As our state and nation continue to fight through the global pandemic, we’ve received some good news. In the last two weeks, two pharmaceutical companies reported that their experimental vaccines to prevent COVID-19 infection were roughly 90% (Pfizer) and 94% (Moderna) effective. In developing what is being called “messenger RNA vaccines,” the companies deployed the same novel approach: injecting a portion of the SARS-CoV-2 genetic code to generate antibodies and T-cells to fight off the virus.
While each company’s clinical trials are still ongoing, and more rigorous evaluations are forthcoming from the federal government, the breathtaking speed of the initiative—dubbed Operation Warp Speed by the Department of Health and Human Services––has far surpassed the usual three-year window for vaccine development. While more needs to be done, including vigorous ongoing surveillance of adverse effects to ensure a high degree of product safety, this man-on-the-moon effort is impressive and unprecedented.
It did not happen by accident. In the Appropriations Committee on which I serve, we have worked to advance drug trials faster. For example, new generic drug approvals increased to 107 in 2019, up from 73 in 2016. The FDA has also enabled more creative non-placebo drug trial testing design, resulting in a near doubling of approval of novel therapies in the two-year period of 2017-2019 compared to the previous five.
Part of our supplemental COVID funding in Congress included $20 billion for the Biomedical Advanced Research and Development Authority (BARDA) to stimulate investment in vaccine development. Under Operation Warp Speed, over $2.5 billion were directed to Moderna for research, testing, and to purchase over 100 hundred million doses of its vaccine. Robust federal support was also provided to eight other drug companies with vaccines in efficacy trials and thirty others in the early phases of human studies.
Dr. Keith Vrbicky, a Norfolk doctor, has been working on two vaccine trials right here in Nebraska. “The new science of this vaccine appears to be highly effective and safe,” he said. “I had two patients who were pregnant at 18 and 26 weeks respectively who each became very sick from the virus. They were very healthy women, yet they were in the hospital. We still don’t know what the long-term effects may be for their babies. Finding a vaccine is important. That’s why I agreed to help do the research right here in Norfolk. In the Moderna trial, we randomized 300 patients 50-50 to a placebo or vaccine group. For the Pfizer trial, we did the same thing with 200 patients. We required weekly diaries and blood draws––some had a sore arm or a nighttime fever. These were among the worst side effects we saw. Not a single patient said they wished they had not entered the trial. Both vaccines were successful in stimulating antibodies for COVID at very high levels. Also, patients in the placebo arm were much more likely to be later diagnosed with COVID than those who got the vaccine.”
This positive news on vaccines does not mean we are out of the corona woods yet. Final safety data, mass production of the vaccines, and transportation and distribution logistics are still being worked out. Additionally, researchers do not conclusively know how long the immunity provided by the vaccine lasts, let alone how much protection the vaccines provide to those most at risk of dying from COVID-19––the elderly and non-elderly with major preexisting conditions. It is also not yet fully understood whether the vaccines simply prevent recipients from becoming dangerously sick or whether they also stop virus spread.
Still, if all goes well, as many as 20 million Americans––mostly first responders and front-line health workers––could get the vaccine by year’s end. In the next phase of the rollout, in early 2021, about 40 million Americans, including the elderly and those with significant underlying health conditions, are expected to get the vaccine.
We are not home yet, but this “viral hope” signifies we are moving quickly towards a sense of normalcy. As with the Huskers first victory of the season, it puts us one step closer to order restored.