Mask Mandate on Public Transportation No More!

On today’s date, April 18, 2022, a federal judge in Florida declared an end to the mask mandate, on all forms of public transportation, that had been in place since the beginning of the Biden administration. This ruling affects not only planes, trains, buses, mass transit, paid transit on our roads (taxicabs, Uber, Lyft, etc.) but also shuttles and mass transit terminals and stations. The Centers for Disease Control and Prevention (CDC) rule, which was due to expire today, had been extended for two weeks to allow more time to assess the ramifications and the direction of the COVID-19 pandemic in light of the BA.2 Omicron variant increases. The judge ruled that the mask mandate exceeded the agency’s authority and that proper procedure for making administrative rules had not been followed. In response to the ruling The Whitehouse deferred to the Department of Justice for a decision regarding an appeal. The federal agency, Transportation and Safety Administration (TSA), which is responsible for administering the rule has declared that the mask mandate will not be enforced at this time. Most major airlines and transportation systems have stopped enforcement.  The bottom-line from a medical standpoint is that each of us should consider our individual risks and the environment.  At this point, if you have been fully vaccinated and are not of high risk, and the level of community spread is low, then it is probably safe to go without a mask indoors in public places and on public transportation. Some establishments such as Broadway theaters and houses of worship, based on their track record of safety, will choose to retain their indoor mask policies as the “price of admission”. 

Another piece of good travel news is that the CDC today removed ALL countries from it’s “Do Not Travel “list.  A system of Travel Health Notices (THNs) is used by the CDC to provide advice designed to be helpful to the public traveling around the world.  There are four levels of notices for international travel in this system corresponding to, in ascending levels of COVID-19 severity, LOW, MODERATE, HIGH, SPECIAL CIRCUMSTANCES (Do Not Travel).  There are no countries in the Level-4, as of today. No matter what the level of notice in the THN, even if the level in your intended destination is “unknown”, the first CDC recommendation is that your vaccination level be fully up to date.  The remaining precautions and recommendations for your international travel is available at   https://www.cdc.gov/coronavirus/2019-ncov/travelers/how-level-is-determined.html. 

A look at the current COVID-19 trends can provide us background for some of these updated decisions. All of the counties in Cincinnati’s Tristate Area remain at a low level of community spread as far as the CDC classification is concerned.  Although the number of daily new cases in the USA remains at its lowest level since the summer of 2021, there are portions of the country where the numbers are rising. The Northeast is most severely affected as cases have doubled in Rhode Island and Washington, D.C. since the beginning of April. The Midwest is not immune to these increases as Illinois, Michigan, and Wisconsin have experienced a forty percent spike over the last two weeks. Fortunately, COVID-19 deaths in the US are down to about 500 per day and hospitalizations are at a level (15,000 per day) not seen since the earliest days of the pandemic. 

These increasing cases are being driven by subvariants of the Omicron strain. This BA.2 strain remains the dominant variant in the US. The great news continues to be that the vaccines continue to keep people out of the hospital, the hospitalized out of the ICUs, and people out of the morgue!  Yet the fight against this coronavirus is not over. The World Health Organization is following cases worldwide of new subvariants, BA.4, BA.5, an XE. The more people get vaccinated, the less virus mutation, and the better the chance that the world avoids a vaccine-escaping variant. 

These travel restriction changes demonstrate continual emergence from the pandemic. We can continue this progress if more of us become fully vaccinated. In the meantime, be comfortable protecting yourself according to your risk. Mask up in COVID-19 unsafe or unvaccinated environments.  Socially distance when necessary and wash your hands!

Be Smart, Consider a 2nd Booster, COVID-19 IS Still Around

We can celebrate that Hamilton County and all of its neighboring counties in Kentucky and Indiana continue to have a Community Level of COVID-19 at the LOW level. If you are at all out and about it is clear that residents of our area are taking to heart the CDC recommendations based on the current level. Masks are off indoors and out. Even though the current level is low, the virus is not gone!  Cases, on a 14-day average, are down by 12% nationwide, although the Greater Cincinnati area is experiencing a slight uptick. Nationwide hospitalizations are down 33% and deaths are down 44%. Yet, 702 Americans died from COVID-19 on March 30, 2022. Although the country is in the midst of a lull in this pandemic, many epidemiologists caution that we are likely to face another surge. Currently, there are other countries that are experiencing surges. Shanghai, China is going into a second phase of a “lockdown.” There are parts of Europe (UK and Germany), experiencing significant waves caused by the BA.2 subvariant of the Omicron variant. Some experts say that the increase in UK cases is due more to the elimination of masking as opposed to the virulence of the strain. This same BA.2 is now the dominant strain in the USA and according to the World Health Organization represents 86% of the sequenced strains globally. This same strain, formerly referred to as the “stealth variant,” is 1.5 times as transmissible as the Omicron BA.1 variant.  Thus far there is no evidence that the illness caused by BA.2 is more severe than that caused by its Omicron relative. One very key point is that people who have received a booster are unlikely to suffer severe disease, hospitalization, or death if they become infected by this newer mutation. 

Considering the record that the first booster is effective as noted above, it might be asked why should I consider a second booster? This query is pertinent since the CDC and the FDA expanded the EUA for both the Moderna and the Pfizer vaccine to allow a second booster for adults over 50 years of age who have “underlying medical conditions that increase their risk for severe disease”, and for any adult over age 65.  This second booster vaccination, if given, should be administered no sooner than four months after the first booster of any COVID-19 vaccine. The rationale for offering a second booster is “waning protection” in people who are immunocompromised or elderly.  Much of the safety and efficacy data that the CDC and FDA used to make the determination to allow the additional booster came from the Israeli experience. The actual decision to proceed with the second booster remains an individual choice based on their personal risks. Our government has given us availability but not a recommendation. 

Irrespectively of your decision regarding a second booster, there are measures that should be taken to prepare for a new wave. First of all, vaccination remains the best way to prevent severe disease and hospitalization. Being unvaccinated or under vaccinated leaves one vulnerable. Increasing our country’s fully vaccinated above the current 71% of the population and the boosted level over the current 45% of the eligible, is actually the best vaccination strategy. Secondly, keep a supply of well fitted masks available and mask if it makes you feel safer.  Masking should continue If you have symptoms, have tested positive, or have been exposed to someone who has tested positive.  The requirement that we remain masked when on public transportation is still in force. Next, keep track of your community level of spread. Be willing to mask up and take other recommended precautions if the level rises. Additionally, have home testing kits available (they are free from the government) and a pulse oximeter to check your oxygen level.  Also, have a plan to get an oral antiviral pill from your doctor within five days of a positive test.  Lastly, have a backup plan for major events so that you will have alternatives should a positive test or COVID-19 illness force you to socially distance.  

A summer or fall surge, just as occurred the last two years, may be on the horizon!

Getting Lifestyles Back from COVID-19_Lives Lost in Ukraine

Russian missiles, bombs, artillery rounds, and mis/disinformation are reigning down on Ukraine. News reports on this humanitarian crisis has pushed the worldwide attention away from the COVID-19 diseases which have plagued the US for over two years.  While the virus remains with us, it finally looks like we have turned the corner in this pandemic. Cases, hospitalizations, and deaths are continuing to recede. The criteria for assessing the community spread of this virus is showing that we are indeed in a better place. Hamilton County and all of the seven counties in OH, IN, and KY which border it, are now in the LOW level CDC classification of disease. With this level of spread people no longer need to wear masks indoors and the maintenance of good indoor ventilation is recommended. The COVID-19 test positivity rate in the City of Cincinnati is around 1%, the best it’s been since June 2021. Consequently, the city has dropped its mask mandate for employees and more people are being allowed to return to in-person work. Masks are no longer required for employees, regardless of their vaccination status. The testing requirement for the unvaccinated is also being eliminated. Very importantly, the new community level guidance of the CDC DOES NOT apply to healthcare facilities.  We still remain masked in hospitals as on public transportation. Healthcare settings such as hospitals and nursing homes continue to rely upon the community transmission rates and the CDC recommendations.

The Cincinnati Public School (CPS) system has also announced the elimination of its mask mandate effective March 8,2022. Masks remain optional for students, staff, and visitors. A section of the new policy says that students who elect to continue wearing masks “are protected from any form of harassment, intimidation or bullying”. Just as with every public place, people who are sick are still recommended to remain at home. A person who tests positive needs to be in quarantine for five days and then for the sake of CPS policy, wear a mask when in schools and/or administration buildings for TEN (10) days.

