NYT:
An experimental vaccine is ready to test in people as soon as the Food and Drug Administration grants permission, researchers at the University of Pittsburgh Medical Center said.
Mice given the vaccine produced high levels of antibodies against the new coronavirus. But only clinical trials can determine whether it will be safe and effective in humans.
"Testing in patients would typically require at least a year and probably longer," Dr. Louis D. Falo Jr., a member of the research team, 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."
Another vaccine, made by Moderna, is already in a clinical trial, which started March 15. Dozens more candidates are being developed by other companies.
The University of Pittsburgh's vaccine will be given in an unusual way: through a small patch dotted with 400 "microneedles" made of sugar mixed with a coronavirus protein. The microneedles penetrate the skin and the sugar melts, releasing the full protein dose in 10 minutes or less, and alerting the immune system to start making antibodies to fight the virus.
"It's not painful," Dr. Falo said in an interview. "The needles don't reach any nerves, nor do they reach blood vessels. They're a little more than half a millimeter long, and the width of a human hair."
This approach takes advantage of the skin's ability to set off a powerful immune response. Skin is the body's first line of defense against a constant bombardment of bacteria and viruses from the environment, and it is teeming with cells that act like scouts for the immune system, looking for things that shouldn't be there.
A vaccination with microneedles uses a smaller dose than the usual shot in the arm requires, allowing more people to be immunized, Dr. Falo said. The vaccine, unlike most, does not have to be frozen or refrigerated, making shipping and storage easier and cheaper.
A report on the research was published in EBioMedicine.
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