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1.
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What vaccines are available?
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Currently, multiple vaccine candidates are going through clinical trials (the scientific process by which a vaccine is tested for effectiveness and safety) and regulatory review. At this time, two vaccine candidates, produced by Moderna and Pfizer, are the first to receive Emergency Use Authorization (EUA) by the FDA. Both COVID-19 vaccines need two shots to be effective.
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2.
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Are the vaccines safe?
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The FDA approval process, even in an EUA situation, prioritizes health and safety.
Both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine should not be administered to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to previous vaccines, to any component of the vaccine, or to the first dose of this vaccine, without additional clinical evaluation (e.g., an allergist).
Immunocompromised people, including individuals receiving immunosuppressant therapy, may have a diminished immune response.
Adverse reactions reported in vaccine trials were mild and included: injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise (generally not feeling well), and lymphadenopathy (swollen lymph nodes).
There is a remote chance that the Moderna COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Moderna COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination.
In addition, individual TMC hospitals expect to deploy teams of researchers and physicians to review the data to ensure that the vaccine meets hospital safety standards.
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| 3. |
Will the vaccines be FDA-approved?
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Yes, eventually. Though several steps have been taken to streamline the process and reduce regulatory obstacles, the underlying full approval process remains the same. Currently, the FDA has granted “Emergency Use Authorization” (EUA) for the Pfizer and Moderna vaccines. EUA occurs if there’s evidence that strongly suggests patients have benefitted from a treatment or test and the treatment is safe, but not all regulatory steps have been completed. Other vaccines that are in the pipeline likely will also be granted EUA before receiving full approval.
The FDA, state health departments, drug producers, and independent physicians and researchers will monitor and track a wide variety of data once the vaccine is available to continue to learn about the drugs’ safety and effectiveness.
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| 4. |
Do COVID-19 vaccines give you COVID-19? |
No. None of the COVID-19 vaccines currently in development in the United States use the virus that causes COVID-19.
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| 5. |
When are vaccines likely to be available? |
Pfizer received the EUA on Dec. 11, and Moderna received EUA on Dec. 18. Vaccine supplies are becoming available in the Texas Medical Center.
Harris Health Lyndon B. Johnson Hospital and Memorial Hermann-Texas Medical Center received their first doses the week of Dec. 14-18. Some UTHealth front-line clinical staff were able to receive a vaccine through our hospital partners.
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| 6. |
What should you mention to your vaccine provider before you receive the COVID-19 vaccine?
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Tell your vaccination provider about all of your medical conditions, including if you:
- Have any allergies
- Have a fever
- Have a bleeding disorder or are on a blood thinner
- Are immunocompromised or are on a medicine that affects your immune system
- Are pregnant or plan to become pregnant
- Are breastfeeding
- Have received another COVID-19 vaccine
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| 7. |
Can I get a COVID-19 vaccine if I’m pregnant or nursing? |
When considering whether to receive the COVID-19 vaccine, the FDA recommends consulting with your primary care provider if you are pregnant or nursing.
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| 8. |
How long will my vaccine appointment take?
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Once a vaccination appointment is made, please be sure to show up on time for the appointment. Doses are specifically scheduled to avoid waste, and the vaccine must be used within a specific timeframe.
The CDC recommends an observation period after receiving the vaccine. For most people this will be 15 minutes after vaccine administration, and 30 minutes for people with a history of allergic reactions to vaccines.
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| 9. |
If I already had COVID-19 and recovered, do I still need to get vaccinated when the vaccine becomes available? |
The Centers for Disease Control and Prevention (CDC) recommends that, regardless of a past COVID-19 infection, you get vaccinated, unless you have had this infection within the previous 10 days. In those cases, you should defer vaccination until fully recovered.
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| 10. |
Can I get a vaccine if I participated in a vaccine clinical trial before? |
Before deciding whether to receive the vaccine, we recommend you discuss it with the investigator for your clinical trial.
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| 11. |
How were the vaccines made available so quickly? |
Due to the unprecedented need created by the COVID-19 pandemic, the FDA and manufacturers, supported by government investment, took the unusual step of creating manufacturing capacity and distribution systems before the drugs were fully approved. |
| 12. |
Who will get the first vaccines? |
Following the guidance of the FDA and the CDC’s Advisory Committee on Immunization Practices recommendations, the EUA authorizes administration of the vaccine to health care personnel and residents of long-term facilities (Phase 1a).
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| 13. |
Do I need to wear a mask when I receive a COVID-19 vaccine? |
CDC recommends that during the pandemic people continue to wear a mask that covers their nose and mouth, even if they have received the vaccine or have previously had COVID-19. People who have trouble breathing or who are unable to remove a mask without assistance should not wear a mask.
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| 14. |
If the first vaccines go to health care workers, when will the general population get the vaccines? |
This is difficult to answer at this time based on a number of factors: the production schedule for the vaccines, the need to vaccinate highly vulnerable populations (people with pre-existing conditions, congregate senior-care settings, individuals over age 65, etc.) and a distribution strategy for a drug that requires careful (cold) storage and two doses.