On the virus front there is news on the “Stealth Omicron” variant (BA.2). It is stealth no more as several tests easily identify this variant. This subvariant continues to increase and crowd out it’s Omicron parent (BA.1). It has become the dominant variant worldwide. This BA.2 variant appears to be more transmissible as it jumped from being 1% of US isolates in February to 11% in early March. The good news continues to be that the vaccines remain effective at preventing hospitalizations and death from this variant. People who have had the booster are well protected against even getting COVID-19 infection from BA.1 or BA.2. Another reason why this “stealth” variant is likely not going to cause a significant surge is that antibodies resulting from the original Omicron infection have proven to be very effective against the BA.2. Lastly the two oral medications, Paxlovid and molnupiravir, as well as remdesivir are effective against both variants if given soon (5d) after symptom onset.

It appears that the world has “dodged a variant bullet” with BA.1 and BA.2. Predictably, a rare new variant, named “Deltacron,” has been identified. Currently, it is not considered a virus of interest. The way to prevent mutation is to prevent replication by vaccination. Only 65% of Americans have been fully vaccinated and only 44% of the fully vaccinated have received boosters.  Even though it may be non-productive to try to encourage an eligible person who is not vaccinated to do so, it is still recommended. Convincing a person who has been previously vaccinated to get a booster is probably more likely to be successful.  The data continues to show that vaccinated and especially those who have been boosted are well protected from hospitalization and death, even from the Omicron and it’s known subvariants. 

We are overjoyed that masking in no longer necessary in Cincinnati. It is wonderful to see people safely out and about without masks.  We must remain vigilant and recognize that this level of safety may not last forever. Masks will need to go back on if the community level increases.  Time will tell if we heed future recommendations.

COVID-19 Masking. CDC Moves Goalposts

Faced with a population increasingly discarding masks in spite of an ongoing pandemic the CDC changed the criterion used to determine the conditions under which masking should be continued. The CDC’s July 2021 transmission-prevention guidance measures were based on the percentage of the previous week’s positive test combined with the rate of new COVID-19 cases. Under those criteria 95% of our nation’s 3,200 counties still remain in the “substantial” or “high” transmission categories. According to the old criteria all of those Americans were supposed to be wearing masks in public. This was not happening, and governmental mandates have fallen to social and political pressure. Cases, hospitalizations, and deaths are continuing to recede from their recent highs, so the CDC (February 25, 2022) is now taking a different approach. This new criterion is based on the degree of strain on the hospital system as measured by the percentage of Covid-19 patients occupying beds and the rate of new cases in the community (county).

There is now information on the CDC website which tracks every county is the USA and determines its status  https://www.cdc.gov/coronavirus/2019-ncov/science/community-levels.html. 

Counties are categorized as being LOW (green), MEDIUM (yellow), or HIGH (orange). Under this new system 70% of the counties in the US are in the low or medium categories. Residents of these counties can stop wearing masks in indoor public places, for now. The decision to get rid of the mask needs to be tempered by an individual’s own risk analysis which includes vaccination (booster) status and his/her preexisting health conditions.  The well fitted mask should still be worn if a person is having symptoms, has been exposed to someone with COVID-19, or tested positive. The federal government has maintained the masking requirement on public transportation (planes, trains, and buses) and indoors at bus and train stations, as well as airports. 

The specific transmission risk of the Greater Cincinnati Area is as follows: Hamilton, Butler, Warren, and Clermont Counties in OH are all at MEDIUM level, along with Dearborn County, IN; Campbell, Boone and Kenton counties in KY are all still at HIGH COVID-19 Community levels. Under the CDC new guidelines this means that when in these N. KY counties, which are part of the Cincinnati area, a well fitted mask is still “recommended when indoors in public regardless of vaccination status (including K-12 schools and other indoor community settings)”. If you are in these areas, the same precautions of avoiding crowds, wearing a respirator mask (KN-95, N-95, or KF-94) pertain if you are immunocompromised or at high-risk for severe disease. Testing and home testing remain valuable tools in HIGH level areas as well. Persons at high-risk for severe disease need to be protected so those around them in HIGH level areas should wear masks and the same even if in a MEDIUM level area. Testing remains essential, regardless of community level, if one is symptomatic. 

The new criterion provides plausible cover for giving people a break from masking, particularly since they were not being worn consistently. We must clearly acknowledge that our country is indeed in a better place than last July.  This is due to the immunity inferred to the 64.9% of Americans who have been fully vaccinated combined with the incomplete immunity for the partially vaccinated.  Additionally, there is immunity, albeit waning, imparted to the tens of millions of US citizens who have been infected by COVID-19. These immunities give the CDC justifiable rationale for changing the measuring sticks. Hopefully, our weariness and fatigue will be sufficiently relieved by this break from masking so that we are willing to “mask up” if these new indicators show our healthcare system about to be overrun.  With this new tool from the CDC, you can become aware of the risk you face in your community and then decide when you will wear a mask.

One might still wonder why I said “for now” a couple of paragraphs ago. This is because we are likely to face new variants and subvariants more contagious than both the Omicron and “stealth” subvariant (BA.2). These anticipated new strains are likely to result in more counties reaching the HIGH community levels in the future. Keep your masks handy, this pandemic is not over!

Omicron. What Goes Up Must Come Down!

We are continuing to see hopeful news regarding the Omicron variant of this COVID-19 virus.  Cases are down by at least 50% in every state, except four, over the last two weeks.  Even though the American case count is down by 80% since the mid-January peak, we are still experiencing in excess of 100,000 new US cases per day.  Hospitalizations and intensive care unit bed occupancy are down 30% in the last two weeks. Unfortunately two of our neighboring states, WV and KY along with AL, are experiencing the highest number of recent hospitalizations. Predictably their vaccination rates lag behind the national average. Although percentage wise the Omicron variant death rate is lower than previous variants, the absolute number of Americans succumbing to this virus remains a staggering 2,300 per day. This number represents a downward trend of 10% over the last two weeks. 

With the falling cases, hospitalizations, and death rates have come the ever increasing cries for the elimination of mask mandates.  As of today, February 19, 2022 Hawaii became the only state that has not at least announced the lifting of the indoor mask mandate. New Mexico lifted its mandates effective immediately and Washington State lifted its mandates effective March 21. All of the state government officials are out in front of the CDC which has declared that it will update its recommendations “within the coming weeks”. We have reason to look ahead as the Institute for Health Metrics and Evaluation (Seattle) states that 73% of Americans have some immunity to the Omicron variant either because of vaccinations (especially boosters),or from having been exposed. The caution is that the latter is more of a waning immunity. Those individuals should clearly get vaccinated. Current CDC guidelines recommend vaccination as soon as an infected person is out of quarantine. It should also be noted that the CDC has changed its guidelines and now recommends that those individuals who received monoclonal antibodies for treatment of COVID-19 no longer wait to be vaccinated. Studies have shown that proper immunity is inferred when they are vaccinated immediately after quarantine. The previously recommended sixty day wait is no longer necessary. 

Another cautionary tale regarding the potential hazard of lifting mask mandates can be found in the Denmark experience. That country was one of the first to lift its mask mandate and this was followed by sharp increases in cases, hospitalizations and deaths. In early February the deaths had surged to 67% of their highest peak. It is noteworthy that Denmark’s lifting of its masks mandates became synonymous with the “end of the pandemic”.  A more appropriate reading of the situation is that the country has decided that it is willing to tolerate whatever happens as mitigation measures have been relaxed or removed. This is apparently where we are in the USA as well. The good news remains that if you are vaccinated and particularly boosted, you are well protected against the currently known variants of COVID-19. Vaccinated Americans have decided that they no longer should be denied the benefits of a return toward normalcy at the sake of those who have decided that they will not get vaccinated. 

The bad, yet predictable, news is that the unvaccinated will still continue to fuel the persistence of the influence that COVID-19 has on all of our lives. Specifically we are seeing the emergence of yet another variant. This one is labeled BA.2 and is a sub variant of the Omicron. It can spread faster. Its virulence (potential to cause disease) is not yet clear.  It has only 20 different mutations from its Omicron parent and therefore is not given its own Greek letter designation. It has also been termed the “stealth Omicron” because it doesn’t have a mutation which allows it to be clearly identified as being distinguishable from its parent BA.1 (Omicron) variant. Currently the boosted vaccine remain effective at preventing even the “stealth Omicron” from causing severe disease, hospitalization, or death.  This sub-variant has been identified in sixty-nine countries and multiple states in the US. 

This virus, its variants, and sub-variants know not geographic boundaries or politics. Neither our frustration nor fatigue will decide when the pandemic is over. COVID-19 will!!

