Researchers at the University of Pittsburgh believe they have tested a potential vaccine for coronavirus, one that could “significantly impact the spread of disease.”
According to a news release from the University of Pittsburgh School of Medicine, the potential vaccine would be “delivered through a fingertip-sized patch” with “a microneedle array” that would inject the vaccine through 400 small needles applied like a Band-Aid.
The potential vaccine was announced in a paper published in EBioMedicine on Thursday. It’s the first potential vaccine to be reviewed by other scientists.
“We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient,” Dr. Louis Falos, the paper’s co-senior author, said in the release. “And it’s actually pretty painless — it feels kind of like Velcro.”
“These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus,” Dr. Andrea Gambotto, co-senior author and associate professor of surgery at the Pitt School of Medicine, said.
“We knew exactly where to fight this new virus.”
“Our ability to rapidly develop this vaccine was a result of scientists with expertise in diverse areas of research working together with a common goal,” Falo said.
Researchers said that the microneedle vaccine was tested on mice and created “a surge of antibodies” that was sufficient to fight the novel coronavirus.
The animals haven’t been tracked yet for the long term, but so far the progress looks promising, the news release stated.
The vaccine has potential advantages over the vaccine being tested in Seattle and developed by Moderna, the University of Pittsburgh researchers said. Unlike that vaccine, which the researchers say uses a more experimental method, the University of Pittsburgh vaccine was developed along the line of the flu shots, “using lab-made pieces of viral protein to build immunity.”
It’s also easily scalable, meaning it could be deployed quickly.
“For most vaccines, you don’t need to address scalability to begin with,” Gambotto said. “But when you try to develop a vaccine quickly against a pandemic that’s the first requirement.”
The University of Pittsburgh is one of what the U.K. Guardian says is 35 biotech firms and academic institutions currently working on vaccines. Moderna, a Boston-based firm, got a jump on the rest by getting its vaccine into tests first.
One bottleneck may be the Food and Drug Administration.
As Reuters reported, the FDA blocked private labs from testing for the coronavirus infection unless they obtained an emergency-use authorization from the agency.
As Reuters noted, the United States relied on the Centers for Disease Control’s test to detect the virus; the test ended up being faulty. South Korea, meanwhile, had gone to the private sector early on and quickly approved tests.
Meanwhile, the FDA’s emergency authorization had its own complications, Reuters reported.
“Paradoxically, it increased regulations on diagnostics while it created an easier pathway for vaccines and antivirals,” Dr. Amesh Adalja, a Johns Hopkins University Center for Health Security senior scholar, told the news agency. “There was a real foul-up with diagnostic tests that has exposed a flaw in the United States’ pandemic response plan.”
Researchers acknowledged that it would be a long way off before the vaccine could be approved for human use. They’re hoping to begin a phase I human trial shortly.
“Testing in patients would typically require at least a year and probably longer,” Falo said. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take. Recently announced revisions to the normal processes suggest we may be able to advance this faster.”
Developing a vaccine is a different animal than developing a test, so one hopes that there isn’t a repetition of history.
President Donald Trump has wanted the FDA to cut red tape on approving drugs for use in humans infected battling COVID-19, the disease caused by the novel coronavirus. Developing vaccines against infection is significantly different from approving promising existing drugs that have done well in trials, of course.
However, there is a similarity: The FDA and CDC shouldn’t be hindrances to innovation in America.
The testing foul-up cannot be allowed to repeat itself on vaccines; the cost is simply too high.
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