If recent months were a Hollywood movie, we’d be at the part where the city is under siege by aliens, and the military, armed only with earthly weapons, is making little headway in its defense. It’s the point just before Will Smith or a host of superheroes show up in the nick of time to save the day.
In real life, the monster threatening our way of life is COVID-19. The superheroes are the scientists and all those who have been feverishly working on a vaccine to neutralize it. Thanks to them, we have a path to victory just a year since the novel coronavirus reared its mighty head.
Bob Frenck, MD, director of the Vaccine Research Center at Cincinnati Children’s, is excited and hopeful as he talks about the role Cincinnati Children’s and the center are playing in the fight.
“We are one of four sites in the US participating in a Phase 1 and 2 clinical trial for the COVID-19 vaccine created by BioNTech SE and Pfizer Inc.,” said Frenck. “We are also testing the AstraZeneca vaccine, and after that is completed, we will start testing the Sanofi vaccine.”
Meanwhile, the University of Cincinnati is testing a vaccine from Moderna.
Pfizer announced that their vaccine is 95 percent effective, while Moderna is reporting an efficacy rate of 94.5 percent. The US Food and Drug Administration (FDA) approved the vaccines for emergency use in December 2020 for high-risk groups, like frontline healthcare workers and the elderly. They could be licensed as early as spring or early summer and ready to be distributed broadly before the beginning of the next school year.
“These results far exceed our expectations,” said Frenck. “This is a game changer.”
Biggest Challenge to Come
Having an effective vaccine against COVID is a huge win, but it will require at least 70 percent of the population to take it to achieve herd immunity. That could be a big hurdle.
“People hear the term ‘Operation Warp Speed,’ and it makes them nervous,” said Frenck, referencing the Trump administration vaccine initiative. “They think it means we’ve cut corners to put something out there. But that isn’t the case.”
Frenck credits the shorter turnaround time for the vaccine to advances in technology that allowed researchers to compress timelines.
“Within a few weeks, we were able to identify the virus and sequence it,” he explained. “We learned the virus has four main proteins, including a spike protein, and we were able to figure out what each one did and which ones were critical. It became obvious that the spike protein allowed the virus to attach to cells in the body, so it was the important one to block. We followed all the same steps we normally do, but we were able to gather information at an incredibly faster pace than we ever could before.”
It also helped that Pfizer had recruited more people to work on the study, which meant their labs could complete analysis of data in days instead of weeks or months.
When the AstraZeneca and Johnson & Johnson studies were paused briefly over questions about side effects, it caused an added stir of concern about vaccine safety.
“Those pauses should make people feel comfortable,” said Frenck. “If we were going full-speed ahead and cutting corners, we wouldn’t have cared about safety signals. We would have kept pushing on. But instead, vaccine enrollment was stopped, and all the data for those vaccines were evaluated by the FDA and the Data Safety Monitoring Board, which is an independent body. They found no causation and determined it was OK to proceed. All the correct steps were followed at the first sign of a potential problem, and they concluded that there was no issue.”
A Matter of Trust
When conducting any kind of clinical trial, trust is essential. Cincinnati Children’s goes out of its way to establish and maintain that trust with the scientific community and its study volunteers.
“We are upfront with those who participate in our trials,” said Frenck. “We go over what the trial is about in great detail, what they will be experiencing and what we want them to do. We explain that the protocols have been reviewed by independent bodies, and we provide a 24/7 nurse line if they have questions or concerns. We’ve been doing clinical trials here for over 25 years, and the reason people come back to enroll in multiple studies is that we are good on our word. We treat them well.
“I feel very strongly that it’s our duty to provide every safeguard for our volunteers. They are doing a service, and without them, we can’t do clinical research. We need them to trust us and to feel comfortable and know we will be there for them.”
Cincinnati Children’s reputation for excellence in this area is one of the reasons we were chosen as one of nine sites in a network called the Vaccine Treatment and Evaluation Units (VTEU). The sites are selected and funded by the National Institutes of Health (NIH) to test vaccines. We are one of the longest standing VTEUs in the US, and to date, we have tested hundreds of vaccines, including the rotavirus vaccine developed at Cincinnati Children’s by Richard Ward, PhD, and David Bernstein, MD, which has saved the lives of millions of children around the world.
Frenck said that this had been a difficult time emotionally and financially for many people. “While it has been a great struggle — and we still have a way to go — I have great hope that we soon will have one, and probably multiple licensed vaccines against COVID. I strongly believe that these vaccines will lead us out of the pandemic and let us resume a normal life.”
Illustration credit: Pfizer