US Leads in Omicron Deaths-A Dubious Distinction

Nine hundred thousand (900,000) Americans dead from COVID-19. This is a milestone that seemed unlikely to be reached a year ago. Nonetheless, here we are. Unfortunately, we have sentiments from “they would have died anyway” and “I am through with COVID-19” to “we would not be here if you all had been vaccinated”, and everything in between. The undisputable statistical bottom-line is that the vast majority of deaths since the US has had an adequate supply of available, safe, and effective vaccines have occurred in those who have chosen to remain unvaccinated.  The Omicron variant which emerged beginning in early December 2021 was not kind to the unvaccinated. This variant was much more contagious resulting in the sheer numbers of cases exceeding prior records. The hospitalization peaks occurred later in the surge than prior variants but nevertheless surpassed them. The deaths have now peeked but remain very unacceptably elevated. The 100,000-interval death increase took eleven weeks to get to 800,000 as opposed to it taking only seven weeks from mid-December to reach this grim 900,000 milestone. This dramatic acceleration in deaths was due to the Delta variant initially and then the Omicron variant. It falls on deaf ears that if you are unvaccinated, you are more susceptible. 

The latest data in American seniors over sixty-five is that if you have gotten two doses of your vaccination, you are twenty times less likely to die from Covid-19 compared to if you are unvaccinated. Twelve percent of this age group is not fully vaccinated and 43% have not received their booster. Compare this to England where only 4% of its seniors are unvaccinated and only 9% are un-boosted. The US and our archrival Russia have similar percentages of citizens who declare that they will never get a vaccination. With these attitudes in mind, it is no wonder that the US death rate from COVID-19 far outraces all other wealthy countries. It did not have to be this bad!  The numbers are less dramatic in younger individuals but nevertheless the hospitalization surge over the last seven weeks remains to be driven by the unvaccinated. 

We must not give up on this public health fight. Every positive event that may be helpful in convincing the skeptical must be emphasized. One of these is the recent full approval of the Moderna vaccine for those 18 years and older. The fact that the Moderna vaccine is no longer being administered under an Emergency Use Authorization, but under full approval, may help to convert some. This two-dose vaccine joins its fellow mRNA vaccine by Pfizer in this full approval class. Hopefully as more adults feel comfortable about the vaccinations, we will be able to chip into the abysmal numbers of unvaccinated children. 

Our kids under five were severely affected by this Omicron wave as were other children. Even though the Pfizer vaccine is available to children 5-11 years old, only 19% have been fully vaccinated and 28% have received their first dose of the EUA available Pfizer vaccine. Up until now it was unknown when children under five would be eligible for the vaccination. Just yesterday, February 1,2022 Pfizer requested that the FDA allow under EUA their vaccine to be administered to children under five. The proposed dosage recommended is one-tenth (3 mcg) of the dose given to those who are twelve and up. A two-shot regimen is being suggested. A decision will not be made until the end of February.

The case count from the Omicron variant rose extremely fast, crested, and is now fallen with the same rate of change. The US did not manage this variant as well as our European allies. Specifically, England saw its deaths rise to 20% of last winter’s surge and the hospitalizations rose 50% compared to so many of our hospitals being overwhelmed.  The difference being a more widespread acceptance of the vaccination program. Rest assured that another variant is coming. We will eventually be attacked by one that is more contagious and more virulent. Even before this happens, we will settle into just living with this coronavirus and tolerate a baseline endemic level of involvement. More unvaccinated Americans will die in both instances.

Wear your Mask as WE Live With COVID-19

Our country continues in the throes of COVID-19 tragically two years since this virus came to our shores. We are within the peak of the Omicron variant surge which now accounts for over 99% of the cases in the USA. Cases reached a record high of 1,364,418 ten days ago (Jan. 10, 2022).  Even though most cases are less severe, the sheer number results in the delayed emergence of hospitalizations and deaths. Yesterday we recorded a single day number of 3,810 American dead. Although this is a high in this season, the number is less that the record 4,442 deaths recorded exactly a year ago, January 20,2021. Although it is not clear from the statistics, we are in a better place than last winter. This is the case because we have vaccines, more and better masks, effective medications to treat Covid-19, more clinical experience in treating those who are sick, finally more testing, and hundreds of billions of taxpayer dollars to address the ramifications of this virus. 

We thought that we were out of the woods once there was a sufficient supply of vaccines for every age group except those under five. Universal vaccination, thus prevention, is the rational approach to this disease. Approximately 64% of the American population is fully vaccinated. It is still the case that the unvaccinated compose 90% of the hospitalized and those dying from COVID-19. In that there is such a high level of community infection, the vaccinated are also exposed to the virus and some are contracting breakthrough infections.  These infections result in proportionately far fewer hospitalizations and even rarer deaths. Nonetheless, those with breakthrough infections are still contagious.  In order to dramatically reduce the spread and thereby reduce the tendency for mutation we need to have the unvaccinated get their shots. Additionally, until the level of community spread lessens, appropriate masking for everyone is our best tool. 

Just last week the CDC upgraded its guidelines regarding masking.  Although “any mask is better than no mask at all”, it is clear that cloth masks are not adequate. They are potentially fashionable, but they are not optimally functional. Early in the pandemic there was a strong push and recommendation for cloth masks or face coverings. This alternative was recommended because of a shortage of multiple ply protective masks. Those masks were to be reserved for health care workers. The multiple ply surgical masks with the elastic ear loops are better than the cloth masks or face coverings. Nevertheless, they lose some of their effectiveness because of the air that more easily enters or escapes, unfiltered on the open sides of the masks. Double masking helps lessen the ingress and egress but makes it much more difficult to breath. 

The science has evolved, and the shortages have been eliminated as production and supply chain obstacles have been overcome. It is now known that there is a 75% leakage with cloth face coverings, in and out. On the other hand, N95 masks filter 95% of the particles and are much better at filtering small particles and aerosols.  Note that the presence of a valve in a mask eliminates its effectiveness and they should not be used.   

The new guidelines indicate that one should wear the most protective mask that can be physically tolerated and of course afforded. The most effective masks are N95, KN95, and KF94s. Legitimate N95s are tested, certified, and regulated by the US agency National Institute for Occupational Safety and Health (NIOSH). Those masks have a properly spelled “NIOSH” marking. The KN95s are tested by manufacturers in China, but in CDC testing 60% of those did not meet the intended Chinese standard, which by the way matches CDC standards. Lastly, there is the KF94 mask which are Korean manufactured and tested by the Korean Ministry of Food and Drug Safety. The Ministry of Korea maintains an online database detailing approved KF94 manufacturers.

Affordability of effective masks has been at issue until now. The Biden administration announced yesterday that it will be taking 400 million non-surgical N95 masks from the Strategic National Stockpile. These will be made available to everyone through pharmacies and federal community health centers.  Get yours FREE next week!

Omicron is Revealing Its True Stripes in the USA

The Omicron variant of this COVID-19 virus has now become the dominant strain in the US constituting over 98% of the virus’ infections in our country. The increased contagiousness of this variant has been one of its predicted characteristics. This is being borne out by the record 1.4 million cases recorded today, Jan. 11, 2022. The seven-day average test positivity rate also surged to an all time high 26.3% compared to the previous high of 23% seen on April 3, 2020. The conventional wisdom still remains that Omicron infection results in less severe disease even though COVID-19 hospitalizations in the US reached 142,388 yesterday, also a record high. This is likely not going to be the last hospitalization record considering that hospitalization peaks lag behind case number by about 2 weeks. Be reminded that the death peaks generally occur one to two weeks later than hospitalization peaks. Currently, the seven-day daily death average is 1,653, up 35% compared to two weeks ago. The good news is that the hospital stays are on average 50% shorter than during the peak of the Delta wave. 

The answer to why hospitalization and death numbers are up, if indeed the Omicron variant is milder, can be found in a number of scenarios. First a smaller percentage of a hugely larger number of cases is a larger absolute number of severe cases, hospitalizations, and deaths. What is more significant is that the number of infections being reported probably severely underestimates the actual number of cases considering the unknown number of positive home tests. There are also a large number of untested asymptomatic or mildly symptomatic people. It is estimated that when all these are added to the mix, there may well be up to three million cases today. 

It remains the case that if you have been fully vaccinated and boosted then you are less likely to suffer severe illness, hospitalization, or death from COVID-19. Without being vaccinated you are ten times as likely to be hospitalized and thirteen times as likely to die from this virus. There remains 38% of eligible Americans who are not vaccinated and 65% of eligible Americans have not gotten their boosters. The Omicron variant will find and infect these folks and this level of community spread results in breakthrough infections in the vaccinated. A cautionary note is that this astronomical level of replication WILL result in future mutations. Will one of these future mutations be more contagious and more virulent?

