The COVID-19 vaccines are one of the best tools available for ending the pandemic. Now that the vaccines coming to Fort Bend County, arming ourselves with accurate vaccine information is critical. Read the facts about the COVID-19 vaccines.
COVID Vaccine Facts
The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Safety is a top priority while federal partners work to make this and other COVID-19 vaccines available.
Safety of COVID-19 Vaccines
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUA) for two COVID-19 vaccines which have been shown to be safe and effective as determined by data from the manufacturers and findings from large clinical trials. These data demonstrate that the known and potential benefits of this vaccine outweigh the known and potential harms of becoming infected with the coronavirus disease 2019 (COVID 19).
Clinical trials are being conducted to evaluate additional COVID-19 vaccines in many thousands of study participants. These trials will generate scientific data and other information that will be used by FDA to determine vaccine safety and effectiveness. Clinical trials on all COVID-19 vaccine candidates are being conducted according to the rigorous standards set forth by FDA in their June 2020 guidance document, Development and Licensure of Vaccines to Prevent COVID-19 . If FDA determines that a vaccine meets its safety and effectiveness standards, it can make these vaccines available for use in the United States by approval or through an EUA.
After FDA determines that a COVID-19 vaccine candidate is safe and effective, the Advisory Committee on Immunization Practices (ACIP), a committee comprising medical and public health experts, reviews available data before making vaccine recommendations to CDC. Learn more about how CDC is making COVID-19 vaccine recommendations.
Vaccine Safety Monitoring
After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials. If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern. Experts then decide whether changes are needed in U.S. vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.
FDA’s June 2020 guidance document also includes important recommendations for ongoing safety evaluation after any COVID-19 vaccine is made available in the United States.
CDC has expanded safety surveillance through new systems and additional information sources, as well as by scaling up existing safety monitoring systems.
Expanded Safety Monitoring Systems
The following systems and information sources add an additional layer of safety monitoring, giving CDC and FDA the ability to evaluate COVID-19 vaccine safety in real time and make sure COVID-19 vaccines are as safe as possible:
- CDC: V-safe — A new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-safe uses text messaging and web surveys from CDC to check in with vaccine recipients following COVID-19 vaccination. V-safe also provides second vaccine dose reminders if needed, and telephone follow up to anyone who reports medically significant (important) adverse events.
- CDC: National Healthcare Safety Network (NHSN) — An acute and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System or VAERS that will allow for determination of COVID-19 vaccine adverse event reporting rates.
- FDA: Other large insurer/payer databases — A system of administrative and claims-based data for surveillance and research.
Existing Safety Monitoring Systems
As people get vaccinated, CDC, FDA, and other federal partners will use the following existing, robust systems and data sources to conduct ongoing safety monitoring:
- CDC and FDA: Vaccine Adverse Event Reporting System (VAERS) — The national system that collects reports from healthcare professionals, vaccine manufacturers, and the public of adverse events that happen after vaccination; reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies
- CDC: Vaccine Safety Datalink (VSD) — A network of nine integrated healthcare organizations across the United States that conducts active surveillance and research; the system is also used to help determine whether possible side effects identified using VAERS are actually related to vaccination
- CDC: Clinical Immunization Safety Assessment (CISA) Project — A collaboration between CDC and 7 medical research centers to provide expert consultation on individual cases and conduct clinical research studies about vaccine safety
- FDA and the Centers for Medicare and Medicaid Services: Medicare data — A claims-based system for active surveillance and research
- FDA: Biologics Effectiveness and Safety System (BEST) — A system of electronic health record, administrative, and claims-based data for active surveillance and research
- FDA: Sentinel Initiative — A system of electronic health record, administrative, and claims-based data for active surveillance and research
Members of the military
- Department of Defense (DOD): DOD VAERS data — Adverse event reporting to VAERS for the DOD populations
- DOD: Vaccine Adverse Event Clinical System (VAECS) — A system for case tracking and evaluation of adverse events following immunization in DOD and DOD-affiliated populations
- DOD: DOD Electronic Health Record and Defense Medical Surveillance System — A system of electronic health record and administrative data for active surveillance and research
- Department of Veterans Affairs (VA): VA Adverse Drug Event Reporting System (VA ADERS) — A national reporting system for adverse events following receipt of drugs and immunizations
- VA Electronic Health Record and Active Surveillance System — A system of electronic health record and administrative data for active surveillance and research
- Indian Health Service (IHS): IHS VAERS data — Spontaneous adverse event reporting to VAERS for populations served by IHS and Tribal facilities
Understanding How COVID-19 Vaccines Work
This web page explains how the body fights infection and how COVID-19 vaccines protect people by producing immunity. It also describes the different types of COVID-19 vaccines that currently are available or are undergoing large-scale (Phase 3) clinical trials in the United States.
Understanding COVID-19 mRNA Vaccines
This fact sheet provides information about mRNA vaccines generally and about COVID-19 vaccines that use this new technology specifically.
Authorized and Recommended Vaccines
As COVID-19 vaccines are authorized and then recommended for use in the United States, it will be important to understand what is known about each vaccine. CDC will provide information on who is and is not recommended to receive each vaccine and what to expect after vaccination, as well as ingredients, safety, and effectiveness.
