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🦘Cacatman's Personal Coronavirus COVID-19 Update Thread

Pfizer, Moderna COVID-19 vaccines highly effective after first shot in real-world use

The risk of infection fell 90% by two weeks after the second shot, the study of nearly 4,000 U.S. healthcare personnel and first responders found.

The results validate earlier studies that had indicated the vaccines begin to work soon after a first dose, and confirm that they also prevent asymptomatic infections.
 

Rituximab use may be a risk factor for severe COVID-19

As reported in The Lancet Rheumatology, 35% of rituximab-treated patients developed severe COVID-19, resulting in intensive care unit admission or death, compared with 11% of those in the no rituximab group. These findings translated into a significant odds ratio of 3.26 after adjustment for factors including age, sex, comorbidities, and corticosteroid treatment using the inverse probability of treatment weighting propensity score method.
 
Cardiovascular Sequelae

Cardiovascular Function - Abnormal Echocardiograms in COVID-19 Patients

69 countries were examined with 1200 patients. 70% male. 55% had an abnormal echo. Left and right heart dysfunction was surprisingly 39%/33%. Postulated to be due to pulmonary thromboembolism. 3% had MI, 3% had myocarditis, and takotsubo cardiomyopathy 2%. 15% had severe cardiac disease.

Abnormalities were often unheralded/severe. The echo findings changed management in 1/3 of patients.

Therefore dyspnoea/SOA, chest pain etc, needs an echo.


Cardiac Tissue Issues
Cardiomyocytes derived from human induced pluripotent stem cells treated with interleukins and infected with SARS- CoV- 2 in cultures, show increased release of troponin, disorganization of myofibrils, and changes in beating mirroring specific pathologies in some COVID-19 patients.

Elevated levels of troponin noted with COVID-19

Cardiac injury is a common condition among patients hospitalized with COVID-19, and it is associated with higher risk of in-hospital mortality.

Reviewers reported weighted mean incidences (WMIs) of a range of cardiovascular events among participants in these studies; each outcome was reported in a subset of studies, sometimes in single studies. WMIs (range when reported) calculated for multiple studies were as follows: 18.0% (0.2% to 71.0%) for shock/treatment with vasopressors; 11.1% for atrial fibrillation; 8.5% (0.0% to 24.7%) for supraventricular arrhythmias; 7.6% for increase in QT interval; 7.4% (0% to 46.2%) for venous thromboembolism; 6.8% (0.0% to 24.0%) for heart failure; 6.1% for deep vein thrombosis; 6.1% (0.0% to 100%) for mortality (increasing to 32% among cohorts entirely enrolled in the intensive care unit [ICU]); 4.3% for pulmonary embolism; 2.7% (0.0% to 12.4%) for ventricular arrhythmias; 2.6% (0.0% to 12.5%) for myocarditis; 1.7% (0% to 3.6%) for myocardial infarction/acute coronary syndrome; 1.2% (0% to 9.6%) for stroke; and 1.1% (0.0% to 8.1%) for extracorporeal membrane oxygenation use.
 
Risk Factors - Update
Conditions that had previously been categorized as “might be” placing individuals at increased risk – but now are listed as high risk – include type 1 diabetes (in addition to type 2), moderate-to-severe asthma, liver disease, dementia or other neurologic conditions, stroke/cerebrovascular disease, HIV infection, cystic fibrosis, and overweight (in addition to obesity).

Substance use disorders, which hadn’t been previously listed, are now also considered high risk.


The new list groups together certain categories, such as chronic lung diseases (chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc) and heart conditions (heart failure, coronary artery disease, hypertension, etc).

Both diabetes types are now grouped under “diabetes.”
 
Astrazeneca - "We think that AZ has embellished data"
Controversy over 2 full doses only being 62% effective, study spread across 2 countries and if half dose given first before 2nd, then 90% effectiveness.


symptoms seen in at least 13 patients, all between ages 20 and 50 and previously healthy, in at least five countries are more frequent than would be expected by chance. The patients, at least seven of whom have died, suffer from widespread blood clots, low platelet counts, and internal bleeding—not typical strokes or blood clots. “It’s a very special picture” of symptoms, says Steinar Madsen, medical director of the Norwegian Medicines Agency. “Our leading hematologist said he had never seen anything quite like it.”

