COVID-19 VACCINATION INFORMED CONSENT FORM
A foundational principal for the ethical practice of medicine in America is informed consent.
Informed consent means the patient, or their guardian understands the rationale for the treatment being offered, and its benefits, risks, and alternatives to the proposed intervention. Proper consent also assumes each person has a right to refuse such treatment.
The following information is intended to inform individuals so that they can weigh their own personal risk of infection, versus the potential benefits and risks of accepting a Covid vaccination.
What is SARS-CoV-2 or COVID-19?
COVID-19 is a type of coronavirus. Coronaviruses are a large family of common viruses. Some cause mild disease like the common cold, and others may cause severe respiratory disease and death like SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).
Although COVID-19 has distinct properties, it shares many qualities of other coronaviruses. It is a similar size; it is highly contagious; and transmitted by respiratory droplets and aerosol. Mutation of this class of virus occurs with high frequency.
Until November of 2020, a vaccine against any type of coronavirus had never been approved, even under EUA for use in humans. Earlier attempts to develop a safe and effective vaccine in animals against SARS were unsuccessful.
How dangerous is the Covid infection?
It is important to assess your own personal risk when considering if a vaccination is right for you.
The data presented below predates the SARS-CoV-2 delta variant impact. The delta variant has been found to be 2 to 3 times more transmissible than the wild type or previous variants. This variant has been described as more transmissible than the chickenpox virus. It also is impacting younger immune naïve individuals to a greater degree than previous versions of this virus.
Infection Fatality Rates for SARS-CoV-2 (NOT including data from the current U.S predominant delta variant)
(source: European Journal of Epidemiology Meta-Analysis from 34 separate locations based upon seroprevalence data. These numbers are consistent with NIH data)
There are preexisting health conditions that increase the risk of adverse outcomes such as death and hospitalization. These include:
1. Obesity
2. Diabetes
3. Obstructive Sleep Apnea
4. Heart, vascular and lung disease
5. Hypertension
How do current Covid mRNA vaccines work?
Evergreen offers Pfizer and Moderna immunizations to our community. These companies developed a completely new vaccine technique to produce an immune response against SARS-CoV-2.
The vaccines inject messenger RNA (carrying genetic code) to instruct our own cells to produce a protein fragment that is identical to a spike protein of the SARS-CoV-2 virus. This protein produces an immune response intended to reduce the risk of infection and transmission of the virus.
Initially, the Pfizer and Moderna vaccines induced a robust antibody response and appeared to prevent infection 95% of the time to the initial wild type and alpha variant. However, as more variants have arisen, effectiveness has been shown to wane.
How does natural immunity work if one is infected and recovers from the virus?
Natural immunity has been shown to protect people who have recovered from infection for at least one year. This includes many in our population who tested positive for the Covid virus but were without symptoms. Multiple studies have validated this finding
Was the Covid Vaccine rushed?
Yes, and for good reason. Covid was considered an emergency. It was released under an emergency-use-authorization in Dec 2020. On 8/23/21 the Pfizer vaccine was granted full FDA-approval for those16 years of age or older, it is still available under EUA for children ages 12 to 15.
Covid-19 vaccines were developed and distributed faster than ever before in history.
The previous record time of production was 4 years to develop and implement a widespread vaccination program for the Mumps Vaccine. Scientists at the time used an existing well-researched technique.
Typically, vaccines take 10 – 15 years to develop.
The SARS-CoV-2 vaccines were developed, tested, and mass produced for distribution within 9 months.
What are the possible adverse effects to the Covid vaccine?
Much is unknown. There has never been a vaccine successfully created against any coronavirus before. There has been insufficient time and data to fully understand all the potential harms or adverse effects that may occur in years to come from the vaccine or conversely from potential harms that could come from COVID-19 infection itself.
Rare occurrence of life-threatening anaphylaxis reactions has occurred immediately after receiving a Covid vaccination.
The spike protein may create inflammation of the lining of blood vessels in some people. Inflammation in the walls of arteries is known to be a factor in causing clots and heart attacks.
People who have already recovered from a natural infection may have an enhanced inflammatory reaction to the vaccine. This may cause more severe symptoms of headache, fatigue, muscle pain, chills, and fever.
Most systemic post-vaccination symptoms are mild to moderate in severity, occur within the first three days of vaccination, and resolve within 1–2 days of onset.
Some physicians and research scientists have raised concerns that the vaccine may produce heart muscle and vascular inflammation that could increase risk of blood clots, heart attacks, or strokes in some vaccine recipients. These concerns are currently unsettled science.
What are Evergreen Family Medicine’s recommendations regarding Covid Vaccinations?
We recognize that it is a very personal decision. There is not a one answer that will fit all people and all situations. Please consult your provider if you remain undecided.
Pfizer has recently gained full approval for their mRNA vaccine. It is approved under the trade name COMIRNATY. It is indicated for active immunization against COVID-19 in individuals age 16 and older. The Pfizer BioNTech remains available for children over the age of 12 under an Emergency use authorization. Moderna is approved for EUA for people aged 18 and older. Evergreen Family Medicine does not endorse vaccine coercion or mandates. Private medical decisions should not be mixed with ideology or politics.
If you are over age 60 or an adult with chronic disease placing you at risk, we would recommend a Covid vaccine.
If you have had a confirmed infection with SARS-CoV-2, and you want to be vaccinated as well, we recommend waiting at least 90 days prior to receiving the vaccine. Also, there is consistent evidence that natural immunity is protective against reinfection for at least a year, likely longer. We have not found conclusive evidence that a Covid vaccine offers a higher level of protection than those who have had a documented natural infection. In our opinion, vaccination in naturally immune individuals would not receive a clear benefit, but they may be exposed to risk.
Parents who decide that there is a lack of scientific justification for subjecting healthy children to this vaccine, given that the Centers for Disease Control and Prevention have previously estimated a 99.997% survival rate if infected with SARS-CoV-2, are making a reasonable choice at this time.
As further information becomes available regarding Covid variant disease and vaccine safety, our recommendations may change.
Dr. Tim Powell
EFM CEO
Dr John Powell
EFM Medical Director