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 > 2019–2022 CORONAVIRUS PANDEMIC POSTINGS

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Deb and Ed M

SW MI & Space Coast, FL USA

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Posted: 10/07/21 06:36pm Link  |  Quote  |  Print  |  Notify Moderator

MEXICOWANDERER wrote:

The population has yet to be forced indoors by cold weather and the closing of doors and windows. The additive effects of no masks, no distancing and no vaccine will start to show up.


It's happening in Michigan - using data from covidactnow.org, the rate of daily new cases has more than doubled since school started. We are having a delightfully-warm fall, so it's not the "being forced indoors" part, but I can't help but wonder if fall sports season has anything to do with it ;-) Last year, when attendance was limited/mask restrictions were in place, this same time period didn't have the peak we do now.

BCSnob

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Posted: 10/08/21 11:33am Link  |  Quote  |  Print  |  Notify Moderator

I found this article from Kreisler Health News a good overview of the ongoing debate on if previous Covid-19 infections should count equally with vaccination.

Covid Immunity Through Infection or Vaccination: Are They Equal?

The discussion on using antibody tests to determine immunity is of special interest me since we manufacture and sell antibody tests at work. The article asks what antibody level is considered high enough to provide immunity. Additionally, I ask, which antibodies provide protection and to which variant(s)? The immune system doesn’t produce one antibody when exposed to a virus or vaccine; it produces 100s.

Here’s how antibody tests work. You cover a surface with a portion of the virus. That surface is exposed to a serum sample from a patient. Antibodies in that sample that recognize the portion of the virus, binds to it. Anti human antibodies (antibodies that recognize human IgG or IgA or IgM are the added and bind all the antibodies from the patient sample that have bound to the virus particle. The test detects all of the anti human antibodies that have stuck to the bound patient antibodies. What virus portion or variant that is put in the surface will affect which patient antibodies are detected.

This means that how the antibody test is constructed will impact what the antibody titer level means in terms of protection against the circulating virus variants; plus one needs to know what titer level is considered protective for each variant due to differences in viral fitness and transmissibility (how fast it replicates and how much virus one is exposed to).

* This post was edited 10/08/21 11:40am by BCSnob *

charlestonsouthern

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Posted: 10/08/21 09:47pm Link  |  Quote  |  Print  |  Notify Moderator

Have vaccinations been approved by the FDA for ages 5 through 11 yet? I believe CNN reported last night that Pfizer has recommended 1/3 of the adult one-shot dosage to be given to ages 5-11 group but given in two shots.

* This post was edited 10/10/21 07:54pm by an administrator/moderator *

Moderator

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Posted: 10/10/21 07:56pm Link  |  Quote  |  Print  |  Notify Moderator

Reminder this thread is for reporting/discussing legitimate research regarding Covid; including citing sources. Thank you.

BCSnob

Middletown, MD

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Posted: 10/11/21 07:34am Link  |  Quote  |  Print  |  Notify Moderator

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
MedRxiv preprint 11 Oct 2021
Here is a preprint of the phase 3 study of the novavax Covid-19 vaccine; the vaccine platform is older technology (not mRNA). A portion of the virus (recombinant spike protein) and an adjuvant are injected to elicit the immune response (like the Hepatitis B and HPV vaccines). The study included 29,949 unvaccinated and not infected people in USA and Mexico randomized 2:1 (vaccine vs placebo).

Quote:

In the per-protocol population, there were 77 Covid-19 cases; 14 among vaccine and 63 among placebo recipients (VE: 90.4%, 95% confidence interval, “CI” 82.9 to 94.6, P90%) for prevention of Covid-19, with most cases due to variant strains.


* This post was edited 10/11/21 07:50am by BCSnob *

BCSnob

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Posted: 10/11/21 02:04pm Link  |  Quote  |  Print  |  Notify Moderator

This will be of interest for at least one poster here.

Effect of heterologous vaccination regimen with Ad5-nCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG antibodies titers.
MedRxiv preprint 11 Oct 2021
Quote:

