Omicron is the Grinch That Stole Christmas

The Center for Disease Control (CDC) is reporting that up to 90% of the infections with COVID-19 Sars 2 Coronavirus are the new Omicron strain. It replicates itself 70 times faster than the Delta strain and contact with an infected person within 12 feet for one or more seconds can result in infection. For those who have been vaccinated against COVID-19 with the Moderna or Pfizer Vaccine, and received a third shot or booster, the expectation is that if they become infected with Omicron, they will either have no symptoms or a mild case. By definition “mild COVID” means your respiratory system is not compromised enough to require hospitalization. Despite this, most of the current deaths in countries which are having a COVID surge are in people older than 65 years of age.

In the past, when patients in this area became infected with COVID-19, we arranged for them to go to the local hospitals to receive an infusion of a monoclonal antibody solution made either by Regeneron or by Eli Lilly. The infusion prevented the infection from becoming severe enough to progress to a severe state requiring inpatient hospital respiratory care. These monoclonal antibodies do not work against Omicron. For this reason, the FDA and CDC have removed the Emergency Use Authorization and ended the administration of these drugs nationwide.

There is a third monoclonal antibody made by Glaxo and Var called Sotrovimab which effectively throttles Omicron, but it is in limited supply. As of today, the State of Florida has received 1050 dosages. Production has been accelerated and hopefully the drug will be available in mid to late January for infusion. There are two new antiviral pills which should work as well. The Pfizer product received FDA approval today and, with production acceleration, some should be available by mid-January. Until these drugs are locally available the medical community has no medications to offer patients who contract the COVID-19 Delta or Omicron variant to limit the severity of the disease.

My advice to my patients and loved ones is to reintroduce distancing and masking. Wear a good N95 mask when you will be around others – especially indoors. If you must be indoors with others, make sure the windows and doors are open and the ventilation is excellent. If there is an air filtration system with HEPA Merv 13 level filters and ultraviolet light that adds protection. Distancing with the aggressive Omicron variant will require 12 feet not six feet.

This is a heartbreaking restrictive change in scheduling and behavior we are asking for at a time of the year when families and friends travel to gather to celebrate. Younger and leaner healthier individuals who are vaccinated will survive this. The real questions are who they will transmit this infection to unknowingly, who is too young to be vaccinated or too old to have a robust immune system?

Our office staff will be reassessing the risk to patients and staff daily. With the local testing positivity rate >10% in Palm Beach County, our contacts will be by phone and telehealth. When the Pfizer anti-viral pill Paxlovid is available, and or Sotrovimab for infusion, we will return to regular in-office patient visits.

I apologize for the inconvenience. Stay safe and call if you have questions.

COVID-19: Bringing Back Precautions & Restrictions

We recently spoke with our Friday night Shabbat Dinner friends of 40 years and cancelled our dinner plans because of the aggressive resurgence of the COVID-19 Delta Pandemic. I remember our last dinner eating outside in early February 2020 on a beautiful evening wondering if we should all be together one last time before suspending our weekly meals together. We were joined by a physician friend and his wife visiting from Cleveland and they were poking fun at my concerns and over reaction to the “Wuhan Flu.” The proverbial “shit hit the fan” the next week and we went into lockdown.

One year later we were all excited lining up for the Pfizer and Moderna vaccine. We really thought that would be the solution. We really thought our leaders at the federal and state levels would stand up and promote vaccinations. We really expected community leaders, respected by people of color, including church leaders, community activists, respected community members would be out there championing the vaccine, helping at vaccination sites and getting the shot into the arms of the most vulnerable.

Several months ago, when things began to calm down, we started having dinner together again in our homes. The rate of positivity in the spring of 2021 was low and our friends masked and kept distance when indoors shopping for supplies. We felt comfortable enjoying our friends’ company once again outdoors at a few restaurants and in our homes. Then came the Delta surge and with it the relaxation of restrictions.

It reminds me of pictures of the start of the Oklahoma Land Rush. A gun was fired, and everyone rode off to stake their claim. In 2021 they made their plane flight reservations, bought their concert tickets, made their hotel reservations and resumed everything they did prior to the pandemic. They stopped tracking cases, and, in many states, they stopped looking for new genetic mutations and variants of the virus. They forgot to get the vaccine to poorer nations but left the air and ship travel paths open to anyone and everyone. They underestimated the ability of the virus to find a way to survive by changing once inside the bodies of the vaccinated and unvaccinated.

Yes, it’s true that if you are vaccinated and get infected with the virus you most likely will not require inpatient hospitalization and die but according to those who went through this you will feel miserable for quite awhile. Yes, it’s true that you probably can transmit it to others even though the data on that is still new and quite controversial including passing it to unvaccinated children and the immunosuppressed.

To make matters worse, our Governor thinks he’s Bob Barker screaming; “Come on Down” as he invites foreign and out of state residents to come visit our beautiful state, spend money, pick up the virus and bring it home to your locale. I bet Florida is the leading exporter of sickness, death and chronic illness in the world over the last 12 months and no one in our state capitol seems to care.

We are returning to a bunker mentality in our household. No more dinners out. No more social engagements with friends whose activities and travels we are unsure of. If our grandson is sent to his preschool my wife will stop being his nanny because she does not want to risk catching the virus.

As college and NFL football season approach, it is unlikely I will sit in a stadium with thousands of unmasked individuals to see my teams play. The same goes for the theater and for travel. It’s really disheartening and depressing but we will do what is necessary to stay healthy and we hope you will too.

The COVID-19 Pandemic Continues Due to Citizen Dysfunction

Last night on the national news coverage of the Sars 2 Coronavirus Pandemic a major story dealt with the large number of children infected with the Delta variant of the virus and the severity of their illness. These children are too young to receive the vaccine.

At best, Pfizer and Moderna hope to have approval to start vaccinating young children by the end of September. These children are dependent on their parents, teachers and counselors keeping them masked, keeping them distanced and keeping them safe. This story dealt with an outbreak in Missouri and Mississippi with 10 youngsters currently on life support systems.

It is a dilemma for parents, especially working parents, about what activities to allow their children to engage in. With previous COVID-19 surges and outbreaks, experts have discussed how mild the illness is in children and how infrequently long-term and life-threatening complications occur. They stress the need for children this age to socialize and go to school and camp but that was prior to the Delta variant and other mutations and variants becoming the dominant source of infection in the USA. It is hard to tell whether the news coverage is sensationalized to promote viewership or is the Delta variant a threat to young unvaccinated children different and more severe than it was 90 days ago?

It’s time for our federal government to take a hard line with health care workers and health care facilities. All employees without a valid health reason for being vaccinated must be vaccinated or face termination. This would include hospitals, outpatient facilities, senior centers, childcare centers, etc. If the result is the facility is understaffed resulting in delays in elective profitable procedures, then so be it until the pandemic is controlled!

Commercial air traffic from regions of the country and world with low vaccination rates and vaccine hesitancy battling large outbreaks of COVID-19 should be halted until their outbreaks are under control. Vaccine passports should be encouraged – not legislated against. When an individual’s actions and decisions threaten others around them by increasing the likelihood of spread of a disease, and its accompanying economic devastation, then the issue is not about loss of freedom. It is about public health and the governments’ sworn duty to protect its citizens.

It’s time to end this Pandemic and the way to achieve that is through mandatory vaccination.

COVID-19 Vaccine Availability

Update January 4, 2021

Last week the Florida Department of Health discussed providing the Moderna vaccine to our office for staff members who wished to receive the vaccine. Our office manager, Judi Stanich, requested enough vaccine to cover the entire practice. We were told we would have a confirmation this morning.

This morning we learned the vaccine isn’t available yet. The vaccine comes in vials of 10 shots. The vials are kept frozen and can remain active in that state or in a refrigerator for 30 days. Once a vaccine vial is opened the entire vial must be used in under six hours or it degrades.

Moderna and the Florida Department of Health require patients to complete legal release forms for the vaccine. They must then be registered into the Florida Shots data bank and a national data bank. That is one of the reasons patients are asked to bring their driver’s license with them.

If you have had a severe allergic reaction to any medication the Pfizer and Moderna mRNA vaccines may not be best for you. If you have ever had to use an Epi Pen or have been treated for anaphylaxis these shots are not for you. The Astra Zeneca Oxford vaccine and the Johnson and Johnson vaccine are thought to be more suitable for those individuals

After receiving your shot, you will need to be observed by medical staff for 15 minutes to look for adverse reactions. You will be given an instructional sheet on how to register with V-SAFE which is a CDC vaccine monitoring app. Every day, at about 2:00 p.m., you will receive a text message with questions about how you feel related to the vaccine.

Medical malpractice insurance companies have not yet formally announced whether physician insurance policies will cover administration of this vaccine in their offices because none have been FDA approved. The Pfizer and Moderna vaccines have received FDA Emergency Utilization Authorization (EUA) which is not the same as approval.

Currently the only avenue to obtaining the vaccine in Palm Beach County is to try and get through on the 561.625.5180 phone number or leave your demographics on an email at CHD50Feedback@Flhealth.gov. Baptist Health System is planning on opening reservations for seniors 65 years of age and older the week of January 11 working with Boca Regional Hospital, Bethesda Hospital and the FAU Schools of Medicine, Nursing and their EMT program. They have not announced how to make a reservation or if they will be using the data from the Palm Beach County Department of Health through the phone number and email address provided above.

I suspect that by the middle of February there will be plenty of vaccine available locally including the Astra Zeneca Oxford product and the Johnson and Johnson products. In the meantime, remain patient and continue to avoid crowds and continue to social distance, wear suitable face masks and keep up the hand hygiene. Please remember that after you complete your vaccinations (two shots for the Pfizer and Moderna Products) we will not know how much immunity the shots will provide and for how long.

We additionally do not know if successfully vaccinated individuals are completely immune or partially immune if they are exposed to the virus. Furthermore, we don’t yet know if you are vaccinated whether you can carry the virus and transmit it to someone else even if you don’t have any symptoms.

Getting the vaccine will not be a reason to resume activities at crowded gyms, crowded bars or go on that cruise ship just yet. The hope is that by the summer 2021 we will have the answers to the many unknowns.

Will I Be Able to Choose My COVID-19 Vaccine?

There are currently four vaccines to prevent COVID-19 in the pipeline. I have been asked numerous times when am I going to have the vaccine in my office and which vaccine should individuals take? This question was addressed by MedPage Today, an online health care periodical on 11/27/2020. The same question was asked of National Institute of Health “chief” Francis Collins, MD, PhD last week at a press briefing. Dr Collins responded there will not be enough vaccine available in December for the whole country and “people who get offered one should feel quite happy about that.” Leana Wen, MD, of George Washington University responded to the same question saying, “Initially there won’t be nearly enough vaccines for hundreds of millions of Americans. We will probably take whatever we are able to get access to.”

If you are a healthcare worker, or in the more vulnerable groups, you are most likely to be offered one of the nRNA vaccines from Pfizer/BioNtech or Moderna because they are further along in completing the FDA required trials and application process for approval. Younger healthier individuals having less priority may get to choose.

Larry Corey, MD, a viral expert at Fred Hutchinson Cancer Institute in Seattle and a leader of the COVID-19 Prevention Network Vaccine Program broke down the numbers at a November 18, 2020 meeting of the American Public Health Association and National Academy of Medicine:

  1. The US Government has contracts for 100 million doses of the Pfizer/BioNTech and Moderna vaccines with production producing the 200 million doses by the spring of 2021. That should cover the highest risk groups including healthcare personnel, nursing home residents, essential workers and the medically vulnerable per the CDC Advisory Committee on Immunization Practices (ACIP) guidelines. The vaccine will be shipped to 50 states, the District of Columbia, 8 territories and five large urban health departments including NYC and Chicago. Who receives it first, and where they receive, it will be decided by the local jurisdictions. This process should take until the end of March 2021 leaving some 200 million Americans waiting for a vaccine. Dr. Corey was clear that “We need other vaccines for the rest of the population.”
  2. In addition to the Moderna and Pfizer/BioNTech mRNA vaccines, there are products from Oxford/AstraZeneca, Janssen/Johnson &Johnson, Merck, Sanofli/Glaxo SmithKline and Novavax. Jay Butler, MD, deputy director for infectious disease at the CDC expects there to be mass vaccinations run by public health agencies and possibly some vaccination programs at community pharmacies. No mention was made of supplying physician offices or clinics.
  3. If there are no major delays, seven different vaccines should be available by the spring of 2021. Naor Bar-Zeev, PhD, of the International Vaccine Access Center at Johns Hopkins University in Baltimore said it is too soon to compare the products because there are no studies comparing them head-to-head. He reminded us that different vaccines might be better suited for different patient populations with pediatric patients, the elderly, the immunocompromised likely to do better with some and not others.

Despite the lack of detail to date, Moncef Slaoui, MD, head of the federal Operation Warp Speed, told CNN that he expects 70% of the US population to be vaccinated by May 2021.