For the healthcare and science community, Christmas came before Thanksgiving this year with the announcement of the results of two very large COVID-19 vaccine trials. In studies with over 74,000 people, vaccines based on a new messenger RNA technology were noted to be 95% effective in preventing COVID-19 with only minor adverse reactions of transient arm pain, fever and fatigue – side effects similar to the flu vaccine. This effectiveness rate is significant in all tested subgroups – old and young, male and female, and black and white. Effectiveness in children is unknown as they were not included in the trials.
The benefit of vaccination greatly exceeds the risk in people with the greatest chance of developing complications of the virus. These include first responders, people working in hospitals, nursing homes, and emergency rooms as well as adults who are over 65 or have underlying medical conditions like obesity, diabetes, COPD, cancer, and heart disease. A high vaccination rate in these groups will lead to huge reductions in nationwide and local community hospitalizations and deaths due to COVID-19.
The benefit of the vaccination also outweighs the risk for any adult who wants to reduce their risk of illness and to return to life, school, and work. How wonderful it will be when we can get back to a world without ongoing COVID statistic milestones, business closures, stay at home policies, curfews, lockdowns, and worry about overwhelming hospitals. The benefit of vaccination exceeds the risk individually and as a whole community.
To say the positive results in these vaccine studies exceed expectations is an understatement. In these times of cynicism, conspiracy theories, and social media, people gravitate to an attitude of this is just too good to be true. However, the science behind these vaccines is clear. There are several reasons to trust what you hear when considering the successful rapid development of these safe and highly effective vaccines.
First, the rapid development of COVID-19 vaccines is benefited by the President’s COVID Task Force creation of Operation Warp Speed. This project is an investment in public-private partnerships. Public investment reduces the financial risk of research and development and allows companies to work on the manufacturing and distribution processes even before knowing whether or not the vaccine will be a reality.
The process of rapid time to development and rollout is not because of compromise, but because pharmaceutical companies could work with each other on all elements of vaccine development and implementation in parallel rather than in sequence. As a result of Operation Warp Speed investment of 10.5 billion dollars in eight vaccines, pharmaceutical companies have been able to run much larger trials and reach efficacy much faster.
Second, the COVID-19 vaccine is the result of a decade of investment in basic science and the persistence of a small number of researchers who dedicated their lives to the development of this new messenger RNA technology for vaccines and drug delivery. Basic research at the National Institute of Health (NIH) and federally funded academic laboratories like here at LSU-Shreveport Health Sciences Center have been essential ingredients in the rapid development of vaccines. Benefit has come from substantially increased NIH funding purchasing power over the last four years of the Trump administration – a reminder of the importance of investment in basic research.
The realization of the potential of messenger RNA technology is the key breakthrough in vaccine technology. Starting from gene sequence, messenger RNA can be produced in a matter of a few weeks. It is fully synthetic and can be made very quickly – no live virus, live cells or DNA cultures as needed in other vaccines. Because the messenger RNA does not attack the DNA of cells, the excellent safety record seen in the initial large trials is very explainable.
Third, the priority reform championed by President Trump’s administration and previous FDA Commissioner Dr. Scott Gottlieb reduces bureaucratic hurdles to FDA approval. There now is real time feedback and clear guidelines to drug and vaccine makers about FDA expectations. This reduces the time required for Phase Three trials from three years to a few months. Without these changes, we would still be months of COVID deaths and economic crisis behind the countries that likely would have developed an effective vaccine ahead of us.
Streamlining bureaucracy in no way lessens the rigorous process for developing the COVID-19 vaccine or the independence and difficulty of obtaining Emergency Use Authorization for the new vaccines. Pharmaceutical companies and researchers are blinded to results until predetermined analysis. The Data Safety Monitoring Board is independent and beholden to no one and the FDA will review every aspect of the vaccine trials before emergency authorization.
Lastly, we should never underestimate the importance of the sharing of scientific discovery. None of this would happen without the early isolation of the viral genome in January by South Korean researchers and the sharing of this discovery with the whole world. These researchers and those who spent their lives working on messenger RNA technology may not be household names but their contribution to the world is enormous.
With the future of widespread immunity from vaccines in sight, this is not the time to quit being prudent about physical distancing, avoiding large indoor gatherings, and wearing a mask when around others. We need to continue to protect the most vulnerable and avoid potential super spreader events like indoor gatherings without physical distancing.
At the same time, our government leaders need to be equally as prudent in deploying curfews, stay at home policies, and lockdowns. We have experienced the negative results of these strategies. We need to still have jobs and small businesses when we have community immunity and return to our life, work, and school.
My mother often told us “don’t cut off your nose to spite your face”. It is easy to see why the lack of trust in government and health policy leaders is so high but I pray that will not stand in the way of people getting vaccinated. To have a way out of the pandemic and not use it would be the worst of tragedies.
In March, we really only had projections to guide decision-making. Now we have real science with vaccines and therapies with proof of positive impact. We have a bright light at the end of the tunnel – a scientific discovery that is a way out of the COVID pandemic. Let’s let it light the path.
Dr. Phillip Rozeman is past Board chair of Northwest LA Medical Society and the Greater Shreveport Chamber and past Chief of Staff at Willis-Knighton Health System and Minden Medical Center.