COVID-19 vaccine hunt gets hotter globally; still no guarantee
Hundreds of men and women are rolling up their sleeves in countries around the world to be injected with experimental vaccines that might stop COVID-19, spurring hope - maybe unrealistic - an end to the pandemic may arrive earlier than anticipated.
About 100 research groups are pursuing vaccines with practically a dozen in early stages of human trials or poised to start out. It’s a crowded field, but researchers say that only escalates the odds a few might overcome the many obstacles that remain.
“We’re not necessarily in a competition against one another. We’re in a race against a pandemic virus, and we really need as many players for the reason that race as possible,” Dr. Andrew Pollard, who's leading the University of Oxford’s vaccine study, told The Associated Press.
The hard truth: There’s no chance to predict which - if any - vaccine will continue to work safely, or even to name a front-runner.
As Dr. Anthony Fauci, the U.S. government’s top expert, put it: “You will need more shots on goal for a chance at obtaining a safe and effective vaccine.”
The first cautious tests of March, when small amounts of volunteers got injections to check on for unwanted effects, have turned into larger studies in China, the U.S. and Europe to watch out for hints that different vaccine individuals really protect.
Next: Finding out for certain if any of the vaccines work in real life by testing large groups of individuals in areas where in fact the virus is circulating - a tricky prospect when study participants could be in places where in fact the virus is fading or they are told to stay home - and finding ways to quickly distribute plenty of doses of any successful candidates.
Policymakers are devising plans to try to overcome both obstacles in an attempt to compress the years it often takes to build up a vaccine. Asked if a vaccine by January was possible, Dr. Deborah Birx, the White House coronavirus task force coordinator, told Fox News Sunday “in writing, it’s possible. It’s whether we can execute,” she said.
Fauci has cautioned that whether or not everything goes perfectly, 12 to 1 . 5 years to build up a vaccine would set a speed record - and January will mark a year since the National Institutes of Health started creating its COVID-19 vaccine, now in trials with Moderna Inc.
MULTIPLE SHOTS WORK IN MULTIPLE WAYS
Depending how you count, there are between eight and 11 vaccine prospects in first stages of testing in China, the U.S., Britain and Germany - a collaboration between Pfizer Inc. and BioNTech the other day began a report in Germany that's simultaneously testing four somewhat different shots. More study sites are about to open in still other countries - and between May and July another couple of different vaccines is defined to commence first-in-human testing.
There’s no shortage of volunteers.
“This enables me to play a tiny role in fighting this thing,” said Anthony Campisi, 33, of Philadelphia, who received his first test dose of Inovio Pharmaceuticals’ DNA-based vaccine at the University of Pennsylvania last month. “I could be considered a guinea pig.”
The initial vaccine individuals work in various ways. That’s important because if one type fails, maybe another won’t.
Several types of vaccines work better in a few virus families than others. But for coronaviruses, there’s no blueprint. Back 2003 when scientists attempted vaccines against SARS, a cousin of the brand new virus, animal studies hinted at safety problems but SARS disappeared and vaccine funding dry out. Vaccines against another COVID-19 cousin named MERS have only reached first-step safety testing.
“In 20/20 hindsight, we have to been employed by harder on coronavirus vaccines in the past,” said Dr. Sten Vermund, dean of the Yale School of Public Health. Now, “we’re obligated to get one of these variety of strategies if we wish fast results.”
PROS AND CONS
China’s Sinovac and SinoPharm are testing “inactivated” vaccines, made by growing the new coronavirus and killing it. The companies have revealed little information about how exactly the shots differ. However the technology is tried-and-true - polio shots plus some types of flu vaccine are inactivated virus - although it’s hard to scale up to rapidly produce an incredible number of doses.
Most other vaccines in the offing aim to train the immune system to recognize a bit of the new coronavirus - mostly, the spiky protein that studs its outer surface.
One way: Use a harmless virus to carry the spike protein in to the body. It’s better to produce but deciding which virus is best “carrier” is a key question. China’s CanSino Biologics brewed its vaccine by using a common cold-causing adenovirus, engineered so that it won’t spread in your body. And in case people’s immune systems fight off the cold virus prior to the vaccine can do its job, Pollard’s Oxford team instead chose an adenovirus that normally infects chimpanzees.
Another way: Inject a bit of the coronavirus genetic code that instructs the body itself to create spike protein that subsequently primes the disease fighting capability to attack. It’s a fresh and unproven technology but the one which promises even faster production. Vaccines created by NIH and Moderna, Inovio Pharmaceuticals, and that Pfizer-BioNtech collaboration use genetic code approaches.
Still more methods are next in line: Vaccine manufactured from spike protein nanoparticles, and even a nasal spray option to shots.
PROVING THEY WORK
Most vaccine studies so far are tracking safety and whether volunteers’ blood shows any immune reactions. Some have jumped to larger numbers quickly, but there’s still concern about having the ability to prove real-world protection.
If study participants are holed up in the home or reside in areas where in fact the virus has quit spreading rapidly, then too little gets sick for scientists to tell if the vaccine or social distancing was what protected them. The Oxford study, for instance, will track about 1,000 people, half given the true vaccine. However the team plans a later-stage study with another 5,000 volunteers for a final answer and knows it might have to proceed to other countries.
“When you’re chasing a pandemic, the area that looks like the right one to go to today is definitely the wrong place fourteen days from now. And that means it is really difficult,” Pollard said.
In the U.S., some lawmakers have urged a different and controversial experiment: Recruit young, healthy volunteers who consent to be deliberately infected with the brand new coronavirus to prove if a vaccine protects them. But some healthy adults do die from COVID-19 - and until doctors better understand why, that so-called “challenge study” produces a risky proposition with serious ethical questions, Yale’s Vermund noted.
The World Health Organization the other day called for countries to offer to be test sites for a global project that will speed the timeline by admitting on a rolling basis promising vaccine candidates for further study in spots where COVID-19 remains widespread at that time.
In the U.S., the Trump administration is planning its project dubbed Operation Warp Speed which will overlap studies of “different applicants that are made differently and act differently,” Birx said.
If early evidence was strong enough and the virus is still widespread, the meals and Drug Administration may consider emergency make use of a vaccine before final test outcomes were in, Dr. Peter Marks, who directs the FDA office that oversees vaccines, recently told reporters.
SUPPLYING THE WORLD
Whenever the first useful vaccine is identified, there won’t be adequate for everyone. So a growing number of vaccine makers say they’re already starting to brew a great deal of doses - wasting millions of dollars if they bet on the wrong prospect but shaving a couple of months off mass vaccinations if their choice pans out.
“We need to get started on building new manufacturing sites now,” said Wellcome Trust vaccine chief Charlie Weller. “And we need to accept that many of these sites will be created for vaccines that will finally fail.”
It’s not simply a gamble for shareholders. The U.S. government already has handles Moderna and Johnson & Johnson that together total almost $1 billion you need to include scaling up production.
“The critical thing at the beginning is just to create as much stuff as we can,” said Dr. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, which is funding several COVID-19 vaccine attempts around the world.
Even if one works, expect rationing in early stages as policymakers determine who most needs the first doses - possibly health workers or older people - until there’s enough for the world, rich and poor countries alike.
“I am worried about what I call vaccine nationalism. That’s the strain between obligations elected leaders will feel to protect the lives of their citizens” versus the imperative for equitable global sharing, Hatchett said.
And with billions who’ll need a dose or possibly several, just one single winner in this race won’t cut it.
“It’s not likely that one manufacturer or one candidate vaccine is going to be able to cope with the global need and supply that require,” Pollard said.
Source: japantoday.com
