How do vaccines work?
A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.
A weakened (or attenuated) whole-cell of a germ that causes the disease is injected. The germ is so similar to the natural germ, your body reacts the same and develops antibodies. Ex: Rotavirus, chickenpox, MMR.
A killed version of the whole germ that causes the disease. Ex: Polio, Hepatitis A, and Rabies.
Uses only specific pieces of a germ – not the whole germ – to trigger an immune response to that piece of the germ. When it encounters the whole germ later on, your body recognizes it and reacts. Ex: Shingles, Hepatitis B, and Pertussis.
*Other vaccine types not mentioned include: Toxoid, recombinant, and conjugate.
Types of Vaccines
What about the COVID Vaccine?
Most COVID-19 vaccines in trials are Sub-unit Vaccines – using the “spike protein” as the little piece of the germ to replicate. On its own, the spike protein is harmless, but is a key identifier of the virus for your body’s immune system to recognize and learn to fight.
mRNA Vaccine – Pfizer and Moderna
How are these different than other sub-unit vaccines? Other sub-unit vaccines take pieces of the actual germ and put those in the vaccine. Growing the germs in a lab takes time. With mRNA, we’re just using genetic information to get your body to build that piece of the germ. Your body is very efficient at growing things.
Aren’t mRNA vaccines new and untested? Yes and no. Yes they are new (relatively speaking) in the vaccine world. But this type of vaccine has been tested for about a decade, including multiple safety trials with years of data. A similar mechanism of utilizing mRNA is also currently being used to treat spinal muscular atrophy (SMA), and is being studied to treat multiple types of cancer.
DNA is the cookbook.
DNA tells you how to make the whole dinner – you can’t change the cookbook. mRNA is the recipe for just one dish you jot down on a piece of paper, copied from the cookbook, telling you how to make it.
Step 1 – Recipe just for spike proteins Lab takes the piece of mRNA sequence with instructions for JUST the spike proteins (the sub-unit for the vaccine) and sticks it in a fat nanoparticle. This is what’s injected during the vaccine.
Step 2 – Fat meet muscle The fat nanoparticle with the mRNA goes into your arm’s muscle cells, and the mRNA teaches the cell how to build the spike protein. But no risk of building the rest of the cells – no recipe for that.
Step 3 – You’ve smelled this recipe before… Your immune system identifies those spike proteins your cells created and mounts an immune response.
Pathway to a Vaccine
Pre-clinical Trials Basic research and preclinical studies, including animal studies. The initial research that supports this type of vaccine has been happening for years.
Phase 1 A small group of healthy people receive the vaccine, to test for safety in humans.
Phase 2 Expand the number of trial participants and study efficacy.
Phase 3 Now that we know it’s relatively safe and effective, vaccine is given to thousands of participants and monitored for efficacy AND safety.
Approval and Surveillance Continuing to monitor for ongoing safety and efficacy.
But how’d this happen so fast?
Overlapping Phases – not shorter The trial phases were not shortened at all, but allowed to overlap to reduce the time necessary to complete all steps.
Increased funding and political will Trials generally take a long time to gather sufficient funding and interest. COVID obviously had significant interest, leading to more easily accessible funding.
So many cases of COVID Most trials take a long time because you’re waiting for a certain amount of participants agree to participate and then to get sick. With COVID being so rampant, reached enough participants and cases quickly.
Simplified redtape Political will also lead to simplified redtape. This does not mean steps or rules were skipped, but rather COVID vaccines were moved to the front of the line for each necessary step.
What is it? A mechanism used to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.
Review Process 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 of the vaccine by conducting a comprehensive review of the safety and effectiveness data from phases 1, 2, and 3 of the trials.
Once Accepted An EUA fact sheet will be created and used to educate the public on the safety and effectiveness of each vaccine, along with recommendations on who should and should not get the vaccine.
- Under an Emergency Use Authorization a vaccine cannot be mandated or required*
Emergency Use Authorization
What do we know?
Requires two doses – 21 days apart
44,000 participants in trial
EUA approved on 12/11/20
Approved for 16 and older
Vaccine ingredients are:
- Fat bubble
- Salts to balance pH Sugar
- That’s it!
What do we know?
Requires 2 doses – 28 days apart
30,000 trial participants
EUA likely coming 12/17
Requested approval for 18 and older
Vaccine ingredients are:
- Fat bubble
- Salts to balance pH
- That’s it!
AstraZeneca, Johnson & Johnson, etc.
