ProMedica Senior Care COVID-19
Adhering to Vaccine Mandate
The U.S. Supreme Court has allowed the Centers for Medicare and Medicaid Services (CMS) standards for healthcare workers to remain in place, while staying the emergency temporary standards from the Occupational Safety and Health Safety Administration (OSHA) that affects companies with more than 100 employees. To remain in compliance with the CMS standards, ProMedica requires employees working in a CMS-covered business must be fully vaccinated according to the ProMedica COVID Vaccine Requirement Policy.
This content is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding the COVID-19 vaccine or a medical condition you may have.
How is a vaccine developed and tested?
Approval of a vaccine for use in people involves multiple phases with different goals for assessing effectiveness and safety in different populations. There are a total of 4 phases and the vaccine needs to meet very intense safety criteria before completing each phase. Once a vaccine is approved for use after phase 3, it has been tested in tens of thousands of people and if no significant harmful side effects are noted, it is considered safe for use. Phase 4 involves continued monitoring and gathering of safety data. This type of clinical trial has been used for decades to approve medications and vaccines.
What is an Emergency Use Authorization (EUA) and if the vaccine is approved for an EUA, what does that mean?
EUA is based on the need to use a vaccine quickly to save lives during an urgent health crisis. EUA is a shorter process but no steps are skipped in the safety evaluation process. This approval can still take weeks and the FDA will re-evaluate the numbers and data to ensure that the calculations are correct. The FDA will assess if the vaccine's known and potential benefits outweigh the known and potential risks. Both advisory boards (VRBPAC and ACIP) will also review all the data and information.
What are the Food and Drug Administration (FDA) requirements for the safety and efficacy of a COVID-19 vaccine?
FDA requires 50% efficacy of a COVID-19 vaccine (the COVID-19 vaccines from Pfizer and Moderna are showing 94-95% efficacy during this trial phase). Many other companies are working on a vaccine and we expect that others will be approved by the FDA. The FDA requires 8 weeks of safety data on the COVID-19 vaccine.
How will we know it is safe?
Safety is the most important requirement for the vaccine and is assessed in trials by independent experts. Most adverse side effects occur within 6 weeks of vaccine administration, and the FDA has required 8 weeks of safety monitoring so it can track any side effects. FDA advises a minimum of 3,000 participants to assess safety. The current phase 3 trials have 30,000 to 50,000 participants. This really demonstrates how safety is a top priority for the FDA and the medical community.
Who else will be evaluating this vaccine to ensure it is safe and effective?
There are 2 advisory committees: 1) The Vaccine and Related Biological Products Advisory Committee (VRBPAC) that advises the FDA; 2) The Advisory Committee on Immunization Practices (ACIP) that advises the CDC. These advisory boards are independent. Their job is to monitor vaccines to ensure safety regardless of money, politics, etc. The people on these committees are experts from academic institutions and they are vetted to not have a conflict of interest. Experts who may have conflict of interest are not put on these committees. The committees will evaluate the vaccine data for safety, efficacy and also help to determine how it will be distributed.
What are the types of potential vaccines that may be approved?
Messenger RNA (mRNA) vaccines are a new type of vaccine undergoing clinical trials. There are also other types vaccines being studied that are similar to vaccines we have used for other diseases. None of these can give you COVID-19! The goal is to give your body the tools it needs to “fight” COVID-19 effectively and/or prevent you from getting it at all. Most of the vaccines that are currently being tested will require 2 doses to be effective, given about 3-4 weeks apart. This is to make sure your body has enough antibodies to “fight” COVID-19. Getting 2 doses within 3-4 weeks has been shown to be safe and there are other vaccines we have been using for years that require multiple doses without causing harm.
How does an mRNA vaccine work?
According to the Centers for Disease Control (CDC) website, mRNA vaccines contain material from the SARS-CoV-2 virus that causes COVID-19. This material gives our cells instructions for how to make a harmless protein that is unique to the virus. This protein cannot build a virus or cause infection. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and build antibodies that will remember how to fight the virus that causes COVID-19 if we are infected in the future. While mRNA technology is new in vaccine development, this technology is being successfully used in cancer treatments.
How long will the vaccine protect us?
It is likely that we will not know the answer to that question when a vaccine is released. That will take more research. This vaccine may be like the annual flu vaccine, where we may need to have vaccine shots for COVID-19 on a regular basis. More research is needed to know this and it also depends if the virus changes over the coming months to years.
When will we be protected after we get the vaccine?
