July19th, 2021

Delta is here in significant volumes and almost all cases are in unvaccinated individuals. This is not an accident of viral activity so much as a problem of choice and outcome.

Latest numbers google/CDC

Most states are at a steady state with vaccinations but now disease from SARS2 is on the rise again because of the steady state. Almost all cases are in unvaccinated persons. There does not seem to be any further movement on the vaccine front. There are increasingly larger pockets of disease in poorly vaccinated communities. Hospitalizations are mildly on the rise but that is likely to change rapidly for all unvaccinated communities and people.

The vaccines continue to be effective against all of the variants including Delta. We will be watching the lambda variant closely for vaccine response but it also appears sensitive to the mRNA vaccines.

As it stands today, the United States has had 34 million known cases and almost 608,000 deaths. This is 3000 more deaths than 2 weeks ago which is the lowest death toll over a 2 week period for quite some time.

There is still no change in the knowledge that more than 80% of deaths are skewed toward the over 55 age group and 94% of all deaths occurred in a person with a co-morbid chronic health disease. More biological antibody medicines are on the horizon that may along with a mixture of vitamin A , D, zinc, quercetin and melatonin be employed for a safe resolution to COVID19. If you did not read the newsletter about an Integrative approach to health in the COVID era, read this link and this link.

As with the first newsletter on this topic, keep solace with the fact that there is a 99+% chance of survival for all of us.

 

Mathematically, you now have a 99.9998% chance of survival once vaccinated and the vaccine safety for the mRNA vaccines continues to look good.

This is much safer than driving a car!

 

 Coronavirus Update 40

It is time for a change of direction for me and my vaccine thoughts. A lot of risk analysis this week in children and opinions on masking to be in schools. I have been steadfastly in the push to vaccinate high risk kids over age 12 years only and all else make individual choices. The data keeps shifting and the risk of a potential concern is increasing for adolescents. Read on....

Quick hits

1) COVID mRNA vaccines for 12 and over - a few days ago, I had the pleasure of interviewing Dr. Danny Benjamin, Professor of Pediatric Infectious Diseases at Duke University and Principal Investigator on the NC school COVID study, about the COVID vaccine, variants and risk factors for problems in children. He is a brilliant and thoughtful teacher and someone that I truly trust. Our interview will be live in 1 - 2 weeks at the Women and Children First Podcast on Apple podcasts. However, there was one HUGE takeaway that I wanted to share now.

According to Dr. Benjamin, the COVID vaccine has already surpassed the necessary amount of time and number of inoculated children over 12 years of age to steadfastly discuss safety as a net known entity. In the history of vaccine development, there has never been a case of a new unknown side effect being discovered 6 months post any individual vaccination if enough people have been vaccinated to see a signal. As was the case with Rotashield, it took a few years to see the intussusception signal that caused the vaccine to be halted. The mRNA Covid vaccines have been administered to enough children, that we have passed that threshold. According to the CDC over 7 million children have received both doses of the vaccine.

He added a clarification post interview:
There are adverse events, AE, that are: a) discovered “late” in the life cycle of the vaccine (e.g., we did not see myocarditis in the mRNA vaccine until they were on the market 6 months, primarily because young people were not getting the vaccine which is the group primarily affected). This can occur, but is extremely unlikely now because so many people have received the mRNA vaccine. The one caveat is that not many young children have received the vaccine, so this is still possible for children <12. b) the belief that there are AE's discovered 12 months or 3 years after an individual receives the vaccine. E.g., the delusion that mRNA impacts fertility. This category has not happened in the history of vaccinology.

Based on the weight of the evidence and my trust in Dr. Benjamin, I am now steadfastly recommending an mRNA vaccine for all children that are 12 and older regardless of risk or comorbid health condition. Changing my mind is a reflection of the changing known data sets, safety of vaccination versus contracting the virus and my trust in Danny. I take these decisions very seriously as I impart this information to you. I always make these decisions based on my own children and your child as well. That being said, this is a personal choice and not one that I would force on any one. As always, I am here to help with data and decision making and that is all. Please do not email me if you are upset with my analysis and choice unless you have data that is useful. I know that there are those of you out there that disagree with this assessment and that is ok. Discourse is the key. We are all in this together.

2) A second take away from the interview was that masking worked very well in schools during the pandemic. Dr. Benjamin stated that no matter what happens moving forward, we should be back in school face to face full time as masking works to stop the spread of SARS2 in schools. Regardless of vaccination status and area SARS2 volume, school activity is safe with masking in place. There has been a lot of fuss over masking for good reason as it is a major annoyance, terrible for the environment and difficult socially for children. However, we have never faced a virus of this infectious capability coupled to its morbidity strength. Therefore, we really need to think about our frustrations in a new light, children's health and in person education.

The MOST IMPORTANT EVENT THAT MUST OCCUR IN THE FUTURE FULL STOP is that children NEED TO BE IN SCHOOL FACE TO FACE FULL TIME FOREVER! We can no longer sanction the educational and emotional nightmare that was last year's virtual learning debacle. And it was all of that and more!

