Safety and Effectiveness
How do we know a COVID-19 vaccine will be safe and effective?
To be declared safe and effective, a COVID-19 vaccine must pass certain tests and standards. Organizations such as the National Academy of Sciences, the National Institutes for Health, and the Food and Drug Administration (FDA) use scientific data from research to help decide if and when new drugs and vaccines can become available to the public.
The fundamental way the safety and efficacy of a vaccine is determined is by conducting clinical trials. In a clinical trial, volunteers are given the vaccine. Other volunteers receive a placebo. Comparisons are made between the groups, and rigorous safety monitoring is conducted to make sure any side effects or safety issues are identified. Once the clinical trials are completed, scientists and regulatory agencies examine the data to determine the safety and efficacy of the vaccine.
Under what circumstances does FutureCare believe vaccines will have been properly vetted before allowing access to our workforce and patients?
We have followed developments of the vaccines very closely, along with our hospital partners. Thus far, we believe proper procedures have been followed by the vaccine developers, those who are testing the vaccines, and the regulatory agencies who will evaluate the vaccines for approval.
Several events give us confidence the proper procedures have been followed:
• The FDA has been very clear about the conditions under which it would issue an Emergency Use Authorization (EUA) or full approval for any candidate COVID-19 vaccine intended for public use. The FDA process is well established. Considerations are peer-reviewed by external expert panels. Any attempt to circumvent the process would rapidly come to public attention and be widely publicized. The FDA leadership has reaffirmed their commitment to scientific data driving their deliberations and any approval decisions.
• Nine vaccine manufacturers (Pfizer and BioNTech, Moderna, AstraZeneca, Johnson and Johnson, Merck, GlaxoSmithKline, Novavax, and Sanofi) issued a rare public pledge that they will not seek FDA approval without comprehensive phase 3 clinical data showing clear results that their vaccine is safe and effective.
• Both Pfizer and Moderna, aware of public sentiment and potential mistrust, have taken the additional step of publishing and making their trial protocols public.
• In addition, the National Academies of Science provided guidance on conditions required for appropriate vetting of candidate vaccines.
• The Association for Professionals in Infection Control and Epidemiology (APIC) will also issue standards it believes must be met.
• Dr. Anthony Fauci publicly stated that the approval process can be trusted. He will speak out if he has any doubts.
How effective are the Pfizer and Moderna vaccines?
Both Pfizer and Moderna report that their vaccines showed approximately 95% efficacy at preventing symptoms of the SARS-CoV-2 virus, including severe disease.
The FDA previously stated that they were likely to approve a vaccine that showed at least 50% efficacy; public health officials were hoping for 60% to 75% efficacy; thus, 95% efficacy is extraordinary and likely to be approved if the FDA is satisfied that the data are appropriately analyzed including consideration of any safety concerns.
Are the Pfizer and Moderna vaccines safe?
Based on known reports from the clinical trials, neither the Moderna nor the Pfizer vaccine trials have reported any serious safety concerns.
Both trials had fully independent safety monitoring boards, and full safety data are being reviewed by the FDA and expert panels. Historically, most serious side effects become apparent early (usually under 40 days) after receiving a vaccine. Still, there will be intense short- and long-term monitoring of individuals who receive the vaccine.
Were there enough different people in the clinical trials of these vaccines so that the high level of protection applies to everyone?
The clinical trials were designed to include significant numbers (about 25%) of underrepresented minorities, older age groups (about 25%), and people with various comorbid conditions, such as obesity, diabetes and heart and respiratory conditions.
Specifically, Pfizer enrolled more than 40,000 people:
• 30% racially diverse, 10% black, 13% Hispanic
• 45% were ages 56 to 85
Moderna enrolled more than 25,000 people:
• 37% racially diverse, 10% black, 20% Hispanic/Latino
• 23% were over 65 years old
The FDA and other reviewers in their deliberations will be looking closely at the populations included in the trials.
Note: The trials did not include pregnant women or children. Trials with these groups are on-going now.
I understand the Pfizer and Moderna vaccines are based on mRNA technology, and this technology has not previously been used for a licensed vaccine.
This is true. It is this new technology that has allowed the rapid development of the vaccine. However, the platform for mRNA vaccine technology had been years in the making.
To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, messenger RNA (mRNA) vaccines teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.
