Getting the Facts:
COVID-19 Vaccination Q & A
Updated: December 30, 2020
With all of the rapidly-evolving information around the COVID-19 vaccine, we want to share critical information with our patients so they can avoid potential confusion and make the best possible choice when it comes to this new vaccine. Here are some commonly-asked questions pertaining to the vaccine along with answers from medical experts. We hope this information helps to educate and dispel fears as we seek to mitigate the COVID-19 virus.
Vaccine Planning & Rollout
What is Illinois’ phased approach to the COVID-19 vaccination rollout?
This approach is being regularly updated. For the most current information, visit IDPH’s website: http://www.dph.illinois.gov/covid19/vaccination-plan
Phase 1: Limited supply of COVID-19 vaccine doses available.
- Phase 1a: Health Care Personnel and Long Term Care Facility Residents
- Phase 1b: Essential Frontline Workers and those 75 and over
- Phase 1c: Adults with high risk medical conditions and those 65 and over
- More guidance to come pending ACIP/CDC recommendations
Phase 2: Focus on ensuring access for Phase 1 not yet vaccinated, extend efforts to reach Phase 2. Possible groups could include:
- Workers in industries and occupations important to the functioning of society
- People with moderate comorbid conditions
Guidance from CDC will help determine who will be eligible in future phases.
Is SIH overseeing the regional vaccination rollout?
No. Per state guidelines, the COVID-19 vaccine is allocated through local health departments. At this time, SIH is only able to administer to providers and staff who work in the SIH system (this includes emergency medical personnel, medical staff, agency workers, etc.). Other individuals in Phase 1 should contact their employer, long term care facility or local health department for vaccination clinic information.
When will the vaccine be available to the public?
Initial supplies of the vaccine are limited, and therefore allocated to health care personnel and long-term care (LTC) residents and staff. Local health departments currently anticipate that it could be April 2021 before vaccination begins with the general population (individuals not eligible in Phases 1 & 2).
As information becomes available, we will share details in the SIH COVID-19 Community Update. Click here register to receive our weekly email and stay up to date with vaccine availability as well as other COVID-19 developments in Southern Illinois.
How has SIH determined vaccine priority for providers and staff in the system?
The vaccine is not mandatory. For those who are interested, a tiered approach, based on exposure risk, is being used to vaccinate staff in direct patient care roles first, along with some employees in roles caring for immunocompromised patients.
Have non-patient care individuals at SIH received the vaccine?
Yes. When additional vaccines are available at a clinic event, we may be able to open up some time slots for a limited number of SIH employees in non-patient facing roles to prevent vaccine waste.
Do I need to continue safety precautions after COVID-19 vaccination?
Yes. Individuals who have been vaccinated need to continue with masking, social distancing and all other recommendations. Why? After receiving both doses of the Pfizer and Moderna vaccine, individuals have a high likelihood of not getting sick if exposed to COVID-19 but potentially could still shed the virus after exposure and infect others. We want to emphasize the COVID-19 vaccine does not contain the virus and receiving the vaccine will not cause an individual to shed the virus.
Is the COVID-19 vaccine safe?
The initial vaccines we have received are from Pfizer and Moderna. Both received Emergency Use Authorization (EUA), have been tested on tens of thousands of people, and have passed safety requirements in Phase I, Phase II and Phase III trials. As an additional layer of protection, multiple independent groups made up of medical and research professionals have reviewed COVID-19 vaccine data. This is how it works for any vaccine seeking emergency approval:
- An independent group of experts, the Data and Safety Monitoring Board, reviews safety and efficacy data from the phase III vaccine trials.
- The FDA staff and their independent vaccine-advisory committee do their own reviews.
- The CDC’s advisory group, the Advisory Committee on Immunization Practices, reviews the data in order to make recommendations about which populations should be first in line to receive the vaccine.
Finally, vaccine safety monitoring systems are in place to collect side effect data. If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern. Experts then decide whether changes are needed in U.S. vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.
Who participated in the vaccine clinical trials?
Pfizer’s clinical trial enrolled 43,000+ participants with 42% globally having racially and ethnically diverse backgrounds. The Moderna phase 3 trials enrolled over 30,000 participants and 37% of the participant pool were from ethnic and racial minorities.