Acute infections can trigger clotting and bleeding, sometimes culminating in DIC, Wendtner notes. But abnormal clotting is also a feature of COVID-19. It’s possible, Wendtner says, that the unusual cases had a COVID-19 infection before they got vaccinated; many were health care workers and teachers who may have been exposed at work. Coming on top of the infection, the vaccine might somehow have triggered an overreaction by the immune system, sparking the clotting syndrome. Ganser thinks patients suffering from CVT may be the tip of the iceberg and that more people may suffer similar, but milder, symptoms.

Vaccine cause ruled out for blood clots



Efficacy Revised Down

76% vaccine efficacy against symptomatic COVID-19

100% efficacy against severe or critical disease and hospitalisation

85% efficacy against symptomatic COVID-19 in participants aged 65 years and over


If it is true that all 7 clots were caused by the vaccine, with 1.6 million immunizations, then that works out to a rate of roughly 1 clot per 230,000 jabs or 0.00044%. While the relative risk increase here sounds scary, that means that this equates to an absolute risk increase for people who have been vaccinated of 0.00038%, which is not quite as huge as the headlines are suggesting.

We can also compare this to the risk of COVID-19. Even 20-year-olds are not immune to the disease, and while their risk of death is much lower than the elderly, it comes out to about 1 death per 16,000 infections. So if the vaccine really is causing these blood clots, which can be fatal, then the risk of dying from COVID-19 for a 20-year-old is about 15 times higher than the risk of having a clot. Again, because both of the risks are very small, the absolute difference is also tiny, at about 0.004%.

UK regulator found total of 30 cases of blood clot events after AstraZeneca vaccine use

British regulators on Thursday said they have identified 30 cases of rare blood clot events after the use of the AstraZeneca COVID-19 vaccine, 25 more than the agency previously reported.

The million (or billion) dollar question now is whether the risks and benefits of the AstraZeneca/Oxford vaccine calculation has changed. That hinges on how risky covid-19 is for any given person, how likely the vaccine is to cause VITT, and how likely that is to cause a genuine problem for the few who develop it. This in turn, hinges on the age of the person considering the question. As we know, age is the single greatest factor in determining a person's risk of developing severe or critical covid-19 after infection with SARS-CoV-2. While the statistics numbers are likely to change with improved surveillance (and vigilance), the University of Cambridge has produced a reasonably credible readout on the risks and benefits of receiving the AstraZeneca/Oxford vaccine, given what we already have learned about VITT rates. The risk of VITT is so low that in areas were coronavirus is moderately prevalent (6 cases per 10,000 people per day) or highly prevalent (20 cases per 10,000 people per day), the vaccine remains safer than covid-19 risks by far. Even among people ages 20-29, in moderate-risk zones, the risk of an intensive care unit admission resulting from covid-19 is double that of any serious harms from the vaccine. In high-risk zones covid-19 is six times more dangerous for that age group. The balance tips in the vaccine's favor more and more with each decade, since covid-19 risk goes up with age, whereas vaccine-related risks appear to go down with age. For adults ages 60-69, covid-19 is over 638 times more dangerous than any vaccine-related risk. The only scenario in which the risk-benefit balance currently leans away from the AstraZeneca/Oxford vaccine is for people younger than 30 years old, in low-risk covid-19 zones, according to the University of Cambridge analysis. That means, that for the first time, many experts would specifically recommend that a particular subgroup avoid one vaccine product in favor of another. Until now, despite all the small statistical differences among the available options, experts have largely stuck to one message: get whichever vaccine you are offered first. That message remains true today, with the exception of persons under age 30 in low-risk areas.
 
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Pfizer Vaccination - 23 Deaths in Norway Following Vaccination
Caution advised if administering to elderly

Pfizer vaccination only 52% effective if ONLY one dose is taken.

