FAQS About COVID-19 VACCINE & CLINICAL TRIALS PARTICIPATION

En español


FREQUENTLY ASKED QUESTIONS

WHAT IS THE COVID-19 VACCINE AND HOW DOES IT WORK?

The COVID-19 vaccine is a type of medicine that works by teaching our body how to recognize and fight the virus that causes COVID- 19. The COVID-19 vaccine will protect us from getting sick and it will help us slowly regain moments together with our friends and loved ones.


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

The process of making the COVID-19 vaccines and the ones underway involves rigorous testing in thousands of participants in clinical studies. Once there is enough information, the U.S. Food and Drug Administration (FDA) determines risks and benefits and recommends or denies the approval of the vaccine before the vaccine reaches the public. The FDA is the agency responsible for ensuring the safety and effectiveness of the COVID-19 vaccines in the United States.

The recently authorized COVID-19 vaccines were made at a speed never seen before which has been a point of worry to many, but we know that the process was closely monitored, and guidelines were followed to ensure the vaccines are safe to use. Now that we have two COVID-19 vaccines available, the FDA will continue to monitor and track side effects as it normally does with new vaccines.


CAN THE COVID-19 VACCINE TRANSMIT THE VIRUS?

No, the recently authorized COVID-19 vaccines and the COVID-19 vaccines in development cannot give us COVID-19. Rather, the COVID-19 vaccines will protect us from getting sick by helping our body build the immunity we need to fight the virus if we become exposed.


DOES THE COVID-19 VACCINE CONTAIN THE LIVE VIRUS THAT CAUSES COVID-19?

No, the recently authorized COVID-19 vaccines and the COVID-19 vaccines currently in development do not contain the live virus that causes COVID-19. As mentioned, the COVID-19 vaccine is a type of medicine that will teach our body to build the mechanisms needed to recognize and fight the virus if we become exposed.


WHAT ARE THE CURRENT COVID-19 VACCINES AVAILABLE?

There are two COVID-19 vaccines that have received authorization for use by the US Federal Food and Drug Administration (FDA). They are:

  • The Pfizer-BioNTech COVID-19 vaccine, approved on December 11, 2020.

  • The Moderna COVID-19 vaccine, approved on December 18, 2020.

ARE THERE OTHER VACCINES ON THE WAY?

Yes, as of December 28, 2020, large-scale clinical trials are planned or underway for three COVID-19 vaccines in the United States:

  • AstraZeneca’s COVID-19 vaccine

  • Janssen’s COVID-19 vaccine

  • Novavax’s COVID-19 vaccine

WHY ARE THERE SO MANY COVID-19 VACCINES IN DEVELOPMENT?

There are seven billion people in the world and COVID-19 has impacted every country on every continent. This means we need to have multiple vaccines to have COVID-19 under control. Also, given the diversity of our communities, having multiple vaccines is a good approach to increase our chances of finding more than one vaccine that is safe and that works for everyone.


HOW OFTEN WILL I NEED TO GET VACCINATED AGAINST COVID-19?

Currently, we do not know how long protection from a given vaccine will last. The virus is changing or mutating, which may make re-vaccination necessary. Also, each COVID-19 vaccine will have its own unique schedule depending on how long protection or immunity will last. Public health experts are keeping a close eye on the virus to learn more about how long the COVID-19 vaccine will protect us once we get vaccinated.


WHO WILL GET THE COVID-19 VACCINES FIRST?

The COVID-19 vaccine is currently available for:

  • Health care personnel

  • Residents of long-term facilities

As of December 22, 2020, the priority groups recommended to receive the COVID-19 vaccine next are:

  • Essential workers like fire fighters, police officers, correction officers, food and agricultural workers, USPS workers, grocery store workers, and teachers

  • People aged 75 years and older

Next on the list are:

  • People aged 65-74 years due to their higher risk of hospitalization

  • People aged 16-64 years with underlying medical conditions

  • Essential workers who work in transportation, food service, housing construction, information technology, public safety, and public health.

