People on six continents are already getting hit in the arm as the race for a COVID-19 vaccine enters a watershed summer, with even larger studies to show if any vaccines really work, and perhaps offer control over reality.
British and Chinese researchers are already chasing the coronavirus beyond its borders, testing possible vaccines in Brazil and the UAE because there are too few new infections in the home to elicit clear answers.
The United States will open the largest tests: 30,000 people to test a government-created vaccine starting in July, followed about a month later, and another 30,000 are expected to test a British vaccine.
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They are likely to be split between Americans and volunteers in other countries like Brazil or South Africa, Dr. Anthony Fauci of the National Institutes of Health told The Associated Press.
Although optimistic, “we have burned before,” Fauci warned.
Multiple successes, in multiple parts of the world, are vital.
“This is not a race of who comes first. That is, getting as many approved, safe and effective vaccines as possible. ”
“This is not a race of who comes first. That is, getting as many approved, safe and effective vaccines as possible, “said Fauci.
Vaccine experts say it is time to set public expectations. Many scientists do not expect a coronavirus vaccine to be as protective as the measles vaccine.
If the best COVID-19 vaccine is only 50% effective, “that’s still a great vaccine for me,” said Dr. Drew Weissman of the University of Pennsylvania.
“We need to start having this conversation now,” so people won’t be surprised, he added.
FILE – In this Wednesday, June 24, 2020 file photo, a volunteer receives an injection of COVID-19 test vaccine developed at the University of Oxford in Great Britain at Chris Hani Baragwanath Hospital in Soweto, Johannesburg, South Africa. People on six continents are testing experimental vaccines as the race for the COVID-19 vaccine enters a watershed summer, with even larger studies to test whether any leading candidates really work, and possibly offering the public a reality check. . (AP Photo / Siphiwe Sibeko)
And despite all the government’s promises to rack up doses in hopes of starting vaccines by the end of the year, here’s the trick: even if a shot does turn out, and it’s one that your country stores, only a few high-risk people, like essential workers, go to the front of a very long line.
“Will you and I get vaccinated this year? No way, “said Duke University health economist David Ridley.
Stretching the house
Vaccines train the body to quickly recognize and defend against an invading germ. About 15 experimental COVID-19 vaccines are in various stages of human study worldwide.
And while there is no guarantee that something will go right, passing three different types to final tests offers better odds, especially since scientists still don’t know how strong the immune reaction gunshots must trigger to protect.
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Measuring that with the first tested vaccine “will really help us understand all of the other vaccines in development, do they have a chance, too?” Said Oxford University principal investigator Sarah Gilbert.
Only China is launching “inactivated” vaccines, produced by cultivation of the new coronavirus and its elimination. Sinovac Biotech and SinoPharm vaccines use that outdated technology, which requires high-security laboratories to produce, but is reliable, the way polio vaccines and some flu vaccines are made.
Most of the other vaccines in the pipeline target not the whole germ but a key piece: the “spike” protein that studs the coronavirus surface and helps invade human cells. Top candidates use new technologies that make shots faster to produce but have not yet been tested on people.
Oxford Method: Genetically engineer a chimpanzee cold virus so that it does not spread, but can transport the gene for that spike protein into cells enough to fool the immune system that is causing an infection.
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Another vaccine made by the NIH and Moderna Inc. simply injects a part of the coronavirus genetic code that instructs the body to produce copies of harmless spikes that the immune system learns to recognize.
Chasing the virus
Investigators must evaluate thousands of people not where COVID-19 is emerging, because it’s too late, but where it’s burning, Fauci said.
Only if the virus begins to spread through a community several weeks after the volunteers receive a vaccine or a dummy vaccine, long enough for the immune system to speed up, scientists have the best chance of comparing which group had the most diseases.
Lacking a crystal ball, the NIH has vaccine testing networks in the United States, South America, and South Africa on hold as it finalizes decisions on summer testing.
“We will do this at various sites with a degree of flexibility” so that the researchers can change rapidly as the virus moves, Fauci said. “Nothing is going to be easy.”
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The Oxford shot, with an ongoing study of 10,000 people in England, already encountered that obstacle. Gilbert told a committee in Parliament last week that there is “little chance, frankly” of demonstrating the vaccine’s effectiveness in Britain after infections plummeted with the shutdown.
Then his team searched abroad. In addition to the planned US-led study, Brazil last week began testing the latest stage of the Oxford vaccine in 5,000 health workers, the first experimental COVID-19 vaccines in South America. In a first, South Africa opened a smaller security study on the Oxford shooting.
With few new infections in China, Sinovac will begin final testing next month on 9,000 Brazilian volunteers. And SinoPharm has just signed an agreement with the United Arab Emirates; The size of that study is unclear.
WAIT FOR IMPERFECT PROTECTION
Animal research suggests that COVID-19 vaccines may prevent serious disease, but cannot completely block infection. A study that leaked the coronavirus in monkeys showed that vaccinated animals avoided pneumonia, but had some viruses lurking in their noses and throats. It is not known if it was enough to spread to the unvaccinated.
Still, that would be a great victory.
“My expectations have always been that we eliminate symptomatic disease. From what we’ve seen of vaccines so far, that’s what they do, “said Penn’s Weissman.
Initial vaccines could be replaced by better later arrivals, as historically happens in medicine, Duke’s Ridley noted.
And while arm injections are the fastest, respiratory disease injections require antibodies to the viruses to get to the lungs. Gilbert said Oxford will eventually explore nasal delivery.
WARNING AGAINST SHORT
Some U.S. lawmakers worry about pressure from the Trump administration to push an unproven shot during the fall election season.
“We want a vaccine, not a headline.”
“We want a vaccine, not a headline,” Senator Jack Reed, a Rhode Island Democrat, said at a recent Senate committee hearing.
Dr. Stephen Hahn, commissioner of the Food and Drug Administration, promised a House committee last week that any decision would be based on science.
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Different countries have different rules on when to launch a vaccine. For the US, Fauci insisted that there will be no security shortcuts, a key reason NIH is investing in such large studies.
Regardless of how and when a vaccine arrives, each country will also prioritize who is first in line as doses become available. Presumably they will start with healthcare workers and those most vulnerable to serious illness, as long as each vaccine is proven to work in risk groups, such as older adults.
Because each vaccine works differently, “what population group it will protect, we don’t know yet,” said Dr. Mariangela Simao of the World Health Organization, which advises countries on how to choose.
