Medical staff at the University of Maryland School of Medicine have begun injecting the first few people with a potential vaccine for the coronavirus as part of an accelerated international effort to have a vaccine ready to begin use in some people as early as this fall.
The trial at the university’s Center for Vaccine Development and Global Health and three other sites in the United States and Germany is for four separate but similar vaccine candidates developed by the pharmaceutical giant Pfizer Inc. and the German biotech company BioNTech. Pfizer announced the U.S. trials Tuesday morning.
“We’re not skipping any steps, but we are speeding them up quite a bit,” said Dr. Kirsten Lyke, an infectious disease expert and the study’s lead investigator in Baltimore. “This vaccine is actually four different vaccines, with testing moving rapidly, head-to-head. ... We’re hoping one rises to the top.”
Lyke, a professor of medicine and faculty member at the University of Maryland’s vaccine development center, said she and other researchers learned a lot from work on quick-moving threats such as the Ebola virus about how to expedite the vaccine trial process.
There are no vaccines or even specific treatments for COVID-19, the disease caused by this coronavirus. With almost 250,000 deaths globally and more than 68,000 in the United States, federal and international regulators have moved with urgency and allowed several vaccine trials to move ahead at unprecedented speed. More than one vaccine likely will be approved and needed to protect billions of people across the globe.
The four vaccines tested at Maryland and the other sites, with Pfizer funding, are variations of the same type of vaccine. The mRNA, or messenger RNA, vaccine works by conveying genetic instructions to a person’s cells to make a specific protein that can induce production of antibodies that would fight the real virus if someone came in contact with it.
It differs from traditional vaccines because it does not inject a virus protein into the body. An mRNA vaccine has been tested but never approved. It’s shown promise for infectious diseases and some kinds of cancer.
Five people were injected Monday and 360 will be injected with one of the vaccines or a placebo in total in the first phase, which is expected to end in June. If any of the vaccines are shown to be safe and effective, they will continue in the process. The trial eventually will expand to 840 people, with results expected by fall.
The first people injected are healthy people as young as age 18, followed by older people up to age 85 and then people with health problems such as diabetes or high blood pressure that put them at risk for complications from COVID-19. They will each get two shots a month apart.
A veteran of vaccine trials, Lyke said she’s never done one quite this way or this quickly but said it should offer hope to the public that the scientific community is working as fast as possible. Absent a vaccine, distancing requirements are unlikely to fully ease.
Many of the university’s trial participants come from the campus and related medical community. Michael Sikorski, who is in the fourth year of a dual medical and doctoral degree at the university, decided to volunteer for the experimental vaccine. He gets a shot Wednesday.
He said he’s familiar enough with the mRNA types of vaccines in development to know they are low risk because he’s not being injected with the actual virus. That was something he was glad to tell his family and friends, some of whom expressed reservations about his participation.
Sikorski said he heard about the trial through a campus newsletter, and feeling thankful to the university generally and his mentors specifically, he wanted to help. The trial also allows him to be part of the effort to stop the spread of the deadly virus.
“This is a pandemic like none of us have seen before,” he said. “If I could play any role in a vaccine, it would be meaningful to me.”
Someday, he expects not only to treat patients, but also to conduct research, possibly into vaccines.
As an early participant, he received a low dose or even a placebo. Even if the vaccine is effective, he may need another vaccination. He said that will be “whichever one gets to the finish line first.”
It also could be one that is produced and available in Maryland. With billions of people around the world needing vaccination, experts believe more than one vaccine will need to be approved, manufactured and distributed.
The manufacturing and distribution system has not been worked out yet. Ramping that up will be the next challenge, Lyke said.
Limited early doses likely would go to those most at risk, such as first responders, medical personnel and nursing home residents.
Other vaccines are in development in the United States, including two others at the University of Maryland.
Emergent Biosolutions, a Gaithersburg-based firm with manufacturing facilities in Baltimore designed for emergency drug production, has partnered with Johnson & Johnson, the Rockville company Novavax Inc. and Vaxart Inc., a California firm working with University of Maryland doctors, on developing different potential vaccines for the coronavirus.
Dr. Kathleen Neuzil, director of the university’s vaccine development center, is working on the trial with Lyke and another one as co-lead of a consortium established by the National Institutes of Health at Emory University in Atlanta to quickly tackle new infectious diseases.
“We are excited to begin testing these vaccine candidates against COVID-19," she said in a statement. "The research is on a fast track given the extreme consequences of this pandemic and the critical need for preventive measures.”
The National Institutes of Health announced last month that it was bringing industry and government agencies together to accelerate vaccine and treatment development and approvals. Officials said there were more than 100 potential therapeutics for COVID-19 in the works, and that the program would provide guidance and help prioritize the candidates.
“Using the most advanced clinical trial methods to rapidly test multiple interventions will help get the answers we need as soon as possible to expedite potential prevention and treatment approaches to fight COVID-19,” said Dr. Stephen M. Hahn, commissioner of the U.S. Food and Drug Administration, in a statement at the time. “Collaboration is a critical ingredient for success and the FDA will continue to use every tool possible under our Coronavirus Treatment Acceleration Program to speed the development of safe and effective medical countermeasures.”
The mRNA trial will go on for 26 months, even if a vaccine is approved for use, so researchers can learn how long immunity may last.
Injections of volunteers in Germany began in late April.
Mikael Dolsten, Pfizer’s chief scientific officer, said in a statement that historically vaccine development takes years, but collaboration with regulators is speeding the process.
“This pursuit requires a crucial multi-pronged approach with a deep collaboration and partnership across our healthcare innovation ecosystem — from the academic community including our initial partnership with New York University and the University of Maryland School of Medicine, industry partners, policy makers and regulatory bodies,” he said. “In the matter of weeks, we’ve accelerated what takes years into months, months into weeks and weeks into matter of days in order to rapidly enter the clinic and face this public health challenge head-on to try to help patients in dire need.”
The trial in Baltimore is still enrolling. Participants are paid a fee of about $1,375. Those interested can call 410-706-6156, email firstname.lastname@example.org or go to the website.