This surge of COVID-19 is not only overwhelming our hospitals in many areas, but it is resulting in tremendous disruptions in our children’s health and education. Childhood hospitalizations are at a pandemic high. A substantial percentage of these sick children are under 5 years of age and thus not eligible for vaccination. They can only be protected from COVID-19 by being surrounded by fully vaccinated adults and eligible siblings, and by appropriate pandemic mitigation measures. From an education standpoint, schools are grappling with how to educate children in the face of severe staff shortages in a raging pandemic surge. The case positivity rate is twice as high in Hamilton County compared to any time in the pandemic. Cincinnati Public Schools have decided to return to remote learning for two weeks. It is widely accepted that remote learning is associated with losses in both educational advancement and socialization. Yet instruction can’t proceed without instructors. Getting our kids back into functional and safe schools ASAP is essential. Our K-12 students need not only vaccinated instructors and school staff, but on-site and at home COVID-19 testing, proper fitting protective masks, and rooms with adequate space and ventilation. 

All of the human statistics that we have used over the last twenty or so months to follow the impact of this disease are likely to worsen over the next few weeks. Yet, we the people are not powerless. We must encourage COVID-19 vaccination and boosters. This continues to be a pandemic fueled by the unvaccinated. We will emerge out of this crisis better and sooner if we wear the best quality mask that we can tolerate and afford, wash our hands, stay home when sick, and maintain six feet of distance when out in public.

The Omicron Surge Rings in the New Year 2022

The constant drumbeat of warnings about this Omicron variant surging into the record books has come to pass as the world begins a third new year coping with the COVID-19 virus. The daily 7-day average of US cases is up 204% compared to two weeks ago to a staggering 405,470 cases. The good news is that hospitalizations have not kept pace as they are up a comparatively low, 35%. The even better news is that deaths are actually down 3% but we are still losing in excess of 1300 Americans a day to this virus. The majority of these deaths were preventable IF they had been vaccinated. The Hamilton County (OH) numbers mirror those nationally, as our cases have risen 123%, hospitalizations are up 19%, and deaths are up 3.6%. These trends may represent a break from the historic pattern and a “decoupling” of case counts from hospitalizations, and deaths. Are we finally seeing the benefits of the vaccines and/or the less virulent nature of the massive number of Omicron cases? Nevertheless, our committed hospital workers are exhausted as they provide the unrelenting care for COVID-19 infected Ohioans (mostly unvaccinated). Ohio Governor Mike Devine has authorized a pause in all non-essential surgical procedures and also the deployment of an additional 1,250 members of the Ohio National Guard. These measures are in an effort to relieve the stress on our state’s hospital systems. These deployed Guardsmen are not medical professionals but staff personnel since pulling Ohio’s soldier nurses, doctors, and extenders would take them away from their usual healthcare jobs. Removing them from their home hospitals would only shift the shortages in Ohio’s hospitals. 

Staff shortages due to the massive number of people in quarantine after COVID-19 infection diagnosis is having a profound impact on our day to day lives. The CDC has adjusted the quarantine requirements specifying five days of quarantine after a positive test followed by five days of masking, as long as no symptoms exist. Nevertheless, thousands of flights were cancelled today (Jan. 3) due to sick flight crews. Although some school administrators are keeping schools closed after the winter break due to concerns about the huge increase in the covid-19 numbers, many schools are returning to virtual because of sick or quarantined instructors. There are schools that are able to maintain in-class instructions by using intensified rapid results testing regimens. Unfortunately, two schools in Cincinnati were closed today due to 50% of the staff being out sick. 

One very timely policy issue announced by the FDA today is that children ages 12-15 years old are now approved to receive the Pfizer COVID-19 booster. This was based on real-world data from Israel where the booster was found to restore vaccine effectiveness to 75% vs the 35% residual level after the two shot mRNA series. Additionally, the FDA reduced the booster waiting period, for all age groups, down to five months instead of six months. This will help get more people boosted, but our bigger problem remains the fifty million Americans yet to receive an initial vaccination, including a 20% level of vaccination in eligible children between 5 and 12 years of age. Lastly, the FDA authorized a third Pfizer vaccination for those children between the ages of five and eleven who are immunocompromised. 

One other tool in the treatment toolbox for the severely immunocompromised (ages 12 years and over) is an AstraZeneca monoclonal antibody cocktail. This has been authorized for pre-exposure prophylaxis (PrEP) or commonly known as preventative treatment, for those who do not develop adequate antibody levels after vaccinations or are unable to be vaccinated, such as those with severe allergic reactions. It should be noted that there are other severe factors which might qualify as severe immunocompromised such as treatment with high-dose steroids or the absence of certain disease fighting cells in a person’s body. 

We are all tired of this virus and we are in a new year. The virus and its variants do not care. We must persist and we will triumph. Get vaccinated and boosted, wear your mask, avoid large indoor crowds, stay home if sick, and wash your hands. If we do these things, January 2022 will be less bad!

The Omicron Blizzard IS on Its Way!

Over the last thirteen days our country has been struck by catastrophic weather events, namely mountain blizzards and monsoon flooding in Hawaii, devastating tornadoes in KY, IL, TN, AR a week ago, and for the first time December tornadoes in IA and MN. The latter were part of a historic weather front which saw hurricane force (100 mph) winds across the upper Midwest. Many climatologists say that the increasing frequency of these historic meteorological events is a result of climate change fueled by the activities of man. America has ignored pleas about caring for our planet and so we reap. 

Under the guise of science denial, political dogma, and rugged individualism 55 million unvacinated Americans are driving the current Delta and the incoming Omicron blizzard.  We blew past the 800,000 Americans dead this past week as the COVID-19 news continues to come fast and furious. It is estimated that the deaths of 150,000 of the Americans who have died since the summer of 2021 did not have to happen because none of them were vaccinated. Hospitalizations are up 18% in the last two weeks and deaths are up 15%. Most of the cases in the US are caused by the Delta variant. Yet it is projected that the Omicron variant is likely to become the dominant variant in the US before the end of January, 2022. This behavior would be mimicking the variant’s behavior in the UK.  

The Omicron is doubling in the USA every 2-3 days and makes up 3% of the COVID-19 cases in the US overall. There is considerable geographic variation typified by 13% of cases being Omicron in NJ and NY. Mathematically, even if Omicron proves to cause less severe infections, the characteristic of being more contagious still means significant stress on our healthcare system. 

The current dramatic increase in COVID-19 is still being driven by the Delta variant.  Ramifications of this current viral storm across the country is again life changing. A number of colleges have returned to remote learning. The NFL has postponed several games this weekend. Record numbers of professional players in football, basketball, and hockey are missing games because of virus protocols. A number of shows on Broadway have gone “dark” and the world famous Radio City Rockettes have canceled the remainder of their season.

The Cincinnati tristate area is not immune to the problems caused by COVID-19. The 40 hospitals in our region are reporting the highest number of patients hospitalized since January of 2021.  Ninety-nine percent of their ICU beds are occupied.  Governor DeWine announced the deployment of over a thousand National Guard personnel. They are being called upon to help relieve exhausted overwhelmed healthcare workers. The waiting times at local emergency rooms are increased and admitted patients are being housed in the ER due to inpatient beds being unavailable. Today Kentucky Governor Andy Beshear announced that the Omicron variant has been identified just across the Ohio River in Kenton and Campbell counties. 

We still have the tools to fight this pandemic. The Moderna and the Pfizer-BioNTech mRNA vaccines remain very effective against the Omicron variant, as far as preventing severe disease and hospitalization, if a person is fully vaccinated and has gotten their booster. Note that the CDC has declared that the mRNA vaccines are preferable to the J&J vaccine. This is due to the blood clots that have been concerns in women under 50 ask well has the loss of efficacy especially in the face of the new variants.  

Experts are once again predicting that things are going to get a lot worse before they get better. Dr. Anthony Fauci says that Americans should brace for “a tough few weeks to months”. The impact of Omicron is yet to be fully realized AND there is still time before the next Greek letter variant rears its ugly head. Rest assured that it is coming!!. Delta showed increased transmissibility and virulence than prior strains. Omicron shows only more transmissibility so far. Will the next variant we see be one which demonstrates increased transmissibility, increased virulence, and immunity escape? Please get vaccinated and boosted so there will be fewer people in which this virus can proliferate and thus mutate.

Omicron is Here but Delta Still RULES!

