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Vaccine Authorization

Two vaccines are currently authorized under an Emergency Use Authorization (EUA) by the FDA. Both vaccines were tested in tens of thousands of adults from diverse backgrounds, including older adults and communities of color:

Pfizer/BioNTech
43,931 enrolled
150 clinical sites
39 U.S. states
Racial/ethnic distribution
13% - Hispanic
10% - African American/Black
6% - Asian
1% - Native American
45% ages 56-85

Moderna
30,000 enrolled
89 clinical sites
32 U.S. states
Racial/ethnic distribution
20% - Hispanic
10% - African American/Black
4% - Asian
3% - All others
64% ages 45 and older
39% ages 45-64
25% ages 65+

At this time, neither vaccine is authorized for use in anyone under the age of 16. Neither vaccine trial included pregnant women, however the EUA authorizes pregnant women to be vaccinated.

Vaccination Monitoring Information

The Coquille Indian Tribe will be administering the Moderna Vaccine.

Clinical trial data show that both vaccines are safe and effective at preventing COVID-19. COVID-19 vaccines are being held to the same safety standards as all vaccines. The FDA continues to monitor the vaccine under the Emergency Use Authorization
 Existing systems and data sources are used to monitor safety of vaccines after they are authorized or licensed, such as: 
◦Vaccine Adverse Event Reporting System (VAERS)
◦Vaccine Safety Datalink (VSD)
◦Clinical Immunization Safety Assessment (CISA)
◦Biologics Effectiveness and Safety System (BEST) 

New systems are being developed to monitor vaccine  safety, such as the after vaccination health checker created called V-safe. 
V-safe is a smartphone-based tool (app) that uses text messaging and web surveys to provide personalized health check-ins after someone receives a  COVID-19 vaccination. Through v-safe, vaccine recipients can quickly tell CDC if they have any side effects after getting the COVID-19 vaccine. Depending on answers, someone from CDC may call to check on the recipient. 

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* 1. The FDA has approved three Vaccinations for Emergency Use Authorization (EUA).

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* 2. Which Vaccine is approved for people under 16?

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* 3. V-Safe is  a smartphone tool that links vaccine recipients to the CDC.

How the Vaccines Work and Possible Side Effects

Both Moderna and Pfizer are a type of mRNA vaccination:

--mRNA vaccines do not use the live virus that causes COVID-19. They CANNOT give someone COVID-19.
--mRNA vaccines teach our cells how to make a harmless piece of the “spike protein” for SARS-CoV-2.
--After the protein piece is made, the cell breaks down the instructions (the mRNA) and gets rid of them. 

Cells display this piece of spike protein on their surface, and an immune response is triggered inside our bodies. This produces antibodies to protect us from getting infected if the SARS-CoV-2 virus enters our bodies:

--mRNA vaccines DO NOT affect or interact with our DNA in any way.
--mRNA vaccines DO NOT result in antibodies, which indicate previous infection.

Getting a vaccine will help create an immune response in your body against the virus, which may help you from getting severely ill - even if you do get COVID-19 - which minimizes risk of a hospital visit or death.

Both Vaccines require two doses for full effectiveness. Moderna requires a second dose given at least 28 days apart from the first shot.

A person may become infected with COVID-19 more than once. The vaccine may still be beneficial if you have already had the virus.

Vaccines are shown to have 95% efficacy; however it is unknown how long this protection lasts

Possible Side Effects
These mRNA vaccines are expected to produce side effects after vaccination, especially after the 2nd dose.​ You should be given an EUA Fact Sheet when you receive your vaccine. Side effects may include: ​
--fever​
--headache​
--muscle aches​
--fatigue

No significant safety concerns were identified in the clinical trials.​ Be sure to talk to your physician about pre-existing allergies.
Some people have reported severe allergic reactions (anaphylaxis) after getting the COVID-19 vaccine. If you have ever had a severe reaction to any ingredient in a COVID-19 vaccine, the CDC recommends not getting that specific vaccine. If you have a reaction to the first dose of one vaccine, the CDC recommends you do not get the 2nd dose.

Latex: The Pfizer vaccine packaging has been identified as latex free by the American Latex Allergy Association. The Moderna vaccine vial packaging is also latex free. 

At least 8 weeks of safety data were gathered in the trials.  It is unusual for side effects to appear more than 8 weeks after vaccination.

