Less than one year after the outbreak of a deadly pandemic that shut down the world, biotechnology saved the day. Former President Trump’s Operation Warp Speed facilitated the development of two COVID-19 vaccines in record time, as well as a promising third vaccine on the horizon. It is surprising that a vaccine would be developed, authorized by the Food and Drug Administration, and met with open arms (and rolled up sleeves) in a matter of months. After all, the next fastest vaccine development was that of the mumps vaccine, which took four years. While Operation Warp Speed facilitated cooperation between the government and private labs, thereby speeding up the process, the small but mighty MVP for both of the life saving vaccines is a single-stranded helix: messenger ribonucleic acid (mRNA).
Before the COVID-19 pandemic, to most Americans mRNA was a forgotten term from high school biology. However, Pfizer and Moderna have reminded many of the power of the human body’s protein synthesis process, which uses mRNA as a key to unlock the reopening of America. The mRNA therapeutics will not disappear from biotech research any time soon, and some key takeaways from the COVID-19 vaccine development should be kept in mind as we look toward putting the pandemic behind us.
First, mRNA technology is not completely new, but it is cutting edge with a fascinating background and curious sources of funding. Second, with great power comes great responsibility. The mRNA therapeutics also open the door to both threats and defenses in the future of biowarfare. Lastly, the FDA approved this vaccine with a level of expeditiousness which, if normalized for other treatments, could save tens of thousands of lives beyond COVID-19. As such, we should use the pandemic’s public-private partnership and rapid FDA authorization as a model for the role of government regulation in health care.
Despite its novelty to the American public, for almost three decades, mRNA technology has been a research hotspot for health concerns ranging from cancer therapeutics to infectious diseases like HIV. While the world embraces the vaccines that will hopefully end the pandemic, mRNA technology has the potential to play a role in bioweapons. Since mRNA is on the forefront of biotechnology development, it is crucial to understand not only the benefits that mRNA therapeutics can bring, but also to assess the risks of the technology in the wrong hands.
Fear of an infectious bioweapon inspired a $25 million grant from the U.S. government less than a decade ago to a company whose name ought to ring a bell by now: Moderna. The United States’ Defense Advanced Research Projects Agency (DARPA) intended for the funding to lead to research in human trials of mRNA therapies. They hoped to develop technology that could quickly combat bioweapons presenting as novel infectious diseases. Some officials under the Trump Administration claimed that evidence supports the idea that COVID-19 originated in a bioweapons lab in Wuhan, China. If another foreign disease were to emerge in the future, the recent success of COVID vaccines suggests that mRNA therapies will surely be a top contender for preventing another year long lockdown. Evidently, the U.S. government has been aware of the threat posed by bioweapons, and mRNA has been a focus for research to prepare for the threat. To this end, it will be interesting to see whether companies like Moderna and Pfizer are able to replicate the incredible success of the COVID-19 vaccine for other future infectious diseases — bioweapons or otherwise.
The U.S. government is not the only investor in mRNA technology. A few years after DARPA’s investment in Moderna’s mRNA technology, the Bill and Melinda Gates Foundation took a special interest in the company’s research, investing $20 million in Moderna’s HIV mRNA therapeutics research and additional funding to its Zika vaccine research. Given the scale of pre-existing funding and research behind mRNA vaccines and therapeutics, the rapid turnaround of the vaccine is not all that surprising — after all, it has been years in the making.
Although the Gates Foundation has been generous in its contribution to mRNA infectious diseases research over the last decade, the foundation’s involvement, alongside Bill Gates’ history of global depopulation and climate change rhetoric, has also fueled some of the vaccine skepticism. According to the Pew Research Center, as of June 2020, 36% of Americans believed that the COVID-19 outbreak was “probably or definitely” planned by powerful people. Despite pushback and vaccine hesitancy, the foundation continues to contribute hundreds of millions of dollars to vaccine distribution.
Unlike DNA editing technologies with gene drive capabilities, mRNA therapeutics introduce foreign nucleic acids to cells. Technological gene drive, which can artificially propagate certain genes in a population, has long been controversial. Several extremist groups including ISIS are rumored to have created biological weapons that turn relatively harmless creatures into deadly weapons — or superkiller mosquitoes. At this point, human instigated gene drives seem to be far more threatening than mRNA technology; however, one can imagine how this potentially life saving biotechnology with the power to create foreign proteins in a host’s body could become a global tragedy in the wrong hands.
Despite these biowarfare concerns, mRNA technology itself remains an accomplishment in bioengineering, but the rapid approval of the safety and efficacy of the COVID-19 vaccines is unprecedented and equally noteworthy. Rather than subjecting the new vaccines to the rigors of traditional FDA approval, the FDA authorized the emergency use (EUA) of the COVID-19 vaccines. The FDA approval process has more stringent standards than EUA, but EUA utilizes the available data to make a risk-benefit assessment. The mass administration of COVID-19 vaccines to 1.3 million Americans a day will serve as an ongoing nationwide data collection project. Just as the FDA performed the risk analysis, Americans have embraced their right to assess their own risk from contracting COVID-19 versus receiving the EUA vaccines.
This personal responsibility and assessment involved with receiving the new vaccine has broader implications that could enable more innovation in healthcare for novel therapies. While the pandemic created significant pressure for the government to rapidly approve a vaccine or treatment, it begs the question of whether the FDA could extend this streamlined authorization process to other life saving therapies. Of course, such a faster process would also require an acceptable level of confidence in the safety and efficacy of the treatment, as has been achieved with the COVID-19 vaccine.
This need for a more efficient FDA approval process is true for not only medications but for biotechnological devices too. The unnecessary bureaucracy especially shines through when comparing the FDA approval process with other countries. Medical devices that are developed in the U.S. are approved two years earlier in Europe than they are by the U.S. FDA. At the very least, the process should allow the use of novel technologies more quickly in dire circumstances rather than solely during a global pandemic. Empowering patients and physicians to perform their own risk analyses after a certain threshold of basic approval could save many lives. Warp speed should be a goal for all healthcare access.
Although we are only one year into this decade, the COVID-19 vaccine will likely be one of the greatest biotech milestones of the 2020s. As such, each of its successes and failures should be noted to improve the use of existing research for rapid novel vaccine development, maximize the efficiency of the public-private partnership in healthcare, and prepare our healthcare system for combatting biowarfare in the future.
Categories: Domestic Affairs