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November 20, 2021

Run, Don't Walk, to Get a Booster Dose of Vaccine

Yesterday the FDA extended the guidelines for fully vaccinated people to get Pfizer or Moderna booster shots at least 6 months after their 2nd dose of vaccine.  Today the CDC Advisory Committee met and unanimously voted for booster doses, and  the CDC Director Rochelle Walensky, signed the Advisory Group recommendations.  Booster shots will be available starting this weekend.

The CDC advisory committee recommended that anyone 18 or older could get a booster, and anyone older than 65 "SHOULD" get a booster.  The vaccines are still very effective, and the majority of Covid-19 infections, hospitalizations, and deaths are occurring in the unvaccinated.   The safety data were reviewed at today's meeting and the side effects in general are slightly less than after vaccine dose 2.  Pfizer reported preliminary data on their randomized control trial of approximately 10,000 subjects.  The booster doses were given at a median of 10 months after dose 2 and subjects were followed for about 2.5 months before this report. No cases of myocarditis were seen.  There were 6 PCR positive Covid cases in the vaccinated group and 123 in the placebo group for a booster efficacy of 95.3% in patients who had never had a previous Covid-19 infection.                         See Below

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Dr. Tony Fauci is in favor of boosters for all fully vaccinated people at 6 months.   He said that there are increasing numbers of ER visits among the 65+ group (vaccinated but not boosted) and an "inkling" of waning protection against severe disease. Many experts say that these mRNA vaccines probably were always 3 dose vaccines.  In addition, there is clear evidence that case numbers in the unvaccinated are rising quickly in the US in more than half of the states after weeks of falling numbers.  Dr. Michael Osterholm always says that there are still many unvaccinated people for this virus to "burn through."  More Good News:  1,970,000 children ages 5-11 years old were vaccinated through the end of this week!   

November 17, 2021

White Tailed Deer are a SARS-CoV-2 Reservoir

There is accumulating evidence that wild white tailed deer can be infected with SARS-CoV-2 and are now spreading the virus among deer herds in the US.  Minks, dogs, cats, and various zoo animals have been infected, but most of these infections are due to human interactions during feeding and care.  It is assumed that the infection in deer had to come from contact with humans, or maybe waste water. The deer do not appear to develop symptoms or to infect humans, although this might be difficult to prove.  The deer have ACE-2 receptors on their cells, like humans, to which the virus binds to gain entry into nasopharyngeal cells.  624 blood samples, from pre and post pandemic were studied and Sars-CoV-2 antibodies were found in 152 of the 2021 samples  - from Illinois, Michigan, New York, and Pennsylvania.  Three samples from early 2020 were also positive.  How did the deer become infected? 

More Data:  (1) There are reports of the virus in 363 nasal swabs from free range white tailed deer in Ohio, pre-delta variant, and genomic sequencing demonstrated that these viruses were the same as those circulating in our human population.  (2) In Iowa lymph node samples were taken from the nasopharynx in approximately 300 deer to look for virus in the tissue and 1/3rd of the samples tested positive by PCR.  (3) Also in Iowa, 97 deer samples (11/23-1/10/2022) were collected and 80% of them were positive for Covid during hunting season.  They sequenced the viruses and the same genomes were present in the white tailed deer and current infections in humans.  See Below  

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There are 30 million white tailed deer in the US and 6 million are supposedly killed by hunters each year.  The new data demonstrate that the SARS-CoV-2 virus is widely present in deer clusters - constituting a reservoir of the virus.  As the virus replicates in the reservoir there are many opportunities for the virus to mutate and at some point they may be able to jump back into the human population.  The mutations can increase transmissibility, increase the virus virulence, or block the effect of vaccine on the mutated virus. Deer are currently monitored for chronic wasting disease and bovine tuberculosis - and now SARS-CoV-2 virus will be followed as well.  Hunters are encouraged to do field dressing outside, wearing gloves.  The deer organs should be disposed of carefully and the meat cooked very carefully.  

November 13, 2021

Natural Immunity vs Vaccination in a New CDC Report

The CDC Morbidity and Mortality Weekly Report just published a study comparing the effectiveness of natural immunity vs vaccination in hospitalized patients (18+ years) from 187 hospitals in 9 states between January and September 2021.  These patients all had documentation of their prior infection or two doses of Moderna or Pfizer vaccines 90-179 days prior to hospitalizations. There were 1,020 hospitalizations among previously infected/unvaccinated patients and 632 among fully vaccinated/but never previously infected patients.  Patients were distributed over all age groups.  Covid-19  infection was confirmed in these hospitalized patients with a Covid-like illness and a positive PCR test.  

There were 89/1020 cases (8.7%) of lab confirmed Covid 19 in previously infected and unvaccinated patients.    