Pfizer Vaccine - One dose results in 33% Efficacy

Information Sheet

Working on Update Vaccination for Newer Strains

Separately, the vaccine, which has been authorized in the U.S., the U.K., the EU and elsewhere, can be stored and transported at between minus 25 and minus 15 degrees Celsius, or minus 13 and 5 degrees Fahrenheit—similar to a consumer freezer—Pfizer and BioNTech said. Currently, the vaccine’s labels say it must be stored at between minus 80 and minus 60 degrees Celsius, requiring sophisticated equipment.

A single shot of the vaccine is 85% effective in preventing symptomatic disease 15 to 28 days after being administered, according to a peer-reviewed study conducted by the Israeli government-owned Sheba Medical Center and published in the Lancet medical journal. Pfizer and BioNTech recommend that a second dose is administered 21 days after the first.

The latest numbers, which were compiled through Feb. 13 and compare the vaccinated and unvaccinated populations, show that the jab has been nearly 96 percent effective at preventing symptomatic COVID-19 infections two weeks after individuals receive their second dose. When it comes to preventing severe infections, hospitalizations, and deaths from the coronavirus, the figure jumps to an efficacy rate around 99 percent.

Israel’s Ministry of Health says benefits of #PfizerVaccine 14 days after 2jab are: • 95.8% preventing illness cases • 98.0% preventing fever and/or respiratory symptoms • 98.9% preventing hospitalization • 99.2% preventing severe illness • 98.9% preventing death

Six months after getting a second dose of the Pfizer-BioNTech vaccine as part of a 46,000-person clinical trial, volunteers remained more than 90% protected against symptomatic COVID-19 and even better protected against severe disease, a new company study found.

Out of 927 trial participants who fell ill with COVID-19 more than a week after their second dose, only 77 had received the active vaccine, compared with 850 who got a placebo.

Fully effective against the South African Variant.

The Pfizer/BioNTech COVID-19 vaccine is more than 91 percent effective six months after people get their second dose, according to new test data released by the companies.

The findings from more than 46,000 trial participants was released Thursday, CBS Newsreported. There were 927 confirmed symptomatic cases of COVID-19 overall, with 850 cases in the placebo group and 77 cases among those who received the vaccine.

100% vaccine efficacy with its COVID-19 vaccine, BNT162b2, in the prevention of the virus is participants 12-15 years old.

Here, for instance, is what the US Food and Drug Administration says is in Pfizer’s vaccine:
  • Active Ingredient
    • nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2
  • Lipids
    • (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (ALC-3015)
    • (2- hexyldecanoate),2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
    • 1,2-distearoyl-snglycero-3-phosphocholine (DPSC)
    • cholesterol
  • Salts
    • potassium chloride
    • monobasic potassium phosphate
    • sodium chloride
    • basic sodium phosphate dihydrate
  • Other
    • sucrose

Pfizer administration instructions
 
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Current evidence for COVID-19 therapies: a systematic literature review/Treatment best practice

Mortality​

In total, 39 randomised and one non-randomised trial reported on mortality, either as the number of deaths that occurred during the study or as a pre-specified study end-point, with or without a statistical comparison between groups [2834, 3654, 5668, 70]. One study included [69] was a re-analysis of data from another trial (Wang et al. [44]) included in the qualitative synthesis. The outcomes for individual trials are shown in figure 2.

Antivirals​

Among trials of antivirals (figure 2a), four trials (n=48–66) reported trends towards decreased mortality with interferons (IFNs), sofosbuvir+daclatasvir, and triazavirin, compared with standard care or placebo in patients with COVID-19 of varying severity [59, 60, 67, 68]. Another trial (n=81) reported a significant reduction in 28-day mortality with IFN-β-1a plus standard care compared with standard care alone (19.0% versus 43.6%; p=0.015) in patients with severe COVID-19 [64]. The analysis also showed that administration of IFN β-1a early in the disease significantly reduced mortality (OR 13.5 (95% CI) 1.5–118) whereas late administration did not [64].
Of four trials that assessed lopinavir/ritonavir, three trials of patients with COVID-19 of varying severity (n=86–127) reported no deaths in either treatment group [37, 39, 62]. One trial (n=199) reported a numerical but nonsignificant reduction in 28-day mortality with lopinavir/ritonavir versusstandard care in patients with severe COVID-19 [31]. Of four trials that investigated remdesivir in patients with moderate or severe COVID-19, two trials (n=1062 and n=236) and the re-analysis of Wang et al. [44] by Shih et al. [69] showed no significant mortality benefit of remdesivir compared with placebo [28, 44], although one study showed a trend towards reduced mortality in patients who received treatment earlier in their disease course (within 10 days of symptom onset) [44]. The other two trials (n=397 and n=596) reported comparable mortality with 5- and 10-day remdesivir treatment [61, 70].

