by Michael Farina
As a nation, the United States is in the worst shape in terms of daily Covid-19 cases and deaths since the pandemic began. Daily cases across the country are on a rise and have reached a grim peak on December 11th at over 280,000 cases reported. This is more than triple the number of cases seen in the previous peaks of Covid-19 transmission that occurred during the spring and summer of this year.
Unfortunately, this rampant spread of the virus has also caused an increased death toll that will only rise as 2020 comes to a close. According to a study conducted by the New York Times, the death toll associated with new waves of Covid-19 infection tend to lag behind new infections by two to three weeks. This exhibits just how imperative it is for the U.S. to not only control the spread of the virus, but to approve and distribute vaccines against Covid-19.
Importance of a Vaccine
The creation of an approved and reliable Covid-19 vaccine that is able to be administered to 75% of the American people will bring a return to normalcy. Once one is vaccinated with the newly-developed Covid-19 vaccine, (and with a booster shot given at a later date), one will become immune to developing the virus even if they are exposed to someone that is a carrier. Once enough people are given the vaccine, herd immunity arises: the inability for the virus to rapidly spread through a population because enough of the population is immune.
The vaccine confers immunity by enabling the body to create antibodies that will fight off the Covid-19 virus once it is inside the body. The vaccine consists of mRNA that codes for the “spike proteins” that are present on the outside of the virus. When injected into the body, the mRNA will be transcribed into the spike protein and trigger an immune response that results in antibodies against these proteins present on Covid-19. These antibodies are able to recognize and bind to the Covid-19 virus if it were to enter the body on a later date. And by doing so, it will mark the virus for destruction by white blood cells--the integral cells of the immune system.
Reaching the point where 75% of Americans are vaccinated for Covid-19 is going to be a great challenge that requires a coordinated effort on behalf of pharmaceutical companies, manufacturers, medical professionals, and federal, state, and local governments. For instance, with each American needing two vaccinations to be immune, over 600 million vaccines will need to be rapidly created and distributed across the entire nation. With the United States being as large and diverse as it is, many are concerned about the vaccine reaching rural communities and being equally distributed by population.
In addition, the order in which groups of people will be vaccinated is still not set in stone. I have elaborated on the planned order of vaccination, but the ethics behind who gets vaccinated first is quite convoluted. For example, it will be quite difficult to decide if we as a nation should prioritize those with pre-existing conditions, those over 65, or essential workers such as teachers, firefighters, and postal workers. With distribution being the dominating issue of the incoming Biden Administration, it likely makes the plan subject to change.
The greatest challenge of all seems to be enticing Americans to be vaccinated. There is great hesitation and fear among many Americans for a variety of reasons. For example, there are many who harbor a great mistrust for the government, particularly African Americans who have historically been mistreated by scientific studies and the government.
Furthermore, the anti-vax movement that was once a niche group of those opposed to routine vaccinations has now grown into a national movement against the Covid-19 vaccine. Their fear of the vaccine stems from a belief in conspiracy theories about the government having ulterior motives for vaccinating people. Though claims from anti-vaxers have been repeatedly shown to be scientifically inaccurate, the group continues to grow larger and larger because it plays off of people’s primal fears of not wanting themselves or their family to be harmed. With social media being their primary source of messaging, their claims remain mostly unregulated and are able to be seen by thousands of people before any social media site is able to flag or remove their content. This will result in many being permanently turned away from wanting the vaccine.
Finally, it has been shown that the American public is generally hesitant toward wanting a new vaccine. Coming from a natural fear of the unknown, this hesitation seems to be decreasing as healthcare workers, politicians and the elderly have publicly received and advocated for the vaccine. However, according to a study conducted on December 15th, 71% of Americans stated they will likely or definitely get the vaccine, up from 50% in May. This is a promising sign as it is only 4% away from the aforementioned 75% of the population needed to reach herd immunity.
Pfizer and BioNTech’s Vaccine
The vaccine developed by pharmaceutical companies, Pfizer and BioNTech, was the first to be approved by the FDA on December 11th. Based on preliminary results released on November 9th, Pfizer announced that their vaccine was 90% effective in protecting against Covid-19 infection and harbored no serious side effects to those injected. Shortly following the release, more data was reported and analyzed from the trials and they concluded that the vaccine was actually 95% effective in preventing infection.
The trials conducted involved 43,000 participants aged 12 and over. Half of the volunteers were injected with two doses of the vaccine three weeks apart, while the other half were injected with two doses of the placebo three weeks apart. The study was then paused for several months until a large enough number of participants contracted Covid-19. It was then determined by an independent board of scientists--with no connection to the company, doctors, or volunteers-- if the infected participants had been injected with the vaccine or the placebo.
On November 18th, the final results of the clinical trial showed the vaccine to be 95% effective in preventing Covid-19 infection. This conclusion was based on 164 participants that had gotten Covid-19 during the trial. It is deemed reliable because of its large sample size. After publishing these results, Pfizer and BioNTech filed for an emergency use authorization from the FDA so that they can begin mass producing and disturbing the vaccine for public use. The United Kingdom was the first country to authorize use of the vaccine on December 1st, followed by Canada a week later and the United states 10 days later.
