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How Close Are We to Finding a COVID-19 Vaccine?

Every vaccine has to go through certain stages in its development before it is approved for use. But what exactly are these stages?

Ever since we were little, we’ve been getting vaccines so we would have an extra immunity boost against different illnesses such as flu, chickenpox, and measles. Any person, no matter what age, continuously gets vaccines throughout their lifetime so they would be protected against viruses that can potentially infect them.

Unfortunately, not all diseases and illnesses have a vaccine yet. This is also why a lot of medical practitioners have been racing to develop vaccines for different diseases—especially those that cause a widespread crisis such as the new coronavirus. (Read: PH to Join Solidarity Trials for Potential COVID-19 Vaccines)

Many experts and pharmaceutical companies are now in the process of developing a vaccine for the deadly disease. However, despite the immediate need for the vaccine, developing one can’t be rushed as it has to go through many tests and trials before it will be ready for public use.

But what exactly are the stages that a vaccine has to go through before it is approved for use? My Pope breaks it down for you.

covid-19-vaccine
Photo from Milken Institute School of Public Health – The George Washington University

Stage 1: Exploratory Stage

This is the research-intensive stage of vaccine development. Researchers try and look for antigens that would either prevent treat a certain disease. An antigen is any substance that can trigger the body’s immune response. *Note: Antigens can also be a weakened strain of a virus.

Stage 2: Pre-clinical Stage

This is when experts perform tissue-culture and animal testing to see if a prospect vaccine does its job to protect the body from a particular virus. Many of the prospect vaccines don’t go past this stage as they would either be ineffective or harmful to the host. (Read: Prayers for Those Affected by the COVID-19 Pandemic)

Stage 3: Clinical Stage

This is when companies submit their report on findings and how the drugs will be created to the Food and Drug Administration (FDA). The FDA will then have 30 days to read through the report and approve the vaccine for clinical trials. Once approved, a vaccine has to undergo three stages of human testing.

    • Phase I: The vaccine is administered to a group of less than 100 individuals. This is where they would initially discover the effects and side effects of the prospect vaccine on humans.
    • Phase II: The vaccine is administered to a larger group—usually around a hundred or more individuals. Here is where researchers determine the ideal dose size and immunization schedule, and the safety of the vaccine.
    • Phase III: The vaccine is tested to thousands of individuals to once again determine the safety and efficacy of the candidate vaccine. This is because some “rare side effects” don’t always show up in small test groups.

ph-solidarity-trials
A pharmacist named Michael Witte giving Rebecca Sirull a shot in the first-stage safety study clinical trial of a vaccine for COVID-19. (Photo from AP Photo / Ted S. Warren / Business Insider)

Stage 4: Regulatory Review and Approval

Once a candidate vaccine passes all three phases of the clinical stage, the developer (usually a private company) will then apply for a license from the FDA.

Stage 5: Manufacturing

This is the stage where drug manufacturers provide all equipment, manpower, and other necessities needed for the mass production of the approved vaccine. (Read: Pope Francis: ‘COVID-19 vaccine should be shared to the world when discovered’)

Stage 6: Quality Control

Despite being approved for use, a newly-approved vaccine will still have to be monitored in order for experts to see if it is actually doing what it’s supposed to do. There are various systems that help in the monitoring of approved vaccines such as Phase IV—an additional phase done after the release of a vaccine—and the Vaccine Adverse Event Reporting System (VAERS).

covid-19-vaccine
In this file picture taken on April 29, 2020, an engineer works at the Quality Control Laboratory on an experimental vaccine for the COVID-19 coronavirus at the Sinovac Biotech facilities in Beijing. (Photo from AFP / Nicolas Asfouri / Philippine STAR)

How Close Are We to Finding a Vaccine?

There is a handful of pharmaceutical companies and institutions trying to find a vaccine for the novel coronavirus, namely: AstraZeneca/Oxford, Sinopharm (in collaboration with the Wuhan Institute of Biological products), Moderna, Pfizer/BioNTech, CanSino Biologic, Sinovac, and the Chinese Academy of Medical Sciences.

According to Science Insider, this is the vaccine progress of the seven developers:

  • AstraZeneca/Oxford – Phase III (*Emergency Use is expected around September)
  • Sinopharm – Phase III
  • Moderna – Phase II (*Phase III is expected this July)
  • Pfizer/BioNTech – Phase II (*Phase III is expected around July or August)
  • CanSino Biologic – Phase II
  • Sinovac – Phase II
  • Chinese Academy of Medical Sciences – Phase II

It should be noted that there could be an emergency use authorization for a COVID-19 vaccine even if it hasn’t been approved in all six stages. The condition is that it should have present strong Phase II and/or Phase III data following clinical trials. The pandemic is considered to be an emergency situation needing immediate mass vaccination.

References: Centers for Disease Control and Prevention; Milken Institute School of Public Health

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