COVID-19 VACCINE & CLINICAL TRIALS PARTICIPATION

Learn about the COVID-19 vaccine and the importance of our participation in COVID-19 vaccine clinical trials.

WHAT IS THE COVID-19 VACCINE? 

The COVID-19 pandemic has disproportionally impacted the Latino community and a vaccine could help protect us from future infections and support a return to “normal.”

But we might be wondering, how would a vaccine grant us protection and how does it work against COVID-19?

A vaccine is a type of medicine that helps our body recognize when it is being attacked by a virus or bacteria, and as a result, our body produces fighting mechanisms to remove the virus or bacteria before it makes us sick. Vaccines have been around for many years and they have been developed in labs by scientists to reduce the burden of disease from several infectious diseases like measles, chickenpox, and influenza. For vaccines to be effective in protecting us, they are developed to contain the same germs that cause disease. For example, the measles vaccine contains a deactivated form of the measles virus and the flu vaccine contains a deactivated form of the influenza virus. A deactivated virus means the virus used is either killed or weakened so that we effectively develop protection for that disease without having to get the disease in the first place. It is important to note that the deactivated virus used in a vaccine has been carefully manipulated, tested, and studied so it does not make us sick and it does not cause adverse side effects, but instead it protect us from becoming sick in the future.

Currently, we do not have an authorized or approved vaccine to prevent COVID-19 in the United States. However, we do know that the COVID-19 vaccine will work similarly to other vaccines created in the past. It will stimulate our body to produce effective fighting mechanisms against the virus that causes COVID-19, and therefore preventing us from getting sick with the virus.

WHO IS LEADING THE DEVELOPMENT OF THE COVID-19 VACCINE? 

A public-private partnership led by the Department of Health and Human Services (HHS), the  Department of Defense (DOD), and the private sector has been working since the pandemic started to make the COVID-19 vaccine available to the public as soon as possible while ensuring that the vaccine is safe and that it works for everyone. This public-private partnership is also in charge to ensure adequate supply and distribution of the potential approved COVID-19 vaccine across the United States.

COVID-19 vaccine candidates have been carefully selected based on rigorous criteria. The vaccine candidate must:

  1. Support clinical safety and efficacy.
  2. Have potential to enter large-scale clinical trials in humans by the fall of 2020.
  3. Can produce the vaccine in large numbers once approved.
  4. Use one or four vaccine technologies that are most likely to result in a safe and effective vaccine against COVID-19.

Currently, multiple COVID-19 vaccines are under development but as of October 13, 2020, only four vaccines have begun large-scale clinical trials in the United States which means they are being tested in many thousands of study participants to determine their safety and effectiveness.

This public-private partnership is focused on speeding the process of the COVID-19 vaccine. However, the U.S Food and Drug Administration (FDA), which is a science-based agency responsible for reviewing and assessing standards for the approval of the COVID-19 vaccine, will still continue to ensure the public’s safety in accordance to their rules. This means that a COVID-19 vaccine will enter FDA's review process before the vaccine is ready for public use. The safety of the COVID-19 vaccine is still a top priority even when we are in a middle of a race to develop a vaccine at a never-seen speed and scale.

WHAT IS THE PROCESS OF DEVELOPING THE COVID-19 VACCINE? 

The development of the COVID-19 vaccine has been under the public eye, and we are constantly receiving updates of every step of the way. Typically, we would only hear news of vaccine clinical trials when scientists were done with the research and had the final say on whether a vaccine recently developed is safe, effective, and ready for public use. For this reason, understanding the process of developing the COVID-19 vaccine is important to mitigate confusion and fear in our community that lives in an environment of constant news and sometimes misinformation.

The development of a vaccine is a laborious process and not an easy task even in normal circumstances. The development of the COVID-19 vaccine started early this year with the first COVID-19 vaccine testing in humans in March. There are approximately 135 vaccines in development worldwide and 48 vaccines in clinical trials with participants in the United States. Having multiple vaccines is a good tactic since multiple vaccines are needed to ensure success in our diverse communities and to increase the chances of finding a few that work.

For the COVID-19 vaccine to prove safe and effective for the public, it will undergo rigorous testing and approval process set by the FDA. One of the many steps the COVID-19 vaccines are undergoing is the clinical development, which is a three-phase process to test safety and usefulness of the vaccine. If the COVID-19 vaccine successfully completes the three phases under the clinical development, scientists must then provide complete vaccine information necessary for the FDA to assess risks and benefits, and to recommend or deny the approval of the vaccine.

The FDA licenses a vaccine only if it is deemed safe and effective and if the benefits outweigh the risks. Additionally, the manufacturer site that will produce the vaccine will also undergo a pre-approval inspection to ensure the production of the vaccine is safe. The vaccine will also have a label for health care providers to communicate with patients about risks and to accurately deliver the vaccine to the community. Even when the COVID-19 vaccine is ready for public use, the FDA will continue to monitor production and could ask for samples of the vaccine to be tested in addition to tracking side effects once the vaccine is being administered to the public.