Antimalarial and mucolytic drugs​

Among eight trials of hydroxychloroquine or its derivatives (figure 2b), one trial (n=81) reported significantly greater lethality with high doses of chloroquine diphosphate compared with low doses (log-rank: −2.183; p=0.03) in patients with severe COVID-19 [29]. Six trials (n=150–821) reported similar mortality with hydroxychloroquine, with or without azithromycin, compared with standard care or placebo in hospitalised [33, 45, 63] or non-hospitalised [30, 40, 42] patients with mild, mild-to-moderate or severe COVID-19. Another trial (n=447) reported no mortality benefit of adding azithromycin to hydroxychloroquine compared with hydroxychloroquine alone in patients with severe COVID-19 [53]. In a trial of the mucolytic drug, bromhexine (n=78), there was a significant reduction in mortality with bromhexine plus standard care versus standard care alone (0% versus12.8%; p=0.027) in patients with COVID-19 of unspecified severity [47].

Anti-inflammatory drugs​

Among trials of corticosteroids conducted in patients with severe COVID-19, three trials (n=149–403) showed numerical but nonsignificant trends towards reduced mortality with hydrocortisone or methylprednisolone compared with placebo or standard care (figure 2c) [46, 50, 66]. One trial (n=62) reported significantly reduced mortality (5.9% versus 42.9%; p<0.001) with methylprednisolone plus standard care versus standard care alone [52] (figure 2c). In a large trial (n=6425) of patients with COVID-19 of unspecified severity, 28-day mortality was significantly decreased with dexamethasone plus standard care versus standard care alone, both overall (22.9% versus 25.7%; p<0.001) and in patients receiving oxygen (23.3% versus 26.2%) or mechanical ventilation (29.3% versus 41.4%) at randomisation (figure 2c) [43]. The mortality benefit was greatest in patients with a longer duration of symptoms (>7 days versus ≤7 days; 12.3 by Chi-squared test for trend) [43]. Another trial (n=105), also conducted in patients with COVID-19 of unspecified severity, showed significantly increased event-free survival with the anti-inflammatory drug colchicine in combination with standard care versus standard care alone (97% versus 83% of patients after 10 days; p=0.03; data not shown graphically) [36].

Other therapies​

Trials (n=20–135) investigating the kinase inhibitor, ruxolitinib [32], the calcium release-activated calcium channel inhibitor, auxora [56], the anticoagulant, enoxaparin [54], and N-acetylcysteine, a mucolytic drug with anti-oxidant properties [49], in patients with severe COVID-19 reported no significant difference in mortality versus the comparator groups (figure 2c). One trial (n=200) reported a reduced 21-day mortality with recombinant human granulocyte colony-stimulating factor (rhG-CSF) added to standard care versus standard care alone (HR 0.19 (95% CI 0.04–0.88)) in patients with severe COVID-19 [48].
Two studies reported on immunomodulatory therapies in patients with moderate and/or severe COVID-19 (figure 2c): one single-arm trial (n=46) reported a mortality of 6.5% with hyperimmune plasma [41], and another trial (n=103) reported numerical but nonsignificant trends towards decreased mortality with convalescent plasma versus standard care [38].

