Coronavirus (COVID-19) Preparedness Information

---

Meadowview Regional Medical Center has taken the following measures to prepare, in accordance with CDC guidelines:

---

Testing FAQs:

• Worsening symptoms – I need to see my provider.
  • Be alert to any changing symptoms and seek prompt medical attention if your symptoms are getting worse. If you feel you need to visit your healthcare provider, call ahead before you arrive to tell them you’re experiencing symptoms that may be related to COVID-19. This will allow your provider’s office staff to properly prepare for your visit and take the necessary precautions to keep others from being infected or exposed.
  • Will I be tested? Your provider will make this determination based on your symptoms, and recent travel history. You may or may not be tested, but your provider will follow all appropriate CDC and Kentucky Department for Public Health guidelines.
    ​
• Emergent symptoms – I am having difficulty breathing.
  • If you are experiencing a medical emergency, please call 9-1-1 and notify the dispatch agent that your emergency is related to possible COVID-19 symptoms.
  • Will I be tested? Your emergency medicine provider will make this determination based on your symptoms and recent travel history. You may or may not be tested, but your provider will follow all appropriate CDC and Kentucky Department for Public Health guidelines.

How do I get tested for COVID-19?
At this time, tests for COVID-19 require a provider order. Visiting a provider does not necessarily mean you need testing or that you will receive testing. Your provider will work with the Buffalo Trace District Health Department to follow all appropriate guidelines from the Centers for Disease Control and Prevention (CDC) and the Kentucky Department for Public Health to determine if testing is recommended based on your symptoms and recent travel history.

What are the qualifications for being tested for COVID-19?
Someone may be a candidate for testing if he or she has:

1. A fever and cough or shortness of breath AND has been in close contact with a laboratory-confirmed COVID-19 case; or
2. A fever and cough or shortness of breath and a history of travel from affected geographic areas; or
3. A fever and cough or shortness of breath requiring hospitalization with no other source of infection..

Can I pick up or buy a test kit for COVID-19?

Over the counter test kits are available. Please check with your local pharmacy.

What do I do if I’ve been exposed to someone with a confirmed case of COVID-19? I want to be tested.

If you have been exposed to someone with a confirmed case of COVID-19, you should self-monitor for fever or symptoms of respiratory illness for 14 days. If you begin to experience fever or symptoms of respiratory illness, and they are mild enough that you can manage them at home, you should remain at home in isolation. For details about how to correctly perform home isolation, tips for managing your illness at home with family members, and guidance on when you can discontinue home isolation, please visit the CDC’s website.

If you are not experiencing symptoms, or you are experiencing mild symptoms you can manage at home in isolation, you do not need to seek medical care or testing.

---

COVID-19 Vaccine FAQs:  3rd Dose for Immunocompromised Individuals

• Why is a third dose of the COVID-19 vaccine necessary? Is it not as effective as we thought?

COVID-19 vaccines have been proven safe and highly effective, even against the Delta variant. The CDC’s Advisory Committee on Immunization Practices (ACIP) now recommends an additional dose of the mRNA COVID-19 vaccines (Pfizer and Moderna) specifically for people who are moderately to severely immunocompromised. A third dose will help this vulnerable population enhance their immune response and further protect them from serious – and potentially prolonged – illness.

• Why is a third dose only recommended for immunocompromised individuals at this time?

Studies have shown that immunocompromised individuals typically have less of an immune response after initially completing a 2-dose COVID-19 vaccine series than those who are non-immunocompromised. The third dose is intended to help enhance their immune response by increasing antibody levels for greater protection against the virus.

• What are the criteria for receiving a third dose?

Individuals may qualify for a third dose if they are moderately or severely immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments. This includes people who have: 

• Been receiving active cancer treatment for tumors or cancers of the blood 
• Received an organ transplant and are taking medicine to suppress the immune system 
• Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system 
• Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome) 
• Advanced or untreated HIV infection 
• Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response 

• Is a doctor’s permission or a prescription required?

No. The CDC has indicated that immunocompromised people will not need a doctor’s permission or a prescription to get a third shot. They will only need to attest that they meet the eligibility requirements for an additional dose. Individuals who are unsure whether they meet the criteria above should consult their provider.  

• Can immunocompromised individuals who initially received the Johnson & Johnson/Janssen COVID-19 vaccine now receive a dose of the mRNA vaccine?

