Once a COVID-19 vaccine is ready for prime time, how will people get it? – Crain’s Detroit Business

Four COVID-19 vaccines have begun Phase 3 human clinical trials in the U.S. and a fifth is expected to be announced this month by Novavax. Two coronavirus vaccines are under development by Pfizer at the Michigan Center for Medical Research in Rochester and by Moderna at Henry Ford Health System in Detroit.

Johnson & Johnson/Janssen and AstraZeneca clinical trials, which had been underway at the University of Michigan, have been paused in the U.S. over safety concerns. The AstraZeneca trial has been paused for more than a month after two people became sick. The J&J trial was paused last week when one person came down with an unexplained illness.

Still, the CEOs of Pfizer and Moderna say their vaccines could be mass produced on a limited scale by the end of the year. The other drug makers say their vaccines are showing promise, but some experts believe mass production is more than six months away.

Pfizer's mRNA-based vaccine now requires ultra cold storage of -70 degree Celsius, rendering administration by doctor's offices, clinics and retail pharmacies virtually impossible.

Moderna's vaccine, also using the newer mRNA-based technology, currently requires -20 Celsius temperature, allowing for greater storage flexibility. The company also said its vaccine can be kept in normal vaccine refrigerators for up to seven days.

Novavax has said its vaccine can be stored at 2 to 8-degree Celsius temperatures in an unfrozen, liquid formulation that can be kept in a standard vaccine refrigerator. The Maryland-based drugmaker is taking a more traditional approach to vaccine development. It is using viral proteins rather than an mRNA genetic code approach to train the body against the coronavirus infection.

Merck and Sanofi, two veteran vaccine makers that got into the vaccine race this summer, are said to be close to beginning Phase 3 trials.

Once one or more vaccines are approved by the FDA, likely through an emergency use authorization, the companies will begin mass production.

Chaz Calitri, Pfizer's vice president of operations for sterile injections, said the drug company has been packaging the filled vaccine doses in Kalamazoo for its Phase 3 trial since earlier this year. More than 300 workers have been hired for the coronavirus vaccine effort, he said.

"If the vaccine is successful and we launch it, we expect to hire up to 700 people" in Kalamazoo, Calitri said. The plant has about 3,000 employees now.

Pfizer's COVID-19 clinical trials have been expanded to more than 44,000 people, including adding more minorities and teenagers and youth as young as age 12, officials said.

"What we will do is have the vials (of vaccine) packed in small pizza-shaped boxes and placed in a container packed in dry ice. It will be like a container in a container that will have a tracker," or a sensor that will monitor location and temperatures, Calitri said.

Doctors have asked Pfizer whether the company will develop a way to store the vaccines at temperatures greater than -70 degree Celsius. Pfizer said it was working on a plan to store its vaccines for up to 24 hours at standard refrigeration.

"They are still running tests to see if there can be less storage time and higher temperatures," Calitri said.

Another question is whether the vaccines will be a one-dose shot, like the proposed Johnson & Johnson/Janssen or Merck vaccines, or two-dose shots like the Pfizer, Moderna and others. Two doses will require careful tracking of people and appointment callbacks, similar to the vaccine for shingles.

Experts also are concerned that the hundreds of millions of vaccine doses will also require ramping up production of syringes and pharmaceutical-grade glass vials needed to transport and administer the vaccines. Operation Warp Speed has awarded major contracts to companies to build up inventories.

Julie Swann, a professor of industrial and systems engineering and department chair at North Carolina State University in Raleigh, said there are a number of logistical challenges in transporting and distributing COVID-19 vaccines, especially the Pfizer vaccine that appears the furthest along toward approval.

"It's not like the vaccines that you know, the seasonal flu vaccine that you might get at a Target or CVS, or your doctor's office. It's different than that," said Swann, who is a vaccine supply chain expert. "It has it has much greater perishability and needs to be kept at a much colder temperature. There's also going to need to be supplies of dry ice through the supply chain."

The Pfizer vaccine, for example, needs to be shipped in containers with dry ice that hold 975 doses.

"So you're going to send this specialized box of 1,000 doses to a hospital and you're only allowed to open it once a day because it will be frozen and you have to take out enough for those people," Swann said.

Vaccines with smaller doses per box, such as Moderna's, which is planned to be released with orders of 100 doses, can be shipped to physician offices, clinics and retail pharmacies, Swanson said.

"If it happens to be the Pfizer vaccine, with the ultra-cold requirements, it is likely to be shipped directly from the drug company to the hospital or large clinic," Swanson said.

CVS Health spokesman Mike DeAngelis said its Minute Clinic sites are well-positioned to administer COVID-19 vaccines.

"We look forward to playing a significant role in the vaccine distribution process, and our experience of providing millions of flu vaccinations each year is helping inform our plans," DeAngelis said in an email.

Most pharmacies and doctor offices have regular freezers and would only be able to store vaccines with lower temperature requirements for short periods of time.

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Once a COVID-19 vaccine is ready for prime time, how will people get it? - Crain's Detroit Business