Even when people receive the vaccine they will not be immediately protected and will need to continue wearing masks, social distancing and practicing frequent hand hygiene. Some vaccines will require 2 shots, with a few weeks between each shot, and protection will usually occur about 2 weeks after the second shot. While no vaccine is 100% effective, the vaccines proposed are anticipated to be more than 90% effective. This will markedly reduce your risk of getting sick with COVID-19 and spreading COVID-19 to your loved ones.
After I have had the second dose of the vaccine and it is 2 weeks after my second shot, do I still have to wear a mask?
Yes. Even though you have received your vaccine, most of the people around you have not. We know the vaccine prevents disease in the vaccinated person, but it still may be possible to transmit the disease to others, especially when most people will still be at risk for getting COVID-19. Wearing a mask, social distancing, and practicing hand hygiene protects those who have not been vaccinated, especially our residents in long term care.
What if I had COVID-19 or I took a test that showed I have antibodies? Should I get the vaccine?
Yes, even if you have had COVID-19, it is safe to get the vaccine, and this can add additional protection without causing any harm. If you have had a test that shows you have COVID-19 antibodies, you should still get the vaccine. It is safe and can increase your protection form future COVID-19 infections.
What are some of the possible side effects of the COVID-19 vaccine? Will the vaccine make me sick?
The vaccines currently being tested in clinical trials can cause short-term discomfort (such as headache, muscle pains, fatigue, chills, fever and pain at injection site) in a percentage of the people who receive them. This is the effect of your body developing immunity. Clinical trial participants reported that the discomfort went away after a day, sometimes sooner. When you receive the second dose of the vaccine, the discomfort can be more pronounced. This is a normal reaction, so be prepared. If you experience discomfort after the first dose of the vaccine, it is very important that you still receive the second dose a few weeks later for the vaccine to be effective. This does not mean that the vaccine has given you COVID-19. Rather, this means that the vaccine is causing your body’s immune system to react and create antibodies to fight off the virus. In other words, if you feel some discomfort, then the vaccine is doing its job! In some cases, a person may already be infected with COVID-19 when they get the vaccine, but are asymptomatic or pre-symptomatic. If they later have symptoms of COVID-19 or test positive for it, it does not mean they got COVID-19 from the vaccine. We should expect that vaccine recommendations will change as additional vaccines are approved. At first we may have one vaccine, then hopefully 2 or 3. As different vaccines become available, some may be found to be better for different populations and different circumstances. Just like our knowledge about the virus itself changes over time, so will the recommendations about vaccines.
Who will be able to get the vaccine in a nursing home?
Residents and staff in a nursing home will be among the first to get the vaccine. Long term care staff will often be able to get vaccinated before the residents to decrease the risk of exposing the residents to COVID-19. Long term care staff will include anyone who works in a nursing home, such as those who work in environmental services, not just those who perform direct patient care. This also includes staff who visit the nursing home, including doctors, physician assistants, nurse practitioners, medical directors, lab technicians and consultants.
What is ProMedica’s next step for senior care?
ProMedica Senior Care appreciates the importance of protecting our centers' patients and residents as well as those caring for our country’s most vulnerable during the pandemic. We are in the process of working with state officials, local hospitals and pharmacy partners to ensure we have a well-planned process for ensuring everyone has access to the vaccine. Our centers and communities will be contacting employees, patients and families with our plan once finalized.
Can a COVID-19 vaccine make me sick with COVID-19?
According to the Center for Disease Control (CDC), none of the authorized and recommended COVID-19 vaccines or COVID-19 vaccines currently in development in the United States contain the live virus that causes COVID-19. This means that a COVID-19 vaccine cannot make you sick with COVID-19.
Vaccines teach our immune systems how to recognize and fight the virus that causes COVID-19. Sometimes this process can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is building protection against the virus that causes COVID-19.
It can typically take 1-2 weeks for the body to build immunity (protection) 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 still get sick. This is because the vaccine has not had enough time to provide protection.
Will a COVID-19 vaccination protect me from getting sick with COVID-19?
Scientific and medical experts agree that the COVID-19 vaccination works by teaching your immune system how to recognize and fight the virus that causes COVID-19, and this protects you from getting sick with COVID-19. You should continue to practice the three W. Watch your distance, Wear a mask and Wash your hands.
Why is it that some people have been diagnosed with COVID-19 after receiving the first dose of the vaccine?
It typically takes a few weeks for the body to build immunity (protection) after vaccination. That means it’s possible that a person could be infected with the virus that causes COVID-19 just before or right after vaccination and still get sick. This is because the vaccine has not had enough time to provide protection.
Is it okay to get my first or second dose of the vaccine if I have recently tested positive for COVID-19?
