09/28/2021
Hello from InnerHealthMD,
Having received many good questions about COVID-19 vaccines, here is the short version of my update on this topic….
- Individuals vaccinated against COVID-19 are 5 times less likely to get infected with COVID-19, 10 times less likely to be hospitalized for COVID-19, and 11 times less likely to die from COVID-19.
- It is increasingly apparent that nearly everyone will either get COVID-19 (more than once) or be vaccinated (or both). The delta variant is much, more more infectious than earlier SARS-CoV-2 variants. Natural immunity varies by 200-fold and lasts as long as about 8-12 months (only 18% of Ketchum seroprevalence study participants with COVID19 infection still had detectable antibodies after 10 months). COVID-19 is mild for some, moderate for many, severe for a sizable few, fatal in a small percentage but large number of people, and causes chronic fatigue and other chronic symptoms in about 20-30%. It is unlikely that the 2020s decade passes with a large portion of the population having neither been infected with SARS-CoV-2 nor vaccinated against it, and most of those will likely either be living in a very highly-vaccinated local population or be living in a very rural, socially-isolated setting.
- COVID-19 vaccines are remarkably effective and safe; there is no statistically significant chance of death from receiving a COVID-19 vaccination. Though rare significant harm likely occurs, the odds of that are exceptionally and inconceivably small in scale. There are commonly reported side effects (sore arm, aching, fatigue, chills, headache), less commonly reported side effects (vertigo), and incredibly rare reported severe adverse events (myocarditis, blood clots, Guillain-Barre syndrome). No observable adverse impact on pregnancy has been observed, and infants born to vaccinated pregnant women all have measurable antibodies against COVID-19 infection.
- PfizerBNT 30mcg 3rd dose booster has been approved by FDA and CDC for the following:
1) Anyone 65 years of age or older
2) Anyone 18-64 years of age with medical conditions that put them at high risk of severe COVID-19 infection (including cancer, chronic kidney disease, lung disease such as COPD or asthma, coronary artery disease, hypertension, heart failure, HIV, dementia or other degenerative neurological condition, immunocompromised state, alcoholic or non-alcoholic liver disease, overweight with BMI 25-29, obesity with BMI > 30, pregnancy or recently post-partum, current or former to***co smoker, recipients of organ or bone marrow transplant, stroke or cerebrovascular disease, substance abuse disorders)
3) Anyone 18-64 years of age who is at high risk for occupational exposure (workers in health care, grocery, teachers, prisons, for example)
- Moderna’s and Johnson & Johnson’s booster data are pending review by FDA and then the CDC. I recommend waiting for that data to be released and FDA/CDC recommendation made before having 3rd Moderna or Janssen booster vaccine unless circumstances related to an immunocompromised state warrant consideration.
- It is anticipated that Moderna’s booster 3rd dose will probably be a half dose (50mcg rather than 100mcg given for the first two doses).
1) Any Moderna booster given at this point (recommended thus far for people with immunocompromised states) remains a full dose (100mcg) until that data has been reviewed and decision announced. A 100mcg dose would likely cause more immunogenic side effects than a 50mcg dose.
2) Johnson & Johnson has announced that it is requesting approval for a booster 2nd dose at or after 6 months from the first dose.
- Neither PfizerBNT, Moderna, nor Johnson & Johnson have announced whether there was a significant difference between the immune response versus the delta variant for those people receiving booster doses of their original vaccine versus their updated vaccine.
- Timing of boosters: I don’t feel that getting a booster "now" is a particularly urgent issue outside of those at greatest risk of severe infection (elderly and underlying conditions). I do think that having a 3rd mRNA PfizerBNT or Moderna (or a 2nd DNA Janssen) vaccine dose is a good idea as we get closer to 12 months after full initial vaccination. I do not expect that a 4th dose will be needed for at least a year afterward, or possibly quite a bit later than that. Time will tell.
- “Mix and Match”
It is not yet known whether it is better to give a booster dose with the same vaccine brand that a person received initially or whether it is better to cross over vaccine/booster combinations (referred to as “mix and match”), because all the studies have been with single-line vaccines (PfizerBNT-PfizerBNT and Moderna-Moderna). For now, I recommend that vaccine boosters be given consistent with the original vaccine received. In the meantime, the NIH began a “Mix and Match” study in June. Results probably won’t be published until next winter/spring.
- Children 55yo participants
- Completed PfizerBNT + booster Moderna
- Completed Moderna + booster Moderna
- Completed Janssen + booster Moderna
- Previously unvaccinated - standard Moderna 1st/2nd dose, then booster Moderna 12-20 months later (unless updated per Fall 2021 FDA/CDC Moderna booster timeline recommendations).
