Steve and Bonnie: The sad truth is that we may not have needed vaccines if we all had optimal vitamin D levels and were practicing optimal self-care. It is a complete and utter failure of our government and public health experts not to address this on a nationwide scale. Moreover, the failure is compounded when there has been no discussion about improving our health and wellbeing during the pandemic. It is human nature to want to spend billions on a miracle cure, instead of millions on cheaper measures such as vitamin D testing, dietary improvement, and supplementation.
But we digress. The following concerns only the Pfizer/BioNTech, Moderna, Janssen/Johnson & Johnson (J&J), and Novavax vaccines as no other COVID-19 vaccine has been approved for use in the United States. NOTE ON FALL BOOSTERS - the FDA authorized new COVID boosters without testing them in people first. This lack of human data means we won’t know how effective the new shots are, if at all, and how safe they are, if at all, until the fall booster campaign is well underway. We have grave concerns about this tactic, especially for the safety of those getting their fourth, fifth, or sixth shot.
Proceed with extreme caution in light of new Centers for Disease Control data which found that almost half the people who were hospitalized with COVID-19 last spring had been fully vaccinated and received a third dose or booster shot.
Moreover, new research indicates the possibility that the virus is accumulating non-spike mutations in an attempt to gain some advantage over collective immunity, especially vaccine-induced immunity. While the new mutations may not make the virus more infectious the way spike mutations do, they could create longer infections.
PFIZER AND MODERNA VACCINES Are these vaccines effective? At preventing transmission of the virus SARS-CoV-2, no. However, data shows robust, long-term protection against severe illness and death, which is why they were fully approved in the United States. In the cases of fully vaccinated persons getting severely ill or dying, there is almost always one or more comorbidities involved. Updated booster formulas are expected this fall to better fight the Omicron variant. However, many experts believe Omicron will no longer be the dominant variant by fall, rendering the updated formulas superfluous.
How many doses do you need? In older age groups at high risk, obese and overweight individuals, and those with other COVID-19 comorbidities, two doses are recommended with a booster.
In younger, healthy adults, and those who already had COVID-19, consider only one dose without a booster. This is especially prescient in young males given the FDA's warning about myocarditis after receiving a second and third dose. Many countries only allow the Moderna vaccine for adults 30 and older as it has consistently shown higher risk than Pfizer. We suggest only the Pfizer for young males and females in all age groups. Note that data has consistently shown the risk for myocarditis is still higher from COVID-19 infection than the vaccine.
Immunocompromised For immunocompromised individuals, here is the latest from the CDC: "People over 18 who are "moderately to severely immunocompromised" and have received three doses of an mRNA vaccine may get a fourth shot (of either the Pfizer, Moderna, or Johnson & Johnson vaccines) at least six months after getting their third Pfizer or Moderna dose, per the CDC." The National Comprehensive Cancer Network (NCCN) has issued updated recommendations for vaccination and preventive treatment of COVID-19 for people with cancer.
Children and Teens
The FDA has authorized Pfizer’s three-dose vaccine for children 6 months to 4-years-old, and Moderna’s two-dose vaccine for children 6 months to 5-years-old. Pfizer/BioNTech was already approved for 5 years-olds and up. Moderna was already approved for 6 years-old and up.
The vaccine should be available for any parent that chooses to vaccinate their child, but healthy children do not need the vaccine. Exceptions include children with obesity, feeding tube dependence, immunocompromised children, and children living in crowded conditions where many are unvaccinated. If you choose to vaccinate your child, limit to one dose or see timing of two doses below. Also, follow our pre- and- post injection protocol that can be found below.
A study recently published in JAMA found mRNA vaccine to be immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. The CDC is encouraging all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated. This is a very personal choice and there is a lack of data to make a cogent suggestion.
Timing of Doses The CDC recommends eight weeks between the initial two vaccine doses for those over the age of 12, particularly young men. The three week (Pfizer) and four week (Moderna) intervals stand for individuals who are immunocompromised, over 65 years old, or in need of rapid protection against the coronavirus.
We think 12 weeks is better spacing between the first and second dose. While we do not recommend a booster, if you are healthy and decide to get it, we suggest waiting at least one year after you received your second dose.
FDA and CDC gave Emergency Use Authorization EAU) for a booster (third dose) for Americans 5 and older for Pfizer and 18 and older for Moderna. EAU is only voluntary, not mandatory. FDA authorized a full booster dose of Pfizer and half dose of Moderna (because of less side effects).
The booster should only be given to those older than 65 who are at high risk, anyone 18 and older with COVID-19 comorbidities (i.e. obesity, diabetes), and those who are severely immunocompromised.
Study after study finds the two-dose regimen exhibiting robust B cell and T cell protection against severe infection, especially from the Omicron variant.