The CDC recommends that vaccination of persons with known and active COVID-19 should be deferred until the person has recovered from the acute illness (if symptomatic) and the criteria have been met for them to discontinue isolation. This recommendation applies to persons who develop a COVID-19 infection before receiving any vaccine doses as well as those who develop a COVID-19 infection after the first dose but before receipt of the second dose.
If I have already had COVID-19 and recovered, do I still need to get vaccinated with a COVID-19 vaccine?
Due to the severe health risks associates with COVID-19 and due to the fact that re-injection is possible, the CDC recommends that the vaccine should be offered to you regardless of whether you already had COVID-19 infection. Data from clinical trials indicate that mRNA COVID-19 vaccines are safe in persons with evidence of a prior COVID-19 infection. Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic COVID-19.
Viral testing to assess for acute COVID-19 infection or serologic testing to assess for prior infection solely for the purposes of vaccine decision-making is not recommended if an individual is asymptomatic.
Can I receive other vaccines like the influenza vaccine, shingles vaccine, or pneumonia vaccine if I get the COVID-19 vaccine?
The CDC recommends that the COVID-19 vaccine series should routinely be administered alone, with a minimum interval of 14 days before or after administration with any other vaccine. However, shorter period are acceptable when the benefits of vaccination are deemed to outweigh the potential unknown risks of vaccine co-administration (e.g., tetanus toxoid-containing vaccination as part of wound management, measles or hepatitis A vaccination during an outbreak) or to avoid barriers or delays to COVID-19 vaccination (e.g., in long-term care facility residents or healthcare personnel who received influenza or other vaccinations prior to/upon admission or onboarding).
Will a COVID-19 vaccine alter my DNA?
COVID-19 mRNA vaccines do not change or interact with your DNA in any way.
Messenger RNA vaccines—also called mRNA vaccines—are the first COVID-19 vaccines authorized for use in the United States. mRNA vaccines teach our cells how to make a protein that triggers an immune response. The mRNA from a COVID-19 vaccine never enters the nucleus of the cell, which is where our DNA is kept. This means the mRNA cannot affect or interact with our DNA in any way. Instead, COVID-19 mRNA vaccines work with the body’s natural defenses to safely develop immunity to disease. At the end of the process, our bodies have learned how to protect against future infection. That immune response and making antibodies is what protects us from getting infected if the real virus enters our bodies.
Were fetal cells used to produce the COVID-19 vaccines?
The mRNA COVID-19 vaccines produced by Pfizer and Moderna do not require the use of any fetal cell cultures in order to manufacture (produce) the vaccine.
Early in the development of mRNA vaccine technology, fetal cells were used for “proof of concept” (to demonstrate how a cell could take up mRNA and produce the SARS-CoV-2 spike protein) or to characterize the SARS-CoV-2 spike protein.
The Pfizer and Moderna vaccines were found to be ethically uncontroversial by the pro-life policy organization the Charlotte Lozier Institute.
Were monkey brains used to produce the COVID-19 vaccines?
CVS Specific FAQs
How is CVS Health working with the CDC to make the COVID-19 vaccine available?
CVS Health has entered into a contract with the Centers for Disease Control and Prevention (CDC) to be one of the official COVID-19 Vaccination Program Providers. As a result, once a COVID-19 vaccine is authorized by the FDA and available, the United States government will make a supply of the publicly funded vaccine available to CVS Health for administration.
Who is eligible to receive the COVID-19 vaccination under the contract?
Under this contract, CVS Health will receive a supply of the publicly funded COVID-19 vaccine and necessary supplies for administration once the vaccine is authorized and available. This supply of vaccine will be used to provide vaccinations to patients consistent with the priorities for vaccination established by the government.
Will patients be charged for the vaccine?
No patient will be charged for the vaccine or its administration. The federal government will provide the vaccine itself and CVS Health will be reimbursed by the patient’s insurance or, in the case of uninsured patients, the Health Resources and Services Administration (HRSA) program for uninsured patients, for the administration of the vaccine. The Centers for Medicare & Medicaid Services (CMS) has established the reimbursement rates for administration of the vaccine for patients covered by Medicare as well as those covered by the program for the uninsured.
Who administers the vaccines at on-site clinics?
Appropriate practitioners under applicable state and federal laws and guidance will administer vaccines to facility patients and employees at the on-site clinics. CVS personnel are trained and certified according to company and state specific regulations. All CVS pharmacists are trained in immunizations, CPR and OSHA.
For more information about CVS Health and the vaccine, visit omnicare.com/covid-19-vaccine-resource
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