- Will I get sick from the vaccine? No. Vaccines do not cause disease. However, vaccines can cause your immune system to respond. This is a sign that the vaccine—and your body’s immune system—is working. Based on information released about the Pfizer and Moderna vaccines, we expect people to have symptoms after vaccination. People may feel some soreness at the site of injection, some aches, and fatigue. These symptoms may be more noticeable than those that occur with a flu vaccine. This is completely normal and will clear up in a few days.
- What is an mRNA vaccine? An mRNA vaccine is a vaccine that uses messenger ribonucleic acid (mRNA) to build a protein that will trigger an immune response. These vaccines give our cells instructions to make a harmless part of the COVID-19 virus—specifically, a protein on the virus’s surface. Once our cells receive these instructions, the mRNA breaks down and our cells get rid of it. Also, because the mRNA never enters the cell’s nucleus, mRNA is unable to interact with DNA in any way. Our cells recognize the newly created protein as foreign. This triggers an immune response. In the process, our cells are learning how to protect against COVID-19 infection and provide immunity.
- Can I get vaccinated if I have allergies? People with a history of severe allergic reaction (e.g., anaphylaxis) to other vaccines (i.e., not Pfizer-BioNTech vaccine) or to an injectable medication should assess their risks with a primary care provider. However, they can be vaccinated. Often, after vaccination, people are asked to wait for 15 minutes to be observed for potential side effects. People with a history of severe allergic reactions should be prepared for a 30-minute observation period. Individuals with a history of other allergies (e.g., to food, pets, insects, environmental allergies) or a family history of anaphylaxis should be vaccinated. People with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the Pfizer-BioNTech or Moderna COVID-19 vaccines should not be vaccinated.
- What is “herd immunity” and how does the COVID-19 vaccine contribute to herd immunity? Herd immunity is a term used to describe when enough people have immunity—either from previous infection or vaccination—that it is unlikely a virus or bacteria can spread and cause disease. As a result, everyone within the community is protected even if some people don’t have any immunity themselves. The percentage of people who need to have protective immunity in order to achieve herd immunity varies by disease and is currently unknown for COVID-19. Continuing to follow COVID-19 precautions, like wearing your mask and watching your distance, even after being vaccinated, is your best chance for protecting your household.
- How do vaccines get approved? Vaccines go through three phases of clinical trial. Each phase tests for safety and effectiveness across an increasing number of test volunteers. • In phase 1, potential vaccines are tested by approximately 20 to 100 people. • In phase 2, the potential vaccines are tested by several hundred volunteers. • In phase 3, vaccines are tested by thousands of volunteers. The US Food and Drug Administration (FDA) will only approve a vaccine if it is safe, effective, and if its benefits outweigh its risks.
- Will the vaccine be safe? Safety is a top priority. COVID-19 vaccines have been tested in large clinical trials with people of different ages, races, and ethnicities to make sure they are safe. No steps involving safety have been skipped— COVID-19 vaccines are being held to the same standards as other vaccines to make sure they are safe. To ensure safety of vaccines in the United States, there is a rigorous vaccine development and approval process. Following approval of a vaccine, there are several systems in place to continue to ensure safety. Please see the answer above describing how vaccine safety is determined in the approval process.
- What steps are taken to ensure safety after a vaccine is approved? After a vaccine is approved and distributed, vaccine monitoring systems are used to watch for possible side effects. If an unexpected side effect is seen, experts study it to determine whether changes are needed in vaccine recommendations. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program of the FDA and the CDC. VAERS collects and analyzes information from reports of adverse events (e.g., side effects) that occur after a vaccine has been approved and distributed. Anyone can submit a report to VAERS by going to this link: https://vaers.hhs.gov/reportevent.html. Vaccine Adverse Event Reporting Systems exist for the Department of Defense, the Department of Affairs, and the Indian Health Service. There are several programs and initiatives, in addition to VAERS, that monitor vaccine safety. These include: CDC’s Vaccine Safety Datalink and Clinical Immunization Safety Assessment Project, and FDA’s Biologics Effectiveness and Safety System and Sentinel Initiative. More information about these different systems is available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html.
- What is v-safe? V-safe is a smartphone-based tool—developed by the CDC—that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. Through v-safe, you can quickly tell CDC if you have any side effects after getting the COVID-19 vaccine. Depending on your answers, someone from CDC may call to check on you and get more information. And v-safe will remind you to get your second COVID-19 vaccine dose if you need one. Your participation in CDC’s v–safe makes a difference—it helps keep COVID-19 vaccines safe. For more on v-safe, visit CDC’s site.
