What is an emergency use authorization (EUA) and how is it used to respond to COVID-19?

In certain types of emergencies, the FDA can issue an EUA to provide more timely access to critical medical products that may help during the emergency when there are no adequate, approved, and available alternative options. The EUA process is different from full FDA approval, clearance or licensing because the EUA standard requires significantly less data than otherwise would be required for approval, clearance or licensing by the FDA. This enables the FDA to authorize the emergency use of medical products that meet the criteria for issuance within weeks rather than months to years. It must be determined that the vaccines are safe and effective in diminishing the severity of COVID-19 symptoms to gain an FDA emergency use authorization or full licensing.

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1. What is a COVID-19 vaccine?
2. What is Operation Warp Speed?
3. How do we know the COVID-19 vaccine is safe?
4. Is a COVID-19 vaccine necessary?
5. Why would I need a vaccine if I can do other things — like social distancing, washing my hands and wearing a mask — to prevent the virus that causes COVID-19 from spreading?
6. What is Maryland doing to help make sure people can get vaccinated against COVID-19?
7. Does Prince George’s County have a campaign to address any concerns people may have about getting the vaccine?
8. What is an emergency use authorization (EUA) and how is it used to respond to COVID-19?
9. What percentage of the community needs to get vaccinated to have herd immunity to COVID-19?
10. How many doses of a COVID-19 vaccine will be needed? Will a second booster dose be needed?
11. Will a COVID-19 vaccine need to be given annually?
12. How long will it take before a COVID-19 vaccine is able to prevent serious illness for the recipient?
13. Will there be enough vaccine for everyone?
14. How will vaccinations be distributed as part of Maryland’s phased vaccination plan?
15. Will I have to pay for COVID-19 vaccination?
16. If you had the virus and recovered will you still need to get the vaccine?
17. Does immunity after getting COVID-19 last longer than protection from COVID-19 vaccines?
18. If I get the vaccine, do I still have to wear a mask and practice social distancing?
19. Will an influenza (flu) vaccine protect me from COVID-19?
20. Why is it important to get the flu vaccine during the COVID-19 pandemic?
21. What can I do to help protect myself from getting COVID-19 until I can receive a vaccine?
22. What phase of the vaccination distribution is Prince George’s County currently in? When will I be able to get the vaccine and where do I go?
23. What is a COVID-19 variant, and will the vaccine protect me from it?
24. When will the County move into additional phases of the vaccination distribution plan, and how will I sign up or be notified that I am eligible?