Hospitalisation

Antivirals​

Three trials of IFNs (IFN-β-1a, IFN-β-1b or IFN-κ+trefoil factor 2) (n=66–81) added to standard care in patients with moderate or severe COVID-19 reported improvements in hospitalisation outcomes, including reduced hospitalisation duration [65, 67] (figure 3a), a greater proportion of patients discharged [64, 67] (table 1) and reduced incidence of ICU admittance [64, 67] (table 1) versusstandard care alone. Other trials (n=66 and n=88) reported reduced hospitalisation duration with sofosbuvir+daclatasvir+standard care (6 versus 8 days; p=0.029) and early versus late administration of favipiravir (14.5 versus 20 days; HR 1.963 (95% CI 1.331–2.894)) in patients with moderate or severe COVID-19 [68] or asymptomatic to mild COVID-19 [51], respectively (figure 3a). Patients treated with sofosbuvir+daclatasvir+standard care also had a significantly higher probability of hospital discharge by day 14 (p=0.041) versus standard care alone (table 1).
Another trial (n=127), conducted in patients with COVID-19 of unspecified severity, reported a significant reduction in median hospitalisation duration with lopinavir/ritonavir+ribavirin+IFN-β-1b versus lopinavir/ritonavir alone [37]. When patients were stratified according to the timing of treatment administration, median hospitalisation was significantly reduced in patients who received treatment within 7 days of symptom onset, but not in those who received treatment later than this [37].
Among trials of remdesivir and the re-analysis of Wang et al. [44], one trial (n=1062) reported a reduced initial length of hospital stay with remdesivir versus placebo in patients with severe COVID-19 (median 12 versus 17 days) [28] (figure 3a). There were trends towards more patients discharged with remdesivir versus placebo/standard care, as well as with earlier remdesivir treatment in the remaining trials [44, 61, 69, 70] (table 1), but between-group differences were either not significant or not tested. A small pilot study (n=20) also reported a reduced mean duration of hospitalisation (7 versus 13 days; p=0.02) with the antiretroviral azvudine plus standard care versus standard care alone in patients with mild COVID-19 [57].

Antimalarial and mucolytic drugs​

Among six trials assessing hydroxychloroquine (n=194–821) [30, 33, 40, 42, 45, 53], with or without azithromycin, no benefit was seen relative to the comparator groups in terms of hospitalisation duration (figure 3a), incidence of ICU admittance (table 1) or incidence of hospitalisation (supplementary figure 3). In a trial conducted in patients with COVID-19 of unspecified severity (n=78), ICU admittance was significantly reduced with bromhexine plus standard care versusstandard care alone (5.1% versus 28.2%; p=0.006) [47] (table 1).

Anti-inflammatory drugs​

One trial (n=6425) reported a numerically shorter median duration of hospitalisation (12 versus 13 days) and a greater probability of discharge alive within 28 days with dexamethasone plus standard care versus standard care alone (rate ratio 1.10 (95% CI 1.03–1.17)) in patients with COVID-19 of unspecified severity [43] (figure 3b and table 1). In another trial of patients with severe COVID-19 (n=403), treatment with a 7-day fixed-dose course or shock-dependent dosing of hydrocortisone were associated with reduced hazard ratios for length of hospital and ICU stay; however, neither treatment strategy met pre-specified criteria for statistical superiority [46]. A further trial (n=62) reported a significantly reduced time to the composite outcome of hospital discharge or death with methylprednisolone plus standard care versus standard care alone in patients with severe COVID-19 (median 11.6 versus 17.6 days; p=0.006) [52] (table 1). Other trials of anti-inflammatory agents (n=54–416) reported no differences in hospitalisation outcomes versus comparators (figure 3b, table 1 and supplementary figure 3) [35, 36, 50, 66].

Other therapies​

Among trials of other therapies, one trial (n=103) reported numerical but nonsignificant trends towards reduced hospitalisation duration and increased numbers of patients discharged with convalescent plasma versus standard care [38] (figure 3b and table 1). Trials of rhG-CSF (n=200), N-acetylcysteine (n=135), enoxaparin (n=20) and ruxolitinib (n=43) reported no significant impact of these interventions on hospitalisation outcomes versus standard care or placebo [32, 48, 49, 54] (figure 3b and table 1).

