COVID-19 Vaccine Information

We are administering COVID-19 Vaccines in accordance with the State of Kentucky's vaccine distribution plan.  Lake Cumberland Regional Hospital with help from Lake Cumberland Medical Associates has administered over 13,000 vaccines to date (as of Friday, May 21, 2020). 

The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Safety is the top priority while federal partners work to make the COVID-19 vaccines. Despite what the name may suggest, “Operation Warp Speed” does not mean that manufacturers were able to skip steps or cut corners in the vaccine development process. Instead, after development of the vaccine, manufacturers took a secured risk and overlapped the study, manufacturing and distribution phases. The FDA committed to giving these vaccinations priority (not rushed) review at all phases of the studies, which helped speed up the overall process. Ongoing monitoring of vaccine effectiveness and side effect reports will continue to be evaluated by the FDA and the manufacturers. 

Yes. For several reasons, a mask and other proven methods of preventing COVID-19 (hand hygiene and social distancing) are still important even after receiving the vaccine. It typically takes a few weeks for the body to build immunity after vaccination. That means it is possible that a person could be infected with the virus that causes COVID-19 just before or just after vaccination. This is because the vaccine has not had enough time to provide protection.

The arrival of the vaccine means that an end to the pandemic and return to normal life may be within reach – but it is going to take all of us doing our part by choosing to get vaccinated.  Be a #VaccineHero!  It is going to take time to get the majority of the population vaccinated, so we must continue to stay vigilant in the weeks and months ahead. 

Yes. At this time, the vaccine is recommended even if you previously tested positive for COVID-19. There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this. More information will be shared as it becomes available.

Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people who have had COVID-19 greater than 90 days ago should proceed with getting the vaccine. Due to limited vaccine supply, if you have had COVID-19 within the last 90 days, your likelihood of reinfection is low enough during this time period that you can wait to get the vaccine until you hit the 90-day mark after being sick.

The COVID-19 vaccine will NOT give you COVID-19.

The vaccine is NOT a live vaccine, and it is NOT possible to contract COVID-19 from receiving the vaccine. Some people experience side effects from the vaccine, such as headache, muscle pain, or fever – but that does not mean you have COVID-19.  It means your body is working to build the necessary immunity against the virus, which is a good thing.

The most common adverse reactions reported have been fatigue, headache, fever/chills and joint pain. This means your body is working to build the necessary immunity against the virus.

You can read more in Pfizer’s FDA Briefing Document about the side effects reported among the vaccine study participants. Moderna information will be available soon. 

The CDC recommends everyone 12 years and older should get a COVID-19 vaccination to help protect against COVID-19. 

The American College of Obstetricians and Gynecologists (ACOG) recommends that COVID-19 vaccines should not be withheld from pregnant individuals. It is important to note that the COVID-19 vaccines currently available have not been tested in pregnant women, so there is no safety data specific to use in pregnancy. Pregnant women should make an informed decision after discussing with their healthcare provider.

For both the Pfizer and Moderna vaccine, two doses are required. The second dose of the Pfizer vaccine should be administered 21 days after the first dose. The second dose of the Moderna vaccine should be administered 28 days after the first dose. It is very important to note that the second dose must be from the same manufacturer as the first dose. 

While it is recommended that you receive the second dose as soon as feasible after day 21 or day 28, we understand that it might not be possible to receive it on the desired date. This could be due to multiple reasons. Please keep the following in mind if you cannot receive the second vaccine dose on the desired date:

1. You must receive the second dose from the same manufacturer as the first dose.
2. Get the second dose as soon as possible after the desired date has passed, as it is better to get the second dose late than not at all. You will still experience the same efficacy in the long run, although you may not see the full effect of the immunity until a few weeks after the second dose.

Similar to the flu vaccine, it typically takes a few weeks for the body to build immunity after vaccination. That means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and get sick. This is because the vaccine has not had enough time to provide protection. As a general rule, the vaccine is considered effective about two weeks after the second dose, according to the manufacturers. There is evidence that the first dose will begin providing some immunity, but it is still very important to receive the second dose for optimal results.

We do not recommend waiting for a specific manufacturer. Both Pfizer and Moderna vaccines have similar efficacy and potential side effects, and have shown decreased disease severity in the small numbers of study participants who contracted COVID-19 after receiving the vaccine. Both manufacturers require two doses. It is important to remember that the second dose you receive must be from the same manufacturer. Early defense is better than no defense against COVID-19.

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.

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.

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

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. 

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.

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.

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 (at least 8 months after the second 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.

The CDC recommends that the third dose only be given to those 18 years old or older. 

The third dose is available for eligible patients by calling 606.451.2756. You can also check www.vaccines.gov to find a COVID-19 vaccine near you. 

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.

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.

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.”

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.

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.

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.

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.

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.

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

According to the Centers for Disease Control and Prevention (CDC), clinical trials have shown that the Pfizer-BioNTech vaccine is highly effective at preventing COVID-19 infection in children ages 5-11. Vaccinations may help keep children from spreading COVID-19 to others and can also help keep your child from getting seriously sick even if they do get COVID-19. From a safety perspective, the vaccine has undergone and will continue to undergo the most intensive safety monitoring in U.S. history.

The vaccine series for children 5-11 years old is two doses given 3 weeks (21 days) apart. It is recommended that you make your child’s appointment for the second dose at the time of the first dose appointment.   

Commonly reported side effects in clinical trials included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days.

Pain relievers are not recommended before vaccination to try to prevent side effects.

No. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens. This recommended dosage has been found to be highly effective in protecting young recipients against COVID-19. This vaccine is NOT interchangeable with the vaccine for individuals 12 years old and older.

To avoid confusion, the formulation for children ages 5-11 years old is packaged with an orange label and orange cap, while the vaccine for adults is packaged with a purple label and purple cap. Our team members who administer vaccines have completed the necessary vaccine safety training and diligently follow the appropriate clinical protocols.

Per guidance from the CDC, pediatricians will allow for a 4-day grace period around birthdays to determine which dose of the COVID-19 vaccine is needed. For children who are 11 when they start the series, they should receive another 10-microgram dose after they turn 12 a few weeks later.

Yes. It is safe for your child to receive a COVID-19 vaccine and other vaccines, including the flu vaccine, at the same time.

Currently, Pfizer is the only vaccine manufacturer that has received emergency use authorization for this age group.

Information on local vaccine resources coming soon...