Abstract

Introduction: The efficacy with one dose Ad5-nCoV has been concerned. As a result, some patients have self-reported getting a boost with BNT. Therefore, this study aimed to compare SARS-CoV-2 spike 1-2 IgG antibodies in plasma samples between two groups: one group immunized with Ad5-nCoV and another with a heterologous vaccination regimen with Ad5-nCoV and BNT. Methods: Prospective observational study included a subgroup analysis of patients who received the Ad5-nCoV immunization during the first trimester of 2021 in a Northern city of Mexico; and agreed to a follow-up for an entire year through SARS-CoV-2 specific IgG antibodies measurement samples. During the three months follow-up, some patients self-reported receiving a BNT boost. We report IgG levels from basal, 21-28 days after Ad5-nCoV dose, three months, and an additional 21-28 days after BNT boost. Results: Seventeen patients 40 (16) years old, 52.9% men, were analyzed. We created four groups: (G1) patients vaccinated with Ad5-nCoV with no history of SARS-COV-2 (n=4), (G2) patients vaccinated with Ad5-nCoV and the first shot of BNT with no history of SARS-COV-2 (n=6), (G3) patients vaccinated with Ad5-nCoV with history of SARS-COV-2 (n=5), and (G4) patients vaccinated with Ad5-nCoV and the first shot of BNT with history of SARS-COV-2 (n=2). The group immunized with a heterologous vaccine scheme reported higher antibodies after 21-28 days of follow-up after BNT boost. Median (IQR): G1 46.7 (-), G2 1077.5 (1901), G3 1158.5 (2673.5), and G4 2090 (-) (p<0.05). Headache was the most frequent adverse reaction when patients received Ad5-nCoV (n = 10, 83%), and pain at the injection site was the most frequent adverse reaction with BNT boost (n = 5, 83.3%). Conclusion: Patients receiving a BNT boost after Ad5-nCoV had higher SARS-CoV-2 spike 1-2 IgG antibodies titers with no severe adverse reaction.


BCSnob

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Posted: 10/12/21 08:15am Link  |  Quote  |  Print  |  Notify Moderator

This prospective study from NY assessing vaccine effectiveness in 8,834,604 New York adults found that the measured decreases in vaccine effectiveness, during the time when Delta was becoming the dominate variant, may not have been due to waning immunity post vaccination.

COVID-19 Vaccine Effectiveness by Product and Timing in New York State
MedRxiv Preprint October 09, 2021

Quote:

In New York State (NYS), over 2.4 million people have been diagnosed, and over 56,000 have died, with COVID-19 through Sept 29, 2021.1 COVID-19 vaccines are a critical prevention tool, with the three currently FDA-approved or authorized products originally shown in trials to be highly-efficacious against moderate-severe disease among adults, with mRNA-BNT162b2 (Pfizer-BioNTech) at 95%, mRNA-1273 (Moderna) at 94%, and Ad26.COV2 (Janssen) at 72% efficacy.2-4 These studies’ endpoints were evaluated at relatively short follow-up of 14-28 days after series completion and during a period when circulating strains were less transmissible than the currently-predominant Delta variant.5

More recently, extended trial follow-up and real-world effectiveness studies have begun to document declines in efficacy and vaccine effectiveness (VE), for some outcomes and populations, during 2021. Studies in Israel documented larger declines in VE than observed in the U.S. for infection and severe disease among its Pfizer-receiving population, which may be due to earlier vaccination, increased sensitivity definitions, or other methodological differences.6-9 U.S. population-based effectiveness studies in NYS and sentinel populations have documented declines in VE, particularly for persons >=65 years, during the period in which the Delta variant became predominant and mitigation strategies and policies were relaxed.10-14 The limitations of open cohort surveillance studies and limited numbers of events in more controlled studies make it difficult to isolate and quantify the extent to which VE declines can be attributed to immunologic waning, Delta variant, behavioral changes, or other causes, particularly across subgroups defined by age, product, and risks for infection or severe illness.


Quote:

Methods

We conducted a surveillance-based prospective cohort study of NYS adults, by linking statewide immunization, laboratory testing, and hospitalization databases. Incident laboratory-confirmed COVID diagnosis and hospitalization were ascertained among closed cohorts of vaccine recipients, defined by age, product, and timing of full-vaccination, during the pre- vs. post-Delta variant period from May 1 (99%), and compared to the cohort of persons remaining unvaccinated.


Results

Cohorts included in the analysis, and their outcomes, are summarized in Table 1. Among a total of 8,834,604 adults in this analysis, 5,787,817 (65.5%) were fully-vaccinated. Among those fully-vaccinated, 48.6% received Pfizer, 41.5% Moderna, and 10.0% Janssen. During follow-up, fully-vaccinated persons experienced a total of 38,778 cases and 2,363 hospitalizations and unvaccinated persons had 116,314 cases and 38,778 hospitalizations.

Incident cases declined for all cohorts defined by age, vaccination status, vaccine product and time cohorts from May 1 through late June and increased thereafter following increases in the prevalence of the Delta variant (Figure S1), with rates consistently highest for the unvaccinated. Across product and time cohorts, estimated VE generally declined from highest levels during the week of May 1 (1.8% Delta variant) to a nadir around July 10 (85.3% Delta variant), with modest changes in following weeks (>95% Delta variant)

All vaccinated patients that were followed were fully vaccinated by May 1; vaccine effectiveness vs time from May 1 to Aug 28 was calculated using breakthrough infections in the fully vaccinated cohorts vs unvaccinated adults in NY.