Viral Vector and inactivated vaccine types
AZ – two dose
J&J – one dose
40,000-100,000 trial participants
Still in Phase 3 – data coming early 2021
Many other companies also in trials.
Other Vaccine Candidates
Vaccine Effectiveness & Immunity
How effective are the vaccines? Efficacy rates for both Pfizer and Moderna sit around 95%
Is there immunity? We know that an immune response generally takes around 2 weeks post vaccination to build up in our systems. Since both Pfizer and Moderna are two dose vaccines, with almost a month between each dose, it could take up to 6 weeks to build up an immune response to COVID-19.
What defines effectiveness? There are a number of factors that contribute to what is considered “effective”, but one of the primary markers is a reduction in infection, in addition to markers looking at the ability of a vaccine to protect against severe disease and mortality.
How long will immunity last? This is something we are still learning about, and don’t have a definitive answer for.
Assessments are done in both…
Clinical Trials Data are collected on thousands of participants to evaluate effectiveness and safety. Clinical testing is done in a controlled environment, which is why additional real-world assessments are completed after clinical trials have finished, to continue to learn about the overall effectiveness of the vaccine outside of such a controlled setting.
Real World Conditions These assessments will compare groups of people who do and don’t get vaccinated and people who do and don’t get COVID-19 to assess how well COVID-19 vaccines are working to protect people. In addition, more data will be collected on participants who were under represented in the clinical trials.
Cumulative Cases placebo vs. vaccine
Moderna Vaccine – same curve seen in Pfizer
Vaccine Safety & Reactions
Definitions are Important
Side Effects = immune response Generally signs that your body is reacting how we expect. Ex: arm pain from your body’s immune system responding to invaders in your arm. Another way to think about it is taking Advil to reduce a fever, your fever going down isn’t a “side effect”, it’s the goal.
Severe Adverse Events The big, scary reactions that trials are watching for-require medical treatment, hospitalizations, permanent damage, or death. Example: Heart attacks.
Note! Not having “side effects” doesn’t mean the vaccine isn’t working! Just means your immune system is a bit more stealthy.
Mild to moderate, self-limited side effects were common. Pain at the injection site, muscle/joint pain, fatigue, and headache were most common complaints.
Side effects were more common after the second dose. Usually occurred 1-2 days after a dose, with a median duration of 1 day for Pfizer and 2 days for Moderna.
VERY few severe side effects. “Severe” side effects prevented daily activity. Example: bad enough headache to spend the day in bed.
Side effects less common in older adults (over 55).
Nitty Gritty – Pfizer side effects
Pain at the injection site 83% after first dose (14%) 78% after second dose (12%) only 1% severe (<1%)
Fatigue 47% after first dose (33%) 59% after second dose (23%) only 3% severe (1%)
Headache 42% after first dose (34%) 52% after second dose (24%) only 2% severe (1%)
New or worsened muscle pain 21% after first dose (11%) 37% after second dose (8%) <1% – severe (<1%)
About 36% of participants used pain medication/fever reducer after a dose.
Nitty Gritty – Moderna side effects
Pain at the injection site 75% after 1st dose (13%) 84% after second dose (12%) only 2% severe (1%)
Fatigue 39% after first dose (29%) 68% after second dose (25%) only 6% severe (<1%)
Headache 35% after first dose (29%) 63% after second dose (25%) only 3% severe (1%)
Chills 9.2% after first dose (<1%) 48.3% after second dose (2%) only <1% severe (<1%)
Other effects seen include joint pain and body aches.
Incredibly rare across all vaccines
- Allergic reaction is most common – 1.3 people for every million vaccine administered (33 cases this year, out of 24 million doses in the US)
- Guillian-Barre Syndrome in 1 person for every million
Things that are more likely to happen than an allergic reaction
- Crushed by a meteorite (1 in 700,000)
- Become a billionaire (1 in 785,000 in US)
- Go to the ER with a pogo-stick injury (1 in 115,300 in US)
Other severe reactions
Talking about a handful of cases across trial and placebo – everything looks balanced between groups and in line with what we’d expect of general public.
- a few cases of Bell’s Palsy
Severe Adverse Reactions
Long-term side effects
Definitions are important here too!
Side effects that arise soon after vaccination with long – term consequences These are the severe adverse events we just talked about. Usually seen in the trial, but some are so rare we don’t see them – that’s why we continue to monitor vaccines on the market. Vast majority are seen within the first two months – why FDA requires a minimum of two months of data.
“latent” side effects arising months/years later Basically not a thing, except for Varicella vaccine causing shingles later in life.
