We are very excited to report that Lurie Children’s has received their fourth shipment of the Pfizer SARS-CoV-2 mRNA vaccine. We have now received nearly 7000 doses, which is enough to vaccinate nearly our workforce. We have vaccinated more than 3000 faculty and staff with plans to continue to vaccinate all of our team members over the next several weeks.
At this time, the Pfizer vaccine will be the only vaccine option for employees offered by Lurie Children’s. The Moderna vaccine will be provided to hospitals and clinics without the cold storage capacity we have secured here. Data suggest that the two vaccines are similarly safe and effective. The Pfizer mRNA vaccine is a new vaccine approved under an emergency use authorization (EUA) by the US Food and Drug Administration (FDA). For this reason, the vaccine will not be mandated by the hospital at this time. However, Lurie Children’s has reviewed the published data and guidance from the CDC Advisory Committee for Immunization Practices (ACIP). We strongly support their findings attesting to the safety and effectiveness of this vaccine for prevention of COVID-19 for most people. There are some patient populations that we do not know enough yet about safety and effectiveness to fully recommend the vaccine in those select patient populations at this time. Thus, in our efforts to make our healthcare environment as safe as possible, we hope that all of our employees choose to be vaccinated unless they have a specific medical condition that presents a caution or contraindication for receiving the vaccine as described below.
Here we provide information about the vaccine to the Lurie Children’s community to help you make an informed decision about this vaccine. In the coming days and weeks, we will provide additional information and answer questions as we receive them. We will host town halls, provide emails, and send additional information. We have also sent out an anonymous survey for you to express your opinions on what types of additional information you need and how we can best deliver it to you.
For additional information, please see these resources:
The fact sheet from Pfizer for those who receive this vaccine
Below is additional information to frequently asked questions, and those marked with an asterisk (*) are new or modified with updated information.
COVID-19 Vaccine Background, Safety, and Effectiveness
An mRNA vaccine is a new technology that uses your own cells to produce tiny pieces of a SARS-CoV-2 protein. Those tiny pieces then trigger your immune system to develop protection against the dangerous parts of the virus. This protection prevents COVID-19 after exposure to the real SARS-CoV-2 virus. These vaccines CANNOT cause COVID-19.
Yes, this vaccine was found to be safe during the four-month period that research subjects were followed thus far. Longer term safety evaluation is ongoing. In a large clinical trial, serious side effects were very rare and no different between those that got vaccine and those that received saline (placebo group). However, the vaccine still can cause side effects related to the immune response that is expected for vaccines. Mild-to-moderate pain at the site of injection, as well as headache and fatigue, are common after getting the vaccine. Symptoms such as these occur in 75-85% of vaccine recipients, similar to other common vaccines such as the Shingles vaccine. More severe reactions, such as fever and swollen lymph nodes, occurred relatively uncommonly (about 9% of vaccine recipients), and when they occur, usually were after the second dose. Side effects are typically short lived and more common after the second dose and in younger people (younger than 55 years old). Side effects are described in more detail by the CDC. If you have concerns about receiving this vaccine, or if you have any underlying medical conditions, please consult with your personal medical provider.
Allergic reactions of any type occurred in 0.6% of those receiving the vaccine and 0.5% in those receiving saline (placebo). One side effect, Bell’s Palsy, was seen in 0.01% of patients who got the vaccine, which is less than the general population. The FDA has plans to monitor for this. Sometimes very rare side effects cannot be recognized even in large clinical trials. This is true for all medications and vaccines after they receive approval or authorization from the FDA. Vaccine safety will be rigorously monitored, and if any very rare events are noted, we will share that with the Lurie Children’s community immediately. We are aware of reports of allergic reactions, and we are prepared to monitor for and respond to these rare events should they occur.
At this time, subjects in large clinical trials have been observed for at least four months from vaccine administration, and the side effects described above are those identified within four months of receiving vaccine. Currently, side effects beyond four months are unknown.
Because some pain or fever-reducing medicines can interfere with the immune response to vaccines, is it advised to not take pain medicine before the vaccine. If you experience pain or fever after the vaccine, you can take pain or fever-reducing medicines per the over-the-counter instructions or advice from your personal medical provider.
Regardless if you have had the vaccine, if you have symptoms consistent with COVID-19, or if you are experiencing other concerning side effects, please call the NM employee COVID-19 hotline as you would currently. The NM employee COVID-19 hotline will help determine if COVID-19 testing is needed and when you can return to work.
This vaccine is extremely effective when two doses are given 3 weeks apart. After the second dose, compared to those who did not get the vaccine, the vaccine prevented 95% of symptomatic COVID-19 infections in the four months after being vaccinated. This means you are 95% less likely to get symptomatic COVID-19 than you would have been if you did not get the vaccine. Importantly, this effectiveness was seen in adults irrespective of age, sex, race, ethnicity, weight, and medical condition, including previous history of COVID-19. The study was not able to determine if the vaccine prevents hospitalization and death, but a vaccine that effectively prevents symptomatic COVID-19 is expected to also prevent those complications from COVID-19.