The key finding here is the breakthrough infection rate increased as the prevalence of Delta increased but the breakthrough infection rate stopped increasing once Delta had become the dominate variant (breakthrough infection rates didn't continue to increase with increasing time from vaccination).

Quote:

Results 155,092 COVID-19 cases and 14,862 hospitalizations occurred. Estimated VE for cases declined contemporaneously across age, products, and time-cohorts, from high levels beginning May 1 (1.8% Delta variant prevalence), to a nadir around July 10 (85.3% Delta), with limited changes thereafter (>95% Delta). Decreases were greatest for Pfizer-BioNTech (-24.6%, -19.1%, -14.1% for 18-49, 50-64 years, and =65 years, respectively), and similar for Moderna (-18.0%, -11.6%, -9.0%, respectively) and Janssen (-19.2%, -10.8, -10.9%, respectively). VE for hospitalization for adults 18-64 years was >86% across cohorts, without time trend. Among persons =65 years, VE declined from May to August for Pfizer-BioNTech (95.0% to 89.2%) and Moderna (97.2% to 94.1%). VE was lower for Janssen, without trend, ranging 85.5%-82.8%.


* This post was edited 10/12/21 08:27am by BCSnob *

BCSnob

Middletown, MD

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Posted: 10/13/21 02:51pm Link  |  Quote  |  Print  |  Notify Moderator

Heterologous SARS-CoV-2 Booster Vaccinations: Preliminary Report
MedRxiv Preprint 13 Oct 2021

Quote:

We evaluated homologous and heterologous booster vaccination in persons who had received an EUA Covid-19 vaccine regimen. Methods: In this phase 1/2 open-label clinical trial conducted at ten U.S. sites, adults who received one of three EUA Covid-19 vaccines at least 12 weeks prior to enrollment and had no reported history of SARS-CoV-2 infection received a booster injection with one of three vaccines (Moderna mRNA-1273 100-mcg, Janssen Ad26.COV2.S 5x1010 virus particles, or Pfizer-BioNTech BNT162b2 30-mcg; nine combinations). The primary outcomes were safety, reactogenicity, and humoral immunogenicity on study days 15 and 29.


This study evaluated adverse reactions to homo or heterologous boosters and measured antibody levels (for multiple variants, spike and just RBD) and pseudovirus (3 variants) neutralization before and after boosting.

Quote:

Immunogenicity was assessed on Day 1 prior to booster vaccination and at Days 15 and 29 (unavailable for all groups) after boost. Serum binding antibody (bAb) levels against S-2P were evaluated with the MSD® 384-well Custom Serology Assay Electrochemiluminescence Immunoassay (4-plex ECLIA) version 2 (in validation) and using the 10-plex ECLIA for emerging SARS-CoV-2 variant spike proteins.19 SARS-CoV-2 neutralization titers expressed as the serum inhibitory dilution required to achieve 50% and 80% neutralization (ID50 and ID80, respectively) were determined by group, age group and timepoint, using pseudotyped lentiviruses presenting SARS-CoV-2 spike variants D614G, and for groups 1 to 3, B.1.617.2 (Delta) and B.1.351 (Beta), as described previously.20 For the Beta variant, only a random subset of samples (20 per EUA vaccine, distributed equally between age groups and sites) was analyzed. Neutralizing activity was expressed in International Units (IU50/mL and IU80/mL) for the D614G neutralization assay.


All booster combinations yielded >2fold increase in antibody levels in at least 96% of the patients.

Quote:

At baseline, bAb levels to the Delta variant were 34%-45% lower compared with binding of the Wa-1 strain in the same assay. Following boost, all participants had detectable bAb to the Delta variant and the level was only 15-36% lower compared with the Wa-1 strain. Sera from the older and younger age groups had similar bAb levels.

Baseline is the antibody level just prior to booster, bAb is the designation these authors are using for binding antibody.

Quote:

All sera from participants who had received mRNA-1273 as an EUA vaccine had pre-booster neutralizing activity to the D614G strain at study enrollment, while sera from 24 (15.8%) individuals who had received Ad26.COV2.S and five (3.3%) who had received BNT162b2 had no detectable D614G neutralizing activity. Serum neutralization (IU50/mL) levels prior to booster vaccination were approximately three-and ten-fold lower for BNT162b2 and Ad26.COV2.S recipients, respectively, compared to recipients of mRNA-1273, irrespective of interval between EUA vaccination or booster vaccination administered (Table 2, Tables S40-S45).