Thus, if we have to suffer masks, which I hope that we do not, in school and out in the environment to have in person school, then we must do this. In my mind, we should all get vaccinated and prevent this problem from manifesting as it is starting to again with the delta variant. Almost all cases that are occurring now are in unvaccinated individuals making the threat of all kinds of dysfunctional methods like lock downs and virtual schooling leave the lips of some in power. We should never go back to that reality as it will haunt us for decades as our stunted children's health and economic trillion dollar handout has to be reckoned with.

I agree with my friend that masking in schools should occur if there is another major spike in disease as many children will not have the opportunity to receive the vaccine coupled to the fact that they are not the major spreaders of disease to begin with but need to be in school no matter what. Currently, masking does not seem necessary and especially not for outdoor sports, but as always, this is a fluid reality.

3) An article in NYTimes Magazine is a worthy read: The Kids Are Alright - Why now is the time to rethink COVID safety protocols for children — and everyone else. (Wallace-Wells, D. 2021) This follows perfectly the above discussion as this article dives deep into a child's COVID health risk overall. The statistics, as I have shown for months, are mirrored in this comprehensive article. The risks of death are infinitesimal overall compared to total case volume in children. The risks of complications are very very small. Simply put, children have low low risk, but again, this is not zero risk.

Therefore, again, we look at all of the data and understand that if we as a society vaccinate effectively and use masks where necessary, unlikely necessary in children, especially young children, currently, life is almost back to normal pending a wholesale variant shift that escapes the mRNA vaccines. Adults and young adults are the vast majority of COVID spreaders especially the super spreaders. Thus, I would recommend that we vaccinate the adults and not mask the children.

4) COVID19 and MIS-C (PIMS-TS) are very rare in children. A new study from the UK states: "Within COVID-19, there were 6,338 hospital admissions, 259 PICU admissions and 8 deaths. Within PIMS-TS there were 712 hospital admissions 312 PICU admissions and <5 deaths. Males were 52.8% of COVID-19 admissions (similar to other causes of admission), but were 63.5% of PIMS-TS admissions. Children and young persons (CYP) aged 10-17 were 35.6 and 29% of COVID-19 and PIMS-TS admissions respectively, higher than in all admission and influenza admissions in 2019/20. In multivariable models, odds of PICU admission were: increased amongst neonates and decreased amongst 15-17 compared with 1-4 year olds with COVID-19, increased in older CYP and females with PIMS-TS, and increased for Black compared with White ethnicity in COVID-19 and PIMS-TS. Odds of PICU admission with COVID-19 were increased for CYP with any comorbidity and were highest for CYP with multiple medical problems. Increases in risk of PICU admission associated with comorbidities showed similar patterns for COVID-19 and all admissions in 2019/20 and influenza admissions in 2019/20, but were greater for COVID-19." (Harwood et. al. 2021)

Again, following the theme of risk as a means to choose vaccine, lifestyle and other decisions, we must have data. Here is another solid piece of data showing very low risk overall. However, never interpret this as no risk as the parents of the 8 deceased children and the 259 seriously ill children would speak to the other end of the coin of choice. We all must measure our reality of risk tolerance.

Let me summarize here.

Based on current data, I believe that the virus is more likely to plague us at all ages past 12 years old with worsening morbidity and mortality with each passing year and lifestyle negative decision. The balance of the data tells me that the mRNA vaccines are less risky on balance overall.

Risks occur primarily with advancing age, comorbid disease and occasionally are sex genetic based.

a) Multiinflammatory syndrome in children - rare - roughly 73,000,000 children and adolescents under age 18 based on the census. 4196 MIS cases and 37 deaths (Census)(CDC) Median age 9 years.

b) death overall under 17 years of age from the CDC was 335 (CDC)

c) long covid - unknown number but provisionally less than 1% of all cases

d) brain atrophy/loss of smell and taste sensory ability - unknown

e) autoimminty especially in female gender - unknown but known to follow inflammatory viral disease for which COVID is a serious inducer of inflammation

Conclusion, the mRNA vaccines appears exceedingly safe and a better risk proposition than any of the above. My 2 cents.

5) Variants continue to be a HOT topic - SARS2 Version B 1.617.2 delta is now at 50+% of US cases and in some locales >90%. Data for the delta variant is still showing significantly increased transmissibility (between 40% and 60% higher than the original UK strain). The mRNA vaccines are still working quite well. The breakthrough cases in vaccinated persons with the delta variant have been almost entirely asymptomatic with little to no risk of outcome negativity. However, this variant is beginning to rage in the previously uninfected and unvaccinated populations raising a few major problems:

a) increased transmission in communities causes people in power to make bad decisions regarding in person school and general intra community movement. We do not want to see a return to the days where churches are closed while casinos and restaurants work at 50% capacity with masking to walk in the door or walk to the bathroom but otherwise not mask.

b) the increased viral activity will mean increased viral replication and increased mutation. Thus, we could end up with a more potent variant that, as Dr. Benjamin calls it, changes the whole lock and puts us at risk even if we are vaccinated.

c) countries that locked down and effectively avoided the early strains are now in worse shape as the delta variant is raging in virally naive populations with a worse variant. This is the cautionary tale of India and Southeast Asia. Again, we see the naiveté of humans thinking that we can control a 120 nm virus built as this one is. There is a lot of reality to the early statements that all early measures were to flatten the curve to prevent healthcare from being overwhelmed and not to halt the virus entirely as most scientists knew to be impossible. We are still in similar territory. Flatten all curves and live life. All else makes little sense to me.

