Great policy and great politics. Can you imagine Trump walking out to the podium circa mid-October with a surprise announcement that a vaccine should be available by New Year’s thanks to aggressive action by his administration to fast-track development?
That might singlehandedly guarantee his reelection, whatever the polls (and the economy) happen to look like on Election Day.
Is it feasible, though? Fauci and other experts have stuck doggedly to the 12-to-18-month timeframe in public comments, a mind-blowing pace to derive a vaccine for any illness. Bear in mind too that science has never produced a human vaccine for any coronavirus (although it has produced them for animals). My ignorant layman’s understanding is that that’s due less to the technical challenge involved than to the fact that common coronaviruses aren’t dangerous and therefore there hasn’t been a pressing need to vaccinate against them. But still — this would be Manhattan-Project-type stuff, taking something that exists for the moment only in theory and turning it into a reality that reshapes the planet in the span of a few years.
Or a few months, if Operation Warp Speed succeeds.
Called “Operation Warp Speed,” the program will pull together private pharmaceutical companies, government agencies and the military to try to cut the development time for a vaccine by as much as eight months, one of the people said…
There are at least 70 different coronavirus vaccines in development by drugmakers and research groups, according to the World Health Organization. But drugmakers have not coordinated their efforts to the extent they could through the Warp Speed project, one of the people said.
Under the effort, the Defense Department would make its animal research resources available for pre-clinical work on vaccines.
The group is also discussing the use of what’s known as a master protocol to test the vaccines. Instead of multiple clinical trials run by each drugmaker, competing for patients and resources, the government would organize one large trial to test several vaccines at once and advance the most promising ones.
Part of the plan involves an idea I first heard from Bill Gates in an interview earlier this month. Normally mass production of a vaccine doesn’t begin until clinical trials are over and the vaccine has proven successful. That means a lag of months between the time we know it works and the time people can finally begin to get vaccinated, which in our present reality means an even longer period of social distancing and an anemic economy. The solution is to start mass manufacturing millions of doses of each of the most promising vaccine candidates earlier in the process. Once clinical trials are finished and we know which candidate is most effective, that vaccine will roll out immediately to doctor’s offices and pharmacies for delivery to the public while the millions of doses of the less promising vaccines go into the trash. It means spending billions knowing that much of that expenditure will go to waste, but it’ll save many billions more in lost economic productivity by expediting vaccinations and herd immunity.
It’ll be the first time in history that wasteful spending was a good idea.
What’s novel about Operation Warp Speed isn’t its ambition to have *some* doses of vaccine by year’s end. It’s the number — 100 million, enough to get the entire country well along the path to herd immunity. But even if it fails, we should expect to see reports this fall of vaccines being dosed out to some greater or lesser extent. Oxford researchers continue to sound bullish about their version (“I have a high degree of confidence about this vaccine, because it’s technology that I’ve used before”) and believe it could be “widely available” by September(!!). The world’s largest drug manufacturer, based in India, is planning to start production next month in the hope/expectation that subsequent clinical trials will confirm its effectiveness. Pfizer is planning to start testing on its own vaccine next week with authorization on an emergency basis possible by fall and full approval by the end of the year. Moderna is aiming to start its final phase of testing by fall and possibly to seek approval by the start of 2021.
And there’s also that interesting variation they’re working on in Pittsburgh, which would apply the vaccine to the skin via a small patch that looks like a band-aid with tiny spikes on it. The many immune cells found in human skin would then jump-start production of antibodies. What makes that interesting? Two things. “There are two additional benefits to the patch delivery system. The first is that it’s easy to produce. The second is that the patches don’t need to be kept cold. Once the antigen is incorporated and solidified in the microneedle array, it’s stable at room temperature.” If the patch wins the vaccine beauty contest, maybe it could be available even sooner than some of its competitors would be.
There’s one more way to speed up the vaccine process, but this one’s controversial. What if we inject human beings with the vaccine in a clinical trial … and then inject them with COVID-19? Deliberate infection. What could go wrong?
Typical vaccine trials take a long time because thousands of people receive either a vaccine or a placebo, and researchers track who becomes infected in the course of their daily lives. A challenge study could in theory be much faster: a much smaller group of volunteers would receive a candidate vaccine and then be intentionally infected with the virus, to judge the efficacy of the immunization…
Morrison says that the people who have signed up to be part of a challenge trial tend to be young and live in urban areas, and are highly motivated to do something constructive to address the coronavirus pandemic. “Many note that they recognize the risk but believe the benefits of vaccine acceleration are so tremendous that it is worth it to them,” he says.
Some members of Congress are open to the idea. America being America, Netflix should fund the whole thing and film the subjects’ progress like a reality show. It’d be the hottest thing on television.
Here’s Scott Gottlieb (a board member of Pfizer) predicting that some companies will have “substantial doses” of vaccine available by fall. Again, that’s not to say that they’ll be generally available — the doses will probably be reserved for emergency use, in case there’s a major outbreak somewhere. But it’s cause for hope.
“I think that there’s going to be a number of companies that have substantial doses available in the fall,” Dr. Scott Gottlieb says about the race to develop a coronavirus vaccine. https://t.co/8Dfiytjqkt pic.twitter.com/726q6nbNsz
— CNBC (@CNBC) April 29, 2020