Not really a thing.
Varicella (chickenpox) is only example where this happens, causing shingles later on. Unique combination of varicella being a live vaccine and the ability of the varicella virus to have a dormant period. This same thing happens if you had chickenpox naturally.
Science The mRNA that goes into your cells breaks down quite rapidly and do not have the ability to reproduce themselves. So the actual vaccine gets processed by your body quickly and doesn’t hang around to cause long-term issues.
Eligibility to Receive the Vaccine
Under an EUA, the government cannot require you to receive this vaccine, but based on your role as an essential worker you could be eligible to receive a vaccine in the near future if you choose. This would be available to you sooner than the general population. Spouses, children or other family members can not receive the vaccine based on your essential worker eligibility.
When are people eligible to receive a COVID-19 vaccine?
It’s based on prioritization of populations and availability of the vaccine. It will be rolled out in phases decided by the Advisory Committee of Immunization Practices (ACIP).
Upon initial roll-out, health care personnel and long term care residents were included in the first phase of vaccination; this includes staff who work in long term care. The CDC has since changed requirements and eligibility. If you would like to be vaccinated, please call the Roseau County COVID Info Hotline for the latest vaccine eligibility: 218.463.4779
I have underlying health conditions or am immunocomprised?
Maybe! Talk with your provider on risks and benefits of receiving a COVID-19 vaccination. Vaccine may be administered to persons with underlying medical conditions who have no contraindications to vaccination.
I am pregnant and/or breastfeeding?
Yes. The FDA did not exclude pregnant/or breastfeeding people from the vaccine. Talk with your provider to determine if it’s the right option for you!
I got my influenza shot last week?
Wait at least 14 days, Pfizer COVID-19 vaccine should be administered alone with a minimum interval of 14 days before or after administration with any other vaccines. They need more information at this point for other vaccinations at the same time.
I already had COVID-19 infection?
Yes. At this time we are unsure how long immunity lasts from a COVID-19 infection. Reinfections can occur so a person could still benefit from vaccine immunity.
I have an active COVID-19 infection?
Yes, but wait until you are out of isolation. You should be recovered from the illness and met criteria to discontinue isolation. No minimal wait time between infection and vaccination. However, current evidence suggests reinfection uncommon in the 90 days after initial infection so a person may defer vaccination until the end of this period.
I am a known exposure to someone with COVID-19?
Yes, but wait until you are out of quarantine. You should be out of your quarantine period before going to get a vaccination to reduce spread to personnel administering the vaccine.
Can You Get Different Covid-19 Vaccine Brands?
Simply put, no. Vaccine brands are not interchangeable.
But I heard this thing on Facebook… Social media myths.
Will the vaccine change my DNA? No! DNA to RNA is unidirectional. Remember the DNA = cookbook analogy. Just because you have a recipe written down from a different cookbook (mRNA) does not change your cookbook.
Will the vaccine cause me to be infertile? No – myth comes from an online message board. Someone noticed a chain of amino acids in placenta protein matched a chain in the spike proteins. Match = 5-6 in a row (out of 1,273 amino acids.) Need 60+ in a row to be interesting. Plus, placenta isn’t formed until around 12 weeks.
Does the vaccine contain fetal cells? No! The mRNA comes straight from the coronavirus and is stuck in a tiny fat cell. Nothing from fetal cells is found in the vaccine.
Does the vaccine give me COVID? No! Because the vaccine only contains information to form the spike protein and not the entire virus, you will not get COVID-19 from the vaccine.
Do you get a COVID-19 Card? Yes! It’s like the reminder cards you get at the dentist. When you’re vaccinated, you will receive a small card that tells you:
- The date you were vaccinated.
- What vaccine brand you were given.
- The date you will need your 2nd dose.
Is there a tracker in the vaccine? No! The only things in the vaccine are mRNA, a fat bubble holding the mRNA, salts (to balance the pH), and sugar. That’s it!
LifeCare Public Health is the provider to distribute the COVID-19 vaccine in Roseau County.
LifeCare Public Health in partnership with Roseau County Altru Clinics; Mattson Pharmacy, Greenbush Pharmacy and Thrifty White are working diligently on planning and distributing COVID-19 vaccine in a phased approach set forth by the Federal and State Government.
For daily covid vaccine updates, please call the Roseau County Covid Info Hotline: 218.463.4779
How much does it cost to get the vaccine? Free! COVID-19 vaccine will be provided to people at no cost.
*DISCLAIMER: Information may change as new data becomes available. We will do our best to put out information as we receive it!