Previously, it took years, even decades to develop a vaccine. As with all vaccine development, mRNA-based vaccines are still subject to standard safety trials before they undergo further clinical trials (called phase III) to see if they work. These phase III trials also include safety monitoring. There have been no serious side effects reported so far in the two trials of the mRNA-based COVID-19 vaccine. Those who receive these (and any other) vaccines under the EUA will be followed very closely for both short- and long-term effects.
What is an Emergency Use Authorization?
An Emergency Use Authorization, or EUA, is a means to provide formal, although temporary, FDA approval of medical products and instruments to make them available as quickly as possible during a public health emergency. It is not the same as full FDA approval and licensure.
Vaccine Availability and Workforce Guidelines
When will a COVID-19 vaccine be available for the FutureCare workforce?
Once the vaccine developers submit their applications to the FDA, it will take about three weeks for FDA regulators to review the materials. If they wish to have more information to make a decision, availability may be pushed back later until the FDA is satisfied that the vaccine meets effectiveness and safety requirements for EUA. The FDA is meeting on December 10 to consider the Pfizer vaccine and on December 17 to consider the Moderna vaccine.
In anticipation of a successful application, we understand the vaccine may be distributed to all states and territories, who in turn have developed plans to distribute the vaccine to hospitals and other facilities for use as soon as EUA has been granted and the CDC has determined the priority eligibility.
Understanding there may be a limited supply of vaccine at first, who at FutureCare will be eligible to be vaccinated early?
The CDC has designated nursing home residents and staff as their top priority to receive the COVID-19 vaccine. The exact criteria for vaccine prioritization will be determined by the CDC and Maryland Department of Health (MDH) guidance, expert infectious disease consultant from Johns Hopkins Hospital, and FutureCare's clinical leadership. After our residents receive the vaccine, people with early access will likely include clinical and non-clinical staff members who are essential to providing direct care and supportive services to residents.
How many vaccines will be available for FutureCare in the first distribution?
We do not know for certain. We anticipate that there will be 40 million doses of Pfizer and Moderna vaccine available in the U.S. before the end of 2020, enough for 20 million people given the need for two injections for each person. We are optimistic that there will be sufficient vaccine initially for those falling into the highest-priority grouping.
What is FutureCare's recommendation as to whether I should get the vaccine if I'm eligible?
We will only offer the vaccine if FutureCare experts are satisfied with proper procedures for evaluation and approval have been followed.
We know that our FutureCare communities are extremely vulnerable to COVID-19 and that our residents and patients are at high risk for serious illness and death if they contract the virus.
Given this and the out-of-control nature of this pandemic, as well as the extraordinary impact on individual lives, a large number of deaths and hospitalizations, and large numbers of people with remaining long-term physical health issues even after they recover, we believe the risks of vaccination are small compared with the large individual and societal benefit of getting the vaccination. At the current rate of new daily infections, it would still take three to five years for U.S. society to reach herd immunity without widespread vaccination.
You alone make the decision about whether to take the vaccine or not. We will provide information, like this FAQ to answer your questions to help you make an informed decision.
Because there are two vaccines, will I get to choose which one I want?
Getting the vaccine for COVID-19 is voluntary. When you become eligible to receive the vaccine, you may have the ability to express a preference for which vaccine you would like to receive, if there is more than one type available at that time. If you are offered a vaccine that you did not prefer, you will have the choice to either accept the vaccine you are offered or to re-enter the pool of people waiting for a chance to receive a vaccination. However, we do not know when an additional vaccine will be available to you.
Please remember that the first types of COVID-19 vaccines to become available require two doses administered three to four weeks apart. Your second dose must be the same type of vaccine as the first one.
Will getting the COVID-19 vaccine be mandatory for FutureCare employees?
Not at this time. The vaccine will be voluntary for those who wish to receive it. Under the FDA's EUA, informed consent is required to administer the vaccine.
Will my job be affected if I decide not to get the vaccine even if I'm eligible?
While we may strongly encourage the use of the vaccine to help end this pandemic and minimize risk of serious illness or death to your residents, there will be no repercussions should you choose not to do so at this time. You may change your mind at any time and, if eligible, receive the vaccine if and when it is available.
As we learn more and as more individuals are vaccinated, there may be changes to FutureCare's Infection Control Plan or other policies and procedures related to our response to prevent and mitigate the effects of COVID-19 which may affect you. We will keep you informed as changes are made.
*Remember, vaccines are the only way to control the COVID-19 pandemic. Everyone has to do their part, and the vaccine will get us back to a normal life.
Who is paying for the COVID-19 vaccine?