- What is an Emergency Use Authorization? Emergency Use Authorization (EUA) is an authority that allows the FDA to make certain medical products (e.g., vaccines, treatments) available during public health emergencies. It also can allow the use of medical products that have been approved, but for use in a different way than originally intended. An EUA lasts for the length of an emergency. A regular FDA approval lasts forever, unless a safety or efficacy issue comes up that needs further review. The FDA has authorized COVID-19 vaccines made by Pfizer and Moderna for emergency use.
- What criteria are necessary to issue an EUA? To issue an EUA, at minimum, the known and potential benefits of a drug, device, or test must outweigh the risks. In addition, the drug, device, or test must meet certain thresholds for safety and effectiveness, and people must be in urgent need of care.
- How do we know that drugs, devices, or tests that have received EUAs are safe? The FDA released guidance for vaccine manufacturers considering requests for an EUA. This guidance explains the criteria that need to be met before any vaccine for COVID-19 will receive an EUA. To meet criteria, manufacturers will use data from a Phase III clinical trial. The vaccine’s potential and known benefits must outweigh the potential and known risks. In addition, the vaccine must be at least 50% effective and must meet certain safety standards among a sufficiently large group of volunteers. The FDA will also consult with an independent advisory committee before issuing an EUA for a COVID-19 vaccine. Granting an EUA does not mean that vaccine clinical trials will stop. Data can continue to be collected through trials even if an EUA is granted. For more on EUAs, visit: Emergency Use Authorization and FAQs on Emergency Use Authorizations (EUAs) for Devices – COVID-19.
- What happens after the FDA authorizes (through an EUA) or approves a vaccine? After the FDA authorizes or approves a vaccine, there are more steps to ensure safety. The CDC’s Advisory Committee on Immunization Practices (ACIP) will hold a public meeting and will review all available information from clinical trials. This includes the descriptions of who received each vaccine, how different groups of people responded to the vaccines, and any side effects experienced. The ACIP then votes on whether to recommend the vaccine and who should receive the vaccine.
- Is the COVID-19 vaccine development and approval process different from a typical vaccine development and approval process? The COVID-19 vaccines are being held to the same standards as other vaccines to make sure they are safe. No steps involving safety have been skipped. There are some differences in other processes that may make the COVID-19 vaccine available much faster than a typical vaccine. Importantly, there has been much collaboration across the scientific community to develop a vaccine. This is a global pandemic. As a result, a lot of time and resources from across the globe have gone into developing several COVID-19 vaccines. Further, researchers had a head start on vaccine development because of research already done on similar coronaviruses. This includes the viruses that caused Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Also, the government began producing doses of certain COVID19 vaccines when they reached phase 3 trials. This way, when these vaccines were determined to be safe and effective, people could get them immediately.
- How many COVID-19 vaccines are in trial? There are many vaccines in various trial phases. However, not all of them will be approved or authorized for emergency use. These vaccines may be received at different times, depending on when they are approved.
- How do we know who was included in trials? Was there enough testing done among people like me? The COVID-19 vaccines that have been authorized were tested in large clinical trials with people of different ages, races, and ethnicities. Information about vaccine trial participants is being released by researchers. Based on recent press releases, we know that the phase 3 trial of the Moderna vaccine includes 30,000 participants ages 18 and older. Nearly half (42%) of the study participants belong to high-risk groups. This means that they are older than 65 or have chronic conditions like diabetes, severe obesity, and cardiac disease. More than one third (37%) of study participants belong to communities of color.
- Is there a blood test to show that I am immune after vaccination? Current blood tests, or serology tests, cannot measure whether a person is immune to COVID-19 from vaccination or from natural disease. Such tests are in development but are not yet available. Therefore, a positive serology test does not necessarily mean that you are protected.
- Do I still need to wear a mask? Studies of the COVID-19 vaccines have only measured whether vaccinated people developed symptoms, not whether they got infected. You can become infected with the coronavirus and be asymptomatic. Asymptomatic people can still spread COVID-19 to others. We don’t know whether a vaccine prevents asymptomatic infections and if there’s still the possibility that a vaccinated person could transmit the virus without knowing it. It is therefore important to continue wearing your mask after being vaccinated and until we have more information about how much and how long these vaccines offer protection against infection and transmission.