We do not yet know if the vaccine prevents asymptomatic COVID-19 infections or transmission of SARS-CoV- 2 in the absence of symptoms.
Because the trial recently concluded, we do not know how long the protection lasts but we will learn more as the clinical trial subjects are followed for two years.
During a public health emergency, products to diagnose, treat, and prevent infection can be given emergency use authorization (EUA) by the FDA. In this case, initial data is rigorously reviewed to determine that it is first and foremost safe, and then determined that it has high likelihood of helping patients. An EUA lasts for one year and has to be renewed each year. Safety evaluation is not compromised when issuing an FDA. In the case of a pandemic, the bar for effectiveness may not be as high as full approval if the disease in question has significant potential to harm people in the community. This is true for COVID-19. Regardless, this vaccine was shown to be tremendously effective for preventing COVID-19 for at least four months after getting the vaccine. In the case of this vaccine, the clinical trial will be ongoing for two years to understand long-term safety and effectiveness, at which time full FDA approval may be granted.
Our goal is to provide vaccine to all of our healthcare providers, staff, volunteers, and affiliates as soon as possible. Our initial supply was limited to 1950 doses, and we will receive another 1950 doses this week. At this time, we do not know specifically when each individual employee will be vaccinated. In general, our phased approach to administering vaccine will be guided by the advice of the Chicago Department of Public Health (CDPH) who suggest that healthcare facilities should consider both frequency of exposure to patients with COVID-19 and risk of COVID-19-related complications when making decisions about vaccine distribution. Exposure is considered among all healthcare workers and staff along the continuum of care and includes those that provide direct patient care and employees who provide support to clinical team in patient care settings. The prioritization of healthcare workers and staff will be performed as listed below, and invitations for vaccine will be sent on a rolling basis as new supply comes available:
Those who have provided care to the largest volume of patients with COVID-19, especially those who do high-risk procedures on those patients, will be prioritized. Individuals who provide patient care generally (but generally not to patients known to have COVID-19) and who are at least 60 years old and/or have medical conditions known to confer higher risk for COVID-19 complications will also be prioritized. Invitations to this group have all been sent.
Next, healthcare workers with these high-risk conditions who do not provide patient care, and healthcare providers who have less likelihood of encountering patients with COVID-19, will be prioritized. Invitations to individuals in this group is ongoing based on vaccine supply.
This will be followed by healthcare workers who have conditions that might increase their risk of COVID-19 complications and those that have contact with contaminated specimens or equipment.
Next, we will vaccinate the remainder of our workforce who do not have patient care responsibilities and without any high-risk medical conditions.
Finally, we intend to offer the vaccine to individuals who are not employed by Lurie Children’s but who we consider very important members of the Lurie Children’s community, including volunteers, community physicians, contractors, etc.
To maximize protection against COVID-19, you need a second vaccine approximately 3 weeks later. The CDC has advised scheduling the second dose as close to day 21 as possible. While it is acceptable to schedule as early as 17 days after, the CDC would prefer scheduling the second dose 17-19 days after dose 1 only when necessary.
We understand that some employees and staff have appointments or employment at multiple medical centers, including NMH. If you are offered vaccine through another medical center, we encourage you to take advantage of the most immediately available option. You will be expected to receive the second dose at the location where you receive the first dose. Please email employee health at firstname.lastname@example.org with proof of vaccine if you are vaccinated elsewhere.
If you decline the vaccine initially, you can always change your mind and be scheduled later based on vaccine availability.
We are confident that we can continue to maintain a safe healthcare environment while vaccine supply improves over the next several weeks to months. The following are strategies that reduce risk of COVID-19: masking; physical distancing; hand hygiene; remaining compliant with Lurie Children’s infection prevention and PPE guidance; avoiding high-risk travel and large gatherings; avoiding coming to work sick and seeking testing when sick.
Currently, healthcare workers are prioritized for vaccination. Vaccination for patients age 16 years and up will start after completing healthcare worker vaccination. Vaccine is not yet authorized to be given to those younger than 16 years.
COVID-19 Vaccine in Special Patient Populations
This vaccine was not yet tested in pregnant or lactating women so we do not know for sure. The vaccine is being tested in pregnant animals, and data will be available soon. Future studies in pregnant women are planned. Pregnant and lactating women routinely receive vaccines safely. This vaccine does not cross the placenta. Pregnant women have an increased risk of severe COVID-19. Pregnant and lactating women will be eligible to receive this vaccine from Lurie Children’s but should first discuss this with their obstetrician and/or primary care provider. Women of child bearing age do not need a negative pregnancy test before getting the vaccine.
We do not know for sure because this vaccine was not tested in a large number of people with autoimmune diseases or weak immune systems, such as those with HIV, cancer, or those taking medicines that weaken their immune system. However, this is not a live vaccine so it cannot cause COVID-19 even if your immune system is weak. Those with a weak immune system might have an increased risk of severe COVID-19 infection and will be eligible to receive this vaccine from Lurie Children’s but should first discuss this with their healthcare provider.