As of Dec. 22, the CDC has recommended starting Phase 1b and Phase 1c. Following the CDC and FDA guidelines, as vaccine availability increases, vaccination recommendations will expand to include more groups.
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| 15. |
Will vulnerable populations (elderly, immune compromised, overweight, etc.) be given priority? |
Yes, the FDA has authorized use in residents of long-term care facilities and nursing homes in Phase 1a.
As of Dec. 22, the CDC has recommended starting Phase 1b and Phase 1c.
- Phase 1b includes frontline essential workers, and people aged 75 years and older.
- Phase 1c includes people aged 65-74 years, people aged 16-64 years with underlying medical conditions, and other essential workers.
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| 16. |
Will children be able to receive
the vaccine? |
The FDA has authorized use of the Moderna vaccine in adults 18 and older. The Pfizer vaccine is approved for people aged 16 and older
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| 17. |
Will there be a choice in which vaccine a patient receives? |
No. |
| 18. |
Where will I be able to be vaccinated if I am not a front-line health care worker? |
UTHealth, which includes clinical practices UT Physicians and UT Health Services, received notification on Saturday evening, Jan. 16, that we have been named a COVID-19 Vaccine Hub in Harris County by the Texas Department of State Health Services.
We are waiting for more information and arrival of vaccine shipments from the state and will provide updates as available.
Thank you for your patience as we work to meet the needs of the community.
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| 19. |
Will the vaccine be required? |
Under an EUA, the vaccine cannot be mandated. Based on currently available data on safety and efficacy, the clinical community is encouraging all residents be vaccinated.
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| 20. |
How long will it likely take to vaccinate our whole community? |
This is difficult to answer at this time; the production schedule for the vaccines is not known and the distribution strategy nationally is still being developed. Another factor is the community's willingness or hesitancy to take the vaccine.
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| 21. |
What might be different about this vaccine from the flu vaccine? |
It is important to realize that this vaccine requires two doses. When vaccinated, follow your clinicians instructions on the second dose. In addition, some of the vaccines require ultra-cold storage, which may require receiving your vaccination at certain locations where storage is available.
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| 22. |
Why is a second dose required? |
The clinical trials showed that a two-dose model was most effective in preventing the spread of COVID-19.
For the Moderna vaccine, a second dose is required 28 days after the first dose. The Pfizer vaccine requires a second dose 21 days after the first. This will be scheduled at your first vaccine appointment.
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| 23. |
How long will immunity last? |
This is a question that has not yet been resolved; the medical community and vaccine producers will continue to study effectiveness and immunity levels to better understand the long-term vaccination strategy.
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| 24. |
Do I need to wear a mask and avoid close contact with others if I have received two doses of the vaccine? |
Yes. It will be important for everyone to continue wearing masks, washing their hands often, and staying at least 6 feet away from others while experts learn more about COVID-19 vaccines under real-life conditions. |
| 25. |
When can we stop wearing masks, physical distancing, handwashing, etc.? |
Masking, physical distancing, handwashing, and other measures will remain critical as rolling vaccines occur and the medical community continues to learn more about the longevity and effectiveness of the immunization effort. |
| 26. |
Should I take the vaccine now or wait until more people have received it to make sure it is safe? |
Getting the vaccine is not mandatory, although we encourage you to get it as soon as it is offered to you. If you have questions, we recommend you discuss this further with your health care provider so that you can make the most informed decision. |
| 27. |
Will I need to get vaccinated again in the future? |
As more data on its effectiveness and safety become available, we will be able to know whether additional doses will be needed. |
| 28. |
What if I opt out of getting vaccinated? |
Getting vaccinated is strongly encouraged, but is not mandatory. If you decline the vaccine now, that doesn’t mean you can’t get it in the future. However, you may have to wait longer to get it. |
| 29. |
Is there a Vaccine Information Statement (VIS) for the new COVID-19 vaccine? |
When a vaccine is authorized under an EUA, they do not have an official Vaccine Information Statement. However, the FDA, together with the manufacturer, will provide a fact sheet when you are vaccinated. This fact sheet is similar to a standard Vaccine Information Sheet. |
| 30. |
Can I take the vaccine if I’m allergic to eggs? |
Yes, these vaccines are not made with any egg components. A history of egg allergy is not a contraindication to vaccination against COVID-19. |
| 31. |
I retired from the University of Texas System. Can I receive the vaccine from UT Physicians? |
UTHealth, which includes clinical practices UT Physicians and UT Health Services, received notification on Saturday evening, Jan. 16, that we have been named a COVID-19 Vaccine Hub in Harris County by the Texas Department of State Health Services.
We are waiting for more information and arrival of vaccine shipments from the state and will provide updates as available.
You can also access additional opportunities through your health care provider, community pharmacies, and additional state/city vaccination hubs.
UTHealth strongly recommends receiving the vaccine to reach immunity within our community.
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