- Do I still need to social distance from others and follow social gathering limits? Yes, for the time being, until we have more research, we still need to remain 6 feet apart when not with people in our household.
- Do I need to quarantine if I have been fully vaccinated and am later identified as a close contact of someone who has tested positive for COVID-19? The exact degree and duration of immunity after receiving an mRNA vaccine is currently unknown. There is no lab test to determine if you are immune and protected. Therefore, if you have received both doses of the vaccine and should you have an exposure to a case of COVID-19, you are expected to continue to follow the current quarantine requirements.
- Do I need to isolate if I test positive on a respiratory specimen (nasal swab) after I am vaccinated? The COVID-19 vaccine does not in any way interfere with PCR or rapid testing from a respiratory specimen. If you test positive for COVID-19, you are infectious and you must isolate whether or not you have received a vaccine. Should this happen, seek guidance from your primary care provider.
- Can I begin to travel without having to quarantine upon arrival to a destination? Vaccinated persons should continue to follow all current guidance to protect themselves and others, including following CDC travel guidance. International Travelers: Not all countries have started vaccinating their populations, so continue to follow COVID-19 guidelines such as mask wearing and social distancing when you travel. Different governments across the world are likely to have different protocols for travelers to prove their vaccination status and to test and/or quarantine if they been not been vaccinated, so check the guidelines of the country you plan to visit before traveling. Domestic Travelers: Quarantine restrictions and rules will continue to vary depending on which state you are traveling to. To learn more about the current restrictions that are in place, check with the health department of the state you are traveling to.
- Is there a cost or co-pay to get vaccinated? According to the CDC, at this time, it is expected that the COVID-19 vaccine will be free to everyone. Those who administer vaccines may charge insurance companies, but not the person being vaccinated, a fee for providing a shot to someone. There will be no cost or co-pay for anyone getting vaccinated for COVID-19. In addition, people without health insurance will be able to get the COVID-19 vaccine at no cost.
- Will there be multiple doses of the vaccine? This depends on which vaccines are authorized for use. Both the Pfizer and Moderna vaccines—the first vaccines to request emergency use authorization—require two doses. The Pfizer vaccine requires a second dose 21 days after the first dose and the Moderna vaccine requires a second dose 28 days after the first dose.
- How will I know when to get a second dose? We are looking into several different methods to help people remember which vaccines they received and to notify people when they need to get their second dose. Those who receive the vaccine will also receive a vaccination card that states when they received the vaccine and which vaccine they received. It’s a good idea to take a picture of this card with your phone so that you can keep your own record. You will learn more about how to get a second dose when you receive your first dose of vaccine.
- Can I receive the COVID-19 vaccine if I am pregnant or breastfeeding? Pregnant and breastfeeding women in high-risk groups should be offered the vaccine, with the opportunity to discuss with their healthcare providers. Note: Routine testing for pregnancy prior to receiving COVID-19 vaccine is not recommended.
- Should I get the COVID-19 vaccine if I already had COVID-19? Yes, you should still receive the vaccine. A previous COVID-19 positive diagnosis does not necessarily mean you have long term immunity and it does not prevent you from receiving a vaccine or limit the vaccine’s ability to work effectively. If you’ve tested positive for COVID-19, you must wait until you have completed your isolation period and are considered recovered. There is no recommended minimum interval between infection and vaccination, but reinfection is uncommon in the 90 days after infection with COVID-19. Thus, you may choose to delay vaccination until the end of that period, if desired.
- Should I get the COVID-19 vaccine if I received monoclonal antibody treatment? The CDC advises waiting 90 days after monoclonal antibody or convalescent plasma treatment before receiving COVID-19 vaccine.
- Should I get the COVID-19 vaccine if I just received a different vaccine (e.g., Shingrix)? People who have received any other vaccine within the past 14 days should wait until 14 days have passed to receive the COVID-19 vaccine.
- What can we do while we wait for a vaccine? There are prevention measures that we know work. While waiting for a vaccine, please continue to wear a mask, wash your hands, watch your distance, and stay home if you’re feeling sick or if you have symptoms of COVID-19. It is important to continue these practices even after you receive the vaccine. We are still learning about how effective the vaccines are and for how long they are effective.
- Where can I learn more? For answers to additional frequently asked questions about COVID-19 vaccine, visit: Frequently Asked Questions about COVID-19 Vaccination-
COVID Allergy FAQ
Posted on by Albany ENT & Allergy Services