Currently, there are insufficient data to support the use of an mRNA COVID-19 vaccine dose after a single-dose J&J/Janssen COVID-19 vaccination series in immunocompromised people. The FDA and CDC are actively working to provide guidance to immunocompromised individuals who previously received the single-dose J&J/Janssen vaccine.

• What if someone has a chronic medical condition like diabetes or asthma? Can they get the third dose now?

These individuals should not receive a third dose at this time. However, it is expected that the general public will be able to get a booster shot sometime this fall. We anticipate that the booster dose will first be available to healthcare workers, first responders and nursing home residents.

• What is the difference between a third dose and a “booster” shot? Are they the same thing?

The vaccine dose is the same, but the intended purpose is different. The third dose is intended to improve immunocompromised people’s response to the initial vaccine series. A booster dose is given to people when the immune response to a primary vaccine series is likely to have waned over time.

• How long after completing the 2-dose series should an immunocompromised individual receive a third dose?

The CDC recommends that people with moderately to severely compromised immune systems receive an additional dose of mRNA COVID-19 vaccine at least 28 days after a second dose of the Pfizer or Moderna vaccine.

• Where can someone get a third dose?

Check www.vaccines.gov to find a COVID-19 vaccine near you.

Pfizer COVID-19 vaccine FDA approval

• What does it mean that the Pfizer COVID-19 vaccine has received full approval from the Food and Drug Administration (FDA)? 

Receiving full approval means the Pfizer vaccine now carries the FDA's strongest endorsement of safety and effectiveness. This is based on thorough research and comprehensive data review over many, many months.

• What did the approval process involve? 

Full FDA approval only occurs when enough data demonstrate that the vaccines are safe and effective for the majority of people who receive them. After many months of studies and hundreds of millions having received a COVID-19 vaccine, the FDA has substantial information on how safe and effective the COVID-19 vaccines are in protecting people, how well they prevent severe disease, and how the vaccines are safely and consistently manufactured.  

• What data did the FDA review? 

The Pfizer-BioNTech COVID-19 vaccine underwent the FDA’s standard process for reviewing the quality, safety and effectiveness of medical products. The FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). The agency also conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. 

The FDA stated the BLA submitted by Pfizer “builds on the extensive data and information previously submitted that supported the EUA, such as pre-clinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.” 

• Is the Pfizer COVID-19 vaccine considered safer than the other two vaccines still under emergency use authorization? 

Like the Pfizer vaccine, both of the currently FDA-authorized COVID-19 vaccines (single-dose Johnson & Johnson/Janssen and two-dose Moderna) have been proven safe and effective based on extensive research. Pfizer was the first COVID-19 vaccine manufacturer to complete the arduous application and rigorous inspection process for full approval.  

• Does FDA approval of the Pfizer vaccine apply to everyone 12 years old and up? 

No. At this time, the vaccine has received full FDA approval for individuals who are 16 years and older. The vaccine is still under emergency use authorization (EUA) for those who are 12-15 years old until Pfizer files its application for this specific age group. The vaccine is also still under EUA for the third dose for immunocompromised individuals. 

• Is Fleming County Hospital planning to require the vaccine for healthcare workers since Pfizer has received full approval? 

We are carefully evaluating our next steps in light of the FDA’s decision to grant full approval for the Pfizer COVID-19 vaccine. At this time, we are still strongly encouraging and supporting all of our staff and our community to become fully vaccinated. We are hopeful that the FDA’s decision will help reduce vaccine hesitancy among unvaccinated individuals and encourage them to roll up their sleeves to protect themselves and those around them from COVID-19. 

• When will the other currently available COVID-19 vaccines be approved? 

Moderna has applied for full approval, and its vaccine is still being evaluated. Johnson & Johnson has indicated that it will likely apply for full approval later this year. 

• Will the name of the Pfizer COVID-19 vaccine change with the FDA approval?  

Comirnaty will be the brand name of the Pfizer mRNA COVID-19 vaccine. It will likely not be commercially available until 2022. Until more information is available, the Pfizer vaccine doses will continue to be distributed to states using the existing process. 

• Once Comirnaty is commercially available, will individuals have to pay for the vaccine? 

Cost and pricing information is not yet available for the FDA-approved product.   

---

Additional Resources: