Updated COVID-19 Vaccine Is Now Available and Helpful!

During this summer of 2024, twenty-five states are seeing an increase in COVID-19 cases. The SARS-CoV-2 wastewater levels are “very high” in thirty-three states, including California, Texas, and Florida; and “high” in eleven other states. The usual summer surges are fueled by increased summer travel, people gathering indoors to avoid the summer heat, and new variants developing or reaching our shores. New variants continue to be bothersome, as predicted a couple of years ago. Recall that the Omicron variant of the SARS-CoV-2 was responsible for the increase in hospitalizations and deaths in the fall of 2021. Our current surge is being caused by a subvariant of the Omicron variant called JN.1. More specifically, a dominant strain of the JN.1 is named KP.3.1.1. It is responsible for 37% of the US cases seen during the middle two weeks of August. The exceptionally good news is that hospitalizations and deaths are not increasing this summer. Nevertheless, it remains protocol that if you test positive, you should be in isolation for five days and mask up to 10 days, when around others. If you are at high risk and test positive, then contact your physician for additional treatment, as necessary. See www.CDC.gov/covid for more specific details.

The increase in US cases is also due to our “herd immunity” decreasing since the natural immunity inferred on people who were infected in 2020-2022 has dwindled away, and because most people have not gotten recent vaccines. Although it is recommended that everyone 6 months of age and older get a vaccination, only 22.5% of adults and 14.4% of children have complied.

In recognition of the new variants that develop continuously, vaccine makers are developing new shots probably on a yearly basis. Most recently both Pfizer and Moderna have new mRNA vaccines that have been approved and granted emergency use authorization by the FDA on August 22, 2024. These new vaccines have been shown to help prevent hospitalization and death, especially in those who are susceptible to severe outcomes from COVID-19.

You can receive your annual flu vaccine and if necessary, the “one time” RSV vaccine at the same time of your new COVID-19 shot. If you are a person who is at high risk, it is strongly recommended that you get your updated vaccinations. The updated Covid-19, seasonal flu, and the RSV vaccines are currently available in your local pharmacies. Protect yourself and those who are vulnerable that might be in your presence.

Clyde E. Henderson, MD, Cincinnati Medical Association

This is WHY You Should Get Another COVID-19 Vaccination

Summer is nearly over but the surge of problems resulting from COVID-19 are not. Hospitalizations due to this SARS-CoV-2 virus are up 8.7% over the last weekly reporting period. Deaths have also increased 4.5%. Covid-19 was responsible for 2.3% of all deaths in the US over the last week. This respiratory disease is the fifth leading cause of death in our country. Note that case numbers are no longer a reliable prevalence indicator because of less reporting from the states and rare home testing being reported. Nevertheless, wastewater surveillance is an ongoing tool for monitoring the existence of the virus. This method shows the presence of the SARS-CoV-2 virus in community sewage.  Genomic testing of the available viruses (wastewater and lab) estimated that the EG.5 subvariant of the Omicron variant represents 25% of the US strains with the other XBB subvariants representing over 50% of the remaining strains. It is clear that the virus continues to mutate as proliferation continues, even though it has slowed markedly since the COVID-19 peak.  

As the presence and consequences of the virus continue, we as citizens must continue to be responsible for our own healthcare decisions. We have been able to emerge from the pandemic to a large extent, because of the immunity imparted by effective vaccinations and the massive numbers of those who became infected. It is estimated that 97% of US citizens 16 years of age and older had developed antibodies as the result of either vaccination or infection. A testament to this is the nearly 50% reduction in COVID-19 death rate between the end of 2021 vs. the end of 2022. Vaccination availability since December 2020 has been essential and a factor in preventing death and severe illness for more people earlier in the pandemic. Initially many people who got COVID-19 succumbed so the immunity benefit of having survived illness were not realized. The virus has followed the biological behavior of mutating as it has been proliferating over the last three years.  The beauty of the mRNA vaccines from Pfizer and Moderna is that they can be targeted to the changes in the virus.  These sorts of adjustments in the vaccines have indeed been occurring. It is therefore wise to take the updated vaccinations as they become available, especially for older Americans and those who are immunocompromised. 

Although our scientists are keeping up with the changes and mutations in the SARS-CoV-2 virus, the detailed processes, and clinical trials necessary for authorization of new vaccines, sometimes lags behind. Case in point is this new vaccine (aka XBB.1.5 vaccine) that was approved by the FDA and CDC on September 12, 2023. At the time (June 2023) when for the next generation of vaccines was occurring, the XBB.1.5 subvariant composed 30.3% of the subvariants.   On September 2nd XBB.1.5, for which the new vaccine was targeted, was only 3.1%. The good news is that the new vaccine is effective against the now most prevalent EG.5 subvariant as well as the very close relative XBB.1.5.  Research shows that all of these Omicron XBB subvariants are very similar in structure. At the time of this new approval, the FDA also withdrew the authorization for the “bivalent vaccine” which had been approved in September 2022, since the BA.4 and BA.5 subvariants, for which it was approved, are no longer in existence in the USA.

After intense study we now have an updated vaccine available and recommended for every American older than 6 months of age. If the past is indeed prologue, getting Americans to take this new vaccine will be a challenge. Concern is present considering that only 17% of Americans received the bivalent booster that was available for nearly a year. Whether one’s immunity is attained after vaccination or/and COVID-19 illness, the protection wanes over time. A higher level of immunity occurs subsequent to illness after vaccination (hybrid immunity).  This hybrid immunity decreases 50% in a four-month period in people who are immunocompromised and those 65 years of age and older.  

Protect yourself and the vulnerable ones around you by getting your newly updated vaccine, especially if you are immunocompromised or 65 or older. Remember your annual flu vaccine can be administered at the same time!

Summer Surge of 2023 Looks Like This

The World Health Organization (WHO) declared an end to the COVID-19 pandemic on May 5, 2023. The Biden Administration earlier this year declared the end of the USA COVID-19 Public Health Emergency (PHE) as of May 11, 2023. After more than three years of massive lifestyle, healthcare, and societal changes caused by this virus, we are not free from its influence. 

The CDC continues to use a variety of surveillance tools to monitor the level of COVID-19. According to the CDC’s county level nomenclature, all the counties in the Greater Cincinnati tristate area remain at the LOW designation. The cautionary news is that COVID-19 hospitalizations in Hamilton, Butler, Warren, and Clermont counties are all up 200% during this last reporting period. Hospitalizations are up 12.1% across the nation, thus one data point in a summer surge. Secondly, there are reports of significant increases in cases in multiple extended care facilities around the country. A third data point indicative of a summer surge is in the wastewater surveillance information. 

In September 2020, the CDC initiated the National Wastewater Surveillance System as an additional tool to monitor the community level of COVID-19. By collecting and analyzing wastewater (sewage) of communities for the RNA of the SARS-CoV-2 virus, early indications of changing COVID-19 virus trends can be obtained. This community-based evaluation is even more valuable since the case numbers determined by testing are vastly underestimated due to the preponderance of unreported home testing. Not to mention that many jurisdictions stopped reporting cases when the PHE ended in May. Two different wastewater monitoring systems across the US are reporting upticks. Although the levels are not as high as previous summers, they have been increasing over the last several weeks. 

There are factors which help to explain the summer surge. Over the last four summers the US has experienced spikes. These might possibly be attributed to the inherent cyclical behavior of the virus. This summer’s surge may be fueled by the dramatic increases in travel by air, train, and bus. Another factor may be that July 2023 was one of the hottest months on record. The severe heat drives people indoors, thus closer together, allowing for easier virus transmission. 

Our country’s mindset has seemingly moved from Covid fatigue to “Covid amnesia.” Evidence of this is in the rather abysmal 17% of the US population having received the bivalent booster which has been available since September 2022. This compares to the 81.4% of Americans who have received at least one vaccine dose and, a still paltry, 69.5% who have completed the primary vaccination series. Our amnesia is apparent by the scarcity of masks and the abundance of face-to-face conversations in cramped lines in airports, conventions, grocery stores, etc. Some by citizens who are knowingly sick! Our post-pandemic behavior needs to be tempered by the memory of the deaths, sickness, hospitalizations, and the financial, educational, social, and societal upheavals caused by this virus. 

Let us be reminded of measures which protect each of us and our communities. Most importantly, be sure that you are up to date with your vaccination and booster. A new bivalent booster from Pfizer is projected to be authorized by the end of August 2023. Secondly, it is wise to have a quality mask, N95 or KN95, readily available in case your environment becomes overly crowded, poorly ventilated, or your personal space is invaded by someone who is sick and should actually be at home. Third, if you are symptomatic, STAY HOME, mask if others are in the home, and test. If you test positive, then isolate yourself at home for five days. If you test positive and are age 50 years or older, or if you have a chronic disease, contact your primary care physician to see if Paxlovid is appropriate for you. Note that it must be started within five days of the onset of your symptoms. After your five days of isolation, you should still stay masked for another five days when around others and still avoid crowds. You can unmask after the total of ten days as long as you are not symptomatic. You can unmask early during that second five-day period if you have consecutive negative tests 48 hrs. apart. 

Stay home if you are sick!

Surprise Them! VOTE on August 8,2023

As strange as it might be, there is an election in Ohio on Tuesday, August 8, 2023. They are trying to sneak one by you! This is a “special election” with only one item on the ballot. This item, Issue 1, proposes three changes to the Ohio’s Constitution as follows: 1) Any future amendment to the Ohio Constitution would require a 60 percent majority to pass (The current threshold is a simple majority of 50 percent plus one vote). 2) Issue 1, if passed, will require that the signature threshold for placing any amendment on the ballot after January 1, 2024, will be 5 percent of the eligible voters from each of Ohio’s 88 counties. Currently signatures are required from only half (44) of the state’s counties. 3) Any ballots submitted for future constitutional amendments which are deemed to have faulty signatures will not be counted. Currently there is a ten day “curing period” during which a voter can correct a signature deemed to be faulty, to allow it to still be counted. 

This ballot initiative to alter our State of Ohio Constitution is being placed before the voters on August 8th by the Ohio General Assembly (OGA), which is led and dominated by members of the Republican party. It is noteworthy that this special election is estimated to cost Ohio taxpayers twenty million dollars. Additionally, this same OGA passed a law just last year, prohibiting special elections in August because they recognized that elections of this nature are not only expensive, but have low turnout. Amazingly, in an about face, the OGA passed a resolution allowing this August 8th, 2023, election in contradiction to the law that they had just passed last year! 

One must ask, why schedule an expected low turnout election during the “dog days” of summer to amend these three aspects of the Constitution of the State of Ohio which have been in place for 111 years? The answer is clearly out in the open. During a Seneca County Republican event on May 25, 2023, Ohio Secretary of State Frank LaRose said about Issue 1, “It is 100% about keeping a radical pro-abortion amendment out of our constitution… It IS about abortion.” What is radical is changing your own rules to conduct an expensive special election. Made worse by acknowledging that a simple majority of the less than 10% of Ohio’s eligible voters, who turnout for the August 8th election, will potentially amend the constitution to enshrine minority rule in Ohio. 

A brief exploration of how other states make amendments to their constitutions is insightful. All fifty states provide for their legislatures to propose constitutional amendments. The citizens must approve the “legislatively referred amendment” in every state except Delaware. The citizen approval vote is by a simple majority (50% plus 1) in all but four of those 49 states. The outliers are Colorado (55%), Florida (60%), Illinois (60%), and New Hampshire (66%). Only 17 states allow “citizen-referred amendments. The same four outliers as noted above are at play in those 17 states. If Ohio passes Issue 1 it will be one of a significant minority of states requiring a supermajority. When one factors in the Issue 1 requirement for signatures from 100% of Ohio’s counties, our state will be in a class by itself. It will be the only state in the entire USA with these signature requirements. This scenario is the definition of radical. 

The reproductive rights amendment to be decided this November 8, has gathered nearly twice the necessary signatures under current Ohio law to be placed on the ballot for November 7, 2023. If Issue 1 passes on August 8th, its 60% threshold becomes effective immediately, thus placing the vote on the November amendment in higher jeopardy. Additionally, passage of Issue 1 will eliminate the century-old power of the majority to implement potential changes regarding issues such as minimal wages, environmental protection, education, health initiatives, gun violence, LGBTQ+ rights, gender affirming care and any others. 

Issue 1 represents an effort by politicians and pro-birth interest groups to eliminate the health care choices for women and the power of we the people to have a majority voice in our governance. A minority of 40% plus one should not be able to thwart the desires of 60% minus one. I encourage you to turn back this cynical attempt at ramming a radical agenda down our throats. Uphold the rights of the majority by voting NO on Issue 1.

One Less Excuse for NOT Getting COVID-19 Vaccination!

There is HUGE news that hit the COVID-19 vaccination scene today, April 18, 2023. The FDA adopted a new protocol for vaccination. The new vaccination protocol simplifies the process and lessens the confusion around when, which vaccine, and how many shots are required for most individuals to be appropriately protected. The current Pfizer and Moderna bivalent vaccinations have been available and used as boosters since September 2022. By definition, each bivalent is a mixture of that manufacturer’s two vaccines, which provided protection against both the original and the omicron BA.4/BA.5 strains of the COVID-19 virus. On-going studies and real-world experiential data have proven the bivalents to be effective as stand-alone, single-dose vaccinations. Bivalent vaccines are to be used for all vaccinations “for people six (6) months of age or older, including for an additional dose or doses for certain populations” (detailed below). Since the updated studies and analyses have now shown that the Moderna and the Pfizer-BioNTech bivalent vaccines are comparable, the confusion around “primary doses” and “boosters” is now eliminated. If you have already had one bivalent injection, unless you are over 65 years of age or severely immune-compromised, consider yourself protected at the current time. Today the FDA also revoked the authorization for the original Pfizer and Moderna (monovalent) vaccines. 

The following provides details of the new FDA COVID-19 vaccination recommendations:

1. A person who has only had monovalent vaccine(s) should receive one (1) bivalent vaccine (unless age 65 or older).

2. If you are younger than the age of 65 and have received a single dose of a bivalent vaccine, you do not currently require another dose of a bivalent vaccination.

3. If you are 65 years of age or older and it has been more than four (4) months since your single bivalent vaccination you should get a bivalent vaccination. (Studies have shown that immunity after vaccination wanes faster in individuals 65 years of age and older).

4. If you have had a bivalent vaccination and are immunocompromised, you are eligible for a bivalent vaccination two (2) mo. after a prior bivalent. The eligibility of immunocompromised children 6 month through 4 yrs. of age depends on the previous vaccine received (ask your healthcare provider).

5. For unvaccinated children, ages six mo. through five yrs., there remains a bivalent Moderna vs. Pfizer difference. These children may receive two age-specific doses of Moderna (6 mo. through 5 yrs.), or three age-specific doses of Pfizer (6 mo. through 4 yrs.)  Five yr.-old children can get two doses of Moderna bivalent or a single Pfizer bivalent. 

6. For children ages 6 mo. through 5 yrs., who have had dose(s) of a monovalent, the number of bivalents will depend on their vaccination history. 

These simplified changes are touted to incentivize vaccination, considering that only a paltry 17% of eligible Americans have received a bivalent injection. It seems astounding, but it is indeed THE unfortunate number according to the CDC. Speculation regarding the reason(s) this is the case is not necessary, because there is data available regarding vaccine hesitancy. For instance, a study out of the Medical University of South Carolina revealed that two of five factors were the main reasons. Respondents to the survey stated that a lack of trust in the science and their providers, and the lack of an ethical obligation to take the vaccination to protect their community were the main drivers. The questions of whether the vaccines were necessary for their health; vaccine affordability and accessibility; and an assessment of the risk of getting sick from the disease were less reasons for vaccine hesitancy. Although it is difficult to overcome the lack of trust and the apparent American “individualism,” we must faint not. More strains of this SARS-CoV-2 virus are on the horizon. The FDA in fact plans to make recommendations for future vaccinations before this fall. The more people decide to get protected, the less likely we will be faced with a strain that is vaccine resistant. The transition to a single injection is a step in the right direction against vaccine hesitancy. Unfortunately, too many Americans are not taking actions for the common good. 

Help protect yourself and those around you by getting current with your COVID-19 vaccination!!

What Now? President Biden Signs END to COVID-19 Emergency

In January of 2023 President Joseph Biden announced that his administration was planning to end the COVID-19 public health emergency (PHE) as of May 11, 2023. That early announcement was designed to provide states and other shareholders time to wind down Medicare, Medicaid, and CHIP waivers put into place to allow for pandemic management. The national health emergency was initially put into place by the former President in March 2020. After a recent Republican House backed bill called the “Pandemic Is Over Act” was passed in the US House, and by a bipartisan vote in the Senate, President Biden signed the bill into law on 4/10/2023. Many experts opine that the month early elimination of pandemic mandated changes will have minimal impact since many of the mandates are no longer in use because the disease has slowed. With that said, there remain practical changes that citizens will feel. Realize that these covid era rules eliminations are occurring in the face of ongoing SARS-CoV-2 illnesses. Updated acute COVID-19 data since our last report six weeks ago reveals that weekly deaths are down 38%, and the daily average hospitalizations are down 42%. Nevertheless, 1,773 Americans died from this virus last week, there were 120,820 cases, and daily average hospitalizations were 2,080 people. Total US deaths since the beginning of the pandemic are at a staggering 1.1 million and the total number of cases is over 104 million. As previously stated, this number represents a dramatic underreporting due to the massive amount of unreported at-home testing. Our Hamilton County is at a LOW community level, as are ALL the adjacent counties in the Tristate area. 

What we have learned since early in this pandemic is that testing is key to fighting this disease. The US would likely be in a different space, with fewer dead and less disease, if testing had been made available and widespread early on. One of the major changes, as the PHE ends, is that free home testing will no longer be available for the uninsured. Those who have insurance may have variable out-of-pocket expense for home testing kits. It would be prudent to be sure that all our households have an adequate supply of Covid-19 tests. You may have appropriate concerns that the kits may reach their expiration dates before they are used, but the FDA has extended the expiration dates of many available test kits. The specifics and the duration of the extension can be accessed, by the lot number printed on the box, at www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list.

Vaccination and boosting have been miraculous tools in preventing death, hospitalization, and severe COVID-19 disease. Another casualty of the end of the public health emergency (PHE), and because Congress has failed to supply funds, is that individuals will have to bear some cost for their vaccinations. Moderna has reversed its earlier decision to charge for its vaccinations and they will now be free throughout 2023. The Pfizer vaccines will cost in 2023 unless one has insurance, in which case the shots will be a covered expense under the guidelines of the Affordable Care Act. For low-income Americans Pfizer has an assistance program and some uninsured adults can be cared for through public health programs. Uninsured vaccine eligible children, six months of age and older, can still get free vaccinations under the auspices of the federally funded Vaccines for Children (VFC) program.

There are other less visible but real-world changes which will result from the end of the public health emergency. Nursing homes, which were under severe stress early in the pandemic, were allowed a shorter training time for nurse assistants. They may now face even worse staffing shortages because the pre-pandemic longer training times will be reimplemented. Secondly, the disallowance for the telehealth prescribing of anti-addiction medication may lead to more lost lives. Thirdly, hospitals stays can be longer and the number of rural hospital beds allowed will return to their lower pre-pandemic levels. Additionally, physician’s assistants and nurse practitioners working in hospitals will return to their pre-pandemic roles. 

We citizens should still protect ourselves despite the PHE ending. Stay up to date on your vaccines and boosters. Know your county COVID-19 level and govern yourselves accordingly. Have masks available and WASH your hands.

Long Covid….Race and Ethnicity Matter

First a brief update regarding where Cincinnati stands in this Covid-19 pandemic.  According to the CDC, our Hamilton County is at a LOW community level, as are ALL the adjacent counties. In the USA Covid-19 deaths are trending slightly downward, yet 2,838 Americans succumbed to this virus last week. The daily average new hospital admissions are 3,571.  Thus, the acute tangible effects of this disease remain a clear and present danger.  

The manifestations of acute COVID-19 are cough, fever, difficulty breathing, fatigue, loss of sense of smell and/or taste, and other symptoms. It has become increasingly clear that when the acute ailment should have run its course, a variety of symptoms may still be around.  Long Covid, aka post Covid-19 syndrome, is said to be present if these complex and alarming symptoms linger, recur, or occur more than four weeks after the initial diagnosis of COVID-19.  Long COVID can last months and even years after one was thought to be “out of the woods” subsequent to an acute infection. The more severe your initial case, the more prone you are to long COVID, yet it does occur after mild or moderate acute cases of COVID-19. 

Symptoms of long COVID can include fever, cough, fatigue, loss of physical stamina, shortness of breath or difficulty breathing.  Nervous system problems can include persistent loss of smell and/or taste, inability to concentrate, calculate, remember, or problem solve. This is commonly referred to as “brain fog”. Problems with balance, headaches, sleep, dizziness, tingling, anxiety, and depression can also be present. Few, if any, of the body’s systems are immune to this long-term disease. The heart can be affected by palpitations, rapid heartbeats, and chest pains. Symptoms in the digestive system can include diarrhea and pain. The vascular system can be involved by blood clots in the legs which may travel to the lungs. Abnormalities in the menstrual cycle and skin rashes may be the indicator of reproductive and dermatologic system involvement. If you are experiencing any of these symptoms a month after your COVID-19 diagnosis, see your doctor to determine the relationship to COVID-19. 

As COVID-19 diagnostics, vaccinations, and treatments have evolved, there is even a governmental diagnostic code (ICD-10) for long covid, “U09.9 Post COVID-19 condition-unspecified”. This code was introduced to the US healthcare system in October 2021.  The diagnostic codes represent the alphanumeric designation by which physicians, researchers, and payors communicate about diseases and ailments. The availability of this long COVID code has allowed the National Institute of Health (NIH) to identify important racial and ethnic disparities in the long COVID symptoms and diagnostic experiences, in two different independent studies. 

The first study, compiled from the medical records of patients at five different hospitals in NYC,  between March 2020 and October 2021, showed a disproportionate number of the severe acute COVID-19 cases were people of color. Blacks and Hispanics compiled 25% each of the severe cases, whereas Whites were only 14%. Whites were more likely to have experienced long-term sleep disorders, cognitive issues, or fatigue compared to the other two ethnicities. Even in those adults with mild to moderate long term disease, Whites were more likely to have documented complaints of “brain fog” and fatigue. The researchers acknowledge that it is unclear why Whites had more recorded nervous system symptoms while people of color had more respiratory, cardiac, diabetes, and musculoskeletal symptoms. 

In the second study from thirty-four US medical centers, two years of data was gleaned from the records of nearly 34,000 adults and children with the coded diagnosis for long COVID. Again, disparities were identified which demonstrated several patterns. Most striking was that the patients carrying this diagnosis were predominately White, female, non-Hispanic, and from” areas with low incidence of poverty” and areas “with better access to health care”. The researchers provided no explanation for the disparities even recognizing that a disproportionate number of acute cases had occurred in people of color.

These two studies show that if you are African American or Hispanic, you may not experience or may not had recorded the nervous system symptoms, or you may not be diagnosed with long COVID, compared to White citizens. Knowledge that these disparities exist is step one to explanations and eliminations of these inequities. 

Winter 2023 Gave Us Less COVID-19..BUT Illness Still Lurks

Fortunately, our country did not experience the surges of COVID-19 illness during this past January that we had seen the two previous years. The peak daily average hospitalizations were 48,240 on January 6, 2023, vs peaks of 137,000 on January 14, 2021, and 159,510 on January 20, 2022.  The community level of COVID-19 remains LOW in all counties abutting and including our Hamilton County except Dearborn County, IN. which is at a MEDIUM level. The absence of a winter surge in probably another indication that this SARS-CoV-2 virus is here to stay and is becoming endemic. This word means that the occurrence of the disease will be a regular feature in our communities. The WHO (World Health Organization) has professed that this virus will be a “permanently established pathogen”.  The researchers who brought us the vaccines which prevented so many people from dying due to this novel virus, are using the technology and knowledge to develop the future vaccines that will likely be recommended on a yearly basis. 

We are in a better place as it pertains to COVID-19 because of vaccines and the fact that so many people have been infected. The protection (immunity) resulting from a person getting a vaccination after having a COVID-19 infection is called “hybrid immunity”. A systematic review of multiple studies published in a United Kingdom medical journal called Lancet, reveals that hybrid immunity provided 97% protection, at twelve months, against hospital admission or severe disease as opposed to 75% after infection alone. Reinfection rates were 42% and 25% respectively in the two groups, respectively at twelve months.

Vaccination remains a critical piece of our ongoing fight against COVID-19. It’s easy to be confused about the  “who and when” of vaccination, considering that vaccination availabilities, varieties, and authorizations have evolved over the last two plus years. In capsule, the current recommendation is that all age groups keep up to date with the appropriate vaccines.  The updated (bivalent) booster is recommended for all people 5 years and older two months after they have completed the primary series. The bivalent booster is also recommended for children ages 6 months to 4 years who have completed the Moderna primary series, at least two months previously. There is currently no recommendation for boosting this age group if the primary series was the Pfizer vaccine. Specific recommendations can be obtained at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html.  

The US government declared a national emergency because of this virus in March 2020 and a public health emergency in April 2020. President Biden has announced that both of these  emergency declarations will  end on May 11, 2023.  Most of us are behaving as though the emergencies are over. There will be profound differences when May 11 rolls around. The widespread FREE COVID-19 tests, and treatments will no longer be universally available. The out-of-pocket-cost of these services will vary according to insurance coverage and on a state-to-state basis. Medicaid rolls are likely to shrink because the pandemic related additional Medicaid funding has already been eliminated beginning this past December. Vaccines are likely to be covered irrespective of the insurance plan but those Americans without ANY insurance will have new costs. Antiviral pills, like Paxlovid, may no longer be covered. Lastly, hospitals will no longer receive increased Medicare reimbursement for providing care for people stricken with COVID-19.

We are still experiencing five hundred deaths a day due to COVID-19.  Some of these people might have been saved if Paxlovid had been used. Remember that this drug is to be taken orally by individuals, 12 years of age or older and weighing at least 88 lbs., “who have tested positive, have mild-to-moderate disease, and are at high risk for progression to severe COVID-19, including hospitalization or death”. The change in reimbursement for Paxlovid will likely be a significant impediment to its use, but currently physicians are just not prescribing the medication. White House data from the first two weeks of January, 2023 reveals that doctors only prescribed it in 45% of the recorded COVID-19 cases. This represents an under-estimate since many more cases are diagnosed by a self-test. Armed with knowledge of Paxlovid, a symptomatic person should contact their physician for this prescription which can save their life.

Bystander CPR/AED…Another Healthcare Disparity

Nearly one thousand (1000) Americans suffer a cardiac arrest (the heart stops beating), outside of the hospital, every day. Tens of millions of people witnessed the cardiac arrest of Damar Hamlin, defensive back for the Buffalo Bills, during Monday Night Football on January 2, 2023.  The medical professionals realized that his heart was not beating and began to administer immediate cardiopulmonary resuscitation (CPR) and used a readily available device called an automated electronic defibrillator (AED) to shock his heart back to activity. Mr. Hamlin is making a remarkable recovery and was able to be transferred to a Buffalo hospital for further care, just seven days after his on the field collapse. Two days later he was discharged from the hospital in Buffalo for further rehabilitation at home and at the Bills facility. 

Longstanding data shows us that the survival rate after out-of-hospital cardiac arrest is much worse for Blacks and Hispanics compared to Whites.  We know that receiving immediate CPR and AED usage are the keys to people recovering from cardiac arrest. Unfortunately, only 40% of people who have a cardiac arrest witnessed by a bystander get immediate CPR by bystanders. What’s even worse is that if you are Black and experience a witnessed cardiac arrest in public you are 37% less likely to receive bystander CPR than if you were white. Black folks who suffer cardiac arrest at home are 26% less likely than whites to receive potentially lifesaving in-home bystander CPR. 

There are a number of possible explanations for this healthcare disparity. First, as it relates to the lower incidence of in-home bystander CPR, we should note that access to CPR training in Black and Hispanic communities is less than in White communities.  Studies also report there is less available dispatcher-assisted bystander CPR.  Both of these can be related to structural racism and the lack of investment in CPR training and cultural/language competency of 911 dispatchers. CPR education requires trainers, mannequins, electrodes, AED training devices, sanitation equipment, and culturally appropriate vision aids. The cost of these items for CPR training is a further impediment to underprivileged communities. The distrust of authorities and the health care system, dissimilar CPR instructors, and potentially immigration status can add to this list of impediments. Secondly, regarding the bystander CPR racial disparities in public places, one need look no further that implicit and explicit layperson biases. Apparently, “public safety concerns may deter bystander response for a Black or Hispanic person having a cardiac arrest as compared to a White person” (NEJM 387:17, Oct. 27,2022). The data seems to indicate that these concerns are present in majority Black and Hispanic  communities as well as low income communities. 

Like all other health disparities, we must try to close the gaps. Providing either no or low-cost CPR will help to overcome the financial barrier. Placing the training in comfortable community locations and securing trainers who look like the clientele or are culturally competent may help as well. A significant investment in the infrastructure of our emergency response is necessary to procure language appropriate dispatchers and those who are trained in dispatcher directed-conducted CPR. Spanish speakers as well as a variety of African languages experts would be helpful. The addition of mannequins in a variety of skin colors me be of benefit as well.

Mr. Hamlin had a cardiac arrest as the result of a freak accident. The exact cause of his heart stopping is not known yet. What is clear is that he was very fortunate to be surrounded by medical professionals who recognized the problem and immediately began lifesaving CPR and used an AED. Too many Americans do not get the same level of care, particularly if they are people of color. Please avail yourself of training which can equip you to save the life of someone that you love or that someone else loves.  It may seem scary, but once you go through the short training you will realize that everyone and anyone can do this.  The AED device even talks you through the process!!Go to www.truecommunity.org,  www.redcross.org,  www.heart.org,orwww.closingthehealthgap.org ,to sign up for training classes. There is FREE training available in Cincinnati at the Center for Closing the Health Gap during Black History Month.

Flu Overwhelms Hospitals as COVID-19 Rises..MASK-Up!

We are early in the flu season and yet flu is on the rampage. Flu hospitalizations in the Greater Cincinnati Area increased 107% in the last week, the week after the Thanksgiving holiday. Hospitals across the country are at 80% capacity due to influenza, COVID-19, respiratory syncytial virus (RSV), and other respiratory viruses. The influenza virus can be one of any four major types A, B, C, and D. Seventy-seven percent of this season’s strain is Type A (H3N2). Even though the vaccine is designed to be effective against all four Types of the influenza virus (quadrivalent), the predominance of one Type makes it easier to craft the vaccine to fight it. Although it is too early to know the efficacy of the 2022 influenza vaccine in the US, the data from the southern hemisphere, which has already seen its flu season, shows that the vaccine was approximately 50% effective. Remember that the main purpose of the flu vaccination is to prevent death and severe illness. 

Anecdotal and preliminary USA information indicates that the available flu vaccine typically results in a milder clinic course and less likelihood of death from the flu or its complications. With that said, 8.7 million Americans are known to have already become infected (last year’s total number), 78,000 hospitalized, and 4,500 have died this season. The flu vaccine will lessen your chance of the potentially debilitating fever, chills, sore throat, runny nose, coughing and sneezing, and the run-down achy body caused by this very contagious virus. These acute symptoms tend to resolve in 5-7 days, but some people suffer from complications such as pneumonia, ear and sinus infections. The complications of influenza can be worse during pregnancy, as well. Those individuals with chronic medical conditions such as diabetes, asthma, and heart failure may experience worsening of their conditions if they become infected with influenza. Getting a flu vaccination will help prevent you from missing school, work, or even the upcoming family holiday celebrations. 

Fortunately, RSV, which represents the second leg of this “Tripledemic” is beginning to wane. Nevertheless, people over 65 years of age, individuals with preexisting conditions or who are immunocompromised, and babies under one year old need ongoing attention. If they are symptomatic and experiencing high fever and shortness of breath, they need to have the nasal swab test for RSV. Early diagnosis and supportive care are the keys to good outcomes. 

Even though we all see less people masked, COVID-19 IS NOT OVER! Ohio’s Hamilton County, the three abutting Ohio counties, and Dearborn County of Indiana are now at the CDC’s MEDIUM levels of COVID-19. All of these Greater Cincinnati counties spent the majority of the last three months in the LOW category. Despite us all wanting to be done with this SARSCoV2 virus, its impact is rising again. The data shows that Ohio has seen a 52% increase in cases over the last two weeks. The USA has experienced a 25% increase in known cases and hospitalizations over the last two weeks. Deaths remain static at roughly 350 per day. 

There is good news on the COVID-19 vaccination front. First, 68% of Americans have been vaccinated and 34% have been boosted. In the sixty-five and up age group, 93% of Americans have been vaccinated and 67% have been boosted. Any wonder why they reach their seventh decade? Secondly, booster vaccination, using either the bivalent Pfizer or Moderna vaccines, has now been approved for all children 6 months of age and older. These boosters should be given no sooner than two months after completion of the primary vaccination. 

Prevention of any of these viral ailments would be a panacea but is not always doable. Shortages in medications for treating the signs and symptoms of these viruses, such as OTC’s, Tamiflu, and amoxicillin are another reason to endeavor to avoid these diseases. We can all minimize our risk of each of these respiratory viruses. Vaccinate for the flu and COVID-19. WASH your hands, keep your hands away from eyes, nose, mouth, or other parts of faces. Socially distance and isolate, as necessary. I am aware of at least two area medical facilities that have reimplemented mask requirements. WEAR your mask in indoor public places!

COVID-19 Takes Backseat to RSV During Triple Threat

With all the current focus on other respiratory viruses one might again get the impression that COVID-19 is through with us although many voiced that they are “through with COVID-19”.  The data shows that the USA is still seeing a two-week running average of 39,090 cases per day (up 3% vs two weeks ago) along with the unfortunate 345 deaths per day (down 6% over two weeks). Hospitalizations have risen 2% to a level of 27,161 day.  The USA maintains the dubious distinction of leading the world with 97.6 million known cases and 1,071,578 deaths.  Be reminded that the actual number of cases is much higher because of the level of home testing in our country. The CDC’s Community Level of Covid-19 remains LOW for the nine counties composing the Greater Cincinnati Area. 

Health news is sensationally and rightfully dominated by the respiratory syncytial (sin-sish-ul) virus, RSV. This virus was first identified in 1955, so it clearly is not new. What is new is the timing and the ferocity of the current outbreak.  Cincinnati Children’s Hospital Medical Center’s emergency rooms and urgent care facilities have been overrun with patients requiring treatment for at least the last two weeks.  Hospital admissions have spiked in Cleveland, Columbus, and Toledo.  Across the country pediatric intensive care units are at or over capacity in twenty-three states.  The peak impact of this virus in previous years has been seen in the late fall and winter seasons. This early fall surge is not only sooner than usual, but the infants and young toddlers being affected are sicker than usual and requiring more healthcare services.   The virus also affects adults especially those who are immunocompromised and those with preexisting conditions such as COPD, asthma, and congestive heart failure. Reportedly, RSV is responsible for over 14,000 deaths per year in US adults.

RSV is an extremely common respiratory virus. The vast majority of children have been infected by this virus by the age of 2. Although symptoms can range from mild cold-like symptoms to high fever and severe difficulty breathing, most children have little difficulty recovering from exposure and illness. Babies under the age of one year old are the ones who more frequently experience the severe course.  The diagnosis is made when symptoms are present and confirmed by a nasopharyngeal swab test. Infected individuals can spread this extremely contagious disease for two days before and 3-8 days after they are diagnosed. The virus is spread not only through the air, but also through direct contact such as shaking hands. The virus can stay alive for hours on hard surfaces as well. Treatment is symptomatic and depends on the severity of the clinical presentation.  There is an antiviral which can be given preventatively for susceptible children. 

Influenza is the third virus of concern at this current time. Flu season typically runs from early October through late May.  The very important news to know is that the CDC is recommending that everyone 6 months and older get an annual flu vaccination. Those citizens 65 years of age and older should get a vaccine that is different than younger adults. Even though it is recommended that the annual flu vaccine be given before the end of October, vaccination at this time, early November, is likely to be effective in preventing severe disease and death. The CDC specifically recommends one of the following three vaccines for individuals 65 and older: Fluzone High-Dose Quadrivalent vaccine, Flublok Quadrivalent recombinant flu vaccine or the Fluad Quadrivalent adjuvanted flu vaccine. If one of these is not available, then a standard flu vaccine is preferable to none at all.

Last Fall and Winter we were concerned about a “twindemic” but now we are vexed by a “Tripledemic”, so to speak.  When COVID-19 was raging, there was more Wearing of masks, Washing of hands, and Watching our distance. The paucity of influenza deaths and the absence of raging RSV last year should make us consider these measures as helpful. We know that the COVID-19 and flu vaccines can reduce deaths and severe disease. A vaccine for RSV is in clinical trials. Please get the available vaccines and consider wearing a mask.

Is The COVID-19 Pandemic REALLY Over

In a Sunday night national television appearance two weeks ago, President Joe Biden referred to the COVID-19 pandemic being over.  Our President’s assertion prompted the Whitehouse to scramble to clarify.  The official position of the US government is that we are still in the throes of a “Public Health Emergency.”  Additionally, one prominent World Health Organization figure noted that worldwide deaths from the virus are at their lowest levels since March 2020.  He thus suggested that “the end of the pandemic is in sight.” Yet pandemics just do not end all of a sudden. There is actually an 18-member panel that makes that determination. They have yet to declare this pandemic over.  

People are still getting sick, hospitalized, and dying as a result of this virus. The US is still seeing over 400 deaths and averaging over 41,000 (known) cases per day.  This is assuredly an underestimate considering the amount of home-testing that is being performed. Admittedly the levels of despair as a result of this virus have waned dramatically. The epidemiologic data is clearly better.  All of the counties in Ohio and Indiana, which surround our Hamilton County, remain at a LOW community level of COVID-19. All Kentucky counties which are adjacent to Hamilton County are at MEDIUM levels. At the LOW level of community involvement, the CDC still recommends:

“Stay up to date with COVID-19 vaccines. Get tested if you have symptoms. Wear a mask if you have symptoms, a positive test, or exposure to someone with COVID-19. Wear a mask on public transportation. You may choose to wear a mask at any time as an additional precaution to protect yourself and others.”

For MEDIUM level CDC adds “If you are at high risk for severe illness, consider wearing a mask indoors in public and taking additional precautions.”

Although the epidemic nomenclature describing that this SARS-Cov-2 virus is somewhat up for debate, the affect that it is having on our lives has clearly changed. Many people are back to in-person work, schools are back in, sporting events and restaurants are being enjoyed. All of this is occurring while mandates and restrictions are being relaxed. Yet we must still care about this virus and its potential impact. We have experienced surges over the last two autumns and this one may be no different. 

If this Fall is different, it will likely be the result of the millions of Americans who have received the new Bivalent vaccine, and less likely the result of the limited and fleeting immunity found in the previously infected. Even prior vaccination without the Bivalent booster is less effective against the current predominant variants. We know that most COVID-19 infections in the USA are caused by the Omicron BA.4 and BA.5 subvariants (for now). 

In order to understand why the new booster is needed we need to review what is immunity? Protection from disease is the short definition. This resistance to becoming ill is gained by the human body developing blood proteins (humeral) and cells which attack the virus that invades the body.   These defense mechanisms develop “naturally’ after an infection, after vaccination, or in a “hybrid” form after both. The humeral immunity is antibody driven. The cellular immunity is driven by helper T cells which identify the invading pathogen, killer T cells which destroy the pathogen, and by B cells which make more antibodies, as necessary. Although people who are infected by the SARS-CoV-2 virus develop all these types of immunity, the benefit derived is not long lasting. On the other hand, the Moderna and Pfizer bivalent boosters are proving effective in preventing severe disease and death caused even by the Omicron BA.4 and BA.5 subvariants. 

Words can declare this pandemic as over. Governmental agencies will be responsible for verifying the epidemiologic parameters that match the assertions. We must continue to be rational with our self-protection. Get yourself and your children vaccinated as have 95% of our senior citizens. Follow the seniors’ over 65% example by getting boosted. Wisdom and great choices have allowed them to reach their age! Be mindful of indoor ventilation and crowding. Get your flu vaccine and wash your hands. Wear a mask in vulnerable environs or when around high-risk individuals.

Get the New Booster to Beat the Fall COVID-19 Spike

We are in the Labor Day weekend which marks the unofficial end to the summer. Our children are back in school, and most adults will be turning to their indoor entertaining and work activities. Employers have been encouraging a return to in-office work. All of these reflect a diminution of social distancing and indoor proximity to one another. These changes of venue have driven past USA autumn COVID-19 spikes and predictions are that this trend will continue. Adding the expected increases atop the ongoing 84,000 daily cases, 5,000 daily hospitalizations, and 407 daily SARS-CoV-2 deaths, it is easy to see the cause for concern.  

In anticipation of the fall surge the pharmaceutical companies and the FDA have been working feverishly, with due safe and scientific speed, to update vaccines in response to the dominant variants. Both Pfizer- BioNTech and Moderna have added mRNA which codes specifically for a portion of the spike protein found in common on the BA.4 and BA.5 subvariants of the Omicron variant. The terminology for this new formulation can be confusing as it is referred to as “bivalent” and also as an “updated booster.” The bottom-line is that these new boosters, which have been given Emergency Use Authorization (EUA) by our Food and Drug Administration (FDA), also contain the mRNA which was found in the originally approved vaccines. Thus, there is double protection.  The clinical trials and studies have shown them to combat the original strain responsible for COVID-19 as well as the currently dominant strains and variants.

According to the new CDC guidelines this new Moderna COVID-19 Vaccine, Bivalent, has EUA for people 18 years of age and older. It is to be administered no sooner than two months after completion of the primary series of the original Moderna. That original vaccine, which is referred to as monovalent, is still used as a two shot, four weeks apart series for those who have never been vaccinated. A person in this age group who has been vaccinated and boosted must wait two months after their primary series completion or last booster before receiving this updated (aka bivalent) booster. 

There is a significant difference with how the new Pfizer BioNTech Covid-19 Vaccine, Bivalent is utilized. It has been given EUA for ages 12 and older. It too is to be administered no sooner than two months after the completion on a primary series or monovalent booster. Note that the Pfizer primary series is two monovalent injections, no sooner than three (3) weeks apart. Essentially, the new Pfizer can be used in adolescents and teenagers whereas the new Moderna does not have EUA as of yet. Just as we experienced with the expanding age groups eligible for the original monovalent vaccines, the same is expected with these bivalent vaccines.  Younger age groups will likely be able to benefit from these new protections as time goes on. 

Another change in the guidelines is that for the twelve and older age group only one of the two new bivalent vaccines is to be used as a booster going forward. The approval for the monovalent vaccines to be used as a booster for these individuals is now rescinded by the FDA. It is extremely important to reiterate that the original monovalent Pfizer BioNTech and Moderna vaccines are still approved for administration as a primary series for individuals 6 months of age and older. Additionally, the original Pfizer BioNTech vaccine is authorized as a single dose booster, at least five months after completing the primary Pfizer BioNTech series, for individuals ages 5-11 years of age. 

Safety and effectiveness are the hallmarks of a beneficial medical therapeutic. The updated vaccines have been found to meet both benchmarks. They have effectively lessened severe illness, hospitalizations, and deaths. The most commonly reported side effects have been pain, redness, or swelling at the injection site; headache, fatigue, fever, or joint pain. 

As we transition back to indoor activities, there is now a new tool in the armamentarium to fight this omnipresent disease. Currently Hamilton is at a LOW, and surrounding counties are at LOW to MEDIUM community levels of COVID-19. This is likely to change soon. Get your updated booster NOW to protect yourself and those around you.

President Biden Gets COVID-19 Rebound, MASK UP Cincinnati!

President Joseph R. Biden tested positive for COVID-19 six days ago. He had received both of his Pfizer/BioNTech vaccines at the appropriate three (3) week interval, before his January 20, 2021, inauguration. He has received both of his boosters, one in September 2021 and the second in March 2022.  The essential nature of early testing after the onset of symptoms was again borne out as the President was started on the prescribed five-day protocol of Paxlovid pills. The Paxlovid remains available by prescription, under emergency use authorization, for anyone twelve and over, who has tested positive and has mild to moderate symptoms of COVID-19, and who is at high risk of severe illness.  The President returned to work in the Oval Office of the White House after five days of quarantine. According to CDC protocol, he was supposed to wear a well fitted mask for ten days. Because of White House protocol he was tested at least daily. This frequent testing was done with the purpose of detecting the “rebound” phenomenon, which reportedly occurs in less than 1% of individuals who have taken the antiviral Paxlovid. This frequent testing detected a positive COVID-19 test four days after his quarantine was over, and again today 7/31/22. Experts are rethinking the frequency of “rebound” as it appears to be occurring 20%-40% of the time for Paxlovid treated Omicron BA.4 and BA.5 variant infections. The original research and clinical trials conducted for Paxlovid were done in the face of different SARS-Cov-2 variants. Just as our vaccines need to be updated, so may the oral antiviral pills. It is incumbent on us to be vigilant and understand that the science changes as does the virus. 

President Biden became infected as the Omicron variants are driving current nation-wide increases. According to the CDC, https://www.cdc.gov/coronavirus/2019-ncov/your-health/covid-by-county.html, all Ohio counties in the Greater Cincinnati area (Hamilton, Butler, Warren, and Clinton) as well as Dearborn County (IN), Boone and Kenton counties of Kentucky are at HIGH level of COVID-19. Campbell county of KY is at a medium level. Recall that when a county is at a HIGH level the CDC recommends that masks be worn indoors in public, people stay current with vaccinations, and early testing if symptoms are present. People at high risk for severe disease should take extra precautions such as social distancing and/or staying out of crowds. These measures remain recommendations in most localities. Mandatory mask wearing has been re-implemented in Louisville (KY) public schools as well as at Ohio University in Athens, OH.  

Our protection from theses surges will come from us following recommendations because mask mandates are not coming in Ohio. Last year the Ohio Senate Bill 22 was passed. It granted lawmakers authority to strike down public health orders.  The experts in public health are thus robbed of their ability to implement measures proven to be effective in a pandemic. These orders could be necessary for both urban, suburban, and rural communities in every state.  The citizens affected by surges in COVID-19 and by lawmakers’ policies reside in small and large municipalities as well as rural areas.  Policy decisions exasperate the racial gap apparent throughout this pandemic, even in rural areas. A recent study has revealed that Black American in rural areas died from COVID-19 at a rate 34% higher than their white counterparts. Current data shows that death rate for the unvaccinated is six (6) times higher than the vaccinated. Additionally average known daily case rates are three (3) times higher in the unvaccinated. Public health policy matters! Protecting oneself from these increases in COVID-19 will be aided by each of us following the recommendation to wear a mask.  

Just as President Biden, along with many high-profile public servants, entertainers, sports figures, and millions of other Americans have been stricken and have, or are recovering, from this SARS-Cov-2 virus. Positive outcomes are much more likely when citizens have been fully vaccinated, boosted, early tested, and treated early.  The residents of all HIGH level counties including, Greater Cincinnati, should heed the recommendations of the CDC. It is time to put our masks back on while indoors, in public, until the COVID-19 level in your locality lowers to an acceptable level.

CDC Ends Social Distancing Yet COVID-19 Remains

Compared to two weeks ago, we in the Greater Cincinnati Area are in a better place when it comes to COVID-19.  The current community levels in Hamilton County, and all abutting counties, is now “MEDIUM” compared to “HIGH” two weeks ago. Around the country 40% of US counties are “HIGH” and 41% are MEDIUM, with approximately 20% being “LOW”. The level nationally was over 90% “HIGH”. Just to reiterate, when community level is “MEDIUM” then wearing a well-fitted mask is recommended when you are indoors in public if you are a person at high risk of becoming severely ill from a COVID-19 infection. Additionally if you have household or social contact with someone at high risk of severe illness then you should consider testing before contact and consider masking when around these susceptible individuals, for their protection.

In the face of the extensive immunity afforded the US public by vaccinations and to a lesser extent by prior infection, the CDC has significantly altered its recommendations (https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12-childcare-guidance.html).  These changes are very much driven by the absolute understanding that our children need to be in school as much as possible. This updated approach recognizes the reality that the educational loss from being absent from the classroom is more of an impact on a larger number of children than the unfortunate health effect of COVID-19 on a small number of kids that get severely ill. Ironically, and tragically, children of color and those of poor communities suffered disproportionately from the educational loss AND the health impact of COVID-19 due to preexisting healthcare, environmental, financial, and workplace disparities. The new guidance was issued on August 11, 2022 and affects every aspect of our day-to-day existence. 

One of the major changes is the elimination of the need to be socially distanced. The “Watch your distance” mantra recommending six (6) feet of separation has been in place since the beginning of the pandemic (March 2020). It is essential to recognize that this change in CDC recommendation is not a license for everyone to be crowded shoulder to shoulder indoors amongst non-household members.  Our government health authority is officially placing the onus on each of us for our individual wellbeing and survival during this pandemic. Each of us needs to consider our individual risk and the risk factors of those with whom we live. If you are unvaccinated, have significant preexisting health conditions, or have household members who are at high risk of severe COVID-19 illness, your safest course is to keep social distancing in your daily activities. 

The CDC’s recommendation for quarantine after being in “close contact” with an infected person no longer exist unless the person is in “high risk congregate settings such as correctional facilities, homeless shelters, and nursing homes”.  The “test to stay” recommendation for schools and early care education (ECE) facilities which required testing after exposure, has been eliminated. Instead, wearing a well-fitted mask followed by testing is recommended, where deemed appropriate. What has not changed is a person tests positive or is symptomatic, they should quarantine five days, test negative, and then mask up for five more days. 

Contact tracing, which has been a hallmark of combating communicable diseases and a major goal while dealing with this pandemic, has now been deemed to be unnecessary except in hospitals, correction facilities, and nursing homes.  Routine screening and testing is also no longer recommended except in group-living situations (e.g. nursing homes, prisons).

We have discussed above two of the three W’s of COVID-19 battle, (Wear mask, Watch your distance). The third component of this triad is “Wash your hands”.  Following proper handwashing procedures remains beneficial in fighting viral diseases including the SARS-CoV-2 and monkey pox.  Be reminded that seasonal influenza has been much less of a problem over the last two winters due to vaccination, hand washing, and social distancing. 

The evolving CDC COVID-19 guidelines is an indication that the agency is saying, in no uncertain terms, that personal responsibility is how we will live with COVID-19.  Our best course of survival is through vaccination and boosting, masking and distancing based on community level, quarantining when sick, testing if symptomatic, and having your physician assess your eligibility for oral medication.

Omicron Marches On as BA.5 Sub-variant Dominates

As Americans have shed their protective masks and resumed the pre-pandemic level of summer travel, COVID-19 continues to tell us that it is not done. Since May, the seven-day average of US hospitalizations has doubled.   The reported daily case number has increased to greater than 130,000. This number represents an undercount considering the significant number of positive unreported home tests being performed.  Cases are rising in more than 40 states.  The reported 14-day in cases is up 16%.  Over this time interval hospitalizations are up 19% and COVID-19 related ICU usage is up 23%.  COVID-19 deaths which had remained steady, or even decreasing for a number of weeks, have increased 11% over the last 14 days.  

These cautionary statistics are being driven by the Omicron BA.5 subvariant, which now comprises 65% of the sequenced SARS-Cov-2 viruses causing disease in the USA.  Another subvariant, BA.4, causes another 15% of our COVID-19 infections.  The BA.5 is the most transmissible version of the virus that the world has experienced.  Its arrival and now dominance on our shores follows a trend that what happens in Europe is coming to the United States.  Cases in Europe have risen 70 percent over the last 14- day period ending July 4th. Researchers on both sides of the Atlantic are reporting a phenomenon called “immune escape.” This means that vaccinations and previous infection do not fully protect against this variant. Fortunately, the clinical severity of disease caused by this subvariant mutation is generally less. The BA.5 was first identified in Portugal and South Africa before popping up in South America, Asia Pacific, and then Europe.  Several European countries are taking precautions. Cyprus has reinstated mask mandates. This small Mediterranean island joins Austria, Great Britain, Germany, Greece, Italy, and Switzerland as world designated COVID-19 hotspots. On the American home front, the cities of New York and Los Angeles and recommending that masks be worn indoors. 

Recall that viruses can only mutate when they replicate.  We in the US have vaccines available but are not using them. We rank 67th in the world when it comes to being boosted. Only a third of eligible Americans have received their booster shots. Even our mature adults and elderly are lagging behind their eligibility. In the age group 65+ the fully vaccinated rate is a wise 92%, although 1st booster rate is 64% and 2nd booster rate is a paltry 22%.  For the 50–64-year age group, the fully vaccinated rate is 82%, with the 1st booster rate being 45% and the 2nd booster rate is only 9%.  Allow me to reemphasize that even the current boosters provide significant protection against severe disease and death. I encourage everyone to follow the CDC vaccination recommendations available at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html#recommendations. In summary, you should be fully vaccinated if you are over 6 months of age, get one boost if you are over 5 and under 50 years old, and get a second booster if you are 50 years or over (or between 12 and 50 years old and moderately or severely immunocompromised).  

Again, we are faced with a summer surge and the promise of an unpredictable fall and winter. Vaccine manufacturers are making plans for even more variant specific vaccines.  FDA and CDC approval for 2nd booster doses for everyone under the age of 50 is in the works.  The availability of boosters and vaccinations only help if we are willing to roll up our sleeves and get jabbed. 

As this new BA.5 subvariant continues its march we can still be proactive and protect ourselves by utilizing the readily available home testing.  The test kits are free at your pharmacy if you are on Medicare and with other insurance companies as well.  Test early if you are symptomatic so that you can get started on Paxlovid (anti-viral pill) available by doctor’s prescription now, and possibly soon directly by pharmacist. 

Do your part to protect our health. Pandemic fatigue must not become the ruler over science.  Get vaccinated, boosted, know your community’s COVID-19 level, and mask when appropriate. Sooner or later, we may face a variant that has the lethality of last year’s Delta and the transmissibility of Omicron, or just maybe something worse?

FINALLY Covid-19 Vaccine Protection for Younger Kids

Eighteen (18) months ago Americans 16 years of age and older gained access to a vaccine against -the SARS-CoV-2 virus which is responsible for the COVID-19.  Children ages 12 to 15 have been eligible for thirteen (13) months and those ages 5 to 11 have been able to get a vaccination for seven (7) months. This past weekend Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), approved the unanimous recommendation of the CDC Advisory panel and the FDA so that children between the ages of 6 months and 4 years can now get this miraculous protection. The delay in this long awaited approval for our younger children has resulted from the need to establish an appropriate dosage and injection interval in this group of children who are less susceptible to the disease.  It therefore takes a larger sample of trial volunteers and thus a longer time to conduct the trials. The long duration of the trials have resulted in a determination of the effectiveness as well as the safety of the regimens that are being recommended. 

The vaccination of these children began yesterday, June 21, 2022. There are seventeen (17) million children in this 6 month to 4yr age group. The regimen for the Pfizer/Bio-N-Tech and Moderna remain somewhat different. If the Pfizer product is used in these younger children, it requires a three dose primary series of 3 micrograms (mcg) each.  The first two doses are administered three weeks apart and the third dose is given eight weeks later.  This compares to the two dose series 3 weeks apart of Pfizer at 10 mcg for 5 to 11 year olds, and 30 mcg for those 12 and older. As far as Moderna is concerned the doses for the 6mo to 5yr age group is a two primary dose series of 25 mcg each, one month apart. Moderna is not authorized by the CDC as of yet for ages 6-17.  The FDA’s recommendation of 50 mcg a month apart for ages 6 to 11 years old, and 100 mcg (one month apart) for ages 12 to 17.  CDC authorization is in the works.   

It is noteworthy that researchers at our own Cincinnati Children’s Hospital were instrumental in conducting trials for these youngsters. These experts and others determined that the most common side effects of the vaccines were pain and sometimes swelling and/or redness at the injection site.  A mild fever, generally not severe enough for acetaminophen or ibuprofen, occurred in 25% of the Moderna recipient as opposed to 10% of the Pfizer participants. Less than 1% of the fevers reached 104 degrees. The rare cases of myocarditis seen in adolescents were not apparent in this 6 month to 5 year age group.  Based on the safety profile developed from extended trials, along with the continue monitoring and data collection after the roll out of shots in these little arms, experts are comfortable with going forward.
 

The question is whether or not parents will be comfortable getting their children vaccinated. We know that children in this age group are even less prone to serious infection and hospitalization from COVID-19 but they are not immune. Over 200 children in this age group have died from this disease since January, 2020.  This represents a higher number of deaths than caused by any other communicable disease during this timeframe. The majority of these 17 million eligible children have already been exposed considering that 202,000 children have lost at least one parent to Covid-19, and there have been nearly eighty-seven million cases in the USA. Nevertheless any immunity inferred from infection has not proven to be long lasting. Vaccination of these young children provides an additional layer of protection which further lessens the likelihood of severe disease, hospitalization, and long term sequelae from COVID-19. The other end result is less disease proliferation and therefore less opportunity for virus mutation. 

The availability of vaccination for this new age group is another major step in fighting COVID-19.  A long and careful process has finally led to available protection for most of our remaining youngest. Providing them protection leaves the elderly and vulnerable less susceptible and is one more step toward normalcy.

Protecting Yourself in This 3rd Summer of COVID-19

A look back on the first summer of COVID-19, 2020, we find a country that had just passed the milestone of two million cases and the very depressing occurrence of over 114,000 deaths.  We were coming out of Memorial Day gatherings and expecting 140,000 Americans dead by July 4, 2020. There was a 2.4 times higher death rate among African Americans vs white Americans from COVID-19.  We had no national policy to compensate for the unequal economic impact of the virus nor to address PPE (personal protective equipment) needs of working people and the public. Fast forward our country a year to June 2021 and we find Americans disregarding recommendations to mask in public and more importantly to get vaccinated. The hope that the 76% vaccination rate for herd immunity would be achieved with more people kept alive by masking proved to be “fool’s gold”.  Only 46% of the population had been fully vaccinated in spite of incentive programs. The Delta variant was beginning to rear its ugly head. Here we are now at the beginning of the third COVID summer.  More than 1,000,000 Americans are dead, only 68% of Americans are fully vaccinated, and the “protection of others by masking argument” has been lost. 

If we are to get ourselves back to some semblance of a normal summer in 2022, we must proactively implement measures to protect ourselves. The mainstay of protection is vaccination. If you are six years of age and over, you can be vaccinated and boosted. The latter has proven to remain effective against the Omicron variants which have been running rampant for the last eight months. We continue to encourage everyone who is eligible to get vaccinated and boosted irrespective of your individual risk. Knowing your risk should be your guide as to your exposure to the summer crowds and travel. If you are fully vaccinated and healthy, you can more safely plan to attend cookouts, concerts, and travel. 