Moderna’s Vaccine
Just one week after Pfizer and BioNTech’s preliminary trial results were announced, Moderna released their preliminary trial results that showed their vaccine to be 90% effective as a barrier against Covid-19 infection. Shortly thereafter, the company released their finalized trial results showing their vaccine to truly be 94.1% effective.
Their trials were conducted in the same way as the Pfizer trials, but utilized only 30,000 volunteers. However, the final efficacy of the vaccine was determined by looking at 196 volunteers that contracted the virus, a slightly greater number than Pfizer. Of those volunteers, only 11 had been given the vaccine and none developed serious disease from the virus! Based on this result, Moderna filed for emergency use authorization on November 30th and has promised to produce 100 million doses of the vaccine for the United States by the end of 2021. It has also signed agreements with the European Commission, Japan, Qatar, and Canada to provide millions of doses to them as well. It was approved by the U.S. on December 18th.
AstraZeneca’s Vaccine
Unlike Pfizer and Moderna, AstraZeneca’s vaccine has faced some obstacles that may hinder it from being approved by the end of the year. Initially, the company released trial results that showed the vaccine had an efficacy of 90% on November 23rd. However, the laboratory procedure used was further examined and it was discovered that there was an error in the dosages given to participants. This led to skepticism about the validity of the results and requires AstraZeneca to clarify the exact dosage required for the vaccine to possess 90% efficacy. This must occur through further trials before the company can petition for emergency use authorization.
Following a month-long review of their data, AstraZeneca petitioned for approval in the United Kingdom and received approval on December 30th. This is a promising sign for the vaccine’s chances to be approved in the United States in the upcoming weeks.
Efficacy vs. Effectiveness of Vaccines
An important caveat to the figures presented above is that those percent effective values represent the efficacy of the vaccine and not its effectiveness, which are two distinct epidemiological terms. A vaccine’s efficacy is a percentage derived from how effective a vaccine is in preventing infection as compared to the placebo group in a clinical trial. It ranges from zero to 100% and is only reflective of the trial population.
Effectiveness, however, is defined as “how the vaccine works out in the real world.” It is a percentage that is typically slightly different from the efficacy of the vaccine. This is caused by differences between the trial population and world population in terms of genetic diversity and health conditions, both of which may impede the well the vaccine truly works.
Distribution
With the approval of Pfizer and Moderna’s vaccines by the FDA, it will be the job of the federal government to regulate its production and distribution across the country. As stated earlier, this will not be a simple task. Pfizer’s vaccine must be stored at negative 94 degrees Celsius as it is being transported, requiring specialized refrigerated trucks that must be produced and distributed across the country. In addition, the placement of factories that will produce these vaccines are crucial because the vaccines must be injected within 20 days of production.
After distribution, it is in the hands of the state and local governments to facilitate the vaccination of its citizens. It has already been stated by Operation Warp Speed that the order in which the public will receive the vaccine will be set by the federal government in terms of priority. Since the FDA approved Pfizer’s vaccine, it has sent out its first shipment of roughly 46 million vials, enough for 23 million people to receive the 2-dose vaccine. These vaccines will be given to healthcare workers and the elderly living in long-term care facilities, who are said to be the most vulnerable to infection.
Following this, there is a plan to vaccinate all essential workers, which are defined as those that must go into work in-person in order to complete their jobs that are needed for our society to function. This group comprises 80 million Americans and with Moderna’s vaccine also approved will likely be completed within the first few months of 2021.
The last priority group that is planned to receive the vaccine before the general public are those who are over 65 years of age or who have an underlying health condition such as heart disease, diabetes, and hypertension. These individuals are more prone to severe infection and death than other members of the general public and make up approximately 100 million Americans (with some overlap with the first 2 priority groups).
According to the head of Operation Warp Speed, General Gustave Perna, if all goes to plan this group may be entirely vaccinated by May of 2021. This along with providing access to the general public in April or May of 2021, will bring us to the 75% immunity threshold that will confer herd immunity and essentially will end the need for many restrictions that have been set to reduce the spread of Covid-19.
Conclusion
As crazy as it may seem, with two approved vaccines and one possibly being approved in the near future, it seems very probable that restrictions and lockdowns will be lifted at some point next year. How far into 2021 this will occur is still uncertain and is affected by a wide variety of variables including vaccine manufacturing and distribution as well as governmental policy regarding who will receive the vaccine when and how apprehensive the broader American public is to receiving the newly-created vaccine. Nevertheless, with millions already being vaccinated, one can be optimistic that the upcoming year holds great promise in the battle against Covid-19 and that life may return to normal sooner than many expect.
Michael Farina is a GW Scope staff writer for the George Washington Undergraduate Review. He is a junior majoring in biology and minoring in STEM teaching. He is interested in a career in medicine and is currently a member of GW’s EMS service, Emerg, and also volunteers with the organization One Tent Health on weekends. Through his articles written with GW Scope, he aims to break down complex biological and medical topics in order to make them accessible to the average reader.
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