Updated: 4 days ago
OUR COVID-19 VACCINE OPINION
*Updated sections will show the date in this color.
Steve and Bonnie: The sad truth is that we may not have needed vaccines if we all had optimal vitamin D levels. A study from May's American Journal of Clinical Nutrition found that habitual use of vitamin D supplements was associated with a 34% lower risk of COVID-19 infection. A study from American Journal of Clinical Pathology found an almost 4-fold increase in death for hospitalized subjects with vitamin D deficiency. The United Kingdom, the Andalusia region of Spain, and other nations understand this, and have given out free vitamin D3 supplements to the most vulnerable.
It is a complete and utter failure of our government and public health experts not to address this issue 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 and supplementation.
But we digress. The following concerns only the Pfizer/BioNTech, Moderna, and Janssen/Johnson & Johnson (J&J) vaccines, which have received emergency authorization. No other COVID-19 vaccine has been approved for use in the United States. Note: at the end of this article, we provide our general opinion based upon the information on vaccines that haven't been approved.
PFIZER AND MODERNA VACCINES UPDATE 6/21: Are these vaccines effective? Yes. 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. The initial group of subjects Pfizer and Moderna have been tracking have shown robust protection for six months and counting.
In the June 16th issue of CDC's Morbidity and Mortality Weekly Report, in real-world conditions of health care personnel, first responders, and other essential and frontline workers in eight U.S. locations, mRNA vaccine effectiveness for prevention of infection was 90% for full immunization and 80% for partial immunization.
For more real-world tracking, Israel recently reported no COVID-19 deaths for the first time in 10 months. The first nation-wide COVID-19 vaccine effectiveness study has been published in The Lancet. Tracking nearly 5 million people fully vaccinated in Israel, the study found vaccination provides more than 95 percent protection from infection, hospitalization, severe illness, and death.
Closer to home, a study of 280 nursing homes in 21 states across the U.S. provides real-world confirmation of the COVID-19 vaccines' effectiveness: About 1% of residents tested positive for the virus within two weeks of receiving their second dose, and only 0.3% did more than two weeks after being fully vaccinated, researchers reported in the New England Journal of Medicine. Most of the cases did not produce any symptoms.
The CDC gave new direction regarding the amount of time between the first and second dose of Pfizer or Moderna. The CDC states you can wait a maximum of six weeks between the first and second dose. This is a departure from their original direction.
So this begs the question: do we need two doses? It depends. In older age groups, obese and overweight individuals, as well as those with COVID-19 comorbidities, two doses are necessary to be effective. However, in younger age groups, healthy individuals, and those who already had COVID-19, one dose should be ample. This is especially prescient given the FDA's emergency meeting last week to discuss the increasing cases of myocarditis in young males after receiving the second dose. If you followed this weekly updated piece, we mentioned several months ago that Israel found the myocarditis issue in young males after the second dose. Simply, a second mRNA vaccine dose in young, healthy males is overkill.
A single dose of Pfizer or Moderna’s COVID-19 vaccines was 80% effective in preventing coronavirus infections, according to a Centers for Disease Control and Prevention study of vaccinated health-care workers. Mayo Clinic findings show Pfizer and Moderna's vaccine gives 75% protection from infection 15 days after 1st dose, rising to 83% after 36 days. Israeli Health Ministry found Pfizer’s vaccine 75% effective at preventing infection two to four weeks after a single shot. Researchers in the New England Journal of Medicine recommend delaying the second dose in order to cover all priority groups as the first dose is highly protective. The United Kingdom's one dose strategy for vaccinating their entire population before administering the second dose has been very successful and is showing greatly reduced severe disease.
In an Medrxiv study, subjects who already had COVID-19 exhibited immune memory and had a robust response to the first dose of an mRNA vaccine. Moreover, another study in Biorxiv showed a reduction of cellular immunity in COVID-19 recovered individuals who got the second dose of the Pfizer vaccine. This shows that those who already had COVID-19 may require only a single dose of vaccine.
With regard to protection from new SARS-CoV-2 variants, there is not enough data to offer a definitive opinion. Although, research suggests mRNA vaccines offer protection to keep us from the worst outcomes, such as hospitalization and death, to the six most prevalent variants.
Less than 1% of the fully vaccinated have had "breakthrough cases," meaning they still get infected with COVID-19, albeit it much less severe. This is much less than the 10% Pfizer and Moderna predicted initially.
Does the vaccine contain the SARS-CoV-2 virus? No. 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? Over 300 million doses have been administered to date, with approximately .005% serious side effects. However, we recommend those with severe allergies (that cause anaphylaxis), self history or family history of Bell's palsy, and autoimmune diseases postpone getting the vaccine as long as possible. We discussed the myocarditis issue in young males earlier in this piece.
The first studies done on individuals with autoimmune diseases have been published and they are encouraging. The first study from Annals of the Rheumatic Diseases states that overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue. However, none of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment. In the same journal, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of with an rheumatic disease at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine. A study in Medrxiv found patients with chronic inflammatory diseases such as inflammatory bowel disease, rheumatoid arthritis, spondyloarthritis, and systemic lupus erythematosus mounted immune responses after two doses of mRNA-based COVID-19 vaccines, though glucocorticoids and B-cell–depleting therapies markedly reduced the response.
