16
November
2020
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17:25 PM
America/New_York

COVID-19 Vaccines: The Clinical Trials and What We Know Right Now

BY KATIE CAVENDER

Updated Nov. 19, 2020

With our world upended because of the pandemic, everyone has their sights set on a vaccine. While we watch the news for updates, scientists, physicians, Federal Food and Drug Administration (FDA) and everyday people are working to make that goal a reality. Several vaccines are already in clinical trial. On Monday, Nov. 16, Moderna announced that its vaccine is 94.5% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection and on Wednesday, Nov. 18, Pfizer announced that data shows its vaccine is 95 percent effective. So, what does that mean for our community? Here’s a breakdown.

Science can’t be rushed

In order for any drug to be approved, it must go through the same 3-4-phases of clinical trials and a COVID-19 vaccine is no different. What is different is that the administrative aspects of the trial, production of the vaccine and distribution will all be expedited. Typically, the phases of a trial occur sequentially, but with COVID-19 treatments and vaccinations researchers are able to begin planning the next phase of the trial before their current phase has concluded.

“The science will take as much time as the science needs,” says Joseph Yozviak, DO, Chief Medical Officer of Valley Health Partners Community Health Center. “The only things eliminated from the trial were unnecessary delays.” The standard clinical trial process includes:

  • Phase 1 – During this phase clinical trials enroll healthy volunteers. In this phase, various doses of a vaccine and various versions of a vaccine are given to different volunteers. The vaccine is evaluated to see if any participants develop antibodies and to see which versions perform the best. It also is examined for safety. Once the vaccine shows indications of effectiveness and safety, the vaccine is moved to phase 2.

  • Phase 2 – During this phase a larger number of volunteers are enrolled, and the type of vaccine and dosage is narrowed down even more to learn the best version. Once that information is gathered, the best version will be used to move forward with a single dose of a single vaccine in phase 3.

  • Phase 3 – During phase 3, trials enroll even more participants. The Pfizer COVID-19 vaccination has been in this phase since late July and Pfizer has enrolled more than 43,538 people. Moderna enrolled more than 30,000 worldwide. This phase further verifies the efficacy of the vaccine and gathers additional safety information.

Both Pfizer and Moderna hope to submit for an Emergency Use Authorization (EUA) with the FDA in the coming weeks. During the review, the FDA will determine if there is enough information to prove that the vaccine is working and that it’s safe – just like any other vaccine. Most side effects of a vaccination are seen in the first two months after it is received, however this clinical trial will continue to monitor participants for two years.

  • Next steps – When the phases are complete, the FDA can consider it for approval for general use. With non-COVID-19-related drugs, it is not uncommon for it to take a year or so after phase 3 has completed before the FDA is able to make a decision about approval. Avoiding delays in reviewing trial data is one of the administrative processes that has been sped up especially for COVID-19 treatments.

Typically, manufacturing begins after FDA approval is received, however many of the manufacturers of a COVID-19 vaccine have already started production in hopes of approval in order to start distribution quickly.

  • Phase 4 – After a vaccine is approved for general use, it may enter phase 4. This phase consists of ongoing surveillance to observe how the vaccine performs in everyday scenarios.

“It's OK to have questions. It’s OK to be uncertain,” says Yozviak. “None of the vaccines have been approved by the FDA yet, but I can assure you that the FDA will not issue an Emergency Use Authorization or approve the vaccine without data proving that this vaccine is safe and effective.”

A vaccine like no other

The Pfizer vaccine and the Moderna vaccine are just two of several COVID-19 vaccinations being evaluated through clinical trials. But there’s something very unique about both of these shots they are made with RNA.

The vaccines we’re used to either contain a weak version of the virus (like for measles or mumps) or a killed virus (like for the flu). The vaccination injects the dead or weakened virus into your body to stimulate your immune response.

Pfizer and Moderna are the only two companies that have produced a SARS-CoV-2 RNA vaccine for clinical evaluation thus far. If approved, they would be the first vaccines to use this simple technology. “The RNA in these vaccines are the same as part of the genetic material from the virus. It’s basically instructions that your body’s cells will use to build the virus’s spike protein, not the whole virus,” says Yozviak. “Our immune system will still respond to the spike protein as foreign and produce antibodies.”

One other important thing to note: “This RNA does not become a part of us. It does not integrate into our DNA.”

To learn more about COVID-19 treatments, testing and clinical trials, visit the LVHN COVID-19 Help Center at LVHN.org/COVID19.