A: There are over 7 billion people in the world. COVID-19 is affecting everyone, and vaccines are needed to end the pandemic. Now that we have vaccines that have proven to be very effective at preventing severe COVID-19 disease, why do we need to continue COVID-19 vaccine research?
There are three main reasons:
A: No. That type of study design is known as a challenge study. Instead, we are using a design known as “randomized, blinded, placebo-controlled” studies. We will enroll people who are more likely to be exposed to the virus and develop COVID-19 illness. Some participants will get the vaccine, and some will get a placebo, which is a sterile saline solution that does not have any vaccine in it. We expect that some people will be exposed to the virus in their everyday lives, and may become sick. We will compare the 2 groups to see if there are fewer people who get sick in the vaccine group than in the placebo group. This is how we will know if the vaccine works.
A: Unlike guinea pigs, people can say yes or no about joining a study. All study volunteers must go through a process called informed consent that ensures they understand all of the risks and benefits of being in a study, and those volunteers are reminded that they may leave a study at any time without losing any of their rights or benefits. The COVID-19 Prevention Network (CoVPN) takes great care to make sure people understand the study fully before they decide whether or not to join. All CoVPN studies follow US federal regulations on research, as well as international ethical standards and any country-specific requirements for the countries where our research is conducted.
A: In order to find a vaccine or antibody that works in all kinds of people, it is necessary to test them in all kinds of people. This is especially true for groups of people that have been hardest hit by the COVID-19 pandemic. Protecting the well-being of study volunteers is the greatest responsibility in every study, and the CoVPN works to make sure that our studies follow the highest ethical standards. These studies are done in collaboration with local scientists and researchers and community representatives with oversight by ethics and regulatory groups in each country. Many studies are done in sub-Saharan Africa, Europe, North America, and South America at the same time and we follow the same procedures and international standards no matter where the study takes place.
A: No, there is no way to guarantee whether you will get the vaccine or the placebo. All the studies will be blinded, which means that neither you nor the clinic staff will know who is getting which product. When someone decides to enroll, it will be a computer who makes a random assignment to the study product group or the placebo group, and only the pharmacist will know which product you get. These steps are necessary to ensure that no assumptions are made, and any immune responses or side effects are dealt with equitably, without favoritism.
A: Yes. All study participants are encouraged to get an approved vaccine if one is available to them. You are asked to talk to the study staff so that they can follow the process to tell you if you got the vaccine or placebo, and if there are any safety or timing considerations for you to follow. Being in the study is not a barrier to getting an approved vaccine.
A: If the vaccine is found to be effective and is granted Emergency Use Authorization (EUA) by the FDA, it will be made available to the people in the placebo group of the study. This is described in more detail in each study’s informed consent form.
A: The trials are enrolling people with a variety of health conditions, because we know that having underlying health conditions is one of the factors that puts people at risk for more severe COVID-19 illness. Each study is different. If you complete the survey to join our Volunteer Screening Registry, a local study team would be able to follow up if they feel you are a good match to a study they have available. Once they reach out to you, you can have a detailed conversation to discuss your concerns and health conditions.
A: We have clinics all over the U.S., but we’re not able to provide a list of specific locations at this time, in part because site selection is still being finalized for each study. Different clinics will be running each of the different studies that are coming up in the next several months. Some trials will also be done internationally. Additional sites are often added to a study to follow where COVID-19 outbreaks are happening or to better serve priority populations, and some sites may close early if they have enrolled their allotted number of participants. The list of clinics that are participating can change frequently.
If you complete the survey on our website, your information will go into our Volunteer Screening Registry. This will enable a local clinic near you to follow-up with you if they feel you would be a good match for a study they have available. This contact could happen soon, or it may be in several months, as there are several studies taking place over the next 6 months. If you do not get contacted, it could mean that there is no participating clinic near you, or that you are not a good match to the eligibility criteria of the study the clinic has available.
A: Yes, people who join a study get compensated for their time and inconvenience. The amount per visit varies depending on how long the visit is and the procedures that take place. The amount also varies from city to city, because the cost of living is different between large metropolitan areas compared to smaller towns and rural areas. The details about compensation will be explained when a person goes through the informed consent process at a local clinic to join a study.
A: When you complete the submission of your survey, you will see a message with the heading “Success!” which means that we have successfully received your information. Our system does not send out an email confirmation message. Your information will be provided to a study site closest to your location. If the study site thinks you may qualify for a particular study, they will reach out to you as soon as possible about participating. We will never ask for your financial, credit, or bank account information. We will never ask for an ID number over the phone.
A: There are many clinical trials evaluating therapies and vaccine candidates against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), as well as studies of people who have recovered from infection. To find out more about those clinical trials, please visit NIAID’s Volunteer for COVID-19 Clinical Trials page or combatcovid.hhs.gov.
A: It is true that vaccines often have side effects, but those are typically temporary (like a sore arm, low fever, muscle aches and pains) and go away after a day or two. Many studies have proven that there is no link between vaccines and autism.
Visit the Centers for Disease Control and Prevention for more answers to questions about Vaccine Safety such as:
A: It is true that the search for vaccines and monoclonal antibodies against COVID-19 has been happening very quickly, but we’re not cutting any corners or skipping any steps. Read COVID-19 Vaccines: How Did We Get Them So Fast? to learn more.
