Written by: Elisa Dong '24
Edited by: Meehir Dixit '24
Each day, Americans head to work masks-up, struggling to keep themselves afloat, while others remain in the seventh month of self-imposed lockdown. The gloomy shadow cast by the COVID-19 pandemic shows no signs of leaving— at least, not unless we take it into our own hands.
American citizens from all groups alike put their faith in one possible solution: a vaccine. This silver bullet will shield those it inoculates from the virus, allowing a return back to “normalcy” without fear of infection. In the meantime, however, it feels like all we can do is wait.
Time is ticking, lives are being lost, and after seven months of the greatest scientific minds devoting their every waking hour to research, the vaccine still isn’t here. What’s the deal?
What is a vaccine?
Vaccines help protect against infection by giving our immune system the tools to fight off invaders. Upon exposure to disease, our bodies naturally create antibody proteins that target and destroy the foreign substance in question. COVID-19 antibodies can continue to remain active for 3-4 months, a phenomenon that correlates with acquired immunity .
Traditional vaccines use viral proteins, while DNA and RNA-based vaccines insert genetic information that’s translated into the necessary proteins (Learn more about vaccine types) . COVID-19 researchers utilize a broad range of technologies to explore different types of vaccines, an approach that the chief of the FDA likens to “taking multiple shots on goal.” 
Most importantly: when it comes to vaccines, safety is paramount. A 0.01% risk of getting a terrible side effect seems minute, but it means that giving 165 million people the vaccine could result in 165,000 otherwise healthy people falling sick. It’s precisely these risks that drive the strict procedural trials of vaccine research.
How is a vaccine developed?
To ensure safety, a vaccine must pass through multiple testing stages as it progressively works its way up to the general population.
Firstly, before giving it to actual humans, scientists must make sure that the vaccine is capable of doing its job. In this pre-clinical stage, the vaccine is given to animals like mice and monkeys and tested for immune response.
When it comes time to try out a treatment on humans, scientists first start out with small groups in what is known as Phase 1. This first run of clinical studies examines the initial results— is it safe? How did human immune systems react to it?
If it passes, it moves to Phase 2, where the vaccine is given to hundreds of people. With this bigger sample size, researchers can fine-tune dosage, determine efficacy, and monitor volunteers for statistically significant side effects.
Phase 3 is the big, final, critical phase that decides whether a vaccine goes to market. The vaccine is given to thousands, and this time there is not only a group who receives the vaccine, but also one who doesn’t—instead, they get a placebo, and neither they nor the doctor know who received what. This double-blind placebo protocol allows statistical analysis to be run to the vaccine’s effectiveness .
Contrary to what many believe, vaccines won’t be 100% effective. In fact, the Food and Drug Administration has set the threshold for COVID-19 vaccines at 50 percent effectiveness, and many American developers are aiming for that goal .
America’s primary COVID-19 vaccine development program, WARP Speed, aims to have a vaccine ready by January . A bit of perspective: the average vaccine faces 10.71 years of development . And this doesn’t even include what comes next: manufacturing, distribution, and regulatory approval.
WARP has a plan. Without “eliminating steps from traditional development timelines,” as it writes on the official government website, it hopes to conduct development and manufacturing in parallel, pumping out doses far before the vaccine’s safety and efficacy is approved. If it turns out the vaccine is ineffective, researchers will throw out the defective vaccines and start over. The primary risk here is purely financial .
…So what is the current state of COVID-19 vaccine development?
As of November 11, the New York Times’ Coronavirus Vaccine Tracker reports that 52 vaccines are currently being tested in clinical trials on humans, with 87 vaccines still in the preclinical phase. 6 have already been approved for limited or early use .
Current Phase 3 frontrunners include US-based companies Moderna, AstraZeneca, and Johnson & Johnson, as well as German company Pfizer & BioNTech. China and Russia are also well underway with research, and have notably and controversially released vaccines to the public before completion of Phase 3 trials .
A strong case can be made for the involvement of nationalist sentiment and PR incentives in the rushing of COVID vaccine releases. The name of Russia’s vaccine, “Sputnik V,” hints at strong national pride . Likewise, people have theorized that China hopes to rebrand itself as a solution to the crisis after criticism of its initial handling .
On November 9, Pfizer and BioNTech reported their COVID vaccine to be more than 90% effective . Sputnik V lagged not far behind, reporting a 90% efficacy rate based on early trials soon after . The first international vaccine approval may be closer than we think.
Consequences of rushing
Why should we heed the ominous warnings from experts against releasing vaccines ahead of their time?
In the rush to vaccinate millions against swine flu in 1976, about 200 Americans had developed Guillain-Barré syndrome, or chronic fatigue syndrome. This program resulted in an increase in public mistrust of all immunization programs soon after its implementation (Read more) . Failure to properly monitor a vaccine’s safety stoked public misinformation, giving rise to the modern anti-vaxxer movement .
Additionally, some vaccine candidates actually worsen the infection by facilitating viral uptake. This phenomenon, known as antibody-dependent enhancement (ADE), has emerged as an explanation for certain severe cases of COVID. 
In 2016, the vaccine Dengvaxia actually increased hospitalizations for children who had received the dengue virus vaccine, despite the warnings from WHO guidelines in Phase 3.  Yes, Dengvaxia had protected a significant amount of children, and saved many lives in the process, but what about those who had been put at risk because of the vaccination? As an article concerning the ethics of the vaccine put it, “What do we owe them?” 
Epidemiological ethics can get tricky when millions of lives are at stake, but non-malfeasance, the moral obligation against causing harm to participants, is one of its most basic principles. Vaccines are delivered to thousands to millions of healthy people, and failure to ensure their safety breaches one of the primary tenets of the Hippocratic Oath— ”First, do no harm.”
On November 9, the US set a new record for coronavirus cases in a single day.  Even as vaccine research propels forward, the rate of COVID infection in the US certainly hasn’t abated.
Despite the immense pressure, researchers must remain vigilant and committed to proper testing protocol, lest they cause more damage in the long term. Facilitating compliance is only possible through public trust. And when it finally comes time to distribute, clear governmental communication is paramount.
A vaccine is coming. This is undeniable fact, and it will undoubtedly aid with the pandemic. But as we wait for a vaccine to come and set things back to normal again— a new normal— we must do what we can to stop the spread: wear masks, wash our hands, and social distance.
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