1.

What vaccines are available?

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, three vaccine candidates have been awarded Emergency Use Authorization (EUA) by the FDA. The Pfizer and Moderna candidates COVID-19 vaccines need two shots to be effective, while the Johnson & Johnson has been proven effective with one dose.

2.

Are the vaccines safe?

The FDA approval process, even in an EUA situation, prioritizes health and safety.

Individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to these vaccines or to any component of these vaccines should not receive one.

Immunocompromised people, including individuals receiving immunosuppressant therapy, may have a diminished immune response.

Side effects reported in vaccine trials were common, but generally mild and self-limited 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).

Fact sheets on the Pfizer, Moderna, and Johnson & Johnson vaccines are available on the FDA website.

3.

Who is eligible to receive a vaccine through UTHealth and UT Physicians? *New*

As part of being named a COVID-19 Vaccine Hub in Harris County by the Texas State Department of Health Services, UTHealth is distributing the vaccine to the most vulnerable community members who qualify for Phase 1A/B according to federal and state guidelines. UTHealth is working diligently to schedule members of our community as quickly as possible, but please be aware we are limited by the number of vaccines received. Here is a quick look at the distribution plan in place:

• Phase 1A focuses on front-line health care workers and residents of long-term care facilities.
• Phase 1B focuses on people 65 and older and those with a medical condition that puts them at greater risk of severe illness from COVID-19.
• School and Child Care Personnel Federal Directive
• Those who work in pre-primary, primary, and secondary schools (including teachers, staff, and bus drivers)
• Head Start and Early Head Start programs (including teachers, staff, and bus drivers)
• Those who work as or for licensed child care providers, including center-based and family care providers

Register to receive a vaccine through the UT Physicians website.

For Phase 1A and Phase 1B patients who have seen a UT Physicians doctor in the last 18 months, you do not need to sign up on our registry. We are currently notifying patients via text message and email to schedule their vaccine. Invitations are based upon vaccine shipment numbers. For patients without text messaging capability or an email address on file, we will personally call you. UT Physicians clinics are experiencing a high number of calls regarding the vaccine. We ask that patients please wait for their invitation to schedule an appointment.

For the general public, UTHealth has opened a registry for eligible Phase 1A and Phase 1B community members and school and child care personnel to register for the COVID-19 vaccine. Please note this is a registry, not a confirmed appointment. Once the registry spots are full each week, the registry will close. Please check back often as we update availability. Wait times for appointments could be weeks or months based off of vaccine availability. If you have an opportunity to receive the vaccine at your doctor’s office or another Hub Vaccine location, please do so.

Register to receive a vaccine through the UT Physicians website.

6.

Why is a second dose required for some COVID-19 vaccines and not others?

The clinical trials showed that a two-dose model was most effective in preventing the spread of COVID-19 for the two mRNA vaccines, Moderna and Pfizer. These require two doses to be fully effective, with immune response showing about two weeks after the second dose.

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.

The Johnson & Johnson vaccine uses viral vector technology, and is a single dose vaccine. A review of the scientific data suggests it is effective about two weeks after injection. Even so, more studies are being conducted on the Janssen vaccine to see if a second dose would add further benefit.

Will the vaccines be FDA-approved?

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, Moderna, and Johnson & Johnson 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.

No. None of the COVID-19 vaccines currently in development in the United States use the virus that causes COVID-19.

What should you mention to your vaccine provider before you receive the COVID-19 vaccine?

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

When considering whether to receive the COVID-19 vaccine, the FDA recommends consulting with your primary care provider if you are pregnant or nursing.

How long will my vaccine appointment take?

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 Pfizer, Moderna, or Johnson & Johnson vaccines. For most people this will be 15 minutes after vaccine administration, and 30 minutes for people with a history of allergic reactions to vaccines.

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.

Before deciding whether to receive the vaccine, we recommend you discuss it with the investigator for your clinical trial. 

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.

The FDA has authorized use of the Moderna and Johnson & Johnson vaccines in adults 18 and older. The Pfizer vaccine is approved for people aged 16 and older.

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. 

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.

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.

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. Fact sheets on the Pfizer, Moderna, and Johnson & Johnson vaccines are available on the FDA website.