Does the vaccine contain the SARS-CoV-2 virus? No. The function of these vaccines is different from any other that have been used on humans. mRNA vaccine research started after the first SARS outbreak over 17 years ago. While many other vaccines to be introduced will contain the dead virus, this vaccine only contains information (messenger RNA) that tells our immune system how to attack a specific part of the SARS-CoV-2 virus (the spike protein). This is what excites us the most about the possibilities of mRNA vaccines. They are noninfectious and contain no viral foreign proteins.
Can the vaccine cause harm? While the risk is low, vaccines do cause harm. Most side effects are minor and short-lived, but there is a small percentage of serious side effects.
Vaccine Adverse Events Reporting System (VAERS) and V-safe data suggest approximately 92% of side effects were non-serious; 6.6%, were serious, non-death; and 1.3%, were death. Participants self-reported local and systemic reactogenicity, more frequently after dose 2. Injection-site pain, fatigue, and headache were commonly reported during days 0-7 following vaccination. Reactogenicity was reported most frequently one day after vaccination; most reactions were mild. More reports of being unable to work or do normal activities occurred after dose 2 (32.1%) than dose 1 (11.9%); less than 1% of participants reported seeking medical care after vaccination.
However, we recommend those with severe allergies (that cause anaphylaxis), self history or family history of Bell's palsy, and autoimmune diseases discuss this in detail with your physician and other health care professionals that you trust.
Does the vaccine contain harmful preservatives and adjuvants? They do not contain adjuvants such as aluminum or mercury to super-excite the immune system, or preservatives such as formaldehyde to kill any contaminants from foreign material and the like. However, Pfizer just changed its buffering agent to TRIS, which is what Moderna uses, so we reserve the right to comment until we see more data.
What will I feel like after getting the vaccine? Most will experience at least one side effect, albeit minor. Women are more likely to experience stronger side effects than men. The majority will get one or more of the following right away, or 2 or 3 days after injection: injection site pain and/or rash, fever, chills, fatigue, headache, muscle pain, and joint pain. Those who have already had COVID-19 report more severe symptoms after inoculation. Data from The New England Journal of Medicine suggests local reaction to Moderna's COVID-19 vaccine can appear up to 11 days after vaccination and symptoms can persist for as long as 11 days.
A JAMA study of over 2 million US vaccine recipients found that 48 percent experienced fatigue after the second Pfizer dose, which was by far the most common side effect aside from injection site soreness. 60 percent of Moderna recipients experienced fatigue after the second dose.
More serious adverse events do occur, but are still a small percentage of doses administered.
There have been numerous reports of persons with post-COVID syndrome or "long haulers" feeling better or experiencing remission after getting the Pfizer or Moderna vaccine. Simply, in some individuals who got COVID-19, the infection led to faulty immunity, and the mRNA vaccine reset the immune system. This has been reaffirmed in a recent Medrxiv study.
A study from Medrxiv found that risk for side effects post-vaccination was lower in individuals with a healthier diet.
What if I do not have side effects after the first, second, or third dose?
You are not less protected than those who experienced side effects. Data suggests that upwards of 50% of vaccinated individuals may not experience any side effects. The most common side effect by far is short-term arm injection site soreness, which is minor.
Is there a SARS-CoV-2 titer to test immunity in those who had COVID-19? Researchers are not confident there will ever be a titer test for SARS-CoV-2. Much like the pertussis bacterium or other coronaviruses, it’s very difficult to pinpoint exactly what level of antibody response is needed. The FDA recently stated that it is against antibody testing for SARS-CoV-2 testing to determine immunity or protection from COVID-19, especially among those who are vaccinated. "The FDA is reminding the public of the limitations of COVID-19 antibody, or serology, testing and providing additional recommendations about the use of antibody tests in people who received a COVID-19 vaccination".
Are Pfizer, Moderna, CDC, and the FDA hiding anything? This has been the most transparent process to date for a vaccine rollout, but there is still room for improvement. The CDC and FDA safety data must be independently scrutinized because as the pandemic has endured, they have been less forthcoming with data.
Will the vaccine eradicate SARS-CoV-2? No. The World Health Organization and Centers for Disease Control both state that SARS-CoV-2 will be with humans for the duration, but in a much less virulent capacity if we are inoculated, much like the common cold affects humans currently.
Should I get the Pfizer/BioNTech or Moderna vaccine?
This is a very personal decision. If you decide to get Pfizer or Moderna, we suggest adhering to all the advice given in this opinion.
How can I minimize the side effects and increase the efficacy of these vaccines?
There are several suggestions we can make for anyone who is getting the vaccine now.
Have an ice pack with you to put on the injection site immediately after inoculation. Then, put it on the injection site every 30-60 minutes throughout the first day. This will help reduce inflammation.
If confirmed by your health professional, take arnica montana by mouth before and after the inoculation.