Although the CDC provides recommendations on who should get the COVID-19 vaccine next, states ultimately have the final say. Search for your local health department in your area here.


WHEN CAN MOST AMERICANS GET VACCINATED AGAINST COVID-19?

Each state determines who, when, and where in terms of vaccine distribution. As vaccine availability increases, vaccination recommendations will expand to include more people. Ask your local health department for up-to-date information. Search for your local health department in your area here.


WILL THE VACCINE BE AVAILABLE REGARDLESS OF ABILITY TO PAY OR HEALTH COVERAGE?

Yes, the COVID-19 vaccine will be available at no cost to everyone in the United States whether you have insurance or not. However, vaccine providers will be able to charge an administrative fee which can be reimbursed by your public or private insurance or by a relief fund if you don’t have health coverage. This will vary by state, so it is important you ask your local health department or your local community health center.


WILL THE VACCINE BE AVAILABLE FOR THE UNDOCUMENTED COMMUNITY?

Yes, the COVID-19 vaccine is available for the undocumented community. Health providers should not discriminate against undocumented individuals from getting the COVID-19 vaccine. Some personal information might be requested, and the personal information requested will vary by site. Although fear is a reality for the undocumented community when giving out personal information, it is important to seek information from community allies. Speak with a local trusted source in your community on how you can get the COVID-19 vaccine in your state and what personal information will be needed from you.


WILL MY LOCAL PHARMACY OFFER THE COVID-19 VACCINES ONCE THEY ARE AVAILABLE TO THE PUBLIC?

State governments are working with retail pharmacies. This work is still in progress. We will provide more information as it becomes available.


WHO VERIFIES THE COVID-19 VACCINES ARE SAFE?

Both the FDA and the CDC ensure that the recently authorized COVID-19 vaccines and those underway are safe and effective for our community. The FDA carefully evaluates all the available information about the vaccine to determine its safety and how well it works. After the FDA authorizes a vaccine, the CDC then reviews the COVID-19 vaccine available information before giving recommendations for public use.


HOW DO I KNOW THE COVID-19 VACCINES ARE SAFE AND EFFECTIVE, GIVEN HOW QUICKLY THE VACCINES ARE BEING DEVELOPED?

The FDA ensures that all vaccines are as safe as possible, and because vaccines are given to millions of healthy people to prevent serious diseases, they’re held to very high safety standards. The COVID-19 vaccines undergo rigorous testing that includes vaccinating tens of thousands of people who participate in a study to generate the information needed for the FDA to determine safety and effectiveness. Even after the COVID-19 vaccines are approved, the FDA continues to monitor public safety.


WHAT ARE THE SIDE EFFECTS OF THE COVID-19 VACCINE?

Sometimes people might feel under the weather for 1-2 days after receiving the vaccine. This is totally normal. The most common side effects are very similar to the side effects seen with most vaccines, such as sore arms, fevers, and tiredness within 3 days after the vaccine. These side effects usually mean that the vaccine is working as it teaches your body to recognize and fight COVID-19. If you don’t have these side effects, that’s normal as well, the COVID-19 vaccine is still working.

Other common short-term side effects that should eventually go away include:

  • Injection site pain and redness

  • Fatigue

  • Muscle aches and pains

  • Joint pain

  • Headache

If you have questions about symptoms or any other side effects after you receive the COVID-19 vaccine, ask your health care provider.


HOW DOES MODERNA’S VACCINE COMPARE TO PFIZER’S?

Both vaccines use the messenger mRNA technology which will teach our body to fight a COVID-19 infection in two ways. First, by stopping the virus, and second, by attacking the virus. Both the Pfizer and Moderna vaccines offer excellent protection against COVID-19. The Pfizer is authorized by the FDA for people aged 16 and older. Moderna’s is for people 18 years and older. Both the Moderna and the Pfizer/BioNTech vaccines require two vaccine doses. The interval between Moderna doses is 28 days, and the interval for the Pfizer vaccine is 21 days. Additionally, Moderna’s vaccine has logistical advantages including that it can be stored in most regular freezers, which makes it easier to distribute.