National Geographic has a comprehensive article on the delta variant. LINK

In the Lancet we see some data on the delta variant in Scotland. It appears to double the risk of hospitalization versus previous circulating variants in the unvaccinated population. (Sheikh et. al. 2021)

Still zero evidence that the delta variant is more problematic to children at any age.

There is a new strain in Peru and South America called lambda that I will be watching closely. It is responsible for over 90% of their cases with similarly high transmissibility and similar morbidity to delta. The rub is that the previously effective COVID vaccines in South America that were made in China are appearing to poorly respond to new variant Lambda. There is good evidence that the mRNA vaccines work well here. (Mishra S. 2021)

6) "We examined its sensitivity to monoclonal antibodies (mAbs) and to antibodies present in sera from COVID-19 convalescent individuals or vaccine recipients, in comparison to other viral strains. Variant Delta was resistant to neutralization by some anti-NTD and anti-RBD mAbs including Bamlanivimab, which were impaired in binding to the Spike. Sera from convalescent patients collected up to 12 months post symptoms were 4 fold less potent against variant Delta, relative to variant Alpha (B.1.1.7). Sera from individuals having received one dose of Pfizer or AstraZeneca vaccines barely inhibited variant Delta. Administration of two doses generated a neutralizing response in 95% of individuals, with titers 3 to 5 fold lower against Delta than Alpha. Thus, variant Delta spread is associated with an escape to antibodies targeting non-RBD and RBD Spike epitopes." (Planas et. al. 2021)

This study notes that the antibody response in vaccinated individuals is lower against delta by 3+ fold meaning that the ability of our immune system to respond to the altered spike protein by binding to it is weaker than it had been to alpha. This is not good as this is the beginning sign that the lock is being changed for immunity that may push us to need a vaccine booster and God forbid a new vaccine. However, we are not there yet clinically, which is the place where the rubber meets the road, as patients are not getting sick in 99+% of cases if vaccinated with 2 doses of an mRNA vaccine.

7) Repeat because of importance in understanding: A disturbing study from MedRxIV is showing that mild to severe cases of Covid are causing relatively similar issues in the brain with tissue loss. This is not a good thing as we do not do a good job of regrowing brain tissue once damaged. They looked at 394 patients and 388 controls who had received a brain scan before the pandemic had affected them and then after developing the illness. Only 15 of the 394 patients required hospitalization. They found a significant loss of brain grey matter especially in the regions related to taste and smell. (Douaud et.al. 2021)

Why this matters is this: we do not know who will be at risk for this type of inflammatory brain tissue loss and that is not a good thing. We also don't know how this will play out clinically, but I can guess based on other studies that the effect will be dysfunctional senses of taste and smell. The other issue is that some studies are showing 5% loss of sensory function at 6 months post illness. Couple that data with these findings and the picture that is painted is not a positive one but decidedly negative. Another reason to look at vaccination through a different lens than just death or serious illness.

8) There is a realistic expectation that the global effort in vaccination will bring the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic under control. Nonetheless, uncertainties remain about the type of long-term association the virus will establish with the human population, particularly whether the coronavirus disease 2019 (COVID-19) will become an endemic disease. Although the trajectory is difficult to predict, the conditions, concepts, and variables that influence this transition can be anticipated. Persistence of SARS-CoV-2 as an endemic virus, perhaps with seasonal epidemic peaks, may be fueled by pockets of susceptible individuals and waning immunity after infection or vaccination, changes in the virus through antigenic drift that diminish protection, and reentries from zoonotic reservoirs. Here, we review relevant observations from previous epidemics and discuss the potential evolution of SARS-CoV-2 as it adapts during persistent transmission in the presence of a level of population immunity. Lack of effective surveillance or adequate response could enable the emergence of new epidemic or pandemic patterns from an endemic infection of SARS-CoV-2. There are key pieces of data that are urgently needed in order to make good decisions. We outline these and propose a way forward. (Telenti et. al. 2021)

This is a good read. The reality is this. Too many unknowns, however, it is likely that we are going to live with this virus for a long time if not forever. Thus, it is likely that everyone will see this virus at one point in time or another prior to the end of their respective lives. Preparing for that day is all that we can do and vaccination makes the most sense despite all of the misinformation and fear. If you choose not to go that route, then route number two would include targeted mask use in high risk areas and an absolute focus on immune health through quality diet, stress reduction, exercise and chemical avoidance. That is my 2 cents at this point after 16 months of data diving.

Let us choose our paths with more data to guide us,

 

Dr. M

Wallace-Wells NYTimes Magazine
Harwood MedRxIV
CDC MMWR
CDC Variants Page
UK Government COVID
Sheikh Lancet
Mishra National Geographic
Yong The Atlantic
Planas Nature
Douaud MedRxIV
Talenti Nature