Omicron numbers and data

The first case of COVID-19 caused by the Omicron variant was discovered in California on December 1, 2021. This first case was in an individual who had just returned from travel in South Africa. At this time, eight days later, this mutation has been identified in over twenty states and thirty countries. With the emergence of every variant the same three questions will be asked. How easily does it spread (contagiousness)? How severe is the illness that it causes (virulence)? Does previous COVID-19 infection and/or vaccination prevent one from becoming severely ill or dying from the new variant? The still evolving answers at this time are that Omicron, which is a highly mutated strain, is more transmissible that the highly contagious Delta variant. This trend is being seen in South Africa and Great Britain. The cautionary note is that the US COVID-19 experience has lagged the UK by a month. Secondly, the fifty or so Americans who are known to have been infected by this new strain have generally experienced mild symptoms.

Another data set which points to less severity is that in spite rampant spread in South Africa, fewer infected patients require high-level care and the hospital stays are shorter than before. Answering the question regarding the protection afforded by prior COVID-19 infection and vaccination continues to emerge. There do appear to be more re-infections and breakthrough infections caused by Omicron. Yet indications are that previous vaccination is associated with less severe involvement when this variant hits. Pfizer-BioNTech reports that both a two and a three-dose regimen provided protection against severe disease although the third dose increased antibody levels 25 times. So overall as Dr. Fauci says the “profile of the disease...might be less severe.”

In spite of financial markets being rattled and travel bands being implemented because of Omicron, the Delta variant is surging and remains a difficult problem. The US death toll is nearly 795,000 and we are losing close to 1300 Americans a day. This represents a 12% increase over the last two weeks. The National Guard has been activated to provide backup to strained healthcare systems in three states including Michigan, our neighbor to the north. Clearly forgetting about Delta is at our own peril particularly since the impending cold weather is likely to make it worse. 

There are especially important updates regarding treating and preventing the spread of this COVID-19 virus. The CDC has approved the Pfizer vaccine boosters for teenagers in the 16- & 17-year-old age group. This means that three million US teens will be eligible to receive safe and effective boosters. The booster should be given six months after the completion of their initial Pfizer series. Current studies are assessing the safety and efficacy in 12-15- year-old adolescents. Secondly, on the treatment front is the expanded use of monoclonal antibodies. Recall that monoclonal antibodies are laboratory made proteins that act like the body’s immune system to fight off disease such as viruses. The FDA issued a revised Emergency Use Authorization (EUA) for a monoclonal antibody cocktail (two drugs at the same time) to allow usage for all pediatric patients, including newborns, who are at high risk of severe COVID-19 or death. This drug combination was previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms. This new authorization is for the treatment of these younger children with mild to moderate disease as well as for post-exposure prevention of COVID-19, provided that the child is at high-risk of severe disease or death from the virus. Lastly on the news front is a new EUA for pre-exposure usage of a long-acting monoclonal antibody for individuals who are moderately to severely immunocompromised or those with a history of a severe allergic reaction to vaccines. 

All of the above is fine and good, but none of these replace the benefits of vaccinations. All too often families of extremely ill unvaccinated patients and those unvaccinated patients who have gotten critically ill, yet fortunate enough to recover, experience a “Hard head makes a soft behind moment” after they narrowly escape a preventable COVID-19 death. We would all be better off if everyone gets vaccinated!

OMICRON Puts the World On the RUN!

Viruses are living adaptable creatures. In this space over the last twenty months, we have emphasized that viruses mutate only if they proliferate. Safe and effective vaccines have been developed and represent our best protection against proliferation. Even though vaccines are available to every American over the age of five, there are still approximately 60 million US citizens unvaccinated. Couple these individuals who are unvaccinated by choice with those billions of people around the world who do not even have assess to vaccines, the US and the world are fertile ground for the emergence of COVID-19 variants. It is therefore no surprise that a new “variant of concern” has been identified. As has been the case with so much of the coronavirus related news, unsurety and rapid evolution continue to be the hallmark. All too often by the time information is written there is new contradictory news. So, expect change and anticipate that what you hear today may not be the case tomorrow. 

Currently we know that the newest variant, dubbed as “Omicron” by the World Health Organization, has been initiated identified in a considerable number of people in The Republic of South Africa. As it turns out the scientists in South Africa are touted to be some of the best in the world as far as virus surveillance and genomic identification. They have alerted the world regarding the presence of the variant in their country and within literally hours the variant has been identified in Europe, Australia, Asia, Israel, and Canada. It has not been identified in the US as of yet, but it is likely here already. The response of our government has been to band travel from South Africa and seven neighboring countries, the UK has blocked some international travel and increased testing, contact tracing, and masking; Israel, has completely closed its borders to foreign travelers for a couple of weeks. Unfortunately, virus variants have no respect for borders and the travel bands will only delay the inevitable spread of this variant around the world. A better useful solution to slowing the spread would be a dramatic increase in PCR testing of travelers, surveillance testing, contact tracing, forced quarantine, and masking. 

Why is there such concern regarding this Omicron variant, which has been an issue for only the last four days? The early reaction and concerns revolve around two times the number of spike protein mutations on the Omicron compared to the deadly Delta variant. Although the clinical consequence of these mutations is not clear, the epidemiologic data from Gauteng province near Johannesburg reveals that positive swab tests increased from 3.6 percent to 9.1 percent in just two days. Additionally, sixty-one passengers on two flights from South Africa to Amsterdam (Netherlands) on November 26, 2021, tested positive for coronavirus and the Omicron variant was the strain identified in 16 of those cases. All passengers had either been fully vaccinated or tested before departure from South Africa. The questions as to whether Omicron is more contagious or results in more severe or deadly disease than Delta are legitimate, but yet unanswered. The possibility that this new variant will escape the immunity conferred by available vaccines or prior infection is also extremely concerning. Measures which are extraordinary to some are being implemented out of an abundance of caution, since it will be two weeks before these questions will have data-driven answers. 

It appears that the world’s more vigorous response to Omicron is influenced by the severe health and economic impact of Delta. The US continues to lose nearly one thousand citizens per day from the Delta variant. New Covid-19 cases, almost exclusively caused by Delta, have increased in approximately thirty states and hospitalizations have increased 10% around the country. 

In pop culture it is said “Nowhere to run, nowhere to hide.”  In our fight against COVID-19 and it’s current and future variants we should RUN to get vaccinated/boosted and WASH our hands; hide our nose and mouth behind a mask when in public places; and hide out at home when we are ill. If we also maintain appropriate social distancing, then our hope that Omicron is not as bad (or worse) than Delta has a better chance of being realized!

Our Superpower.. Preventing a Twindemic

As our country approaches cooler weather, and thereby our seasonal flu season, every measure needs to be taken to lessen the impact of two respiratory viruses, COVID-19, and influenza. The U.S. Food and Drug Administration (FDA) took a major step today toward continuing our progress out of this COVID-19 pandemic. On November 19, 2021, the FDA expanded the Emergency Use Authorization (EUA) for both the Moderna and the Pfizer-BioNTech COVID-19 vaccines. A booster shot of either can be used for every American, age 18 and over. This half dose vaccine booster should be given at least 6 months after the initial series of the two dose Pfizer or Moderna vaccines or at least two months after the completion of the one dose Johnson & Johnson vaccination. This new EUA expansion for these two remarkable vaccines clears the air of confusion regarding who is eligible for a booster. It represents clear acknowledgement that COVID-19 continues to be a threat and protecting the public is of primary importance. Cases are increasing in twenty-four states and the 14-day case change is up 25% over the last 2 weeks. Michigan and Minnesota are leading the country in cases per capita. The National Guard has recently been requested to assist in Michigan. Even states with the highest vaccination rates are suffering significant outbreaks. Deaths in the US are over 770,000 and the incidence of death is fourteen times (14X) higher in the unvaccinated. The good news is that deaths and hospitalizations are not increasing across the nation.

One of the exceedingly rare positives from the Covid-19 pandemic experienced during the last flu season (fall of 2020 until the winter of 2021) is that our country lost less than one thousand citizens to influenza. Historically, between 2010 and 2020, the flu has killed between 12,000 and 52,000 yearly, including an estimated 20,000 in the 2019-2020 season. As a result of the successful push for flu vaccinations last fall and winter, as well as the mitigation measures of social distancing, limiting hand to face contact, hand washing, and covering up coughs and sneezes, we escaped the profound effects of the seasonal influenza. The “we” referred to consists of America at large. African Americans and ethnic minorities remain disproportionately affected by influenza. It remains true that when “America catches a cold, black folks get pneumonia.” The impact of the influenza that African Americans catch is both more severe and more deadly. The statistics from the CDC are that for the ten flu seasons between 2009-2019, the flu-related hospitalizations per 100,000 were 69 for African Americans, 49 for Non-Hispanic American Indian or Alaska Native people, 45 for Hispanic or Latino individuals, 38 for Non-Hispanic White folks, and 32 for Non-Hispanic Asian people. Both flu-related ICU admission rates and death rates were highest among Black people during the aforementioned ten-year timeframe. 

