Vaccines Are On The Way: What You Need To Know
(Disclaimer: La Tonique Media LLC does not represent any political ideology. While we do not espouse any political beliefs, we do seek to provide a balance perspective by incorporating voices from both sides of the political spectrum.)
By Matthew Laurence
As the end of 2020 is fast approaching, there was worry that the bad fortune this year has brought wouldn’t end with it. The coronavirus that began spreading around the world last March has radically changed the world. For a long time, it felt as if there was no end in sight. Finally, there seems to be some light at the end of the tunnel. A coronavirus vaccine will not fix the problem overnight. But it’s the first concrete step to ending this pandemic and getting life back to normal.
Two companies are leading the charge in the development of coronavirus vaccines. Pfizer Inc. and its partner, BioNTech, are asking the U.S. Food and Drug Administration to give them the go-ahead on the authorization of their vaccine candidate. Moderna Inc. is close behind them. They are getting ready to submit a similar request to the U.S. FDA, and the first doses of the vaccines could be on their way to hospitals, doctors’ offices, and pharmacies as early as late December.
The turnaround for the development of these vaccines is historic. On May 15 of this year, President Donald Trump officially announced Operation Warp Speed. OWS is a public-private partnership to “accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” This program focuses on three primary objectives for a coronavirus vaccine in the United States with ten billion dollars in additional funding: development, manufacturing, and distribution. It is comprised of components of the Department of Health and Human Services. This includes the Center for Disease Control, the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the Department of Defense.
At the beginning of this operation, the U.S. government gave funding to a variety of companies in hopes it would help them develop a coronavirus vaccine candidate. OWS selects the most promising vaccine candidates and assists in setting protocols to demonstrate safety and efficacy. This allows clinical trials to proceed much quicker than normal. OWS also assists in the manufacturing capacity for selected vaccines. Once a vaccine candidate looks promising, they will begin manufacturing large quantities of the vaccine so it will be available to the public sooner. Typically, manufacturing only takes place once a vaccine has completed all trials and is approved by the FDA. This investment in manufacturing goes along with the increased capacity for distribution. The Operation Warp Speed program is helping with logistics and putting important infrastructure in place so when that vaccine is available, the 300+ million doses the U.S. government has purchased can be distributed widely.
The FDA determines which coronavirus vaccines will be authorized for first use. For the Moderna and Pfizer candidates, that may come in late December. Once that happens, the federal government, in partnership with McKesson Corp., will begin distributing the initial 6.5 million doses of the vaccines within 24 hours. Pfizer has its own distribution network and will follow suit. Plans to begin vaccinations will occur within 48 hours.
The CDC Advisory Committee for Immunization Practices held a meeting to advise those distributing the vaccine on which group should get it first. At the top of the list are the frontline workers in hospitals and their support staff. The Trump Administration, also through the Dept. of Health and Human Services, has partnered with pharmacy chains CVS and Walgreens to administer the vaccine to staff and residents of long-term care facilities who are being disproportionately affected by this disease. The CDC's Dr. Kathleen Dooling says, "Long term care facility residents and staff accounted for 6% of cases and 39% of deaths in the US, despite the fact that long term care facility residents account for less than 1% of the US population."
In addition to healthcare personnel, there are also millions of essential workers, adults with high-risk medical conditions, and Americans who are 65 and older. Because those groups are in a higher risk pool they can be expected to be vaccinated first. The federal government has estimated that 40 million doses of the vaccine can be available in late December.
Because of the assistance of Operation Warp Speed, experts such as Dr. Larry Corey of the University of Washington, who is heading the vaccine clinical trials, has said, “if both Pfizer and Moderna get vaccines authorized, they could supply 50 million more doses in January and 60 million more in February and March.” This is promising news considering only a few months ago a viable vaccine was not even in sight, let alone in mass production and distribution.
Thankfully, these vaccines will be free to U.S. citizens. A decision was made long ago by the government to cover all costs of the vaccine to ensure access. The administration fees associated with the vaccine will be billed to private or government insurance plans, as well as a special government relief fund for those who are uninsured. This is key to promoting and achieving herd immunity, where between 60% to 70% of the population needs to develop an immune response to the virus.
Of course, the question everyone wants to know is when will this be over? It’s hard to say for sure, as a lot of variables are at play. But there is a reason to be optimistic. HHS Secretary Alex Azar, head of the federal agency that oversees the FDA, was gushing to CNBC about the results of the vaccine candidates. Although we will have to wait until all essential workers and high-risk populations get their vaccines, he estimates it will be widely available to the public in the second quarter of 2021.
To those who have gotten sick and passed, their family members, and frontline workers, fighting this virus has been hell. There are also millions of people who have lost their jobs. Those who have been forced to isolate themselves at risk to their mental health, and those who have lost their businesses. Which has given way to one of the biggest economic collapses we have ever seen. This way of life is clearly unsustainable. With prospects of a second lockdown looming, there is a reason for hope. We are almost there, there is a light at the end of the tunnel, and thanks to human innovation we will be there soon.
Matthew is a political writer for La Tonique.