1. What is the FDA doing to respond to the COVID-19 pandemic?
The FDA, along with other federal, state, and local agencies and public health officials across the country and internationally, plays a critical role in protecting public health during the COVID-19 pandemic. FDA staff are working around the clock to support development of medical countermeasures and are providing regulatory advice, guidance, and technical assistance to advance the development and availability of vaccines, therapies, diagnostic tests and other medical devices for use diagnosing, treating, and preventing this novel virus. The FDA continues to monitor the human and animal food supply and take swift action on fraudulent COVID-19 products.
2. How can I prevent COVID-19?
The best way to prevent illness is to avoid being exposed to the virus. The CDC recommends everyday preventive actions to help prevent the spread of respiratory diseases. They include:
- Wash your hands often with plain soap and water. The CDC recommends washing your hands often with soap and water for at least 20 seconds, especially after you have been in a public place, or after blowing your nose, coughing, or sneezing. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol. Learn more about safely using hand sanitizer.
- Cover your mouth and nose with a cloth face covering or non-surgical mask when around others. Find more information about how to select, wear, and clean your mask.
- Get the COVID-19 vaccine when it is offered to you. Once you are fully vaccinated, you may be able to start doing some things that you had stopped doing because of the pandemic.
- Follow CDC guidance on large gatherings, social distancing and mask wearing, based on if you are fully vaccinated or not.
3. Should I wear a face covering or mask when I go out in public?
The CDC recommends wearing masks in public when other social distancing measures are difficult to maintain. Effective February 2, 2021, masks are required on planes, buses, trains, and other forms of public transportation traveling into, within, or out of the United States and in U.S. transportation hubs such as airports and stations. Read more about the CDC’s Mask Requirement.
The FDA has authorized the emergency use of face masks, including cloth face coverings, that meet certain criteria for use as source control by the general public and health care personnel in accordance with CDC recommendations during the COVID-19 public health emergency. The FDA also regulates other medical devices, including personal protective equipment (PPE) such as surgical masks and N95 respirators.
4. Is hand sanitizer effective against COVID-19?
The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the CDC. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.
5. Am I at risk for serious complications from COVID-19 if I smoke cigarettes?
Yes. Data shows that when compared to never smokers, cigarette smoking increases the risk of more severe illness from COVID-19, which could result in hospitalization, the need for intensive care, or even death. Smoking cigarettes can cause inflammation and cell damage throughout the body, and can weaken your immune system, making it less able to fight off disease.
There’s never been a better time to quit smoking. If you need resources to help you quit smoking, the FDA’s Every Try Counts campaign has supportive tips and tools to help you get closer to quitting for good.
6. If I vape tobacco or nicotine am I at risk for complications from COVID-19?
E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of COVID-19 or the severity of COVID-19 outcomes is not known. However, many e-cigarette users are current or former smokers, and cigarette smoking increases the risk of respiratory infections, including pneumonia.
7. How long does it take to approve COVID-19 vaccines?
On August 23, 2021, the FDA approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty (koe-mir’-na-tee), for the prevention of the disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for children 5 through 15 years of age, and for the administration of a third dose in certain immunocompromised individuals. More information on the approval can be found here.
Each review of a COVID-19 vaccine for approval is unique and the amount of time it takes may be different. Having safe and effective approved COVID-19 vaccines is a top priority for the FDA. The process involves incredible expertise and attention to detail, which is critical to ensuring that the FDA’s rigorous standards are met.
Our team is reviewing tremendous amounts of data. Vaccine applications have the equivalent of hundreds of thousands of pages of data and other information – more than what is submitted as part of an EUA. When a BLA comes in, we have to make sure there is accurate safety and effectiveness information and manufacturing data. We also conduct inspections and develop testing protocols to make sure that every lot of vaccine that is released meets rigorous quality standards.
We fully support the quality and rigor of our review process. We conduct our own analyses of the information in the BLA to make sure the vaccines are safe and effective and meet our standards for approval. We must be able to stand behind our decision once we approve these vaccines, so we and the public can feel confident that the vaccines they receive are safe and effective. Americans expect that of the agency.
8. Am I currently eligible for a COVID-19 vaccine booster does, and if so, which one?
Everyone ages 12 and older can get a booster shot. View or print eligibility chart.
Ages 12 to 17: The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for a single booster dose for people ages 12 to 17 at least five months after completion of primary vaccination. People ages 12 to 17 should receive only the Pfizer-BioNTech Vaccine or Comirnaty (COVID-19 Vaccine, mRNA) as their booster dose.
Ages 18 and older: If you are 18 or older and received the Pfizer-BioNTech COVID-19 Vaccine, Comirnaty (COVID-19 Vaccine, mRNA) or Moderna COVID-19 Vaccine for your primary vaccination series at least 5 months ago, then you may receive a single booster dose of any of the currently available COVID-19 vaccines. They are:
- Moderna COVID-19 Vaccine
- Pfizer-BioNTech COVID-19 Vaccine
- Comirnaty (COVID-19 Vaccine, mRNA)
- Janssen (J&J) COVID-19 Vaccine
If you are 18 or older and received the Janssen (J&J) COVID-19 Vaccine as your primary vaccination at least 2 months ago, then you may receive a booster dose of any of the currently available COVID-19 vaccines.
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for people ages 12 and older, when prepared according to their respective instructions for use, can be used interchangeably without any safety or effectiveness concerns.
9. Are there any vaccines or other medical products available to prevent COVID-19?
Yes. The FDA issued emergency use authorizations for three COVID-19 vaccines and on August 23, 2021, the FDA approved the first COVID-19 vaccine. More information on the approval can be found here.
Additionally, the FDA is working with other vaccine developers, researchers, and manufacturers to help expedite the development and availability of medical products such as additional vaccines, monoclonal antibodies, and other drugs to prevent or treat COVID-19.
For information about vaccine clinical trials for COVID-19 visit clinicaltrials.gov and the COVID-19 Prevention Network. Note: The information on clinicaltrials.gov is provided by the sponsor or principal investigator of a clinical trial. The listing of a study on the site does not reflect evaluation or endorsement of the trial by the Federal government.
10. How do I report COVID-19 vaccine side effects?
If you experience a severe allergic reaction or any life-threatening symptoms such as trouble breathing, call 911, or go to the nearest hospital.
Call the vaccination provider or your health care provider if you have any side effects that bother you or do not go away. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include the name of the vaccine in the first line of box #18 of the report form.
You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.
11. Are egg products used in COVID-19 vaccines?
The COVID-19 vaccines currently authorized or approved by the FDA are not manufactured using egg products or egg culture. See COVID-19 vaccines for more information.
12. Is it safe for me to donate blood during the coronavirus pandemic?
If you are healthy and interested in donating blood, the FDA encourages you to contact a local donation center to make an appointment. One way to make a difference during a public health emergency is to donate blood if you are able.
- AABB: www.aabb.org +1.301.907.6977
- America’s Blood Centers: www.americasblood.org
- American Red Cross: www.redcrossblood.org +1.800.RED CROSS (+1.800.733.2767)
- Armed Services Blood Program: www.militaryblood.dod.mil +1.703.681.8024
- Blood Centers of America: www.bca.coop
All information in the above article is sourced from the U.S. Food & Drug Administration. Information is current as of January 7th, 2022.
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