Meanwhile, Johnson and Johnson says their coronavirus vaccine is in the last phase of trials before it goes to the FDA for approval.By Dr. Maria Simbra

PITTSBURGH (KDKA) – As a practice run for an eventual coronavirus vaccine, UPMC has launched Operation One Shot with the goal of immunizing as many of its employees as possible against the flu.

“We have seen great excitement in participating in this fashion,” says Knox Walk, UPMC Emergency Preparedness director.

Starting this week at 13 sites across UPMC, the mass vaccination is happening in different ways.

“Some are doing a one-day event, some others are doing a five-day event,” says Walk. “We’re doing the non-clinical in a scheduled fashion, and we’re doing the clinical staff by someone going to the clinical unit and performing the vaccine on the unit for the staff.”

UPMC has learned that technology helps with scheduling and tracking who has been immunized.

“What we anticipated as a two or three minute per person process, folks are down to about 30 seconds,” Walk says. “In most of these cases, we’re going to achieve well over the 50% or 60% mark.”

In other news, Johnson and Johnson’s coronavirus vaccine is entering phase three trials — the last phase before a vaccine can go before the FDA for approval.

“Safety is number one,” says Dr. Mathai Mammen, global head of research and development, the Janssen Pharmaceutical Companies of Johnson and Johnson. “Efficacy I’m even more confident about, but you never know until the data are in. Late this year, early next year.”

Of the vaccines in development, this is the only one given as a single shot. The others require two.

“It’s a big deal to give a single shot,” Dr. Mammen says. “In a mass vaccination situation, that is a tremendous advantage.”

And it doesn’t require a special freezer: “You can put it in the fridge for months.”

The vaccine uses a viral–vector strategy: the gene for a coronavirus spike protein variant goes into a harmless, modified common cold virus.

The trials will enroll 60,000 people, including minorities and people with existing health conditions. Worldwide, 215 sites will participate, with a priority on hotspots.

“University of Pittsburgh is one of the sites we’ll be using in the United States,” Dr. Mammen says.

Even ahead of approval, Johnson and Johnson has been scaling up production.

“We will make over a billion doses in 2021,” says Dr. Mammen. “I do think the world needs multiple vaccines to be successful.”

This phase three trial is event-based. In other words, a certain number of people will have to get sick in order for researchers to pick up a difference between the vaccinated group and the placebo group.

Dr. Maria Simbra