Currently, two vaccines are authorized and recommended to prevent COVID-19:
Vaccines in Phase 3 Clinical Trials
As of November 24, 2020, large-scale (Phase 3) clinical trials are in progress or being planned for two COVID-19 vaccines in the United States:
- AstraZeneca’s COVID-19 vaccine
- Janssen’s COVID-19 vaccine
Learn more about U.S. COVID-19 vaccine clinical trials, including vaccines in earlier stages of development, by visiting clinicaltrials.gov.
CDC has learned of reports that some people have experienced severe allergic reactions—also known as anaphylaxis—after getting a COVID-19 vaccine. As an example, an allergic reaction is considered severe when a person needs to be treated with epinephrine or EpiPen© or if they must go to the hospital.
This page will be updated as quickly as possible when we get new information.
If you get a COVID-19 vaccine and you think you might be having a severe allergic reaction after leaving the vaccination site, seek immediate medical care by calling 911.
What CDC Recommends
If you have ever had a severe allergic reaction to any ingredient in a COVID-19 vaccine, CDC recommends that you should not get that specific vaccine. If you have had a severe allergic reaction to other vaccines or injectable therapies, you should ask your doctor if you should get a COVID-19 vaccine. Your doctor will help you decide if it is safe for you to get vaccinated.
CDC recommends that people with a history of severe allergic reactions not related to vaccines or injectable medications—such as allergies to food, pet, venom, environmental, or latex—may still get vaccinated. People with a history of allergies to oral medications or a family history of severe allergic reactions, or who might have an milder allergy to vaccines (no anaphylaxis)—may also still get vaccinated.
If you have a severe allergic reaction after getting the first shot, you should not get the second shot. Your doctor may refer you to a specialist in allergies and immunology to provide more care or advice.
Safeguards Are in Place
CDC has provided recommendations for COVID-19 vaccination providers about how to prepare for the possibility of a severe allergic reaction:
- All people who get a COVID-19 vaccine should be monitored on-site. People with a history of severe allergic reactions should be monitored for 30 minutes after getting the vaccine. All other people should be monitored for 15 minutes after getting the vaccine.
- Vaccination providers should have appropriate medications and equipment—such as epinephrine, antihistamines, stethoscopes, blood pressure cuffs, and timing devices to check your pulse—at all COVID-19 vaccination sites.
- If you experience a severe allergic reaction after getting a COVID-19 vaccine, vaccination providers should provide rapid care and call for emergency medical services. You should continue to be monitored in a medical facility for at least several hours.
Learn more about what to expect after getting vaccinated for COVID-19, including normal side effects and tips to reduce pain or discomfort.
CDC Is Monitoring Reports of Severe Allergic Reactions
If someone has a severe allergic reaction after getting vaccinated, their vaccination provider will send a report to the Vaccine Adverse Reporting System (VAERS). VAERS is the national system that collects reports from healthcare professionals, vaccine manufacturers, and the public about adverse events that happen after vaccination. Reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies.
Since November 2020, the United Kingdom (UK) has reported a rapid increase in COVID-19 cases in London and southeast England. This rapid increase in cases has been linked to a different version—or variant—of the virus that causes COVID-19 (SARS-CoV-2). Public health professionals in the UK are evaluating the characteristics of this new variant.
What we know
Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Sometimes new variants emerge and disappear. Other times, new variants emerge and start infecting people. Multiple variants of the virus that causes COVID-19 have been documented in the United States and globally during this pandemic.
The virus that causes COVID-19 is a type of coronavirus, a large family of viruses. Coronaviruses are named for the crown-like spikes on their surfaces. Scientists monitor changes in the virus, including changes to the spikes on the surface of the virus. These studies, including genetic analyses of the virus, are helping us understand how changes to the virus might affect how it spreads and what happens to people who are infected with it.
Recent reports indicate that about 6 in 10 cases reported in London are caused by the new variant. Genetic analysis of the new variant shows changes to the spikes on the virus and to other parts of the virus. Initial studies suggest that the new variant may spread more easily from person to person. So far, scientists in the UK see no evidence that infections by this variant cause more severe disease.
What we do not know
It is still very early in the identification of this variant, so we have a great deal to learn. More studies on the new variant are needed to understand
- How widely the new variant has spread in the UK and potentially around the world
- How the new variant differs from earlier variants
- How the disease caused by this variant differs from the disease caused by other variants that are currently circulating
What it means
Public health officials are quickly studying the new variant to learn more so that they can control its spread. They want to understand whether the new variant
- Spreads more easily from person to person
- Causes milder or more severe disease in people
- Is detected by currently available viral tests
- Responds to medicines currently being used to treat people for COVID-19
- Affects the effectiveness of COVID-19 vaccines. There is no evidence that this is occurring, and most experts believe this is unlikely to occur because of the nature of the virus.
Some countries have announced travel bans to and from the UK while scientists work to better understand the new variant.
What CDC is doing
CDC is monitoring the situation in the UK and communicating with the European Centre for Disease Prevention and Control. CDC and state and local health departments are continually monitoring and studying the virus spreading in the United States to quickly detect any changes. As new information becomes available, CDC will provide updates.