This discussion regarding the flu is relevant in this age of COVID-19 because flu is already on the upsurge. The CDC initiated an epidemiologic analysis at the University of Michigan (Ann Arbor) because of an outbreak of 528 cases on campus since October 6, 2021. There were actually 313 cases during the week of November 8. Of note is the fact that 77% of those who contracted the flu were unvaccinated. The penetrance of the flu vaccines is 11% less in Michigan this year compared to last. This failure of our citizens to get the flu vaccine goes hand-in-hand with the aversion of tens of millions of unvaccinated Americans who continue to drive our COVID-19 pandemic. Only three out of five Americans have been fully vaccinated against COVID-19. It is essential to emphasize that the flu vaccine and the vaccination against COVID-19 can indeed be administered at the same time. 

Mitigation measures have proven to be effective in lessening COVID-19 cases as well as seasonal influenza. Vaccinations, especially the initial series necessary for full Covid vaccination, Covid boosters for those eligible, and one against the seasonal flu, are our primary ticket for avoiding these two phenomena. Hand washing, staying at home when sick, washing hands, and covering the nose and mouth when sneezing and coughing are sage messages. If we just heed the advice, we can prevent a twindemic!

Kids Can be Vaccinated and International Travel Resumes

There is optimistic news on the COVID-19 front in spite of the US having suffered 47 million cases, 3.3 million hospitalizations, 752,000 deaths, hundreds of billions of dollars in economic losses, millions of lost jobs, widening educational gaps, and social/cultural upheaval. The road to normalcy has been long but yet the journey is not over. 

The first piece of good news is that there is now a vaccine authorized for our children between the ages of 5 and 11 years. This opens the door for 28 million more Americans to be vaccinated. The Pfizer- BioNTech vaccine for this age group is a dose that is one-third of the dosage which is used for adolescents 12 and over and for adults. Smaller needles are used for these younger children as well. The human trials revealed the vaccine to be 91% effective in this age group.   The side effects were temporary and not serious, such as sore arm, fever, or achiness.  Recall that the Pfizer vaccine is the only one authorized for people between the ages of 5 and 17. Both the Moderna and the Johnson & Johnson’s Janssen vaccines are available for people 18 years of age and over. Since the Emergency Use Authorization was granted four days ago over 300,000 of our younger children have received their first dose the vaccine. Their second dose will be due approximately three weeks after the first. The appropriate dose of the vaccine is provided free by the federal government to anyone living in the USA independent of their insurance or immigration status.  

In spite of children experiencing less frequent and milder acute problems from COVID-19, there remain ample reasons for them to get vaccinated. For instance, at the current time, 25% of our country’s new COVID-19 cases are in children.  There have been over 700 deaths of children as a result of COVID-19. One out of every seven infected children suffer from long COVID symptoms. Thousands of COVID-19 infected children have developed the multisystem inflammatory syndrome in children (MIS-C) which can have serious involvement in the brain, heart, lungs, kidneys, skin, and gastrointestinal organs. Additionally, more than a million children have been affected by the over 2,000 school closures caused by the highly contagious Delta variant since the beginning of the school year. Since we all want to have our children and the rest of us out of masks, getting them vaccinated is essential. 

A second news-worthy event announced on 11/8/21 is that the US lifted significant  international travel bans. It has been over eighteen months since restrictions which severely limited travel from our northern neighbor Canada and across the southern border of Mexico. So many other tourists, relatives, and businesspeople have been held back from getting into our country. The travel ban, which involved more than 33 countries, resulted in losses approaching $300 million and over a million American jobs. In an effort to continue to protect Americans, vaccination and testing requirements for these travelers are in place. Fully vaccinated travelers who have proof of a negative COVID-19 test within 72 hours of travel will be allowed entry. Americans not fully vaccinated and children under 18 will need proof of a negative coronavirus test within one day of travel. There are exemptions and other specifics which can be found at www.CDC.gov. Airline and hotel reservations are already filling up as the holidays approach. Although improvement is happening already, a full recovery of international travel to pre-pandemic levels will not occur until 2024. 

Both of the newsworthy items detailed above further demonstrate that vaccination is the mainstay of our getting back to normalcy. The repetitive telling of this story is beginning to have a positive affect on the African American and the Latino communities. The racial gap in vaccination compared to our fellow White Americans is narrowing. Unfortunately, the rate of COVID-19 illness, death, hospitalizations, as well as vaccination between red and blue states continues to widen. The red state political skepticism is affecting them adversely. We can only hope that the political dogma will be pushed to the background as these vaccinations for children prove to be safe and effective. Children need to be allowed to benefit from the helpful science.

What You Should Know About COVID-19 Booster Shots

The wrath of COVID-19 continues to wane although it is clear that we are not out of the woods as of yet. The seven-day average of cases was down to 73,896 on 10/22/2021 which represents a 25% decrease compared to 14 days ago. Hospitalizations are down 19% during that same period. The seven-day average of deaths remains bothersome although down 15%. We are still losing slightly more than 1,500 Americans a day and the total number of COVID-19 deaths is over 735,000 since the beginning of the pandemic. The Delta variant is responsible for 99% of the current COVID-19 deaths in the US. The good news is that we have three safe and effective vaccines in our country. Approximately 66% of Americans have had one dose of a vaccine and 57% have been fully vaccinated. We still have 50M adults unvaccinated. 

Vaccines truly represent our ticket out of this pandemic. The death last week of 4-star General Colin Powell from the complications of COVID-19 demonstrates that even the vaccines will not prevent every death. He was one of many Americans who are immunocompromised and therefore remain more vulnerable even after being fully vaccinated. Those Americans, as well as our children who are not yet eligible to be vaccinated, can be best protected from the ravages of COVID-19 by every eligible adolescent and adult getting fully vaccinated. In addition, as we follow those who have already been vaccinated it has been discovered that their immunity is beginning to decrease. This phenomenon of waning immunity is not unusual. The CDC has thus approved and recommended the administration of another injection, called a “booster” for certain populations at this time. The who and when boosters are to be administered varies. Let us attempt to bring clarity to the CDC recommendations. 

According to the CDC, if you are in the following group of people and you received the Moderna or the Pfizer COVID-19 vaccine at least six months ago, you are eligible for a booster: 1)65 years and older 2) Age 18+ who live in long-term care settings 3) Age 18+ who have underlying medical conditions 4) Age 18+ who work or live in high-risk settings.  The Moderna booster should be half of one of the original doses and the Pfizer booster dosage should be the same as the original dose. 

About fifteen million Americans received the single dose Johnson and Johnson COVID-19 vaccination, and they are eligible for their full-dose J&J booster TWO months after their initial vaccination. 

It is important to note that the FDA and CDC have approved a “mixing-and-matching” approach to boosters. This means that although many people will want to get the same booster as their initial injection, there is no scientific reason to stick to the same brand of vaccine. As you make your decision for which booster you will take, consider a recent NIH study which shows that receiving any different vaccine as a booster increased one’s antibody level. Most notably, a person who had an initial J&J vaccination the increase in antibody levels after a subsequent J&J booster was fourfold, compared to a 35-fold increase after a Pfizer booster, and a 76-fold increase after a Moderna booster!

We are all eager to get back to our lives without COVID-19. Unfortunately, the SARS-Cov-2 virus may well become endemic whereby it continues to cause illness in an exceedingly small number of individuals on a regular basis. The CEO of Pfizer is predicting that it will be about a year before this pandemic is over. Ridding America of the pandemic will be helped by the boosters, eligible Americans experiencing a change of heart or mind about getting vaccinated, and the authorization for vaccines for children ages 5-11. The latter will be considered by the FDA starting on 10/26/21. 

Lastly, we need to do everything possible to keep ourselves healthy while we fight this COVID-19 scourge. Our masking, social distancing, flu vaccinations, and handwashing drove the flu to a historic low, globally, over the last 18 months. In fact, one strain of influenza may have been eliminated completely according to epidemiologists. If we maximize vaccinations and mitigation measures, we will drive down COVID-19 as well. 

US Surpasses 715,000 Covid-19 Dead! We Can Do More for Kids

On June 14, 2021, this update reported that the USA had reached the grim milestone of 600,000 Americans dead. Over the last three and a half months we have reached 715,000 US souls lost. That number is greater than the populations of the cities of Cincinnati and Cleveland combined. The vast majority of the deaths over the summer have been due to the Delta variant and did not have to happen, because we have safe and effective vaccines. The good news is that cases, hospitalizations, and deaths are all falling. Over the last seven days cases are rising in only seven states. There has been a 44% decline in daily US cases last week when compared to the peak average daily cases in mid-September. The daily average last week was still 95,917 cases. There is also a 35% drop in Americans hospitalized with Covid-19 currently when compared to a month ago.