Novavax’s COVID-19 vaccine has been studied in >30,000 people, found to be 90.4% effective in preventing COVID-19 infection and reportedly has a better side effect profile compared with current vaccines (which are themselves very safe but do commonly cause several days of fatigue, chills, and aches in many, some other less common side effects in a sizeable minority, and incredibly rare instances of heart inflammation, blood clots, or neurological effects). It is a more traditional form of vaccine, delivering copies of the coronavirus spike protein to the body directly so as to provoke an immune response to the spike protein (rather than delivering mRNA so that our cells can make the spike protein first and then generate an immune response to it). While Novavax anticipates an ability to produce 2 billion doses a year by sometime in 2022, it has postponed applying for FDA approval until December 2021 or later, due to production scale issues. It has applied for approval by the World Health Organization and can be transported and stored at refrigeration temperatures, making it likely to benefit rural and underserved populations around the world.
Here is some information on COVID-19 vaccine safety with a focus on safety in children….
Summary:
While rare reports of significant harm by COVID-19 vaccines have been described and are summarized below, COVID-19 vaccines have a very good record of safety and effectiveness and represent a very important means of reducing deaths and hospitalizations, reducing the impact of pandemic on our economy and general way of life, and reducing the emergence of variants by reducing the number of people infected.
Mortality:
In regards to vaccine safety, fatality rates among the >100,000 study participants in the combined COVID-19 vaccine trials indicated that there is no vaccine-associated mortality compared with unvaccinated individuals. However, vaccinated individuals are 5 times less likely to get infected with COVID-19, 10 times less likely to be hospitalized for COVID-19, and 11 times less likely to die from COVID-19.
Myocarditis:
While there are rare serious adverse effects that can certainly harm, these are remarkably rare and almost always self-limited. There have been rare cases of inflammation in the heart in youth called myocarditis. For every 1 million COVID-19 mRNA vaccine doses given, there have been 67 cases of myocarditis in boys aged 12 to 17 (nine in girls of that age group), 56 in those aged 18 to 24 (six in girls), and 20 in males 25 to 29 (three in girls). That means the risk is about 6-7 per 1,000 in those age groups combined. Overall there have been 669 confirmed cases of myocarditis or pericarditis out of >300 million COVID-19 vaccine doses.
Blood Clots:
The risk of developing a blood clot following administration of the Janssen vaccine has been reported to be 39 cases out of >13 million doses as of July 2021, mostly in women 13 million doses of Janssen vaccine. This condition is rarely seen in response to a number of viral infections and rarely associated with other vaccinations.
Safety in Pregnancy:
A observational study of pregnant women receiving COVID-19 vaccination published in June 2021 in the New England Journal of Medicine included 35,691 pregnant women aged 16-54 yo and found no difference in adverse pregnancy and neonatal outcomes compared with studies involving pregnant women that were conducted before the COVID-19 pandemic. No report of nor proposed mechanism of action of persisting harm to reproductive health has been described.
Lastly, here is a sobering thought on COVID-19 in the years to come...
Consider measles. You can get it only once or you can have a pair of two vaccines - either way, immunity lasts a lifetime. Measles is crazy-infectious; it is an R0 of 12-18 (meaning that, on average, one infected person will infect 12-18 others). The percentage of society that must be vaccinated in order to prevent a measles epidemic is ~94% (for just a two-dose vaccine series for lifetime immunity).
Coronaviruses (the common cold ones and SARS-CoV-2) can infect someone about every 10-18 months or so. "Natural" immunity to COVID-19 varies by 100-200-fold in quality and wanes away by about 10-12 months in most. mRNA vaccine response duration is not known but based on the 6 month data, may last about 18 months (wild guess there, since the first ones were given about a year ago). The Delta variant of SARS-CoV-2 has an R0 of 6-9 (meaning one person can infect 6-9 others); this compares with the original SARS-CoV-2 virus which had R0 of about 2.2-2.9. Influenza has an R0 of about 1.3-1.8, maybe as high as 2). We didn't see influenza last year here locally, because we got serious about masking and distancing at the right times.
With measles having R0 12-18 and requiring ~94% vaccination rate to prevent epidemic outbreaks (of an infection that you can only get once), it seems likely that the delta variant of SARS-CoV-2 with its R0 of 6-9 would require a combined vaccination rate PLUS recent-last-year infection rate of somewhere in the range of maybe 80-88% (my best guess as a non-epidemiologist).
With such a huge number of people refusing COVID-19 vaccination, assuming that mass bad decision persists, it will take some 15-18% of the population getting infected with COVID-19 roughly every 1-2 years (about 30-50 million a year), along with 65-75% of us continuing to vaccinate at what could be 12-24 month intervals (wild guess, depending on duration of immune response to 3rd mRNA dose, ie: booster).
Living with COVID-19, masking/distancing when needed, vaccinating when it's time; rather than be "over it", get "good at it."
That wraps up this COVID-19 vaccine update.
Be safe, stay well, protect others, and be radically kind to everyone - meaning everyone.
Tom Archie MD
InnerHealthMD