There have been several cases of shingles that occurred shortly after the inoculation in Israeli citizens with autoimmune disorders such as rheumatoid arthritis, according to this study.
One study showed that the drug Methotrexate, taken by those with IBD and Crohn's disease, blunts the effectiveness of mRNA vaccines. Six million Americans are taking these kinds of immunosuppressants that could interfere with the vaccine.
The immune response is complex, so even for those who are immunocompromised who are discouraged when their IgG and IgA antibodies show no response to the vaccine, a study in Nature Medicine suggests T-cells can still generate a response.
Does the vaccine contain harmful preservatives and adjuvants? Only one potential preservative and much less than any vaccines that have preceded them. One reason we are encouraged by the mRNA vaccine is it does not require 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. Some experts suspect that the allergic reactions that have occurred so far could be due to a component of the nanoparticle called polyethylene glycol (PEG), a preservative that is in both vaccines.
If you are worried about a potential allergic reaction to PEG, you can ask your allergist for a skin test, as the first PEG anaphylaxis case just appeared in Clinical & Experimental Allergy.
What will I feel like after getting the vaccine? Public health officials are very transparent and state that most will experience at least one side effect, albeit minor and expected. Women are more likely to experience stronger side effects than men. The Pfizer/BioNtech vaccine requires two doses 21 days apart. Moderna requires two doses 28 days apart. There will most likely be discomfort after one or both injections, especially at the injection site. 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. We are concerned for those with allergy anaphylaxis history, self history or family history of Bell's palsy, or autoimmune disease, which is why we suggest postponing as long as possible.
One client complained of tinnitus symptoms after one dose of Moderna. There are anecdotal reports of this issue, but not enough cases to become a recognized issue as of yet.
There have been numerous reports of persons with post-COVID syndrome or "long haulers" experiencing remission of symptoms after getting the Pfizer or Moderna vaccine. The first study to possibly explain this phenomenon recently appeared in Medrxiv. Simply, in some individuals who got COVID-19, the infection led to faulty immunity, so their immune systems either do not go back to normal, or the virus is still active, albeit a less severe manner. The mRNA vaccines reset the immune system properly so it either eradicates SARS-CoV-2 and/or calms the immune system.
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 and/or second 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 we have ever witnessed for a vaccine rollout. The fact that vaccines often take a decade(s) to get approved, and this vaccine received emergency approval in less than one year, warrants the over-the-top transparency. Pfizer provided unprecedented access into how it makes its mRNA vaccine in this recent article.
CDC released safety data after administration of 13.8 million doses of the Pfizer/ BioNTech and Moderna vaccines. In a recent Morbidity and Mortality Weekly Report, 6,994 reports of adverse events after vaccination were recorded in the national surveillance system/app with 90.8% of them classified as non-serious and 9.2% as serious. A total of 113 deaths were reported. While no causal link between COVID-19 vaccination and fatalities were reported, investigations are ongoing. Experts now recommend patients schedule their mammogram before receiving a COVID-19 vaccine, or space out the two appointments, after some women have been mistaking swollen lymph nodes for breast lumps. These swollen lymph nodes, which are a side effect of the COVID-19 vaccine, can also show up in mammograms and other types of imaging scans
The CDC and FDA have watered down the strength of their safety warnings since the rollout. The safety data also must be independently scrutinized. We will not downplay the seriousness of safety when it comes to these vaccines and will keep you informed every step of the way.
The CDC has also recommended women speak to their physician about putting off their mammograms if they have recently received a COVID vaccine.
Is this vaccine approved for very young children or pregnant women? The Pfizer/BioNTech has only been approved for 12 years and older and the Moderna for 18 years and older. 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.
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. We have already seen mutant, more contagious, and in some cases more deadly, strains appear in almost every part of the world. The wonderful thing about mRNA vaccines is that they can be quickly manipulated to address mutations that may occur. Data in The Lancet and New England Journal of Medicine has shown fully vaccinated patients are able to stave off severe disease from the B.1.1.7, B.1.351, and P.1 variants so far. The mRNA vaccines seem to show some effectiveness against the variant from India, B.1.617, that has the world most concerned.
mRNA vaccines not only lower severe infection and death, but new data from Journal of the American Medical Association is the first to show the vaccines can reduce the number of asymptomatic infections, which is a major cause of transmission.
There are rare cases of "breakthrough infections," which means full vaccinated individuals can still get COVID-19 infection. Research has shown in these cases, viral RNA load is much lower, and symptoms and illness duration are much reduced.
How do the Pfizer/BioNTech and Moderna vaccine differ? The vaccines both use a genetic molecule called mRNA that is enclosed in a nanoparticle to deliver instructions to cells to make the coronavirus’ spike protein, which the virus uses to break into cells. The immune system then learns to recognize and defend against the spike when it is encountered in an infection.
While both vaccines showed virtually the same success rate in reducing infections requiring hospitalization, early evidence suggests that Moderna’s may do a better job fending off symptoms as early as two weeks after the first dose (80 percent versus 50 percent). Some early data also suggest that the Moderna vaccine might protect vaccinated people from asymptomatic i