Does the vaccine alter your DNA?
No. Both vaccines utilize mRNA technology (more on this under Vaccine Ingredients) and never enters the nucleus of the cell and does not affect or interact with a person’s DNA. This has been verified by medical doctors independent of the vaccine development teams.
Can the vaccine give you COVID-19?
No. mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person.
Can you receive the COVID-19 vaccine when pregnant or lactating?
The American College of Obstetricians & Gynecologists (ACOG) has issued a practice advisory for clinicians in the treatment of pregnant and lactating women. The ACOG recommends that COVID-19 vaccines should be offered to pregnant and lactating individuals who meet criteria for vaccination. Since COVID-19 vaccine development and regulatory approvals are rapidly progressing, information and recommendations will continue to evolve as more data is collected. To read the full practice advisory, click here.
What ingredients are in the vaccine?
Both vaccines contain mRNA (“messenger” ribonucleic acid) as well as lipids to ensure delivery of the mRNA. mRNA contains instructions for making proteins. You rely on proteins every day to keep your body healthy. Our bodies use mRNA to tell our cells which proteins to make. In this case, they instruct the body to make COVID-19 antibodies. Vaccines that use mRNA are typically quicker and easier to produce, which has helped accelerate the COVID-19 vaccine development process.
Watch a video on how mRNA vaccines work.
Are mRNA vaccines new?
mRNA technology is new to use in a commercial vaccine, but not unknown. Researchers have been studying mRNA for decades. Early-stage clinical trials using mRNA vaccines have been carried out for influenza, Zika, and rabies. Beyond vaccines, numerous studies have used mRNA to stimulate immune responses targeted at clearing or reducing malignant tumors.
What ingredients are NOT used in the vaccines?
Several ingredients that have a history of use in vaccines were not used in Moderna’s or Pfizer’s COVID-19 vaccine. These include:
- Adjuvants (aluminum salts) or preservatives (ethylmercury)
- Fetal tissue
- Weakened, inactivated or live virus components
Vaccine Development & Approval Process
How were the clinical trials able to progress so quickly?
Pharmaceutical companies have dedicated significant resources to developing a COVID-19 vaccine because of the impact and severity of the COVID-19 pandemic worldwide. An emergency response was needed to combat this global health threat, but that doesn’t mean that critical safety protocols were overlooked or ignored. The companies involved in developing a vaccine have completed all of the regulatory steps required for product safety and high-level standards were maintained throughout the process.
In order to expedite the process, the U.S. government coordinated government agencies, international counterparts, academia, nonprofit organizations, and other pharmaceutical companies to develop a strategy for prioritizing and speeding the development of the most promising vaccines.
Did the vaccines go through FDA approval?
The FDA authorized the vaccines under an EUA (Emergency Use Authorization) based on two months of safety data. Both Pfizer and Moderna must collect six months of safety data to apply for full FDA approval. For an EUA to be issued for a vaccine, the FDA must determine that the known and potential benefits outweigh the known and potential risks. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 trial.
Has the approval process encountered disapproval or resistance?
No. To this point, public health officials from both independent and government agencies have expressed solid support for the vaccine. Regulators from Britain, Canada, and four other countries have also authorized the Pfizer vaccine based on their own analysis of the vaccine data.
Is the vaccine approval process influenced by political figures?
The approval process necessary for vaccine approval does not involve any elected officials. Rather, the scientific data and information generated by large-scale clinical trials is reviewed by the U.S. FDA, medical and public health experts from the Advisory Committee on Immunization Practices and the CDC before a vaccine is approved and made available. The federal governmental effort for the COVID-19 vaccine, called Operation Warp Speed, has no formal oversight of, or control over, the vaccine approval process that determines safety and efficacy.
For More Information:
CDC - https://www.cdc.gov/vaccines/covid-19/
FDA - https://www.fda.gov/
IDPH Vaccination Planning Guide - http://dph.illinois.gov/covid19/vaccination-plan
ACOG - https://www.acog.org/
Pfizer - https://www.pfizer.com/science/coronavirus/vaccine
Moderna - https://www.modernatx.com/covid-19-resources/publications-and-external-resources