After receiving your vaccine, you will be asked to wait on site for 15-30 minutes to monitor for adverse reactions. Be sure to build that time into your schedule!

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* 4. The Moderna Vaccine can interact with DNA.

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* 5. People with pre-existing allergies should talk to their physician before accepting the Moderna Vaccine.

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* 6. After receiving the COVID-19 vaccine, people are asked to wait how long before leaving the Tribal Clinic?

Vaccine Distribution

Moderna is distributed to the State of Oregon and Indian Health Services including the Coquille Indian Tribe.
The Moderna Vaccine must be stored at -20*C

The Moderna Vaccine is distributed in vials that contain 10 does per vial. Once the seal is broken, the vial must be used to administer the 10 doses within 6 hours.

The Coquille Indian Tribe has received an initial shipment of 100 does of Moderna Vaccine. Tribal Council has approved through Resolution the distribution of Vaccines through a phased approach, starting with Phase 1 which should begin the week of December 28, 2020. (See below: Vaccination Distribution as a Phased Approach, Figure 1.)

PHASE 1 -Initial distribution approved to:
•Health and Human Services employees direct (in person contact) mission essential services to the Coquille Indian Tribe membership
•Tribal members and spouses over 55 with chronic medical conditions in the 5 county service area

When can I get my COVID19 Vaccine?

Vaccines are in limited supply and are being shipped in installments. We will update distribution plans and eligibility as more information becomes available.

Some estimates indicate it could take until autumn for everyone who wants a vaccine is able to get one.

If you don’t get the vaccine right away, you will be able to get it in a future distribution. More information will be shared with the community as it becomes available to the Tribe.

We will post information on Facebook, MyTribe, and the Kwen about how to get your vaccine.

You will not be asked for your personal information to secure a vaccine or to provide payment to enhance your chances to receive the vaccine. Be alert for fraud!

Is the COVID19 Vaccine Mandatory?

Vaccines are not currently mandatory for anyone. We are strongly encouraging vaccination and promoting education about the vaccine and COVID-19.

The vaccine helps protect you – but even with the vaccine you can still become infected with COVID-19 and may still be able to pass it onto your loved ones. Until we have reached herd immunity, we must all continue to do our part to protect our community.
We do not currently have a “return to work” plan. At this time, all staff are to continue masking and social distancing. Community safety is our priority, and we will make decisions using all the scientific information available to us to keep staff and membership healthy.

I Got Vaccinated...Now What?

•Remember that both vaccines need two doses to be effective.
•Enroll in v-safe to help the CDC monitor for any health effects after vaccination.
•While the vaccine may prevent you from experiencing severe symptoms, it may not prevent you from being a carrier and spreading COVID-19 to others.

Remember to continue following CDC recommendations to protect yourself and others offers the best protection:
o Wear a mask that covers your mouth and nose.
o Avoid gatherings and close contact with others. Stay at least 6 feet (about 2 arms’ length) from other people.
o Avoid touching your eyes, nose, and mouth with unwashed hands.
o Clean and disinfect frequently touched surfaces daily.
o Wash hands often with soap and water.
o Use an alcohol-based hand sanitizer with at least 60% alcohol if soap and water are not available.

The CDC recommends everyone continue these measures until approximately 70% of the population is vaccinated to achieve herd immunity.
Should I get the vaccine if I've already had COVID-19?

◦Since the antibody levels drop after a natural infection, it is currently recommended that people who have had the illness be vaccinated to boost the immune response and provide longer term protection. 
◦It is recommended to wait 1 month after recovery of illness before getting vaccine, but you can wait as long as 90 days
◦All persons who are vaccinated with COVID-19 vaccine should have two doses, even if they have already been infected with COVID-19.  

How long for full effect after the 2nd dose? 

Clinical trials measured efficacy of the COVID-19 vaccines.  Each vaccine requires two doses to be effective. 

◦Moderna vaccine -  Two weeks after the second dose you are fully protected. 
Pfizer vaccine – One week after the second dose you are fully protected.

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FIGURE 1

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* 7. How many doses of Moderna COVID-19 Vaccine did CIT receive in the first shipment?

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* 8. You must continue to follow CDC recommendations to protect yourself  and others by continuing to wear a mask and follow  safety precautions even after YOU receive the COVID-19 Vaccine.

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