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Last updated January 18, 2021. 6 minute read

COVID-19 vaccines in development: what can we expect and when?

The US Food and Drug Administration has granted emergency use authorization for two vaccines – one made by Pfizer and one made by Moderna. There are many other vaccine candidates being used around the world and dozens more still in development (WHO, 2020).

Dr Chimene Richa Md Written by Chimene Richa, MD
Reviewed by Mike Bohl, MD, MPH

Since its start in Wuhan, China at the end of 2019, the new coronavirus disease 2019 (COVID-19) has become a global pandemic affecting over 96 million people worldwide and more than 24 million people in the United States (as of Jan. 18, 2021) (ArcGis, 2020). Many people with COVID-19 infections have no symptoms or only mild symptoms. Unfortunately, this contributes to the spread because it is possible to transmit the virus to others even if you don’t feel sick. When symptoms do occur, they tend to start around 2–10 days after COVID-19 exposure, according to the Centers for Disease Control and Prevention (CDC, 2020). COVID-19 symptoms include (CDC, 2020):

  • Cough
  • Fever or chills
  • Muscle pain (myalgias)
  • Headache
  • Shortness of breath (dyspnea)
  • Coughing up mucus
  • Sore throat
  • Diarrhea
  • Nausea/vomiting
  • Loss of smell (anosmia)
  • Change in the sense of taste (dysgeusia)
  • Stomach pain
  • Runny nose

Vitals

  • COVID-19, caused by the novel coronavirus SARS-CoV-2, is a global pandemic affecting millions of people.
  • Using the “pandemic paradigm” of vaccine development, researchers have developed a range of different candidate vaccines.
  • The vaccine produced by Pfizer became available for people over the age of 80 in early December.

    The FDA also approved the Moderna vaccine for emergency use in December.
  • There are also treatments being used for people who have already contracted the virus, including remdesivir, favipiravir, dexamethasone, and immunomodulators.

Older people or those with chronic medical conditions, like heart disease, diabetes, obesity, and lung disease, are at higher risk of developing severe disease. Severe symptoms may require hospitalization, admission to the intensive care unit (ICU), oxygen support, or mechanical ventilation (intubation). In the worst cases, COVID-19 has led to death in over 400,000 people in the U.S. and over 2 million people worldwide (ArcGis, 2021).

COVID-19 vaccines

Around the world, scientists are working hard on a range of COVID-19 vaccines. Many of the vaccine candidates are ones that were initially designed to treat other diseases, like Ebola, SARS, and influenza, but are being modified for use against COVID-19. In early December, the United Kingdom rolled out access to a vaccine made by Pfizer for citizens over the age of 80. Clinical trials showed that the vaccine was more than 90% effective. Citizens will receive two doses (CNN, 2020). Later, the US began distributing Pfizer’s vaccine followed by that of Moderna beginning with frontline workers and individuals at high risk of contracting a serious case of the virus. It may be some time before the vaccines are widely available in the United States.

Vaccine development usually takes a long time—around ten years on average (Pronker, 2013). Typically, after spending many years in the preclinical testing arena, a vaccine may be tested in a small group of people to observe side effects and figure out the best dose—these are phase 1 clinical trials. Phase 2 involves more people to look at how well it works and any additional side effects. 

Lastly, there are phase 3 trials that test the vaccine on thousands of people for more extended periods. After phase 3, then you can have licensure and large-scale manufacturing of the vaccine. Because each stage of vaccine trials has to be completed and the data analyzed before the next phase can begin, this process takes years.

However, in light of the global pandemic caused by SARS-Cov2, new strategies have to be used. The Coalition for Epidemic Preparedness Innovation (CEPI), an international nongovernmental organization, supports vaccine development for epidemic diseases, like COVID-19. The “pandemic paradigm” has allowed researchers to decrease the time from laboratory vaccine research to clinical trials from the traditional 3–4 years down to 16 weeks (Lurie, 2020). 

For example, in the case of COVID-19 vaccines, phase 1 clinical trials in humans started at the same time as animal studies. Most of the vaccines in development act against the spike protein of the outer shell (the “corona”) of the virus particle, but the details vary by the developer (Thanh Le, 2020). The candidate vaccines use different platforms to affect the coronavirus particles—there are DNA vaccines, inactivated virus vaccines, mRNA vaccines, and non-replicating viral vector vaccines.

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In October of 2020, Pfizer announced that the early data on the coronavirus vaccine they had been developing demonstrated “90% efficacy at preventing infection” with no serious safety concerns (NYTimes, 2020). Then in early December, Pfizer’s vaccine received emergency use authorization from the FDA, followed by approval for the Moderna vaccine a week later. While initial distribution during the last few weeks of 2020 will be limited to high-risk individuals and essential workers, distribution will be expanded in early 2021.

Other treatments

Scientists all over the world are not only working on a COVID-19 vaccine. They are also researching potential treatments to alleviate the symptoms of SARS-CoV-2. Possible treatments include antivirals, convalescent plasma, and immunomodulators (NIH, 2020). Hydroxychloroquine was a potential treatment option early on, but it has since fallen out of favor because of concerns over the risk of heart rhythm problems and death in some people (ISDA, 2020).

Antiviral drugs interfere with a virus’ ability to replicate. The antiviral medication remdesivir was approved by the FDA in October 2020 for the treatment of COVID-19. This medication, which is administered by injection, was shown in clinical trials to shorten hospitalization time and improve symptoms in hospitalized patients (Beigel, 2020). It’s currently approved for the treatment of adults and children over the age of 12 hospitalized for COVID-19 (FDA, 2020).

Clinical trials have already begun on favipiravir, an antiviral that was initially developed to treat influenza (Stanford, 2020). This medication is being tested not only on hospitalized COVID-19 patients but also on people whose symptoms do not warrant hospitalization.

The FDA also granted emergency use authorization for a medication called bamlanivimab, manufactured by a company called Regeneron. This drug is a type of monoclonal antibody, which is essentially a laboratory-manufactured version of a tool our immune system uses to fight off infections. While this drug has shown some promising results, it’s not for everyone. It’s specifically used in patients at risk of developing a serious or life-threatening case of coronavirus (FDA, 2020).

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Convalescent plasma is blood plasma taken from people who have recovered from SARS-CoV-2 infection. This plasma may contain antibodies against the virus and, if given early enough to a patient with a severe COVID-19 infection, could help them fight off the disease quicker and more effectively. This treatment is still considered experimental, and, according to the National Institutes of Health, there is not enough information to recommend for or against the use of convalescent plasma (NIH, 2020).

Immunomodulators, like dexamethasone, help to regulate your immune response. COVID-19 can cause your body’s immune system to overreact, leading to severe symptoms (like ARDS) and can damage your lungs and other organs (leading to death in the worst cases). By keeping your immune system in check, these types of medications may improve mortality and overall outcomes.

Dexamethasone is being used in COVID-19 patients who are hospitalized and require supplemental oxygen or mechanical ventilation (intubation) (NIH, 2020). Other immunomodulators under investigation are interleukin-6 (IL-6) inhibitors (e.g., tocilizumab, sarilumab, and siltuximab), and “antibody cocktails,” like REGN-COV2 (UpToDate, 2020).

What can you do now?

While we are all waiting for wider distribution of the vaccines for the prevention of COVID, there are steps you can take to protect yourself, your family, and your community. Remember to practice social distancing when you are out of the house—avoid large groups of people and stay at least six feet away from others. Wear a face mask in public and wash your hands frequently.