There were 324/6328 cases (5.1%) with lab confirmed Covid 19 in fully vaccinated and previously uninfected patients.                    See Below:   

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Conclusion:  In this US epidemiologic study vaccine-induced immunity was 5.49 times more protective than infection-based immunity, including infection during the period of the delta-variant with a Calculated Odds Ratio 5.49 (95% CI = 2.75 - 10.99). . Based on this real-time US study it is currently recommended that unvaccinated people who have a Covid-19 infection should have 2 doses of vaccine as soon as they have recovered from the infection to boost their immunity.   

November 10, 2021

Long Covid - NIH Research, Clinical Centers for Patients

Long Covid, or Long Haulers' disease was seen very early in the Covid-19 pandemic.  Patients, with mild or severe disease had symptoms that lasted more than 4 weeks after their diagnosis and were varied.  Over time it was noted than as many as 1/3 of Covid patients had at least one of the persistent symptoms.  Fatigue or drop-dead exhaustion, is very reminiscent of chronic fatigue syndrome which can occur following a variety of viral illnesses.  Clinicians and investigators are hoping that studies done in the current long covid patients will help to elucidate the mechanisms for these devastating symptoms.  The NIH recently launched a huge initiative to study Long Covid.

Nearly 40% of people who became infected still had at least one symptom 3-6 months after the infection. Persistent symptoms are varied, but can include any of the following:  Fever, change in smell or taste, difficulty breathing, cough, chest pain, stomach pain, diarrhea, fast beating heart/palpitations, joint or muscle pain, fatigue, post-exertional malaise, headache, brain fog, mood changes, pins and needles, sleep problems, dizziness on standing, rash.  The mechanisms for these persistent symptoms are unknown, but there is speculation that there may be a lingering virus reservoir or viral remnants that cause chronic inflammation or autoimmune disease.  Some patients report their symptoms improved after they received the Covid vaccine.    See Below    

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There has never been evidence that explains the Chronic Fatigue syndrome.  But patients and clinicians hope that having a viral infection that can be studied in the many patients who develop Long Covid might be able to find answers that will help delineate the cause and provide information for treatment for all post-viral infection disorders.  There are at least 44 centers for these patients in the US, many at medical school hospitals - and patients should be referred to the centers who can assemble a team of doctors based on the symptoms expressed.  Patients with chronic fatigue syndrome rarely have the attention or resources to analyze the symptomatic patients and now they are being included in this much bigger pool of chronically ill patients.  In a recent Washington Post article Survivors Corps, which has 180,000 members was listed as an advocacy group.  Body Politic, also listed, launched a feminist support group.  Patients who suffer from Chronic Fatigue Syndrome hope that this attention will provide greater understanding of the other post-infection diseases.

November 6, 2021

Paxlovid- An Oral Drug to Treat Covid 19 in High Risk Patients

Yesterday Pfizer had a press release about their anti-Covid pill Paxlovid, and the early results are very promising.  Paxlovid is an protease inhibitor that blocks viral replication if given shortly after symptoms occur. The current clinical trial was done in subjects with a high risk of severe disease - older age, obesity, and diabetes.  There are two other clinical trials in progress - one in subjects with standard risks and the other in volunteers living in a household with Covid+ patients in order to test the ability to prevent transmission and infection.  The High Risk Clinical trial was stopped by an Independent Data Monitoring Committee after they examined the data and recommended that Pfizer not enroll more subjects in the placebo group because of the large differences in hospitalization, and death between the treated and placebo groups.

This was a randomized control double blind trial and subjects were treated with 5 days of medication or placebo.  The volunteers were further subdivided into two groups - one that was treated with drug or placebo within 3 days of developing symptoms and the other group treated within 5 days of developing symptoms.  The "within 3 day" treated group had 3 hospitalizations and 0 deaths.  The "within 3 day" placebo group had 27 hospitalizations and 7 deaths for a reduction in hospitalizations and deaths of 89 %.   The "within 5 day" treated group had 5 hospitalizations and 0 deaths and the "within 5 day" placebo group had 41 hospitalizations and 10 deaths (85% reduction).  P values were <0.0001 in both groups.  See Below   

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Paxlovid was specifically designed to block the SARS-CoV-2 protease.  It is administered with low dose ritonavir which prolongs the activity of the Paxlovid in the body and it is potent when tested against variants of concern.  The pills of each drug are taken every 12 hours for 5 days.  Safety was assessed in almost 1900 volunteers and mild symptoms were seen in 19% of treated patients and 21% of placebo patients.  Fewer serious adverse events were also seen in the treated patients (1.7 treated vs 6.6% placebo).  Pfizer will submit the data to the FDA for an EUA and the drug should be available by the end of the year. 

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