Need for ventilation

Antivirals​

Most trials of antivirals did not report a significant impact of the interventions assessed on the number of patients requiring ventilation, or on related outcomes including duration of respiratory support (figure 4a and supplementary table 4). However, there were trends towards decreased use of ventilation with IFN therapies, sofosbuvir+daclatasvir and triazavirin (figure 4a) [59, 60, 64, 68]. Additionally, one trial (n=81) of patients with severe COVID-19 reported an increased number of patients extubated following treatment with IFN-β-1a plus standard care than with standard care alone (53.5% versus 11.8%; p=0.019) [64] (supplementary table 4). Another trial (n=1062), also conducted in patients with severe COVID-19, reported fewer patients requiring new use of oxygen (36% versus 44%), noninvasive ventilation (17% versus 24%) or intensive mechanical ventilation (13% versus 23%) with remdesivir versus placebo (figure 4a) [28].

Antimalarial and mucolytic drugs​

Four trials (n=194–665) reported no significant impact of hydroxychloroquine, with or without azithromycin, on reducing the need for ventilation or improving other respiratory outcomes compared with standard care, in patients with COVID-19 of a range of severities [33, 40, 45, 53] (figure 4b and supplementary table 4). Among two trials (n=78 and n=18) of bromhexine plus standard versus standard care alone, one reported significantly reduced numbers of patients with COVID-19 of unspecified severity requiring intensive mechanical ventilation with bromhexine (2.6% versus 23.1%; p=0.007) [47] (figure 4b). The other trial showed a numerical but nonsignificant trend towards reduced need for oxygen therapy with bromhexine (16.7% versus 33.3%; p=0.11) versus standard care, in patients with mild or moderate COVID-19 [55] (figure 4b).

Anti-inflammatory drugs​

Among studies of anti-inflammatory drugs (figure 4b and supplementary table 4), one randomised trial (n=6425) reported a statistically significantly decreased need for invasive mechanical ventilation with dexamethasone plus standard care versus standard care alone in patients with COVID-19 of unspecified severity [43] (figure 4b). The risk of progression to invasive mechanical ventilation was also significantly lower with dexamethasone than with standard care (risk ratio 0.77 (95% CI 0.62–0.95)) [43]. Another trial (n=62) of patients with severe COVID-19 reported a significant reduction in the proportion of patients receiving oxygen after 3 days of treatment with methylprednisolone, compared with before treatment (82.4% versus 100%; p=0.025) [52] (figure 4b).

Other therapies​

In a small trial (n=30), fewer patients with severe COVID-19 required invasive mechanical ventilation; and the composite end-point of death or invasive mechanical ventilation occurred significantly less frequently in patients receiving auxora than in those receiving standard care (HR 0.23 (95% CI 0.05–0.96); p<0.05) (figure 4b and supplementary table 4) [56]. In another small trial (n=20), administration of enoxaparin significantly reduced the median number of ventilator-free days compared with low molecular weight/unfractionated heparin (0 versus 15 days; p=0.028) and resulted in a higher ratio of successful liberation from mechanical ventilation after respiratory failure (HR 4.0 (95% CI 1.035–15.053); p=0.031) in patients with severe COVID-19 (supplementary table 4) [54]. Trials of ruxolitinib, N-acetylcysteine and rhG-CSF (n=43–200) showed no significant efficacy in reducing need for ventilation in patients with severe COVID-19 [32, 48, 49] (figure 4b and supplementary table 4).




 
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Erectile Dysfunction
The study found that surviving COVID-19 may be associated with erectile dysfunction (ED). The research points to three factors that can lead to the potential onset of ED in men who have had the virus:

  • Vascular effects. Erectile function is a predictor of heart disease, so we know that the vascular system and reproductive system are connected. We also know that COVID-19 can cause hyperinflammation throughout the body, especially in the heart and surrounding muscles. Blood supply to the penis can become blocked or narrowed as a result of a new or worsened vascular condition caused by the virus.
  • Psychological impact. Sexual activity is closely associated with mental health. The stress, anxiety and depression caused by the virus and pandemic can be linked to sexual dysfunction and poor mood.
  • Overall health deterioration. ED is typically a symptom of an underlying problem. Men with poor health are at greater risk for developing ED and also for having a severe reaction to COVID-19. Since the virus can cause a plethora of health issues, general poor health is cause for concern both for ED and other complications.
 
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