This assay measured how well the patient serum sample prevents these pseudo viruses from binding to the ACE2 receptor. This is a link to how the neutralization assay works (Pseudovirus neutralization assay), see this heading in the materials and method section.

This is an ongoing study with additional data to be collected.

Quote:

Our study has limitations. It was not designed to directly compare responses between different booster regimens. The sample size is insufficient for inter-group comparisons, and the demographics of those studied are not representative of the US population. Volunteers were not randomized into groups, nor stratified with respect to population characteristics or interval from last vaccination. Similarly, the sample size and interim follow-up period were not sufficient to identify rare or late adverse events following booster vaccination, and the interval between completion of the primary series and the booster vaccination evaluated is shorter than the 6 months authorized for BNT162b2. The immunogenicity data are limited to immune responses through Study Day 29, and only serologic responses are reported. The different homologous and heterologous vaccination regimens may vary in terms of cellular and humoral immune responses as well as longevity of the response. In summary, this preliminary report demonstrates that boosting with any of the three vaccines currently licensed or authorized for emergency use in the US will stimulate an anamnestic response in persons who previously received of the primary series of any of these vaccines. Homologous boosts provided a wide range of immunogenicity responses, with heterologous boosts providing comparable or higher titers. Reactogenicity and adverse events were similar across booster groups. These data suggest that if a vaccine is approved or authorized as a booster, an immune response will be generated regardless of the primary Covid-19 vaccination regimen.


MEXICOWANDERER

las peñas, michoacan, mexico

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Posted: 10/13/21 05:40pm Link  |  Quote  |  Print  |  Notify Moderator

I elected to go with a heterologous primer (Sinovac) and 120 days later the mRNA booster (Moderna). Sharps would only agree to mail the results of my titer which will reside in my USA mailbox until mid-November.

Regardless, I have elected to proceed with a 2nd jab of Moderna mid-November. That would space the mRNA jabs at 90 days. Justification: Age 75, and 5 major comorbidities.

The age related sag in neutralizing antibodies is a major factor.

Thank you for your work posting the above data studies. It reinforces my decision.

BCSnob

Middletown, MD

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Posted: 10/14/21 02:36pm Link  |  Quote  |  Print  |  Notify Moderator

This is no surprise. Livestock farmers give vaccine boosters to pregnant livestock to provide passive immunity to newborns.

Breastfeeding infants receive neutralizing antibodies and cytokines from mothers immunized with a COVID-19 mRNA vaccine
MedRxiv preprint 14Oct2021
Quote:

Abstract

Objective: To evaluate the immune response to COVID-19 mRNA-based vaccines present in breastmilk and the transfer of the immune response to the breastfeeding child. Methods: A prospective cohort study enrolled 30 lactating women who received an mRNA-based COVID-19 vaccine between January and April 2021. Women provided serial milk samples, which included milk expressed before vaccination, milk expressed across 2-3 weeks after the first dose, and milk expressed across 3 weeks after the second dose. Women also were asked to provide their blood, spotted on cards (dried blood spots; DBS) 19 days after the first dose and 21 days after the second dose. Stool samples from the breastfed infants were collected 21 days after mothers received their second dose. Pre-pandemic samples of milk, DBS cards, and infant stool from prior studies were also utilized. Milk and infant stool samples were tested by ELISA for receptor-binding domain (RBD)-specific IgA and IgG. Milk samples were tested for the presence of neutralizing antibodies against the spike and four variants of concern (VOCs): D614G, B.1.1.7 (alpha), B.1.351 (beta), and P.1 (gamma). Milk samples were also tested by electrochemiluminescence assay for levels of 10 cytokines. Results: Milk from COVID-19-immunized women neutralized the spike and four VOCs and this response is primarily IgG-driven. The immune response in milk also included significantly elevated levels of interferon-? (IFN-?). The immune response to maternal vaccination was reflected in breastfed babies; anti-RBD IgG and anti-RBD IgA was detected in 33% and 30% of infant stool samples, respectively. Levels of anti-RBD antibodies in infant stool correlated with maternal vaccine side-effects. Conclusion: Humoral and cellular immune responses to mRNA-based COVID-19 vaccination are present in the breastmilk of most women. The milk anti-RBD antibodies can neutralize SARS-CoV-2 spike and VOCs. Importantly, we describe for the first time the transfer of anti-RBD antibodies to breastfed infants, with the potential to confer passive immunity against SARS-CoV-2


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