PITTSBURGH — A “Band-Aid-like” array of microneedles could be the key to a successful coronavirus vaccine, according to University of Pittsburgh and UPMC researchers.

The vaccine, administered by an array of 400 small needles on a fingertip-sized patch, caused mice to create a surge of antibodies able to fight against SARS-CoV-2 — the coronavirus at the helm of the COVID-19 outbreak — in just two weeks.

The microneedle array contains a mixture of virus protein and sugar that dissolves into the skin.

It's an old technique made with modern technology — much like the original smallpox vaccine — the first-ever widely administered vaccine.

“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,” said Dr. Louis Falo, co-author of a paper published Thursday describing the vaccine and professor of dermatology at Pitt School of Medicine, said in a news release. “And it's actually pretty painless — it feels kind of like Velcro.”

Researchers will ask the nation's regulatory bodies to fast-track the vaccine through the approval process, which still could take 12 to 18 months.

Ready for clinical trials

“We're ready to initiate clinical trials as soon as we are able to meet the necessary requirements,” Falo said, adding that this approach to a coronavirus vaccine has numerous advantages.

Although the vaccine itself contains a relatively small amount of COVID-19 antigen, he explained the microneedle injection just under the skin makes it “very potent.”

In fact, the administration of the vaccine — monikered the PittCoVacc, short for Pitt coronavirus vaccine — under the skin is based on the body's largest organ being a barrier against germs.

“The skin is our first line of defense against viruses, bacteria and other harmful invaders,” Falo said. “Because of that, it has evolved to be very efficient at mounting immune responses, which means less vaccine is needed compared to a traditional shot.”

The microneedle array mimics the original process for delivering the smallpox vaccine, in which the skin of a patient would be scratched to create small abrasions and a solution containing the virus would be applied.

Researchers began working on the vaccine in late January, when the virus' genetic sequence was published. Their earlier work on other coronaviruses — including the SARS outbreak in 2003 and the MERS epidemic of 2014 — contributed to the speed of developing a vaccine for the 2019 virus.

Dr. Andrea Gambotto, associate professor of surgery at The University of Pittsburgh School of Medicine, said this vaccine is different from ones put forward by other researchers because it focuses on the virus' protein, rather than its genetic material.

Other potential vaccines, Gambotto said, contain the coronavirus' RNA, the genetic material needed to create proteins.

This one, however, contains the coronavirus' spike protein, which the virus uses to enter human cells. Introducing the spike protein to the body allows the immune system to recognize it as a foreign invader.

“It does not rely on the body to make the protein, like some of the experimental vaccines under development,” Gambotto said.

The researchers say the vaccine is highly scalable, meaning they would be able to ramp up production during the testing process to ensure widespread administration if it proves safe in humans and is approved by the Food and Drug Administration.

Unlike, for example, most seasonal influenza vaccines, the PittCoVacc can be produced with basic lab equipment.

Making vaccine quick, simple, inexpensive

“Our process for making this vaccine does not require any overly complex or expensive equipment, so it is very scalable,” Falo said. “At the present time in our lab, one person with a set of molds and a centrifuge can make hundreds of microneedle arrays in a single day.”

PittCoVacc also doesn't need to be kept frozen or refrigerated, making the costs of distribution lower, and the vaccine can be transported to under-developed countries more easily than standard vaccines.

By the time the vaccine is approved and ready for wide distribution, Falo said, there will almost certainly be an underlying level of herd immunity, which occurs when individuals who have fallen ill with a disease recover and retain antibodies capable of fighting a future infection.

That, too, will help decrease transit costs, as fewer people will need the vaccine to ensure full herd immunity, which can help prevent immunocompromised or unvaccinated individuals from contracting the respiratory illness.

Because the vaccine must be monitored for both safety and efficacy, the approval process will still likely take more than a year, researchers said, even with waivers of certain standard events during that process.