CAN I CHOOSE WHICH COVID-19 VACCINE TO GET?

Vaccine availability may be limited, and it might be difficult to choose which vaccine to get. Once we have access to a COVID-19 vaccine, it is important we get the vaccine that is available to us.


CAN I TAKE THE PFIZER DOSE AND THEN LATER THE MODERNA OR OTHER IN THE SECOND ROUND?

No, the current recommendation is to take two doses of the same vaccine. Stick with one vaccine from one provider and remember or save the name of the COVID-19 vaccine you receive for when you get the second dose. Ask your health care provider who is administering the vaccine to give you a record.


IS IT WORTH GETTING THE COVID-19 VACCINE IF WE WERE ALREADY COVID-19 POSITIVE?

Yes. You should still get the vaccine even if you already got COVID-19 before. This is because we do not know how long natural immunity lasts. Some studies suggest that it is possible to get COVID-19 twice. The recommendation is to wait at least four weeks after full recovery from COVID-19 infection to get the COVID-19 vaccine.


DOES THE COVID-19 VACCINE HAVE ANY CONTRAINDICATIONS IF I AM TAKING OTHER MEDICATIONS?

Always seek the advice of your health care provider with any questions you may have regarding a medical condition and if you have any medical contraindications to either COVID-19 vaccine.


ARE THE CURRENT COVID-19 VACCINES APPROVED FOR CHILDREN?

No. Moderna nor the Pfizer COVID-19 vaccine are approved for children younger than 16. We still don’t know when the COVID-19 vaccine will be approved for children, but we do know that Pfizer and Moderna is testing its vaccine in 12 to 17-year olds in clinical trials.


WHAT IF I AM PREGNANT OR BREAST-FEEDING, IS IT SAFE FOR ME TO GET THE COVID-19 VACCINE?

Additional tests are now underway to further determine the safety and effectiveness of the vaccine in pregnant individuals. It is best for pregnant and breast-feeding women to seek the advice of their health care providers about receiving the COVID-19 vaccine.


WILL I HAVE TO GET THE COVID-19 VACCINE EVERY YEAR?

We do not know the answer at this time. Since COVID-19 hasn’t been around for a long time, we don’t know how long the vaccine will protect us from getting sick with COVID-19. However, medical professionals and public health experts are committed to learning this information and we will share as soon as it's known.


WILL I HAVE TO FOLLOW OTHER PREVENTION MEASURES AFTER I RECEIVE THE COVID-19 VACCINE?

Yes, after receiving the COVID-19 vaccine, we should continue to wear masks, practice physical distancing, and wash hands with soap and water for at least 20 seconds. These are some of the steps we can continue to follow to slow the spread of the virus in our community after we have been vaccinated. This is especially important to protect family members and friends who are waiting to get vaccinated. Keep in mind that one tool alone is not going to stop the COVID-19 pandemic. We will need a combination of different tools to stop COVID-19 transmission.


WILL I HAVE TO FOLLOW OTHER PREVENTION MEASURES AFTER I RECEIVE THE COVID-19 VACCINE?

Yes, after receiving the COVID-19 vaccine, we should continue to wear masks, practice physical distancing, and wash hands with soap and water for at least 20 seconds. These are some of the steps we can continue to follow to slow the spread of the virus in our community after we have been vaccinated. This is especially important to protect family members and friends who are waiting to get vaccinated. Keep in mind that one tool alone is not going to stop the COVID-19 pandemic. We will need a combination of different tools to stop COVID-19 transmission.


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.

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.


Special thanks to UNIDOSUS


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Posted by Latino Lubbock Magazine Digital Media Read the Digital Issue of Latino Lubbock Magazine online at https://www.latinolubbock.net/magazine-preview Please visit www.latinolubbock.net for a centralized list of COVID-19 resources. For advertising call (806)792-1212

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