In the United States, COVID-19 vaccines are in the clinical development but zero have been approved for full use. Experts predict that by December 2020, scientists will find a COVID-19 vaccine that is safe and effective for the public. However, even if a COVID-19 vaccine is found by the end of this year, widespread vaccination will not take immediately, and we will most likely have to wait until later in 2021 for a COVID-19 vaccine. If there is limited supply, some groups may be prioritized and recommended to get the COVID-19 first. Also, it is possible that the first COVID-19 vaccines won’t be approved for children. For updated information, please visit: Coronavirus Vaccine Tracker.

WHAT ARE CLINICAL TRIALS? 

Clinical trials are science-based studies performed in people to test safety and effectiveness of a new medication, treatment, screening, vaccine, and more. It is important to note that before entering the clinical development, an investigational vaccine has previously been studied to make sure it is safe to test on humans. There are three phases to the clinical development for a new vaccine to be approved:

Phase I: During Phase I, scientists test the investigational vaccine on a small group of healthy participants usually in a group of 20-80 people. Usually, scientists judge safety and side effects and determine the correct prescribed amount of the vaccine (dosage).  

Phase II: During Phase II, scientists continue to test the investigational vaccine on more people, usually in a group of 100 to 300 participants. While the emphasis during Phase I is safety, Phase II aims to collect preliminary information on whether the vaccine is effective in people with various conditions. Phase II continues to study safety and short-term effects.

Phase III: During Phase III, the investigational vaccine goes under an extensive test on more people, usually in a group of several hundred to 3,000 participants. Phase III gathers more information about safety and effectiveness, and it studies different prescribed amounts of the vaccines (dosage) and observes how the vaccine works in different populations. If the FDA agrees that the information produced by the investigational vaccine during the clinical trials is positive, it will approve and license the investigational vaccine. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval and license.

Phase IV: Phase IV happens once the vaccine is approved and licensed, the vaccine will continue to be monitored for safety and effectiveness for the population at large for a longer time to ensure it continues to be safe and effective for everyone.

It is important to note that at any moment during the clinical development, if scientists observe concerning side effects, they can put the clinical trial on pause and it is only after a detailed investigation when scientists decide to continue or abandon the clinical trial. Pausing clinical trials during the clinical development is common and they have and will continue to occur during the development of the COVID-19 vaccine. These pauses are only signs that scientists are following protocols to ensure safety.

Click here for a visual of how a new vaccine is developed, approved, and manufactured.

journey vaccine eng

WHY IS IT IMPORTANT TO PARTICIPATE IN A CLINICAL TRIAL? 

Our participation in clinical trials is crucial to ensure we have a diverse group of people included in the clinical development of a vaccine. Therefore, increasing the chances of having a COVID-19 vaccine that works for everyone. Historically, people who are Latino, Black, Native American/Alaskan Native, and people from other racial and ethnic minority groups, which are also communities disproportionally impacted by the COVID-19 pandemic, have been significantly underrepresented in health research. For instance, the Latino community represent about 18% of the U.S. population, but less than 5% participate in clinical trials, which is why it is so important for our community to become partners of this medical advancement.

Public health experts and scientists are concerned that Phase III clinical trials for the COVID-19 vaccine do not have enough participants from diverse backgrounds which can consequently have an impact on the development of a vaccine that works effectively for our diverse population. For this reason, public health experts are making a call to action to ensure that people from racial and ethnic minority groups become part of clinical trials for the COVID-19 vaccine. Those who have participated in clinical trials say their motivation is to help advance health care and contribute to scientific findings for the collective good.

 

WHERE DO I FIND A CLINICAL TRIAL FOR THE COVID-19 VACCINE? 

As of November 3, 2020, 11 vaccines are in large-scale tests also known as Phase III of the clinical trials. Our colleagues at COVID-19 Prevention Network have created a participant screening registry for potential participants who want to partake in current or future COVID-19 prevention clinical trials. Please note that each trial is at different phases of the recruitment, so information will vary. If you are interested in taking part of the registry, click here to begin survey and you could become part of clinical trials currently looking for participants. The survey typically takes 10 minutes to complete

The National Institutes of Health’s Community Engagement Alliance Against COVID-19 Disparities (CEAL) {The Alliance} also aims to ensure that COVID-19 prevention and treatment clinical trials include racially and ethnically diverse communities most affected by the pandemic; and to conduct outreach and seek input from communities to raise awareness about COVID-19 and to address misinformation and mistrust about the pandemic and efforts to combat it. The Alliance research teams are working to expand community outreach efforts by NIH COVID-19 trial networks while engaging with trusted organizations and people. For more details, click here.  

WHERE DO I FIND ADDITIONAL RESOURCES? 

Infographics:

Fact Sheets:

Social Media Toolkits: