Dr. Tom Frieden, the director of the CDC from 2009 to 2017 wrote “Developing a COVID-19 vaccine is the most important thing we can do to restore some order and normalcy in our world”. It is true. In the last couple of weeks, we have become aware of the results of two very large trials involving COVID vaccines developed by Pfizer and Moderna pharmaceutical companies. These trials show safety and 95% effectiveness of each of the vaccines. In comparison, the effectiveness of a traditional flu vaccine any given year is at best 30-60%.
In March and April, healthcare providers knew vaccines would be the best hope to stop COVID-19. We shared the hope of a vaccine but knew the history of vaccine development. We knew the development of vaccines had not always been successful and we knew the shortest previous development time for a vaccine was four years in the case of the mumps vaccine.
The development of a safe and 95% effective vaccine for COVID-19 in less than a year is a miraculous feat. In April of this year, an opinion piece in the Wall Street Journal by the previous commissioner of the FDA Dr. Scott Gottlieb noted “America needs to engineer a development and regulatory process that is unprecedented in size and urgency.” He wrote “the first country to the finish line will be first to restore its global economy and global influence”. America made this happen with Operation Warp Speed.
President Trump has received plenty of criticism over the handling of the pandemic – some deserved and some not. Operation Warp Speed should not elicit criticism. The U.S. has invested ten billion dollars into R&D of eight COVID vaccine candidates and there will be millions of doses of vaccine ready when the FDA confirms Emergency Use Authorization for the current effective vaccines.
This project is an investment in public-private partnerships that enable private enterprise to meet the goal of creating a safe and effective vaccine. The government took on much of the financial risk that allowed for more rapid vaccine development and allowed companies to work on the manufacturing and distribution process even before anyone knew if the vaccine would work. The work occurred in parallel.
Operation Warp Speed is a high risk investment but one that will undoubtedly save hundreds of thousands of lives in our country and across the world. The investment will bring us closer to hugging grandparents, being comfortable with our children’s schools, returning to work, and living again with less fear.
All treatments and vaccines have identified benefits and risks. When we watch television commercials on medications, we see that displayed. For the new COVID-19 vaccine, the benefits are 95% effectiveness in preventing COVID-19 with all the physical and mental health benefits and peace of mind that comes with it. The identified risk in the 30,000 patients in clinical trials followed two months post vaccination have been pain at the site of injection and sometimes fever and fatigue for a day or two after the two injections in 20% of patients.
The biggest challenge to widespread vaccination of COVID will not be scientific, technical, or logistical challenges – though there are challenges in these areas. The biggest challenge will be our lack of trust in government leaders and fear of the unknown sowed since the beginning of the pandemic. We all have been inundated with so much pessimism, we have begun to believe there really is no hope – not even with the vaccine we prayed for in March and April of this year. It will be up to each of us individually to weigh the benefits and risks and decide on whether or not to be vaccinated.
The more people vaccinated the faster we get to life not dominated by COVID-19. However, it is important to remember that the key is not the overall vaccination rate but what people actually get vaccinated. As has been the case all along, the protective measures of COVID-19 are most important in those at highest risk of transmission and complications of the virus. This is the case for the first groups eligible for the vaccine – first responders, healthcare and nursing home workers, elderly in nursing homes and at home, and the most vulnerable with chronic medical conditions. The vaccination rate in these individuals is the most important number.
The hospitalization and death rate will be reduced enormously if only high risk groups have a high vaccination rate. The positive impact of the vaccination is exponentially greater in people at highest risk. An added benefit in healthcare workers is the vaccination’s role in keeping people healthy, off quarantine, and back at work to care for the ill in the community. An added benefit to community is lessened worry of asymptomatic children passing the virus to the elderly.
What is really important for reducing complications of COVID-19 quickly is not when the rollout is complete but when it starts. The faster we vaccinate the high risk, the quicker we see lower death and hospitalization rates. As we look for places to work together, a good place to start might be a communication from both President Trump and President-elect Biden to the FDA to work seven days a week to consider the Emergency Use Authorization of both COVID vaccines. Slowing the process for no good reason will only cost lives.
A high vaccination rate in people at high risk should end consideration of widespread lockdowns, curfews, and stay at home policies with the business failures and unemployment that accompanies these policies. Physical distancing and avoidance of large indoor gatherings will still be needed until we reach community immunity, and the time required for this to happen will depend a great deal on the vaccination rate of those with lower risk of complications to the COVID virus.
In Scott Gottlieb’s opinion piece in April, he closed with this statement “A successful vaccine will allow Americans to reclaim the country’s safety and sovereignty. The first country to reach this prize will be the first nation to recover”. Thanks to Operation Warp Speed, it’s getting closer to the time America reclaims its safety and sovereignty; returns to work and school without significant restrictions; and begins to live again with less fear.
Dr. Phillip Rozeman is a practicing cardiologist. He is past board chair of the Northwest Louisiana Medical Society, Greater Shreveport Chamber of Commerce, and Blueprint Louisiana