A: Usually, the 2nd dose of an mRNA vaccine will cause more noticeable side effects, but everyone’s experience is different.3
A: Rest, and in some cases, over-the-counter medication (examples: acetaminophen, ibuprofen) might help if you have a fever or aches and pains. These medicines should not be used before getting a vaccine, only afterward to treat side effects.3
A: The risk of allergic reaction is extremely low. Talk to your doctor if you have a history of allergic reactions or anaphylaxis before getting a COVID-19 vaccine.
There are guidelines in place that may require you to be observed for more than 15 minutes after vaccination in the event of a reaction so that it can be immediately treated.7
A: No, it is not possible for the mRNA vaccines to impact a person’s DNA in any way. mRNA is a piece of genetic code that tells the muscle cells to make the spike protein from SARS-CoV-2 and display it for the immune system to see. You can think of this like a recipe for making food, which has the step by step directions. The vaccine doesn’t have any real ingredients that could cause infection, just the instructions. The vaccine goes to work in the outer part of muscle cells, and does not cross into the nucleus, where people’s DNA is located. You may also know that the mRNA vaccines need to be stored at very cold temperatures to keep them stable. This is because when they heat up, the mRNA starts to fall apart. Once the vaccine is given to a person, it starts to heat up in the body, and it dissolves within 1-3 days.
A: Yes. People who want to get pregnant in the future may receive the COVID-19 vaccine.
Based on current knowledge, experts believe that COVID-19 vaccines are unlikely to pose a risk to a person trying to become pregnant in the short or long term. Scientists study every vaccine carefully for side effects immediately and for years afterward, and people who get vaccinated track their symptoms. The COVID-19 vaccines are being studied carefully now, and the side effects data will continue to be studied for many years, similar to other vaccines.
There is currently no evidence that antibodies formed from COVID-19 vaccination cause any problems with pregnancy. In addition, there is no evidence suggesting that fertility problems are a side effect of ANY vaccine. People who are trying to become pregnant now or who plan to try in the future may receive the COVID-19 vaccine when it becomes available to them. 2
A novel coronavirus is a new coronavirus that has not been previously identified in people. Coronavirus disease 2019 (COVID-19) is caused by the new virus called severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). This is not the same as the coronaviruses that commonly circulate among humans and cause mild illness, like the common cold.
A: COVID-19 can affect anyone, regardless of their race or ethnicity. However, data show that it is disproportionately impacting Black/African American, Latinx, and American Indian/Alaska Native/Native Hawaiian populations. This is largely due to social and structural factors that impact some communities more than others. These factors include poverty, poor housing conditions, challenges with accessing medical care, and limited resources, among others.
A: No. Antibiotics help stop bacterial infections and are not effective against viruses such as SARS-CoV-2.1
A: No. Some people who do get SARS-CoV-2, the virus that causes COVID-19, experience flu-like symptoms. COVID-19 currently has a higher death rate than the flu and appears to be more contagious than the flu.2 We do not know yet whether COVID-19 will change with the seasons like influenza. In the US, the CDC recommends that everyone aged 6 months and over receive an influenza vaccine every year.
A: Yes. Scientists have found that people who have SARS-CoV-2 and have no symptoms (i.e., asymptomatic) can still pass along SARS-CoV-2 to others.2 In fact, people infected with SARS-CoV-2 seem to be most infectious before they even show signs and symptoms.
A: Depending on your age, health history, and how long you have had COVID-19 symptoms, you may qualify for treatment with a monoclonal antibody. Treatment with a monoclonal antibody can reduce the amount of the SARS-CoV-2 in the body. Having a lower amount of virus in the body means you may have milder COVID-19 symptoms and decrease the likelihood of being hospitalized or dying.
Monoclonal antibody treatment may help people who:
Currently, the following monoclonal antibodies have been authorized for emergency treatment use by the FDA for people who are 12 years or older, who weigh at least 88 pounds, and are at high risk for severe COVID-19:
Monoclonal antibody treatments for COVID-19 may only be administered by licensed medical providers. Please speak with your medical provider or contact your local or state public health department for more information.
Other drugs that may be given to people who are hospitalized with COVID-19 include:
A: Face masks can reduce your chances of getting SARS-CoV-2, but the primary purpose of face masks is to protect others from you in case you are infected, especially if you are not showing symptoms. It is recommended that the public wear well-fitting multi-layer cloth masks, including homemade masks, to help prevent transmitting the virus to other people. You may also want to consider wearing 2 masks, which can offer additional protection if your mask is a little loose and doesn’t fit snugly around your nose and mouth. 4
A: SARS-CoV-2 can be transmitted in all areas, including hot/humid and cold climates.1
A: While gargling with warm saltwater can make a sore throat feel better, it has no effect on SARS-CoV-2.5
A: There are simple things you can do to help keep yourself and others healthy. Wash your hands often with soap and water for at least 20 seconds, especially after blowing your nose, coughing, sneezing, going to the bathroom, and before eating or preparing food. When in public, wear a well-fitting multi-layer cloth face mask that covers your mouth and nose. You may also want to consider wearing 2 masks, which can offer additional protection if your mask is a little loose and doesn’t fit snugly around your nose and mouth. Avoid touching your eyes, nose, and mouth with unwashed hands. Stay home when you are sick. Cover your cough or sneeze with a tissue, then throw the tissue in the trash.2 Stay 6 feet apart from other people when you are out in public.
A: No. You can help stop COVID-19 by knowing the signs and symptoms, which can include:
Seek medical attention immediately if you or someone you have been exposed to has emergency warning signs, including:
This list of symptoms is NOT all inclusive and is being updated as new information becomes available. Please consult your medical provider for any other symptoms that are severe or concerning.2
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