a vaccine or vaccines will be the key to resolving the coronavirus pandemic.
However, easier to say that achieve we were told by the experts.
They said it usually takes 12 to 18 months, at a minimum, for a new drug to go through all of clinical trials and other tests to assure efficacy.
I was encouraged – we all need potential silver linings in the black clouds of the pandemic these days – when I read a story in hill.com that charted the development of four potential vaccines.
None is proven yet, but pharmaceutical companies believe they are pursuing the right goals. Here are excerpts from the story on four U.S. and European vaccine efforts that have started clinical trials.
Oxford University/AstraZeneca
Some of the highest hopes, and the most ambitious timeline, come from researchers at Oxford University, who are now working alongside British pharmaceutical giant AstraZeneca.
“The aim is to have at least a million doses by about September, once you know the vaccine efficacy results and then move even faster from there,” Oxford professor Adrian Hill told the BBC last month.
The potential vaccine began testing in healthy volunteers in a Phase I clinical trial late last month at five sites in England. Data from that trial could be available this month, and later-stage trials could start by the middle of the year, AstraZeneca said on April 30.
The potential vaccine has had success in preventing coronavirus in rhesus macaque monkeys during a test at a National Institutes of Health (NIH) lab in Montana, The New York Times reported last month. It works by using a weakened version of a different virus known as adenovirus, which causes infections in chimpanzees, to deliver genetic material of part of the coronavirus into the body. The body then would generate an immune response to the section of coronavirus, providing protection.
Moderna/NIH
The Massachusetts biotech company Moderna Inc. is partnering with Anthony Fauci’s team at the National Institutes of Health on another leading vaccine candidate.
Moderna said last week it will begin a Phase II study with 600 people “shortly” and plans to start a Phase III trial with thousands of people by “early summer.”
Stéphane Bancel, the company’s CEO, told CNBC that the process is progressing at an unexpectedly fast clip.
“It has gone faster than my best case scenario back in January,” Bancel said. “When we started this back on Jan. 11, partnering with the team of Dr. Tony Fauci, we were hoping to get in the clinic in the summer.”
Instead, Phase I clinical trials started on March 16, and Phase II trials are about to begin.
He said his employees have been “working long days, working seven days a week since January,” and collaborating closely with the NIH and Food and Drug Administration (FDA).
Through a partnership with the Swiss biotech company Lonza, manufacturing of the vaccine could start as early as July, Bancel said, even before trials are complete.\
Still, he acknowledged all that vaccine candidates worldwide “will all be supply constrained for quite some time, meaning we won’t be able to make as many products as will be required to vaccinate everybody on the planet.” He anticipates working with governments to decide how to allocate the first doses, for example to health care workers and first responders.
This potential vaccine works differently than the Oxford one. It uses messenger RNA (mRNA) to deliver the genetic code for part of the coronavirus, which then provokes a response from the body’s immune system, offering protection.\
Pfizer/BioNTech
Pfizer and the German company BioNTech are also working together on a potential vaccine using mRNA.
They are testing four potential vaccines at once, using different formats of mRNA to see which one works best.
The companies last week announced they had begun a Phase I trial with up to 360 people at sites including New York University and the University of Maryland.
Mikael Dolsten, Pfizer’s chief scientific officer, told CNBC that the company expects to produce “millions of doses” by October, with plans for “tens of millions” later this year and “hundreds of millions” in 2021.
“So it’s a very quick plan,” Dolsten said.
Pfizer, a drug manufacturing powerhouse, said it has selected its facilities in Massachusetts, Michigan and Missouri, along with one in Belgium, to be the initial manufacturing centers for the vaccine.
Inovio
The biotech company Inovio is working on a potential vaccine that uses DNA rather than RNA to code part of the coronavirus and produce an immune response.
The company says its DNA vaccines can be produced faster and stored more easily, in addition to being safer than other types. This vaccine would require an added step of a hand-held device to deliver an electrical pulse that helps the vaccine enter human cells.
Inovio announced at the end of April that it had enrolled 40 people in its Phase I study at the University of Pennsylvania and a clinic in Kansas City. Interim results are expected by June and further stages of trials could start this summer, the company said.
“If we are on track, this could be as early as by the end of this year or early next year,” Inovio CEO J. Joseph Kim told The Hill when asked when the first doses of vaccine could be ready for the public.
He said it is “quite a challenge” to be able to scale up manufacturing a “thousandfold” to produce hundreds of millions of doses, and that more funding from the federal government would help.\
“More funding and resources will help us scale up to a larger manufacturing scale,” he said.
Kim acknowledged the skepticism about his company, namely that it has never had a product approved by the FDA.
But the company has shown promising results in other areas like the MERS virus and cervical cancer, Kim argued.
“I think healthy skepticism is always fair,” he said.
Ultimately, the results of the COVID-19 trials will have to show the coronavirus vaccine is effective.
In addition to finding a vaccine or more than one, a critical factor will be how long it takes to produce sufficient quantity, given that the pandemic is not a respecter of persons or borders. It is, in fact, worldwide.
That’s why, beyond what one firm is doing by securing manufacturing centers early, a friend of mine told me yesterday he hopes governments will step up to the plate to provide financing – even in the form of loans – to help companies lease more space and higher more staff to build more and more vaccines.
And, another point from me – if companies make money on the process, so be it.