OPINION:
The U.S. Food and Drug Administration (FDA) has approved two COVID-19 vaccines under the Emergency Use Authorization (EUA) process. With these approvals, the immunization of health care workers and those in long-term care facilities has begun, providing them with a measure of protection against COVID-19.
Waiting in the immunization queue are essential workers and at-risk populations. The expectation is that vaccines will be available for all who wish to be immunized by the middle of 2021.
Although the Pfizer and Moderna vaccines represent historic achievements for science, with 95% effectiveness during clinical trials, the world’s struggle with COVID-19 is far from over. Like the first few miles in a marathon, the race has just begun. FDA approval of the first two vaccines represents positive steps in what is likely to be a lengthy transition period to a new normal in the U.S.
The New York Times’ Coronavirus Vaccine Tracker reports 63 vaccines that are in human clinical trials. With three clinical trial phases (evaluating safety, efficacy and dosage across a swath of the population) to pass, only a small fraction of vaccines will make it through the rigorous approval gauntlet. However, those vaccines that gain approval will add additional weapons in the COVID-19 vaccine arsenal, providing more options for immunization.
To return to any semblance of normalcy requires many additional vaccines to gain FDA approval, likely through the EUA process. Additional data will continue to be collected on the first two approved vaccines during Phase IV, as larger and more diverse populations are immunized.
Although no severe or life-threatening adverse side effects are expected, the first three months of vaccinations, with millions of people immunized, will provide invaluable medical and public health data.
The cold chain requirements for the Pfizer vaccine are sufficiently severe that it will have limited use in locales that cannot support such extreme temperatures. Rural and isolated parts of the U.S. may not have access to high performance refrigeration systems, hence relying exclusively on dry ice to keep vaccines stable.
The Moderna vaccine’s cold chain is less taxing, but will still be challenging in warmer climates around the world. This alone highlights the need for additional COVID-19 vaccines that are stable at room temperature, removing any cold chain requirements.
Within Operation Warp Speed, pharmaceutical companies are working independently to develop COVID-19 vaccines. Yet, many of these companies are using similar technologies and approaches, suggesting that collaboration, not competition, might have yielded even better results.
For example, both the Pfizer and Moderna vaccines use messenger RNA, or mRNA, technologies to deliver immunization. If they had worked together, would an even better final product have been possible, perhaps with less stringent cold chain requirements? Could Johnson & Johnson’s adenovirus vaccine research benefit other companies following similar approaches? Given that the federal government is the sole payer and customer for all vaccines, requiring widespread collaboration and sharing of vaccine development data could have been an option. Would this have led to even safer, more effective, and easier to manage and administer vaccines?
Multiple vaccines available using different technologies could mean that different vaccines may eventually be used for different segments of the population. With multiple vaccine options, personalized immunization recommendations may be developed.
This will take some of the uncertainty out of each vaccine’s supply chain and provide a more complete picture of how each vaccine can provide the best protective role in the population. Moreover, with a new strain of the coronavirus surfacing, it is likely that periodic booster vaccines will be required, further highlighting the value of multiple vaccines, some of which may offer longer immunity windows.
The current pandemic is certain to not be the last. Lessons learned over the past year will be invaluable to better prepare for subsequent pandemics. The science employed to develop vaccines can serve as a launch pad for new vaccines in the future.
COVID-19 is a formidable foe. It patiently exploits every vulnerable spot in society. Safe and effective vaccines are a critical and important step on the road to recovery for our nation and the world. A full arsenal of vaccines are needed to reach the finish line and move our nation, and the world, forward on the road to normalcy.
• Sheldon H. Jacobson, a founder professor of computer science at the University of Illinois at Urbana-Champaign, served as a member of the National Academy of Medicine standing committee for the Strategic National Stockpile. Janet A. Jokela, MD, is the acting regional dean of the University of Illinois College of Medicine at Urbana-Champaign.
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