In general, anaphylaxis to vaccines occurs approximately 1-2 times for every million doses of vaccine given. If you have a history of anaphylaxis to any vaccine ingredients (described in the Pfizer fact sheet), then you should not receive this vaccine. In consultation with our Allergy-Immunology experts, a history of anaphylaxis to any of the ingredients would be very rare. The most likely ingredient to which an allergy will occur is polyethylene glycol. If you have common allergies to medications, foods, inhalants, insects and latex are no more likely than the general public to have an allergic reaction to the COVID-19 vaccine. However, if you have a history of severe allergy to any vaccine or medication, you should first discuss the COVID-19 vaccine with personal medical provider.
To date, no cases of Guillain-Barré syndrome (GBS) have been reported following vaccination with a COVID-19 mRNA vaccine. Therefore, individuals with GBS can receive the vaccine. One side effect, Bell’s Palsy, was seen in 0.01% of patients who got the vaccine in the Pfizer clinical trial, which is less than the general population. The FDA has plans to monitor for this, but at this time, those with a history of Bell’s Palsy can get the vaccine.
To make sure you do not have a bad reaction to the vaccine, we recommend you be observed by the vaccine team for at least 15 minutes if you are pregnant or breastfeeding, have a weak immune system, have a family history of anaphylaxis, or if you have had a non-severe allergy to any item in the past. If you have a history of severe allergic reactions of any kind, such as anaphylaxis, we recommend you to be observed for 30 minutes.
COVID-19 vaccine has not been tested in combination with other vaccines, so we do not know if they interfere with each other. Therefore, you should not get other vaccines within 2 weeks before or after the COVID-19 vaccine.
As we learn more about this vaccine, clinical information and information about special populations will be posted by the CDC here.
COVID-19 Vaccine in those with history of COVID-19 Infection, Exposure, or Vaccine Clinical Trial
It is possible that the vaccine will provide additional protection that natural infection does not. Therefore, even if you had COVID-19 and/or have detectable antibodies against SARS-CoV-2, we still recommend getting the vaccine. In general, we recommend getting the vaccine when you are no longer infectious, which is typically up to 20 days after infection. It is thought that natural infection protects you for up to 90 days after infection. While you may choose to wait 90 days to get the vaccine, we are advising receiving it sooner while we have supply reserved for our healthcare workers.
We do not recommend getting antibodies tested prior to the vaccine. Even if you had COVID-19 and/or have detectable antibodies against SARS-CoV-2, we still recommend the vaccine.
If you have symptoms of COVID-19, you should not get the vaccine until COVID-19 has been ruled out. If you do have COVID-19, you should wait until 20 days after the infection has started before getting vaccinated.
If you have been recently exposed to someone with COVID-19, you should wait 14 days until after the exposure. If you do not have symptoms of COVID-19 at that time, you can then receive the COVID-19 vaccine.
If you received treatment for COVID-19 with monoclonal antibodies, you should wait 90 days before receiving the vaccine.
All clinical trials allow you to take steps to learn about new alternatives should they come available. When you are eligible to receive vaccine at Lurie Children’s, we advise you to discuss with the clinical trial study team of “unblinding” yourself to find out if you received vaccine or something that does not protect against COVID-19 (like saline, also known as placebo). If you received placebo, we recommend you to receive the vaccine from Lurie Children’s.
Life After the COVID-19 Vaccine
Yes, even if vaccinated, universal masking and infection control policies for patient care will continue to be in place. You should also avoid group gatherings. This is because it is not yet known if the vaccine prevents asymptomatic infection. Because the vaccine is not 100% effective, you should still avoid working when sick and get tested if you have symptoms of COVID-19. However, we anticipate that as more people get the vaccine that COVID-19 activity will decrease, eventually allowing us to discontinue universal masking and return to normal social activities.
We anticipate that as more people get the vaccine that COVID-19 activity will decrease and policies will change. However, at this time, we recommend all individuals follow policies for travel and quarantine after exposures that are based on health department guidance.
No, there will not be any additional blood draws or confirmation of immunity following the vaccine.
Avoiding Vaccine Misinformation
Unfortunately, there are a lot of people, both intentionally and unintentionally, sharing incorrect information about vaccines online. In general, please try to focus your attention on reliable sources, such as the CDC, the FDA, local health departments, your medical providers, and Lurie Children’s experts. Here is a website that provides more information about reliable medical information.
The COVID-19 pandemic required an urgent response to developing a vaccine. However, the Pfizer vaccine was subject to the same thorough safety evaluation as any other vaccine. A large phase 3 clinical trial was completed in more than 40,000 adolescents and adults. The FDA applied the same rigorous safety evaluation to this vaccine as to others. Here is more information from the FDA on this topic. Further, CDPH convened a workgroup to address this and confirmed the expected rigorous safety and efficacy evaluation process was appropriately performed.
No, mRNA viruses do not change your own DNA.
This is not true for the type of vaccine we will administer at Lurie Children’s. An unrelated vaccine in Australia resulted in false positive tests for HIV, and this trial has been suspended for this reason.