Take one 12 hour Claritin Reditab or Zyrtec and one Pepcid AC or three Alka Support one hour before inoculation. It is important to take an antihistamine to prevent overt mast cell/histamine production that could lead to anaphylaxis or overreaction.
Make sure your vitamin D levels are optimal prior to vaccination.
Get a good night sleep post-vaccination.
Do not perform rigorous exercise for 2-3 days after inoculation.
Directive for Athletes and Exercise There are valid reasons for why it is critical that physical activity be avoided for 2-3 days after getting a COVID-19 vaccine. First, there is increased risk for heart inflammation, especially in young adults (males even more so), the first few days after receiving the shot. Second, your immune response becomes heightened in response to the vaccine. Adding high intensity physical activity could create a hyper-inflammatory state.
The first-of-its-kind study in Medrxiv was just published examining elite athletes' response after getting the COVID-19 vaccine. The results show that there certain markers are heightened initially, and can last up to two to three weeks.
Thus, allowing the body to relax and immunologically respond while not taxing it with intense exercise is a safe, wise choice.
NOTE ABOUT PAIN RELIEVERS: Since mRNA vaccines were approved, we have recommended AGAINST taking ibuprofen or other pain relief medication prior to, and after, injection. The Centers for Disease Control agrees with us and added this caveat to their clinical considerations. The CDC added this consideration "because information on the impact of such use on mRNA COVID-19 vaccine-induced antibody responses is not available at this time". Doctors are also advising against doing steroid shots within two weeks of getting your COVID vaccine.
JANSSEN/JOHNSON & JOHNSON (J&J) VACCINE
The one shot J&J vaccine (now two doses are suggested) consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) based upon a platform that has already been studied as vaccines for Ebola, Zika, filovirus, HIV, HPV, malaria, and respiratory syncytial virus. J&J is not an mRNA vaccine. This vaccine does not contain live or dead SARS-CoV-2 virus or virus particles. **On Thursday, December 16, a panel of vaccine experts that advises the Centers for Disease Control and Prevention (CDC) on the use of vaccines in the United States said the Pfizer and Moderna mRNA COVID-19 vaccines should be preferred over the use of the Johnson & Johnson (J&J) shot for all adults because the J&J shot carries the risk for a rare but potentially fatal adverse effect that causes blood clots and bleeding in the brain.
From an ingredient perspective, while no heavy metal adjuvants such as aluminum or mercury exists, we are more concerned about the configuration of J&J's vaccine than either the Pfizer or Moderna. There are four corn-derived ingredients including ethanol (grain alcohol). There are several acid compounds including hydrochloric acid (stomach acid). Finally, polysorbate 80 is a preservative that is highly reactive in sensitive individuals.
For these reasons, we DO NOT recommend getting the J&J.
NOVAVAX VACCINE This the fourth vaccine approved in the United States.
Unlike the other three authorized vaccines, which deliver genetic material to direct protein production by the cells, the Novavax vaccine delivers proteins directly. This approach, called recombinant nanoparticle technology, is more traditional to vaccine development similar to influenza, pertussis (whooping cough), diphtheria, and tetanus vaccines.
Novavax uses the Matrix-M adjuvant that comes from saponins, naturally occurring compounds in the bark of the Quillaja saponaria (Soapbark) tree, commonly found in Chile. Saponins have a long history of being used for their medicinal properties. The Matrix-M adjuvant is mixed with vaccine nanoparticles to produce the finished, ready-to-use vaccine.
Adjuvants are used to "excite" the immune system to pay attention to the virus material. We have very little data on this more natural adjuvant and how it will affect humans. While we are encouraged that the adjuvant is not a heavy metal such as mercury or aluminum, there is still very little we know about it.
Data the FDA considered was tabulated BEFORE Omicron was the dominant variant, so we do not know how or if it works well on newer variants.
Data showed, as with the other three vaccines, a small risk for myocarditis and pericarditis. There were also similar non-serious side effects.
Active ingredients: SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 (SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373)
Inactive ingredients: CHOLESTEROL, MONOBASIC POTASSIUM PHOSPHATE, POTASSIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, POLYSORBATE 80, SODIUM HYDROXIDE, HYDROCHLORIC ACID
Novavax is a two shot regime. If you decide upon Novavax, please adhere to a minimum of 8 weeks between doses, although we prefer 12 weeks.
Many will be tempted to try Novavax because of the "natural adjuvant." Because we know so very little about it, we rate Novavax the same as Pfizer, but both rate higher than Moderna.
If you receive any COVID-19 vaccine and have side effects, you are encouraged to report it through the CDC's V-Safe app.
How Do I Know Which Vaccine I Am Getting?
You need to ask before you make your appointment. Once you're sure of which vaccine you are getting, have the technician show you the vial to which they are drawing from so you can be sure you are getting what you asked for.