Although cases are decreasing, the demographics of those infected, hospitalized and dying continues to evolve toward younger individuals. One constant characteristic remains, those with severe disease and dying have yet to be vaccinated. The Delta variant has resulted in the summer rise of not only Covid-19 cases but also the MIS-C, Multisystem Inflammatory Syndrome in Children. Although most kids recover from this ailment, it can be fatal and there can be significant involvement of the heart, lungs, kidneys, brain, and digestive system. Unfortunately, the trend of Covid-19 having a disproportionate affect on people of color continues. The CDC reports 5,217 MIS-C cases and forty-six MIS-C deaths, 61% of which are in African American and Hispanic/Latino children. The majority of the children affected by MIS-C are in the 6–11-year-old age group. MIS-C cases doubled in July and August of this year. Although pre-Delta, when MIS-C developed, its average onset was six weeks after Covid-19. Youngsters who develop MIS-C after a Delta variant infection suffer the onset at roughly two weeks after the Delta infection. Recall that no COVID-19 vaccine has been authorized for this age group. Additionally, over 1.5 million children worldwide have experienced significant mental, emotional, and social health issues as a result of being left without a primary caregiver (parent, custodial grandparent, or other custodial relative) who died from COVID-19. We can best prevent additional children from joining these unfortunate ranks by eligible adolescents and adult getting their COVID-19 vaccinations!

For those children ages 5-11 years old there is help on the horizon. Pfizer has requested FDA authorization for its vaccine in this age demographic, which consists of twenty-eight million children in America. That request will be taken into consideration by the appropriate FDA panel on Oct. 26th. The shots for these youngsters will probably be available in early November and the White House is urging states to gear up to administer these injections safely and efficiently. These young children need to be vaccinated, firstly, because when they are infected, they can spread the virus to vulnerable adults and the unvaccinated. Secondly, a small but significant enough number of infected children can become seriously ill or suffer from sequelae like the MIS-C, discussed above. 

The authorization and eventual approval of COVID-19 vaccines for all children under 12 years old is likely. In the meantime, we can protect them and the entire population best by the sixty-eight million eligible unvaccinated Americans rolling up their sleeves. One of the tools in this process are the federal mandates previously detailed. Specific guidance for companies employing more than one hundred people is working its way through the Occupational Safety and Health Administration (OSHA). Many companies have issued their own rules for vaccination or frequent testing as condition for in-person work. Some are allowing remote work while others are declaring compliance as a condition for continued employment. Although mandates remain controversial, an analysis by The White House has shown that 20 percent of the companies, educational institutions, public sector agencies and health systems experienced increased vaccination rate when mandates were put into place. For example, United Airlines reports over a 99% vaccination rate after the implementation of a company vaccine mandate. 

Please get vaccinated! It is our ticket to normalcy and our children’s path to growing up with less obstacles.

Booster Shots Alone Will Not Rid US of This Pandemic Pain

We continue to suffer the pain of illness, hospitalization, death, educational disruption, and economic and social upheaval because of the persistence of this COVID-19 pandemic. The ongoing impact of this virus is fueled by those who are unwilling to get vaccinated. A recent poll by the Kaiser Family Foundation reveals the motivation for many of the Americans who have changed their minds and joined the ranks of the vaccinated. The study of people vaccinated since June 1 shows that 39% were motivated by concerns about the highly transmissible Delta variant, 38% by the burden on the hospitals, and 36% because they knew of someone who had died from Covid-19. Additionally, considering that a person could give multiple areas of concern, 35% reported vaccination due to activity requirements such as travel, 19% cited employer mandate, and 15% stated that the FDA full approval of the Pfizer vaccination was part of their rationale. Only 2% citing this as the main reason. This report also found that the biggest lag in vaccination was in low-income populations, rural populations, and among Republicans. 

Another group that is suffering mightily from the lack of vaccination is pregnant people. The CDC issued an urgent Health Advisory on September 29th strongly recommending urgent action to increase COVID-19 vaccination among people who might become pregnant, attempting pregnancy, pregnant, or recently pregnant (including those lactating). The data shows that “97% of pregnant people hospitalized with confirmed SARS-CoV-2 infection were UNVACCINATED”! Racial inequities are apparent in this data as well. Specifically, full vaccination coverage exists in 15.6% of the pregnant non-Hispanic Black people compared to a better, but still low, 31% of the entire group of pregnant people.

In total, seventy million eligible Americans remain unvaccinated. Our fully vaccinated rate of 63% puts us behind Canada, United Kingdom, China, several large south American countries, much of the European Union, and many other countries. Many eligible Americans have failed to get their first shot. Nevertheless, the CDC has approved a booster, or third shot, for certain Pfizer vaccine recipients because of concerns regarding decreasing immunity over time. The booster recommendation is for people over age 65 and residents in long term care settings; people aged 18-64 with underlying medical conditions including obesity, diabetes, hypertension, and chronic kidney, lung, and heart disease; people aged 18-64 who are at increased risk of Covid-19 exposure because of their jobs. The booster for Moderna and J&J recipients is still under evaluation. Although the boosters will provide additional protection for those already reasonable well protected by their initial Pfizer series, our much larger problem is the considerable number of Americans who remain unvaccinated. The Covid-19 death rate is four times higher in the ten states with the lowest vaccination rates. The overwhelming majority (90%) of those hospitalized and dying from COVID-19 are unvaccinated (most are preventable!).

As previously stated, at least some of the increase in vaccinations is due to the vaccine mandates implemented for the federal and large business civilian workforce. The legality of the vaccine mandates in health care facilities is being upheld locally by a Federal judge in Covington who declared that” Actual liberty for all of us cannot exist where individual liberties override potential injury done to others.” This reinforces the medical soundness of each of us doing what we can to protect each other. 

The journey toward extricating us from this pandemic by enough people becoming fully vaccinated will be helped by younger kids getting approval for vaccination. Once they are vaccinated it will leave fewer potential victims for this virus and its variants to infect. The virus is hospitalizing 30,000 kids a month. Having vaccines available for children aged 5-11 will be a huge relief to children, parents, and educators. Pfizer has submitted its data to the FDA and a decision is anticipated in 4-6 weeks. In the meantime, it is essential for children to be masked in school. Three studies analyzed by the CDC this week show a 3.7 times risk of COVD-19 outbreaks in schools with no mask requirements compared to schools with early masking. 

Our ticket out is vaccination, so encourage all around you to get vaccinated and shorten this trek.

Ending This Ongoing Pandemic is Within OUR Power

The US has passed an unenviable Covid-19 milestone of more American deaths than the flu epidemic of 1918. That virus killed 675,000 people. Johns Hopkins University is reporting 676,747 deaths in the USA from Covid-19. Unfortunately, the new cases are affecting our children more.  Two weeks ago, 25% of the US Covid-19 hospitalizations consisted of children. This has now increased to nearly a third (32%).  The number of children sick with Covid-19 is now 27 times higher than seen in June. The Cincinnati Children’s Hospital and all children hospitals in the State of Ohio are being overwhelmed with hospitalized and ICU treated children, many of whom are requiring ventilators. Unfortunately, so many of these children remain at the mercy of unvaccinated adults since they are under the age of 12 years-old and therefore vaccination ineligible.  The ongoing tragedy of our situation is that 25% of eligible adults and 54% of eligible adolescents (ages 12-18) still remain unvaccinated.  It can’t be over-emphasized how their individual choice to remain unvaccinated affects not only themselves. The impact of this disease and its variants is indeed profound on the unvaccinated.  In nearly all jurisdictions health officials are reporting that approximately 90% of the Covid-19 hospitalizations and deaths occurring at this time are in the unvaccinated (and therefore PREVENTABLE!). On the other hand, people who are vaccinated are also paying a price for the unvaccinated’s choice. The US Centers for Disease Control and Infection and Prevention (CDC) reported on August 30 that the incidence of severe “breakthrough infection” is 1 in 13,000 of the vaccinated population. This unusual scenario has affected 12,908 Americans. Those requiring hospitalization and dying from breakthrough infections are more likely to be seniors and people with underlying conditions such as diabetes, heart disease, and autoimmune disorders. Of those hospitalized, 75% were 65 or older and of those dying, a staggering 87% were 65 or older. 

Recognizing the necessity of getting a larger percentage of the eligible American population vaccinated, the Biden administration has released a strategy to “Vaccinate the Unvaccinated” as part of its six-prong action plan for our “Path Out of the Pandemic” available at www.whitehouse.gov.  Though these mandates are controversial and certainly to be contested, they are designed to get us closer to the 85% vaccination rate necessary for immunity.

It has been established that WEARING a mask is a mainstay of fighting this virus. No matter where you venture, you can truly notice that masking is being disregarded.  It therefore merits reiteration that because of the Delta variant’s contagiousness, the CDC recommends masking indoors in public, irrespective of vaccination status if you are in an area of substantial or high transmission. Every state in our country remains at “high” levels except CA which is “substantial”.  As cases, hospitalizations, and deaths have risen with the variants many large businesses have reversed course. They now recommend masking for their customers. Although politically unpopular, 32 school districts in Ohio have switched to universal masking requirements over the last seven days.  Only one Hamilton County school district remains without a mandatory mask mandate for students, faculty, and staff. Note that Cincinnati Public Schools was the first major district in Ohio to mandate masking (Aug 21).

There is more good news on the vaccination front. Firstly, vaccine protection for children ages 5-11 is closer to being realized. Pfizer-BioNTech submitted data to the FDA on September 20th detailing the safety and effectiveness of their vaccine, in a smaller dosage, for this age group. FDA authorization and therefore shots in kids’ arms is still probably 4-6 weeks away. Secondly, the FDA has recommended a booster shot of the Pfizer vaccine (3rd dose), six months after the 2nd dose, for people over 65 and those at risk for severe Covid-19 infection. Lastly, Johnson & Johnson released data that demonstrates a second dose of their vaccine, given two months after the first, resulted in 94% protection against symptomatic Covid-19 and 100% protection against severe infection and death. 

Our government is doing what it can to oversee our emergence from this pandemic. We the People, are all eager to safely return to our normal. This is within our power and within our reach. Encourage all to get vaccinated and WEAR your mask!

Covid-19 Rages on In Spite of Other HUGE US Crises

Were it not for this pandemic either of two major news stories could be dominating the news.  Louisiana and the Gulf Coast were hit by Hurricane Ida two days ago leaving over a million people, including residents of New Orleans, without electricity.  Significant sections of Louisiana are still without electricity, drinkable water, and cell phone connectivity. A second current event is that the twenty (20) year history of the American military involvement in Afghanistan came to an end yesterday.  Both of these monumental events are pertinent to our battle against Covid-19. The latter will see 117,000 refugeed citizens of Afghanistan, which has a fully vaccinated rate of 1.1%, spread out across the world after many were crammed into crowded cargo planes and intermediate transit facilities. Closer to home, the hurricane’s ground-zero was Louisiana, a state which was already overwhelmed by hospitalizations and full ICUs due to the Delta variant.  We must worry about the magnitude of the surge of Covid-19 cases, hospitalizations, and deaths, that will result from storm victims being pressed into rescue vehicles and shelters. Not to mention their suffering in conditions without drinking water and refrigeration for food, the impracticality of masking, and of course eliminating the vaccination deficiency cannot be a priority.  There are reports of hospital emergency generators failing which resulted in brave healthcare providers manually ventilating very ill Covid-19 patients.  Our country’s already stressed medical reserve system is being diverted from Covid-19 care to attending to the crisis that is Hurricane Ida. 

The people who staff our medical system are becoming burnt out because too many Americans have shunned safe and effective Covid-19 vaccinations. Even though the Pfizer-BioNTech vaccine was granted full FDA approval on August 23, 2021, there has not been a huge rush of people to get vaccinated. Despite 63.5% of US adults over 18 being fully vaccinated and 74.2% have received one dose, there still remains too many unvaccinated adults who allow this virus to be a threat to our children. Ohio reported 5,395 cases one day last week, the highest number in seven (7) months. Children now account for 25% of the new Covid-19 cases across the state compared to 20% last week. The trend with the Delta variant is that the children who are infected are sicker and more require hospitalization. 

Childhood infections are on the rise because the vaccines are not approved for children under 12 and kids are going back to school where they are exposed to the third of the eligible population that remains unvaccinated. Even though masking works, as discussed in this space recently, so many school administrations and local governments are bowing to the political pressure from a loud minority. Once the inevitable outbreaks in schools begin, then the authorities revert to masking as a defense after the students return from a temporary shutdown. This scenario is playing out in Lebanon City Schools which are closing for the three school days before, and including, the Labor Day weekend.  This is due to 16% of the children being in quarantine because of close contact to other infected students and staff. It is much more than conjecture that unvaccinated teachers can spread infection to unvaccinatable students.  The CDC’s publication MMWR on Aug. 27 documented a 50% attack rate in an elementary classroom depending upon the proximity of the seating from an infected unvaccinated teacher. The publication reiterates that preventive strategies such as vaccination, universal masking indoors, proper spacing, and staying home when you are sick, are essential to protect children too young to be vaccinated.

In order to keep their students and staff safe colleges are beginning to implement vaccine mandates. The University of Cincinnati announced a vaccine mandate today. This occurred along with Miami U. (OH), and Ohio University yesterday and Ohio State and Xavier (Cin) last week. They are finally implementing policy that puts the value of in classroom instruction ahead of unscientific criticism of a small boisterous few. 

As long as this virus rages out of control and our daily lives are affected, it cannot be said enough. Please get vaccinated. WEAR a mask when indoors even if you are vaccinated. Maintain social distancing when possible. Get your flu shot when it is available.

Déjà vu All Over Again…Wear Your Mask!

“What’s old is new”, “Hard head makes a soft behind”. These are examples of acknowledgement that bad things happen when we don’t learn from prior bad experiences.  This is the unfortunate reality of the preventable disaster that is the current state of the COVID-19 pandemic in the USA. We are tragically plummeting toward the fourth peak of this pandemic.  Confirmed cases are nearly 38 million in the USA and deaths have increased to nearly 628,000.  The Delta variant is now 99% of the isolates of Covid-19 found in the US.  The protectiveness of our vaccines is starting to wane although they remain very effective at preventing serious disease, hospitalizations, and deaths. As a result of these two factors the FDA has recommended a booster dose for the immunocompromised and very high-risk groups, and they may eventually approve boosters for everyone. Many states, particularly in the South, are beyond their capacity to care for the sick.  Two field hospitals have been set up in Mississippi in the parking garages at the only Level 1 trauma center in the state. They are out of ICU beds. Alabama and Louisiana are tethering on the brink of medical disaster as federal medical units are warmly greeted as they provide care and a respite for the overwhelmed nursing and medical staffs.  These dramatic increases in cases and hospitalizations are likely to confront the northern states once the weather is cooler and people start staying indoors.  Now and in the future, we are likely to see the continuing, albeit avoidable, trend of the Covid-19 hospitalizations and deaths occurring in the unvaccinated. Approximately 2% of the 19,000 Ohioans hospitalized this year were among the ranks of the vaccinated. Only 1% of the people who died from Covid-19 this year in Ohio had been vaccinated. It is exceedingly clear that getting vaccinated is the way to cope with Covid-19!  

The great news is that vaccinations have increased in our country over the last two weeks. In fact, on August 20th over a million citizens received a Covid-19 vaccination.  Multiple news reports are that the FDA will license the Pfizer vaccine as early as 8/23/2021 and thereby remove the Emergency Use Authorization. It will be interesting to see if there is a rise in vaccinations since one of the frequent excuses for not getting vaccinated is that the vaccines are not licensed. 

While we work and gradually overcome vaccine hesitancy it is worthwhile to revisit one of the mitigation measures that have been recommended for over a year.  Specifically, the wearing of a mask! Unfortunately, mask wearing has become a political football as governors prohibit mandates from being put back in place. Citizens, governments at all levels, and the courts are in the mist of ferreting this issue out. Healthcare providers want to save lives and get up out of this pandemic ASAP. Science ought to be our guide and not political ideology and misinformation. The science is that the mask keeps your respiratory droplets and particles from infecting other people. We now know that the Delta variant is 2-3 times more contagious than the original strain of the virus. Additionally, the viral load which exists in an infected person is much greater, irrespective of vaccination status. In spite of the new data developed because of the Delta variant, many skeptics doubt the effectiveness of masks.  In the literature I find thirty-nine (39) peer-reviewed studies which show the effectiveness of masking.  A number of these are published in prestigious medical journals such as JAMA, New England Journal of Medicine, Lancet, and the Annals of Internal Medicine. The loud proclamations of a boisterous few can not just make the science disappear from reputable publications. There is additional great anecdotal evidence of the value of masking, social distancing, hand washing, and increased flu vaccination when one looks at the influenza numbers from 2020.  There were 1,016 US cases last season compared to 65,000 the season before.   

None of us want to wear masks again, but the Delta variant is out of control. We have the tools to stop the spread, hospitalizations, and deaths.  Get vaccinated and WEAR a mask when you are indoors with people with whom you do not live.