If you are planning to utilize public transportation note that masking is now optional. Do not be afraid or feel embarrassed if you determine that wearing a mask at various times during your travel is the best course for you. The decision to do so should be governed by your vaccination status and your underlying risk factors. Make your travel reservations early and consider trip insurance because the start or the progress of your vacation may still be affected by this persisting virus. 

Most destinations have reopened for tourists. This does not mean that every individual will be safe traveling to every vacation site.  The CDC has a classification system for international travel. This “Risk Assessment Level” is available on the CDC web site.  If domestic travel for the summer is your plan, first check the CDC web site for community spread by county in the USA (https://www.cdc.gov/coronavirus/2019-ncov/your-health/covid-by-county.html). Be not afraid to implement mitigation measures, such as masking and socially distancing, to protect yourself when the level of spread merits the precautions.

Lastly, preventing spread of this virus is still very dependent upon knowing when a person is positive so that they can quarantine. One of the critical downfalls of our government early in the course of this pandemic was the lack of available testing.  This is no longer the case since every American has access to now a third round of free, easy to use home test kits. You may access yours at www.covid.gov/tests or by calling 1-800-232-0233. If you have Medicare, you are eligible for eight (8) test kits per month through your pharmacy, without charge. Whether traveling our not, a good supply of these free testing kits should be in every household and also in your travel luggage. It is comforting to know your test status before you are around someone who might be vulnerable, or after you are exposed to someone known to be or suspicious of being positive; or for just reassurance that symptoms which you develop are nothing more than seasonal allergies.  

Get out there and enjoy the family, friends, and destinations that you have put on hold since 2019.  Taking the practical measures that we have outlined will make your journeys safer for you and those around you.

Fighting COVID-19 Continues to Change in USA

We recently discussed the tragic ascent of the USA death toll from COVID-19 to the previously unimaginable level of 1,000,000.  Having this number of our fellow citizens succumb to this virus is a uniquely American FAILURE!  None of the largest wealthy countries have a COVID-19 death rate as high as ours. There is a myriad of factors which contribute to this situation. The foundation of our plight is a pre-existing healthcare system that devotes inadequate resources to public health, preventative, and primary care; exhibits grossly inadequate access, and underinvests in long term care. Parenthetically, although per capita spending is almost twice as much as other wealthy countries (Kaiser Family Foundation), we lag behind other systems in metrics such as life expectancy and infant mortality. Preexisting conditions such as hypertension, diabetes, obesity, and chronic diseases of the lungs, kidneys, heart, etc. contribute to the severity and ultimate outcome of being exposed to this coronavirus.  Upon this foundation we add the initial governmental incompetence by not providing truthful information or timely personal protective equipment. Most importantly elected officials and pundits fueled the mis/disinformation and therefore, politicization of this pandemic. An American ideology has thus developed and continues to prevent too many from accepting vaccination, masking, and social distancing when necessary. 

As we are approaching a third consecutive Memorial Day weekend enthralled in this pandemic our country is averaging more than 100,000 COVID-19 cases per day, the highest level since February 2022. This case number in actuality represents an underestimate of the case numbers since there is so much unreported home testing occurring. Hospitalizations have risen 28% in the last two weeks. The good news is that deaths have deceased 15% over the last two weeks. Hamilton County and all of the bordering counties remain at the CDC’s “Low” level of community spread.

This SARS-coV-2 virus continues to proliferate as a quarter of eligible Americans have not been vaccinated. The predicted result is the emergence of new mutations. A new Omicron subvariant, known as BA.2.12.1 has become the dominant strain in the US. It now makes up 58% of the sequenced strains in the country. Currently there is no evidence that this strain is more severe than the original Omicron. Cases in New York City are surging and driving a fifth wave of COVID-19. Mask wearing in crowded public places is being encouraged but not mandated. On the other hand, there are school and university communities in the northeast and Hawaii which have reimplemented mask mandates. 

In order to combat this continuing battle with this virus, getting vaccinated remains the mainstay of management. The vaccines will not prevent disease, but experience shows us that severe disease and death are likely to be prevented. Because of the FDA and CDCs recent recommendations our children between the ages of 5 and 11 are now eligible for a COVID-19 booster. This injection by Pfizer/BioNTech is authorized at least 5 months after the second shot has been shown to increase a child’s immunity especially against the Omicron variant.  The data reveals that childhood cases and hospitalizations are on the rise and yet only 36% of children in this age group have received even their first dose. This new recommendation for a booster for this 5-11 age group adds to the prior recommendation for a booster in children ages 12 to 17.  A second booster for all persons aged 65 or older and for those 50 years and older if they have certain preexisting conditions has also been authorized. Pfizer and Moderna’s requests for authorization for a vaccine for children under five is to be considered in early June. 

An extremely important update on the vaccination front is that the FDA has restricted the use of the Johnson & Johnson (Janssen) Covid-19 vaccine exclusively to individuals 18 years and older who are not able to get a mRNA vaccination. The agency has decided that the risk of a rare clotting disorder associated with low platelet count outweighs the benefit of the vaccine in that age group.  (https://www.fda.gov/media/146304/download).

The virus continues to mutate, we must adapt as information, occurrences, and science changes. We continue to look forward to life after COVID-19, but we are not there yet.

One Million Americans Dead from COVID-19!

On today’s date, May 12, 2022, President Joseph R. Biden ordered U.S. flags to be flown at half-staff in recognition of our country reaching the avoidable tragic milestone of one million (1,000,000) souls lost to COVID-19.  This is more than just a number.   It represents family members lost and lives, livelihoods, and communities disrupted.  Researchers estimate that 250,000 American children have lost their primary caregivers. This has ongoing daily impact and generational altering implications. 

Our organization, the Cincinnati Medical Association, advocates for the healthcare concerns of underserved communities and the interest of African American physicians.  It was clear early in this pandemic that African Americans and other people of color were suffering from the ravages of this SARS-CoV-2 virus in a disproportionate manner. We approached this advocacy role regarding COVID-19 in early March of 2020. By early April 2020 we were astounded by the total of 7,000 American deaths. In April of 2020, the world had few tools to combat this scourge. Recall the mantra of the 4W’s. Wash your hands, Wear your mask, Watch your distance (6ft), and Wait for a vaccine. Unfortunately, “American exceptionalism” and “rugged individualism” reared their ugly heads early on. This was a harbinger of things to come and a major driver of the factors which have resulted in America doing so poorly at managing this COVID-19 pandemic. The USA has 4% of the world population and 16% of the COVID-19 deaths. Too many of the citizens of the USA refused to accept the 4W’s even though they were quite simple and proven public health measures for prior pandemics. The objections of these Americans have continued even against the pandemic-fighting advances developed by US scientists.

Despite a 142-fold increase in COVID-19 deaths in merely two years, all too many Americans do not believe that COVID-19 is real. They consider the recommended measures an affront to their “freedom “. Secondly, our healthcare disparities and pre-existing conditions have been exposed as fuel for this pandemic. Additionally, many African American, Indigenous Americans, and other people of color retain long held justified suspicions of the medical community. They therefore remain reluctant to consider the potential benefit of the new medications and vaccines. 

The actions, or inactions, of our federal government in 2020 further ingrained suspicion and resistance and contributed to the COVID-19 management failure.  A March 2020 Inspector General (Dept. HHS) report documents the early deficiencies under which our nation’s hospitals were operating.  The failure of the then president and his administration to convey a consistent message that the threat of COVID-19 was real and to use the Defense Production Act to help address the hospitals’ needs for adequate testing, sufficient personal protective equipment (PPE), staffing, supplies, and durable medical equipment.

This same 2020 American federal government demonstrated superior judgement by pushing for the rapid development of three vaccines, Pfizer, Moderna, and Johnson & Johnson. Unfortunately, the effort was labeled “Operation Warp Speed” and suspicions of inadequate vetting were amplified. The then president initially failed to tout the value of these safe and effective vaccines.  This along with other political and social factors have resulted in only 70% of Americans being fully vaccinated in spite of the widespread availability of the vaccines. These vaccines have been gamechangers. Those who are fully vaccinated and boosted do not become severely ill or die even if they become infected by one of the variants that continue to develop.  We fail to vaccinate, the virus replicates and mutates. The adverse political attitudes regarding this pandemic have been festering for two years. This counterproductive political divide is fertile ground as cases are on the rise again.

What is different from 2020? Vaccines are available for nearly all individuals six and above. There is adequate testing available. We understand better the method of transmission, mitigation measures (masking, social distancing, proper ventilation) and more effective treatment methods. There are oral medications for treatment early after a positive test, and antivirals, steroids, and monoclonal antibodies for later in the clinical course. Yet we mourn the deaths of so many of our fellow citizens. The most fitting tribute to them would be to get more people vaccinated, boosted, and following the recommendations of our public health experts.