Vaccine doses purchased with U.S. taxpayer dollars will be given to the American people at no cost. However, vaccination providers will be able to charge an administration fee for giving the shot to someone. Vaccine providers can get this fee reimbursed by the patient's public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration's Provider Relief Fund. Since the vaccine providers are permitted to get reimbursed for administering the vaccine, they may ask for your insurance information. However, there should be no fee to you.
Potential Side Effects, Doses, Immunity
What are the side effects of these two vaccines?
Pfizer and Moderna report side effects that include pain at the injection site, fever, muscle aches, fatigue and headaches, mostly lasting about a day or two.
The side effects described above seem similar to some of the symptoms of COVID-19. What should I do if I experience these?
The side effects are most likely to be experienced after the second dose for either the Moderna or Pfizer vaccine. If you have any of these symptoms, you should notify the facility Infection Control Practitioner (ICP) or Director of Nursing (DON) immediately upon experiencing any of these symptoms. These symptoms should only be present for a day or two. If symptoms persist, you should notify the facility ICP or DON as well as your health care provider.
How many doses do I need?
Both, Pfizer and Moderna vaccines require two doses administered several weeks apart (Pfizer at three weeks apart, and Moderna at four weeks apart).
When am I considered "immune" after getting the vaccine?
Generally, it takes 10 to 14 days for your immune system to respond to a vaccine and provide protection against infectious disease. Because we are still learning about how long immunity may last after natural infection with the SARS-CoV-2 virus or following COVID-19 vaccination, you should still continue to practice the recommended infection-prevention precautions, including wearing a mask, physical distancing, hand hygiene, and avoiding large indoor gatherings.
How long does immunity last after the vaccine?
We do not know for certain. For most people with natural infection, detectable antibody wanes after two to four months. However, there is increasing evidence that immunity lasts much longer than initially thought. There have been a few rare cases of individuals seemingly being naturally infected twice, but fortunately, this seems to be rare at this time.
The SARS-CoV-2 virus appears genetically stable compared with most respiratory viral pathogens. This means it has not mutated in more significant ways than other viruses, even within the coronavirus family. However, it is possible that it may yet mutate in the future. The implications for immunity (natural or vaccine-derived) are unknown.
Can I be vaccinated if I already had COVID-19?
Yes. The vaccine trials reportedly included people previously infected with the SARS-CoV-2 virus. Full evaluation of the data will allow us to know how well the vaccine performed in such people. We do know there were no serious short-term safety issues reported. It is generally thought that natural infection results in better immunity than a vaccine, but this is not uniformly the case. For example, tetanus and HPV vaccines are considered better protection than natural infection.
*Note, the vaccine cannot be taken if you are actively infected with COVID-19.
Can you mix vaccines?
Each vaccine is manufactured differently, even those that use similar underlying technology such as Pfizer and Moderna. Once given one type of vaccine, the second dose should be the same type.
Safety Measures
Can I stop wearing a mask and stop physical distancing practices after the second shot?
No. Even with a vaccine that is 95% effective, about 1 in 20 people who receive the vaccine will not become immune. It is also unclear if having effective immunity protects you from carrying the virus and passing it along to others.
Until a significant portion of the population becomes immune (either from the vaccine or natural infection), the precautions must be carefully followed by everyone. Given the enormous task of immunizing a sizable proportion of the population to stop the spread of the virus, it will take months before we can consider cutting back on these basic safety precautions.
Who should I contact if I have additional questions?
Please feel free to speak with your Executive Director or call FutureCare's dedicated COVID-19 Answer Line with any questions: 888-290-0000.
Important Note:
*As new information becomes available, we will be providing you with updates as quickly as possible. While this FAQ tool is a great resource, the everchanging nature of this virus and how it responds to the vaccine will likely require updates to the information we have received and our FAQs. As noted above, if you have any questions or concerns or just want to clarify something you have read, heard or seen, please contact your Executive Director, call the COVID-19 Answer Line or speak directly with your own health care provider.
Additional Resources
Walgreens COVID-19 Vaccine LTC Consent Form
https://covidlink.maryland.gov/content/faqs/#faqVP
https://www.cdc.gov/vaccines/covid-19/downloads/all-of-our-tools.pdf
https://www.cdc.gov/vaccines/covid-19/downloads/top-priority-for-vaccination.pdf
https://www.cdc.gov/vaccines/covid-19/downloads/top-priority-for-vaccination.pdf
The Pfizer-Biontech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers
